Section 1: General Human Research Protection Program Policies
- 1.1 Human Research Protection Program (HRPP)
- 1.2 Authority Granted to the IRB by the Organization
- 1.3 UNMC IRB Serving as the Single IRB for Multisite Research
- 1.4 UNMC Ceding Review to an External Central IRB
- 1.5 Requirements for Research Conducted with International Sites
- 1.6 IRB Composition, Leadership, Qualifications, and Responsibilities
- 1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management
- 1.8 Investigational Activities Requiring IRB Review and Approval
- 1.9 Resources Necessary to Protect Subjects
- 1.10 Scientific and Other Committee Review of Research
- 1.11 HRPP Access to Legal Counsel
- 1.12 Sponsored Research
- 1.13 Compliance with ICH-GCP Guidelines
- 1.14 Research Subject to Department of Defense Regulatory Requirements
- 1.15 Research Subject to Department of Justice Regulatory Requirements
- 1.16 ORA Record Keeping Requirements
- 1.17 Retention of Research Records
- 1.18 Review and Approval of HRPP Policies and Procedures
- 1.19 IRB Signature Authority
- 1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)
- 1.21 Post-Approval Monitoring of Research
- 1.22 Assessment of the Effectiveness and Efficiency of the HRPP
- 1.23 HRPP Training Requirements
- 1.24 HRPP Training Requirements for IRB Members
- 1.25 Financial Conflicts of Interest
- 1.26 PI Qualifications and Responsibilities
- 1.27 Research Personnel Qualifications and Responsibilities
- 1.28 External Investigator Assurance
- 1.29 ClinicalTrials.gov Reporting
- 1.30 Use of the Rapid Response IRB
- 1.31 Observers at IRB Meetings
- 1.32 Confidentiality of the Review Process
- 1.33 Posting of Clinical Trial Consent Forms
- 1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs
1.1 Human Research Protection Program (HRPP)
Last Revised: 1/16/2023
1.0 Purpose
The purpose of this policy and procedure is to provide a basic description of the Organization’s Human Research Protection Program (HRPP) through: 1) the Organization’s stated mission, 2) application of ethical principles to guide all human subject research under the oversight of the Organization, and 3) regulatory compliance with all applicable federal, state and local laws.
2.0 Policy
It is the policy of the Organization that the HRPP will ensure the rights and welfare of human subjects are protected, will evaluate and continually improve the protection of human research subjects, and will foster important human subject research in accordance with its mission.
3.0 Organization
- 3.1. The Organization is comprised of the following affiliated entities:
- 3.1.1 University of Nebraska Medical Center (UNMC)
- 3.1.2 Nebraska Medicine consisting of:
- 3.1.2.1. Nebraska Medical Center and all affiliated clinics (including, but not limited to, Nebraska Medicine - Village Pointe)
- 3.1.2.2. UNMC Physicians
- 3.1.2.3. Bellevue Medical Center (BMC)
- 3.1.3 Children’s Hospital & Medical Center (CHMC), including Children’s Physician practice offices.
- 3.1.4 University of Nebraska at Omaha (UNO)
- 3.2. As specified in HRPP policy 1.2 (Authority Granted to the IRB by the Organization) and the associated IRB authorization agreements, these entities have granted authority to the IRBs operating within the HRPP for oversight of human subject research under its jurisdiction.
- 3.3. These HRPP policies and procedures serve as the governing procedures for the conduct and review of all human subject research conducted under the auspices of this Organization (“Research Protection(s)”).
- 3.4. All HRPP policies are made available to all investigators and research staff through the IRB website and the online application system – Research Support System (RSS).
- 3.4.1 When modifications are made in HRPP policies, a Summary of Changes will be appended to the updated policy manual found on the IRB website and RSS.
4.0 HRPP Mission
- 4.1 The mission of the HRPP is to:
- 4.1.1 Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are fully protected.
- 4.1.2 Facilitate excellence in human subject research in accordance with the highest ethical standards in full compliance with all applicable regulatory and organizational requirements.
- 4.1.3 Provide research personnel with high quality education on the ethics and regulation of human subjects research.
- 4.1.4 Engage in continual quality improvement, including timely response to new ethical and regulatory challenges in order to ensure the highest possible degree of protection of human subjects.
- 4.1.5 Engage in community outreach activities designed to educate the public about research.
- 4.2 To ensure compliance with the stated mission, the HRPP will:
- 4.2.1 Exercise oversight of research protection through the Office of Regulatory Affairs (ORA).
- 4.2.2 Establish a formal process to monitor, evaluate and continually improve the protection of human research subjects.
- 4.2.3 Educate the research personnel about their ethical responsibility and regulatory requirements to protect human research subjects.
- 4.2.4 Assure investigators and other research personnel have the appropriate expertise and training in the protection of human research subjects to responsibly conduct their research with integrity.
- 4.2.5 Assure investigators and other research personnel display the highest possible degree of technical skill and care during the conduct of research.
- 4.2.6 When appropriate, intervene in ongoing research and respond directly to the concerns of research subjects.
- 4.2.7 Assure investigators and other research personnel adhere to the highest possible standards of research ethics, comply with all applicable federal, state, and local laws and regulations, and always place the rights and welfare of research subjects first.
- 4.2.8 Assure investigators and other research personnel respect all ethnic groups, cultures, and socioeconomic strata of the community served by this Organization.
- 4.2.9 Assure all IRB members and ORA staff keep abreast of the latest developments in the ethics and regulation of human subject research and perform thorough and consistent review of research proposals.
- 4.2.10 Receive from the Organization sufficient resources to support the mission of the HRPP.
5.0 Ethical Principles
- 5.1. All levels of the Organization consider protection of the rights and welfare of human subjects to be of the highest priority. The HRPP will uphold the cardinal principles for the ethical conduct of research (respect for persons, justice, and beneficence) described in the Belmont Report. In addition, due consideration will be given to the principles of the Nuremburg Code, the World Medical Association Declaration of Helsinki (2013), the ethical guidelines put forth by the Council for International Organizations of Medical Sciences (CIOMS), and the International Council for Harmonization (ICH) Guideline for Good Clinical Practice.
- 5.2 The HRPP, in partnership with the Organization’s research community, is responsible for ensuring the ethical and equitable treatment of all human subjects in research conducted under its auspices.
6.0 Regulatory Compliance
- 6.1. The HRPP and the Organization will comply with the following:
- 6.1.1. The Federal Policy for the Protection of Human Subjects (hereinafter referred to as the Common Rule) for all research conducted, supported, or otherwise subject to regulation by the Common Rule departments and agencies:
- 6.1.1.1. For convenience, this and other HRPP policies will refer to specific regulations using the HHS regulatory designation. For example, the designation 45 CFR 46.111 will be used rather than (for example) 34 CFR 97.111 for Department of Education funded research, or the more generic §_.111.
- 6.1.1.2. The Common Rule was revised on January 19, 2017 (FR 82:7149, 2017). For convenience, this will be referred to as the Revised Rule. The Common Rule prior to the revision is referred to as the pre-2018 Rule.
- 6.1.1.3. When these policies provide a regulatory citations this refers to the Revised Rule (except when both rules are noted, in which case citations which are based on the Revised Rule will be noted with the prefix “rev”).
- 6.1.1.4. Research initially approved by the IRB, or for which a determination was made that the research was exempt, before the effective date of the Revised Rule, shall comply with the pre-2018 Rule.
- 6.1.1.5. Research initially approved by the IRB, or for which a determination was made that the research was exempt, on or after the effective date of the Revised Rule, shall comply with the Revised Rule.
- 6.1.2 Applicable subparts to HHS regulations at 45 CFR 46, including Subparts A, B, C, D and Subpart E for all research conducted, supported, or otherwise subject to regulation by HHS.
- 6.1.3 FDA regulations at 21 CFR 50 including Subpart D (as required), 21 CFR 56, and other regulations as required.
- 6.1.4 Additional regulations and requirements of the other Common Rule agencies (as required).
- 6.1.5 The HIPAA Privacy and Security Rules at 45 CFR 160, 164 (as required)
- 6.1.6 Applicable federal, state and local laws.
- 6.1.7 HRPP policies.
- 6.1.1. The Federal Policy for the Protection of Human Subjects (hereinafter referred to as the Common Rule) for all research conducted, supported, or otherwise subject to regulation by the Common Rule departments and agencies:
- 6.2 If a conflict arises between federal, state, and local law, the IRB will consult the University of Nebraska’s General Counsel Office, UNMC Chief Compliance Officer, or the General Counsel for CHMC as appropriate.
- 6.3 The Organization will apply equivalent protections to all research not subject to the Common Rule.
- 6.3.1 These protections will be based upon the ethical principles in the Belmont Report. In addition, the requirements in 45 CFR 46, Subpart A, B, C, and D will be applied to the greatest extent possible in consideration of the nature of the research.
- 6.3.2 The Organization applies the ICH-Good Clinical Practice (GCP) E-6 Guidelines to clinical trials when the sponsored agreement specifies compliance with ICH GCP in accordance with HRPP policy 1.13 (Compliance with ICH-GCP Guidelines).
7.0 Federalwide Assurance (FWA)
- 7.1. The HRPP operates under the authority of its current Federal Wide Assurance (FWA00002939).
- 7.2. Research conducted at Children’s Hospital and Medical Center, or any of its wholly owned Children’s Physician’s Practice offices, operates under the authority of the FWA held by that legal entity.
8.0 Written Policies and Procedures
The HRPP Policies detail the policies of the Organization and regulations governing conduct of research involving human subjects under the auspices of the Organization. Review and revision of these policies and procedures will be conducted in accordance with HRPP policy 1.18 (Review and Approval of HRPP Policies and Procedures).
9.0 Description of the HRPP
The HRPP is a comprehensive system to ensure the protection of human subjects participating in research. The HRPP consists of the IRBs listed in section 7.0 above, other review committees, administrative offices, and administrative officials as described in this policy.
- 9.1 Institutional Official
The ultimate responsibility of the HRPP resides with Institutional Official (IO). The IO is an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program. The IO is legally authorized to represent the Organization, and is the signatory of the FWA and assumes the obligations specified in the FWA.
The IO is ultimately responsible for the following:
- 9.1.1 Foster, support and maintain an institutional culture supporting the ethical conduct of all research involving human subjects in full compliance with applicable Organizational and regulatory requirements as specified in Sections 4.0, 5.0 and 6.0 of this policy.
- 9.1.2 Ensure the HRPP has the resources and support necessary to comply with all Organizational policies and with federal regulations and guidelines that govern human subject research, including:
- 9.1.2.1. Ensure HRPP and IRB staffing is commensurate with the size and complexity of the research enterprise.
- 9.1.2.2. Ensure there is adequate HRPP and IRB space, equipment, materials, and technology.
- 9.1.2.3. Ensure there are sufficient resources for the production, maintenance and secure storage of HRPP and IRB records.
- 9.1.2.4. Ensure there are sufficient resources for auditing and other compliance activities and investigation of noncompliance.
- 9.1.2.5. Ensure there is access to legal counsel.
- 9.1.2.6. Ensure there are sufficient resources for the identification and management of conflict of interest involving the HRPP (including IRB members, Office of Regulatory Affairs (ORA) staff, Principal Investigators and research staff, and the Organization).
- 9.1.2.7. Ensure there are sufficient resources to support the HRPP Post-Approval Monitoring (PAM) program per HRPP Policy 1.21 (Post-Approval Monitoring of Research).
- 9.1.2.8. Ensure there are adequate resources to support community outreach programs related to Human Research Protections.
- 9.1.2.9. Support educational opportunities related to Human Research Protections for IRB members, ORA staff, research personnel, and other members of the research community.
- 9.1.3 Oversee of the IRB within the Organization and ensuring the IRB functions independently.
- 9.1.4 Appoint and oversee of the IRB Executive Chair.
- 9.1.5 Exert ultimate oversight over the conduct of research conducted by all investigators and other research personnel within the Organization.
- 9.1.6 Ensure investigators and other research personnel fulfill their responsibilities to protect the welfare of human subjects in accordance with HRPP policies.
- 9.1.7 Remain informed of the activities and decisions of the IRBs.
- 9.1.7.1. The IO will receive copies of the IRB minutes, meet with the IRB Executive Chair and the Assistant Vice-Chancellor for Regulatory Affairs on a regular basis, attends ORA staff meetings and convened IRB meetings periodically. In addition, the IO will be promptly advised of all compliance problems, complaints, or any other significant concerns regarding human subject protection.
- 9.1.8 As necessary, further review and approve or disapprove research as it relates to the Organizations mission and priorities; however, the IO may not approve research that has not been approved or has been disapproved by the IRB.
- 9.1.9 Advise Organizational officials on key matters regarding research conducted within the Organization.
- 9.1.10. Oversee the development and implementation of an educational plan for IRB members, staff, and investigators.
- 9.1.11. Attain and maintain current CITI (Collaborative Institutional Training Initiative) Human Subjects Research Program certification as per HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel), and participate in other training in Human Subject Protection as appropriate.
- 9.1.12. Assure all IRB members are CITI certified and are appropriately knowledgeable to review research in accordance with ethical standards and applicable regulations.
- 9.1.13. Assure all investigators are CITI certified and are appropriately knowledgeable to conduct research in accordance with ethical standards and applicable regulations.
- 9.1.14. Work with the IRB Executive Chair to develop, manage, and evaluate policies and procedures that ensure compliance with all state, local and federal regulations governing research. This includes monitoring changes in regulations and policies that relate to human research protection and overseeing all aspects of the HRPP program.
- 9.1.15. Ensure that any investigator, research personnel, or IRB member has free and direct access to the IO in order to express any concerns.
- 9.1.16. Implement the Organization’s HRPP policies and procedures.
- 9.1.17. Submit, implement, and maintain an approved FWA through the DHHS Office of Human Research Protections (OHRP).
- 9.1.18. Oversee the finances of the HRPP.
- 9.1.19. Perform an annual evaluation of the HRPP in accordance with HRPP policy 1.22 (Assessment of the Effectiveness and Efficiency of the HRPP).
- 9.2 Institutional Review Boards:
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9.2.1 There are six fully constituted IRBs registered with DHHS OHRP and the FDA which are responsible for review and approval of all non-exempt human subject research conducted by the faculty, students, staff, or other representatives of the Organization, or by any non-affiliated investigators, when the research is conducted on the premises of any of the components of the Organization, as described in HRPP Policy 1.2 (Authority Granted to the IRB by the Organization).
- 9.2.1.1. IRB-01 (IRB00000670) - primarily reviews research involving adult subjects.
- 9.2.1.2. IRB-02 (IRB00000671) - primarily reviews research involving adult subjects.
- 9.2.1.3. IRB-03 (Rapid Response) (IRB00002686) - utilized on an as-needed basis for research requiring expeditious IRB review per HRPP policy 1.30 (Use of Rapid Response IRB).
- 9.2.1.4. IRB-04 (Joint Pediatric IRB) (IRB00007222) - primarily reviews research involving pediatric subjects.
- 9.2.1.5. IRB-05 (SIRB) (IRB00012770) – primarily reviews research where the Organization acts as the reviewing IRB for multi-site projects.
- 9.2.1.6. IRB-06 (IRB00013435) - primarily reviews research funded or conducted by the Department of Defense.
Note: In all of the HRPP policies hereafter, “the IRB” will refer to all boards unless otherwise indicated.
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9.2.2 The IRB is responsible for the protection of the rights and welfare of human research subjects through assuring compliance with HRPP policies and Sections 4.0, 5.0, and 6.0 of this policy. A description of the IRB membership and qualifications is found in HRPP policy 1.6 (IRB Composition, Leadership, Qualifications, & Responsibilities).
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9.2.3 The HRPP utilizes the NCI Central IRBs for review and approval of applicable cooperative oncology group protocols involving adult and pediatric subjects in accordance with HRPP policy 1.4 (UNMC Ceding Review to an External Central IRB).
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9.2.4 The HRPP may utilize selected independent commercial IRBs or other IRBs associated with universities, academic medical centers or hospitals for review and approval of applicable protocols in accordance with HRPP policy 1.4 (UNMC Ceding Review to an External Central IRB).
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9.2.5 The IRB may serve as the IRB of record for external organizations in accordance with HRPP policy 1.3 (UNMC Serving as Central IRB).
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- 9.3 Legal Counsel The Organization relies on Legal Counsel for interpretations and applications of law, as described in HRPP policy 1.11 (HRPP Access to Legal Counsel).
- 9.4. Departmental Chairperson or Authorized Delegate Departmental chairs or authorized delegates are responsible for ensuring Principal Investigators (PIs) are qualified by training and experience to conduct the proposed research and have sufficient resources and facilities to conduct the research in a manner that fully protects the rights and welfare of subjects HRPP policy 1.9 (Resources Necessary to Protect Subjects).
- 9.5. Principal Investigator The PI holds primary responsibility for the proper conduct of research in accordance with the approved research protocol. The specific responsibilities of the PI are defined in HRPP policy 1.26 (PI Qualifications and Responsibilities).
- 9.6. Other Review Committees
- 9.6.1 Other Organizational review committees have specific responsibilities to review proposed or continuing research, as defined by HRPP and other Organizational Policies. These committees include but are not limited to: 1) Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC), 2) Pharmacy & Therapeutics Committee (P&TC), 3) Investigational Device Committee, 4) Institutional Biosafety Committee (IBC), 5) the Radioactive Drug Research Committee (RDRC), and 6) Conflict of Interest Committee (COIC). The responsibilities of these committees are described in HRPP policy 1.10 (Scientific and Other Committee Review of Research).
- 9.6.2 Other review committees may not approve research to commence that has not been approved or has been disapproved by the IRB.
- 9.7. Other Related Units within the HRPP
- 9.7.1 Sponsored Programs Administration and UNeHealth
- 9.7.1.1. Sponsored Programs Administration (SPA) and/or UNeHealth staff review all research agreements with federal, non-federal (foundation and private), and commercial sponsors, as specified in HRPP policy 1.12 (Sponsored Research).
- 9.7.1.1.1. UNMC SPA reviews federal and non-federal grant research agreements, and industry sponsored non-clinical research agreements, involving UNMC, Nebraska Medicine, BMC and CHMC.
- 9.7.1.1.2. UNeHealth reviews industry sponsored clinical research agreements, involving UNMC, Nebraska Medicine, BMC and CHMC.
- 9.7.1.1.3. UNO SPA reviews research agreements involving UNO.
- 9.7.1.2. Only designated senior officials have the authority to execute the research agreements on behalf of the Organization.
- 9.7.1.1. Sponsored Programs Administration (SPA) and/or UNeHealth staff review all research agreements with federal, non-federal (foundation and private), and commercial sponsors, as specified in HRPP policy 1.12 (Sponsored Research).
- 9.7.2 Research Subject Advocate
- 9.7.2.1. The purpose of this individual is to promote human subject protection in all clinical research conducted at UNMC and Nebraska Medicine through education, training, advocacy, and outreach.
- 9.7.2.2. The Research Subject Advocate is listed on all consent forms as another contact for current, former, and prospective research subjects or others, in the event there are problems, concerns, and questions concerning the research.
- 9.7.2.3. The Research Subject Advocate is also a contact point for questions, comments, concerns, or complaints from individuals internal and external to the Organization.
- 9.7.2.4. The Research Subject Advocate works with the IRB and other Organizational Officials to resolve issues, obtain information, or offer input.
- 9.7.3 Pharmacy
- 9.7.3.1. Nebraska Medical Center Pharmacy & Therapeutics Department (including Investigational Drug Service):
- 9.7.3.1.1. This department oversees the use of pharmaceutical and investigational agents in human subject research conducted at Nebraska Medicine and affiliated clinics, UNMC, and BMC in compliance with hospital policy.
- 9.7.3.1.2. This department will ensure compliance with all federal, state, and local regulations related to pharmaceutical and investigational agents used in clinical trials at Nebraska Medicine.
- 9.7.3.1.3. The Pharmacy & Therapeutics (P&T) Committee reviews all clinical protocols conducted at UNMC, Nebraska Medicine, or BMC, which involve the use of investigational or marketed drugs in accordance with HRPP policy 1.10 (Scientific and Other Adjunct Review of Research).
- 9.7.3.1.4. The Investigational Drug Pharmacist is available to address questions or concerns. All investigational agents are ordered, dispensed, or administered only through the Investigational Drug Pharmacist and only after assurance of compliance with the regulations as reviewed by the P&T Committee and the IRB.
- 9.7.3.2. CHMC Pharmacy Department:
- 9.7.3.2.1. This department oversees the use of pharmaceutical and investigational agents in human subject research conducted at CHMC in compliance with hospital policy.
- 9.7.3.2.2. This department will ensure compliance with all federal, state, and local regulations related to pharmaceutical and investigational agents used in clinical trials at CHMC. The Pharmacy Manager or other representative of the CHMC Pharmacy is a member of the Joint Pediatric IRB and reviews all protocols to ensure compliance with all federal regulations.
- 9.7.3.2.3. All investigational agents are ordered, dispensed, and administered through the pharmacy department only after assurance of compliance with the regulations as reviewed by the IRB.
- 9.7.3.1. Nebraska Medical Center Pharmacy & Therapeutics Department (including Investigational Drug Service):
- 9.7.4 Health Information Management
- 9.7.4.1. A legal medical record will be maintained for each individual who is evaluated as an inpatient, ambulatory care patient, or emergency patient per the specified hospital’s medical record policy.
- 9.7.1 Sponsored Programs Administration and UNeHealth
- 9.8 Relationship Between Components
- 9.8.1 The IRB functions independently of, but in coordination, with other Organizational regulatory committees - see HRPP policy 1.10 (Scientific and Other Committee Review of Research). The IRB, however, makes an independent determination whether to approve or disapprove a protocol.
- 9.8.2 Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the Organization. However, those officials may not approve human subject research that has not been approved or has been disapproved by the IRB.
- 9.8.3 The UNMC Compliance Committee meets to ensure dialogue is maintained between the various compliance entities within the Organization. Membership is comprised of representatives from the major components of the Organization with the Chief Compliance Officer as chair. The committee acts in an advisory capacity to the UNMC Chancellor/Vice Chancellor for Research, monitoring the effectiveness of existing compliance programs, developing new or revised policies as changes in requirements occur, and disseminating updated compliance information to the research community.
- 9.9 HRPP Operations
- 9.9.1 The Office of Regulatory Affairs (ORA) is responsible for the day-to-day operations of the HRPP. All ORA staff must comply with all ethical standards and practices as well as local, state, and federal regulations in accordance with Sections 4.0, 5.0 and 6.0 of this policy. The ORA reports to the Assistant Vice-Chancellor for Regulatory Affairs and has a close working relationship with the IRB Executive Chair and the committees specified above.
- 9.9.2 The ORA is located in the Academic Research Services Building at UNMC and is equipped with all necessary office space, file storage space, meeting space, and equipment to perform the functions required by the HRPP. The adequacy of the personnel and other resources required by the HRPP is assessed on an annual basis by the IO.
- 9.9.3 The Office is staffed by IRB Analysts and office support staff. The duties and responsibilities for all of the staff are found in their respective job descriptions on file with Human Resources and in the ORA. IRB Staff are supervised on a daily basis by an IRB Analyst and/or the Assistant Vice-Chancellor for Regulatory Affairs. The performance of all Analysts and support staff is evaluated on an annual basis, in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP).
- 9.9.3.1. IRB Analyst Ongoing Training
- 9.9.3.1.1. IRB Analysts are expected to become Certified IRB Professionals (CIP) as soon as they are eligible and engage in on-going continuing education to enhance their knowledge and skill levels.
- 9.9.3.1.2. IRB Analysts must complete, and keep current CITI certification. IRB Analysts are expected to stay informed of new regulations and guidance issued by relevant authorities by attending IRB conferences and/or webinars, and by reviewing articles or other published works related to human subject protection.
- 9.9.3.2. ORA Staff Ongoing Training
- 9.9.3.2.1. All IRB staff are encouraged to become Certified IRB Professionals (CIP) as soon as they are eligible and engage in on-going continuing education to enhance their knowledge and skill levels.
- 9.9.3.2.2. IRB Staff must complete, and keep current CITI certification.
- 9.9.3.1. IRB Analyst Ongoing Training
- 9.9.4 Training Records
- 9.9.4.1. The ORA is responsible for maintaining all initial and continuing education training records for IRB Analysts and ORA staff. The ORA will monitor the status of CITI certification for all IRB analysts and staff and notify them when it is time for renewal.
DOCUMENT HISTORY:
Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded
Revised: 3/27/2018 - revision not documented
Revised: 9/4/2018 - revision not documented
Revised: 5/3/2021 - Added IRB-05 (SIRB) (IRB00012770) in section 7.2.5; revised sections 6.1.1.3 and 6.1.1.6 to delete and clarify references to transition to Revised Common Rule; cClarified that section 9.6.1 does not represent a complete list of ancillary committees; clarified that the Pharmacy Manager or other representative of the CHMC Pharmacy is a member of the Joint Pediatric IRB (section 9.7.3.2.2); deleted specifics of job requirements for IRB Administrators and ORA Staff (redundant to job descriptions); simplified and clarified training requirements for IRB Administrators and ORA Staff. Notification: not documented
Revised: 1/16/2023 - Added IRB-06; specified Children’s Hospital & Medical Center (CHMC) includes Children’s Physician practice offices; clarified that Children’s Hospital and Medical Center and it’s wholly owned Children’s Physician’s Practice offices operates under the authority of the FWA held by that legal entity; deleted comment that IO is the Associate Vice-Chancellor for Clinical Research; specified that the IO is an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program; replaced “Administrator” with “Analyst”; minor stylistic changes.
1.2 Authority Granted to the IRB by the Organization
Last Revised: 5/28/2021
1.0 Purpose
The purpose of this policy and procedure is to describe the authority granted by the Organization for the IRBs operating within the HRPP.
2.0 Policy
It is the policy of the Organization that:
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2.1 All research involving human subjects conducted at the Organization or conducted by faculty, students, staff or other representatives of the Organization at external sites must receive approval by a designated IRB before the research may commence.
- 2.1.1 The IRB is authorized to independently review and approve all non-exempt human subject research conducted by the faculty, students, staff, or other representatives of the Organization, or by any non-affiliated investigators, when the research is conducted on the premises of any of the components of the Organization. The IRB may accept review and approval from external IRBs for any research conducted within the Organization on a case-by-case basis in accordance with HRPP policy 1.4 (UNMC Ceding Review to an External Central IRB).
- 2.1.2 The IRB is authorized to independently review and approve all non-exempt human subject research conducted by the faculty, students, staff, or other representatives of Organization, or by any non-affiliated investigators, when the research is conducted at an external institution. However, the Organization may accept external IRB approval in accordance with HRPP policy 1.4 (UNMC Ceding Review to an External Central IRB).
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2.2 The IRB shall review and approve all non-exempt human subject research before such research is initiated, as per Section 2.1.
- 2.2.1 Full IRB Review: The full IRB has the authority to approve, require modifications in (to secure approval), or disapprove any research activities conducted under the jurisdiction of the IRB in accordance with HRPP policy 2.2 (Full IRB Review).
- 2.2.2 Expedited Review: When expedited review is used, in accordance with 45 CFR 46.110; 21 CFR 56.110, the expedited reviewer designated by the IRB Executive Chair or IRB Chair has the authority to approve or require modifications in (to secure approval) of research activities conducted under the jurisdiction of the IRB. The expedited reviewer is not authorized to suspend or disapprove research in accordance with HRPP policy 2.3 (Expedited Review).
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2.3 When IRB approval of non-exempt human subject research expires, or is terminated by the IRB or the Organization, or when the research is classified as completed by the investigator or the IRB, no further research activities may occur. This includes collection of existing or additional identifiable private information, or analysis existing identifiable private information.
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2.4 All exempt research, which is conducted by faculty, students, staff, or other representatives of the Organization must be reviewed and approved by the UNMC Office of Regulatory Affairs (ORA) before it is initiated in accordance with HRPP policy 2.6 (Exempt Research). The ORA will accept approval of exempt research by an external institution on a case-by-case basis.
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2.5 The IRB has the authority to approve a waiver or an alteration of the Authorization requirement of the HIPAA Privacy rule per 45 CFR 165.512.
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2.6 The IRB has the authority to observe or have a third party observe the informed consent process for ongoing research protocols.
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2.7 The IRB has the authority to observe or have a third party observe the conduct of the research for ongoing protocols.
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2.8 The IRB has the authority to review or have a third party review files related to the research under the jurisdiction of the IRB and when an external IRB serves as the IRB of record.
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2.9 The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or HRPP policy, or that has been associated with unexpected serious risk or harm to subjects or others.
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2.10 The IRB Executive Chair/designee, in consultation with the IO and others as necessary, has the authority to suspend research that is not being conducted in accordance with the IRB’s requirements or HRPP policy, or that has been associated with unexpected serious risk or harm to subjects or others.
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2.11 Research approved by the IRB may be subject to further review by an authorized official of the involved component of the Organization. Approval by the IRB can be overturned by those authorized individuals. However, no official of the Organization may approve research that has not been approved by or has been disapproved by the IRB.
- 2.11.1 The reason(s) for administrative disapproval of research by the authorized official shall be provided in writing to the PI and the IRB.
- 2.11.2 The PI may appeal the administrative decision to overturn IRB approval by submitting a written justification. The authorized official, in consultation with the IO as appropriate, will make the final determination.
-
2.12. The IRB or the ORA may be periodically charged by the IO with review of other research activities. Charge by the IO constitutes authority to perform that review and requirement by faculty, students, staff, or other representatives of the Organization to abide by the findings of the IRB or ORA.
-
2.13 Any attempt to unduly influence the IRB from either within (including Organizational conflicts of interest) or outside the Organization is strictly prohibited and must be reported to the IO. The IO will take appropriate action including but not limited to notifying the supervisor of the individual who attempted to influence the IRB, the Chief Compliance Officer and other appropriate officials of the Organization. A thorough investigation will be undertaken and corrective action including counseling or other disciplinary action will be taken as necessary.
DOCUMENT HISTORY:
Written: 4/4/2016 (Approved: 4/4/2016)
Revised: 3/9/2018 - revision not documented
Revised: 5/28/2021 - Clarified who may act as an expedited reviewer (section 2.2.2); added that the IRB or ORA may be charged with review of other research activities, and granted authority to do so; deleted reference to other specific committees and activities. Notification: not documented
1.3 UNMC IRB Serving as the Single IRB for Multisite Research
Last Revised: 11/13/2024
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for the UNMC IRB to serve as the Single IRB (SIRB) for multisite research.
2.0 Policy
It is the policy of the Organization that:
- 2.1. The UNMC IRB may serve as the SIRB for multisite research as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114.
- 2.2. The IO has the sole authority to determine whether or not to allow the UNMC IRB to serve as the Single IRB for multisite research.
- 2.2.1. For all non-exempt research, the Organization requires execution of a Reliance Agreement.
- 2.2.2. For exempt research, the Organization does not normally require execution of a Reliance Agreement.
- 2.3. The UNMC IRB may serve as the IRB of record as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114 for NIH-funded research, in accordance with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD-16-094).
- 2.4. Research conducted at external organizations where UNMC is the IRB of record must comply with HRPP policies of the relying institution, except as specified in this policy and/or in the Reliance agreement.
3.0 Definitions
- 3.1. Cede Review: An institution agrees to transfer IRB review and oversight authority for specified research to another institution’s IRB (reviewing IRB).
- 3.2. Local Context: Unique legal requirements, cultural or religious values, or other site-specific variables that exist at a site where subjects are enrolled in research.
- 3.3. Reliance Agreement (also known as an Authorization Agreement): An agreement between two Organizations engaged in human subject research that documents respective authorities, roles, responsibilities, and communication between the reviewing and relying institution.
- 3.4. Relying Institution: A participating Institution that cedes IRB review to the IRB of record (reviewing IRB) designated under a Reliance Agreement.
- 3.5. Site Principal Investigator (Site PI): The lead investigator at each institution participating in multisite research usually responsible for the conduct of the research at the participating institution.
- 3.6. Lead Principal Investigator (Lead PI): The study wide lead Principal Investigator with ultimate responsibility for the conduct and integrity of multisite research.
- 3.7 Reviewing IRB: The IRB which is responsible for conducting IRB review and approval as described in 45 CFR 46.109 for cooperative human subject research.
4.0 UNMC IRB, Relying Institution, and Lead PI Responsibilities
- 4.1. It is the responsibility of the UNMC IRB (as reviewing IRB) to:
- 4.1.1. Conduct review of the research in full accordance with applicable federal and state regulations, and all relevant HRPP policies (including, but not limited to, initial review, continuing review, review of amendments, noncompliance, unanticipated problems involving risk to subject or others, deviations, adverse events, study holds, suspensions, and terminations).
- 4.1.1.1. Review any COI management plans from the relying institution to assure the plan is adequate in consideration of the nature of the conflict. The UNMC IRB as reviewing IRB may apply additional restrictions and/or limitations but may not override those required by the relying institution.
- 4.1.2. Obtain any additional approvals from DHHS when the research involves pregnant women, fetuses, and neonates; or children; or prisoners, as required by DHHS and FDA regulations.
- 4.1.3. Determine if the relying organization(s) apply their FWA to some or all of the research and ensuring the IRB review is consistent with the requirements of the Relying Institutions FWA (as applicable per DHHS and FDA regulations).
- 4.1.4. Report all determinations of serious or continuing noncompliance, unanticipated problems involving risk to the subject or others, and suspensions or terminations to the Relying Institution, Institutional Officials and Federal Agencies HRPP Policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies)
- 4.1.5. Report to the Relying Institution:
- 4.1.5.1. Any unanticipated problems involving risk to the subject or others associated with subjects enrolled at the institution.
- 4.1.5.2. Any serious or continuing noncompliance.
- 4.1.5.3. Any serious complaints which impact the rights and welfare of research subjects.
- 4.1.5.4. The results of any external audits conducted by FDA, OHRP, sponsors, and CROs.
- 4.1.5.5. Any reports filed with the FDA or OHRP.
- 4.1.5.6. Any FDA Form 483 or warning letter pertaining to the study or IRB review.
- 4.1.5.7. Any other communication from FDA or other governmental agency citing improper or inadequate research practices.
- 4.1.6. Notify the Investigator and the Relying Institution (when applicable) of the IRB’s determinations.
- 4.1.7. Provide the Relying Institution’s investigators and research staff with the Point of Contact (POC) to obtain answers to questions, express concerns, and convey suggestions regarding the IRB.
- 4.1.8. Upon written request, provide Relying Institutions with access to relevant records related to IRB review (including, but not limited to minutes, approved protocols, consent forms, and other records that document the IRB’s determinations to the Relying Institution).
- 4.1.9. Ensure HRPP policies are readily accessible to Relying Institutions through the IRB website and there is a mechanism for communicating updates to the policies.
- 4.1.10. Maintain all research records for at least seven years after completion of the research and make available for inspection or copying by the HHS Office of Human Research Protection (OHRP) and/or FDA upon request in accordance with federal regulations.
- 4.1.11. Ensure compliance with UNMC’s OHRP-approved FWA.
- 4.1.1. Conduct review of the research in full accordance with applicable federal and state regulations, and all relevant HRPP policies (including, but not limited to, initial review, continuing review, review of amendments, noncompliance, unanticipated problems involving risk to subject or others, deviations, adverse events, study holds, suspensions, and terminations).
- 4.2. It is the responsibility of the Relying Institution to:
- 4.2.1. Advise the UNMC IRB of any applicable state or local laws which govern research conducted at the site.
- 4.2.2. Advise the UNMC IRB of completion of all additional reviews required by the Institution, including but not limited to biosafety review, radiation safety review, recombinant DNA research review, human stem cell research review and conflict of interest, and of any requirements resulting from the additional Institutional reviews.
- 4.2.3. Advise the UNMC IRB of any circumstances when the review must take into account additional regulatory or local HRPP requirements.
- 4.2.4. Ensure that all investigators participating in the research are members of the Institution’s medical staff in good standing and are credentialed and privileged to perform the procedures outlined in the studies.
- 4.2.4.1. Notify the UNMC IRB within three business days of the termination, suspension, or modification of any clinical privileges of members of its Medical Staff who are participating in the studies authorized by the UNMC IRB.
- 4.2.5. Advise the UNMC IRB of any allegations of noncompliance. The UNMC IRB, in conjunction with the participating site IRB, will determine how best to handle the allegation in consideration of the need to maintain due process and protect the whistleblower.
- 4.2.6. Advise the UNMC IRB of any complaint directly from subjects or others. The Research Subject Advocate Office will assist in the resolution of the complaint as necessary.
- 4.2.7. Inform the UNMC IRB of any contact by the FDA, HHS, or any other persons or entities regarding any of the research within three business days of contact. The relying Institution will also notify the UNMC IRB within three business days, in the event that the FDA or other governmental agency issues the relying Institution any “Notice of Inspectional Observations”, “Warning Letters”, or other communications citing improper or inadequate research practices with respect to the research specified above.
- 4.2.8. Ensure that all investigators participating in the research understand their responsibilities under applicable federal regulations (45 CFR 46 including subparts as applicable, 21 CFR 50, 56, 312, 812, and HIPAA Privacy Rule), state laws, institutional policies, and the protocol.
- 4.2.9. Ensure that all research personnel involved in the process of consent or assent are properly trained and are fully aware of their responsibilities relative to the obtainment of informed consent/assent according to institutional policies, applicable federal regulations, and state law.
- 4.2.10. Maintain a copy of the signed informed consent document in accordance with relying institution policies, applicable HHS and FDA regulations, and ICH-GCP.
- 4.2.11. Maintain all research records in accordance with relying institution policies, applicable HHS and FDA regulations, ICH-GCP and HIPAA Privacy rule as appropriate.
- 4.2.12. Ensure compliance with its OHRP approved FWA (if applicable).
- 4.2.13. Permit the UNMC IRB, or its authorized representatives, the FDA, and OHRP to the extent permitted by law, to conduct the following:
- 4.2.13.1. Examine and inspect the Relying Institution facilities used for the performance of the studies, including storage and use of any investigational products.
- 4.2.13.2. Observe the conduct of the studies.
- 4.2.13.3. Inspect and copy all documents relating to the studies, including research records, patient medical records, informed consent documents, Investigational Product logs, and other study specific data.
- 4.2.13.4. Interview, as necessary, all necessary personnel involved in patient care for the studies.
- 4.3. It is the responsibility of the Lead (UNMC) PI to:
- 4.3.1. Serve as the primary contact with the UNMC IRB. The Lead PI assumes primary responsibility for notifying the relying sites of all UNMC IRB actions.
- 4.3.2. Promptly respond to questions or request for information from Site PIs and/or study teams at relying institutions or the Relying Institution IRBs.
- 4.3.3. Assure the Site PIs have access to the HRPP policies.
- 4.3.4. Ensure all site consent forms/information sheets follow the UNMC IRB approved template and include applicable site-specific required language provided by each relying institution.
- 4.3.5. Provide participating sites with the IRB approved versions of all study documents.
- 4.3.6. Promptly report to all Site PI’s any unanticipated problems involving risks to subjects or others, research related subject injuries, or significant subject complaints that are related to or may affect subject’s willingness to continue participation in the study.
- 4.3.7. Notify Site PIs of all UNMC determinations and communications, including initial review, continuing review, Requests for Change, and reportable events.
- 4.3.8. Ensure Site PIs submit in a timely manner the participating site (pSite) Continuing Review Application.
- 4.3.8.1. The Lead PI must notify the Site PI of any lapse in IRB approval of their site and any applicable corrective action plans.
- 4.3.8.2. Provide access, upon request, to all study records by audit by any Relying Institution, the UNMC IRB, and other regulatory or monitoring entities.
- 4.3.8.3. Further description of PI responsibilities are defined in HRPP policy 1.26 (PI Qualifications and Responsibilities).
5.0 Procedures
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5.1. A single IRB request form must be submitted for each research protocol to the UNMC IRB. The sIRB request form requests:
- 5.1.1. The identity of the research network (if applicable) and participating sites
- 5.1.2. Provides rationale for use of the UNMC IRB as the sIRB for the research.
- 5.1.3. Identifies any relevant deadlines or funding agency requirements.
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5.2. The UNMC IO must agree to allow the UNMC IRB to serve as the SIRB.
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5.3. An IRB Reliance Agreement must be executed between the respective institutions. The fully executed IRB Reliance Agreement must be maintained as documentation verifying the responsibilities of each organization to ensure compliance with the requirements of the Common Rule.
Note: The Organization prefers to utilize the “SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement” electronic platform. However, if justifiable, an alternate form of the Reliance Agreement will be initiated between the Reviewing and the Relying Institutions/IRBs.
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5.4. Each Relying Institution IRB must agree to cede IRB review to the UNMC IRB for each specific research proposal by completion of the Reliance Agreement and Implementation Checklist, or other agreed upon mechanism.
Note: All local institutional requirements regarding ceding review to the UNMC IRB must be completed before study activation at the Relying Institution.
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5.5. Once the Organization has agreed to serve as the sIRB, the Lead PI will complete the appropriate UNMC IRB application through in RSS in compliance with HRPP Policy 2.1 (Submission of Items for Review by the IRB).
Note: Section I of the IRB application must clearly identify the participating site(s) requiring UNMC IRB oversight.
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5.6. The research will be reviewed by the IRB in accordance with the criteria for approval specified in HRPP Policy 2.5 by either full IRB review HRPP Policy 2.2, or expedited review HRPP Policy 2.3 as applicable.
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5.7. All research conducted at participating sites will be subject to UNMC HRPP policies related to reporting adverse events, deviations, and noncompliance. Research conducted at participating sites will otherwise be subject to relevant participating site HRPP policies (including but not limited to compensation, use of the short form, advertisements, identification of potential participants, consent process).
- 5.7.1. In the absence of a specific relying site policy, the site will comply with the relevant UNMC HRPP policy.
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5.8. The UNMC-approved consent forms and information sheets will serve as the template for the relying sites. The template consent forms/information sheets to be used for the participating sites will be created by the UNMC study team in RSS. Forms are then made available to participating sites, modified with local context information by the participating site study team, and reviewed and approved by the IRB.
DOCUMENT HISTORY:
Undocumented activity: 4/4/2016
Undocumented activity: 3/27/2018
Revised: 10/21/2021 - Major revisions in format; content revised to be consistent responsibilities described in HRPP 1.4, Notification: not documented
Revised: 8/25/2023 - Added additional responsibility for UNMC HRPP regarding review of relying institution COI management plan (section 4.1.1.1).
Revised: 11/13/2024 – clarified which UNMC HRPP policies must be complied with by participating sites (section 5.7); corrected typographic errors; stylistic changes.
1.4 UNMC Ceding Review to an External Central IRB
Last Revised: 1/22/2024
1.0 Purpose
The purpose of this policy and procedure is to describe the Organization’s requirements for the UNMC IRB to cede review to an external IRB.
2.0 Policy
- 2.1. It is the policy of the Organization that all non-exempt research under the authority of the UNMC IRB and conducted, supported, or otherwise subject to regulation by any Federal department or agency which has adopted the Common Rule will rely on upon approval by a single IRB for that portion of the research that is conducted in the United States, in accordance with 45 CFR 46.114, unless excluded from this requirement under 45 CFR 46.114(b)(2).
- 2.2. It is the policy of the Organization that all NIH-funded research will rely on upon approval by a single IRB, in accordance with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD-16-094), unless excluded from this requirement under NIH policy (NOT-OD-18-003).
- 2.3. It is the policy of the Organization that selected independent commercial IRBs may serve as the IRB of record as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114 for new commercially sponsored clinical trials, with the exceptions specified under Section 2.5 below.
- 2.4. It is the policy of the Organization that the National Cancer Institutes (NCI) Central IRBs (CIRBs) may serve as the IRB of record for pediatric and adult research sponsored by the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114.
- 2.5. It is the policy of the Organization that other external IRBs may serve as the IRB of record as permitted by HHS regulations at 45 CFR 46.114 and FDA regulations at 21 CFR 56.114 on a case-by-case basis, with the exceptions specified under Section 2.6 below, provided the following conditions are met:
- 2.5.1. For research which constitutes greater than minimal risk, the external IRB is part of an accredited HRPP or has completed the OHRP QA Self-Assessment Tool
- 2.5.2. For research which constitutes no more than minimal risk, the external IRB reviews the research appropriately, in compliance with all federal, state, and local regulations, and the review criteria utilized by the external IRB are in compliance with the Organization’s ethical standards and with applicable laws and regulations, and with the specific approval of the IO, in consultation with the IRB Executive Chair as appropriate.
- 2.5.3. The external Institution has a valid FWA, and the external IRB is registered with OHRP and FDA (as applicable).
- 2.6. It is the policy of the Organization that, unless use of a single IRB subject is required by 45 CFR 46.114, or required by NIH policy, the use of an external IRB is not permitted for:
- 2.6.1. Clinical trials initiated by a UNMC investigator.
- 2.6.2. Use of a Humanitarian Use Device (HUD) subject to 21 CFR 814.124(a).
- 2.6.3. Emergency research subject to FDA regulations at 21 CFR 50.24.
- 2.6.4. Research that involves the use of vaccines developed or manipulated at UNMC.
- 2.6.5. Research involving gene transfer.
- 2.6.6. Emergency use of a test article subject to FDA regulations at 21 CFR 56.102(d) and 21 CFR 56.104(c).
- 2.6.7. Research involving prisoners as subjects.
- 2.6.8. Research involving fetal tissue or HESCs, or their derivatives.
- 2.7. It is the policy of the Organization that the IO, in consultation with the IRB Executive Chair as appropriate, has the sole authority to determine whether or not to allow the UNMC IRB to cede review of research described in 2.5 to an external IRB.
- 2.8. It is the policy of the Organization that the IO, in consultation with the IRB Executive Chair as appropriate, has the sole authority to allow exceptions to the exclusions in 2.6 above.
- 2.9. It is the policy of the Organization that it will accept the review and approval of an external IRB for human subject research exempt under 45 CFR 46.104; however, the Organization will not require the execution of a Reliance Agreement.
- 2.10. It is the policy of the Organization that there must be an executed Reliance Agreement between UNMC and the external IRB’s institution or the commercial IRB, prior to utilization of the external or commercial IRB, for all non-exempt research.
- 2.11. It is the policy of the Organization that all Organizational review requirements must be completed, and the Reliance Agreement be fully executed before the research will be released to the external or commercial IRB, for all non-exempt research; however the IO and Executive Chair have the authority to allow exceptions to this policy.
- 2.12. It is the policy of the Organization that the research may not commence until approval has been granted by the external IRB.
- 2.13. It is the policy of the Organization that research conducted under the purview of an external IRB will be subject to all relevant policies of the external (reviewing) IRB, and investigators of the Organization must comply with those policies, except as specified in addendum 2.
- 2.14. It is the policy of the Organization that investigators must comply with Organization policies as described in Addendum 2.
- 2.15. It is the policy of the Organization that all research conducted under an external IRB is subject to post approval monitoring per HRPP policy 1.21 (Post-Approval Monitoring of Research).
3.0 Definitions
- 3.1. Cede Review: The Organization has agreed to transfer IRB review and oversight authority for specified research to another institution’s IRB (reviewing or external IRB)
- 3.2. Reliance Agreement (also known as an Authorization Agreement): An agreement between two Organizations engaged in human subject research that documents respective authorities, roles, responsibilities, and communication between an organization between the reviewing and relying IRBs.
- 3.3. Relying Institution: A participating Institution that cedes IRB review to the IRB of record (reviewing IRB) designated under a Reliance Agreement.
- 3.4. Reviewing IRB (or External IRB): The IRB which is responsible for conducting IRB review and approval as described in 45 CFR 46.109 for cooperative human subject research. For the purpose of this policy, reviewing IRB and external IRB are the same.
4.0 External IRB, UNMC IRB, and PI Responsibilities
- 4.1. It is the responsibility of the external IRB (as reviewing IRB) to:
- 4.1.1. Conduct review of the research in full accordance with applicable federal and state regulations, and all relevant policies of the external IRB (including, but not limited to, initial review, continuing review, review of amendments, noncompliance, unanticipated problems involving risk to subject or others, deviations, adverse events, study holds, suspensions, and terminations).
- 4.1.2. Obtain any additional approvals from DHHS when the research involves pregnant women, fetuses, and neonates; or children; or prisoners (as applicable per DHHS and FDA regulations).
- 4.1.3. Report all determinations of serious or continuing noncompliance, unanticipated problems involving risk to the subject or others, and suspensions or terminations to the Relying Institution, Institutional Officials and Federal Agencies.
- 4.1.4. Report to the UNMC IRB:
- 4.1.4.1. Any unanticipated problems involving risk to the subject or others associated with subjects enrolled at the institution.
- 4.1.4.2. Any serious or continuing noncompliance.
- 4.1.4.3. Any serious complaints which impact the rights and welfare of research subjects.
- 4.1.4.4. The results of any external audits conducted by FDA, OHRP, sponsors, and CROs.
- 4.1.4.5. Any reports filed with the FDA or OHRP.
- 4.1.4.6. Any FDA Form 483 or warning letter pertaining to the study or IRB review.
- 4.1.4.7. Any other communication from FDA or other governmental agency citing improper or inadequate research practices.
- 4.1.5. Notify the Investigator and the Institution (when applicable) of the IRB’s determinations.
- 4.1.6. Provide a Point of Contact (POC) and contact information for UNMC researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the use of the external IRB.
- 4.1.7. Upon written request, provide UNMC with access to relevant records related to IRB review (including, but not limited to minutes, approved protocols, consent forms, and other records that document the IRB’s determinations).
- 4.2. It is the responsibility of the UNMC IRB and HRPP (on behalf of the relying institution) to:
- 4.2.1. Advise the external IRB of any applicable state or local laws governing research conducted at this Organization.
- 4.2.2. Advise the external IRB of completion of all additional reviews required by the Institution, including but not limited to biosafety review, radiation safety review, recombinant DNA research review, human stem cell research review and conflict of interest, and of any requirements resulting from the additional Institutional reviews.
- 4.2.3. Advise the external IRB of any circumstances when the review must take into account additional regulatory requirements or local HRPP requirements.
- 4.2.4. Ensure that all investigators participating in the research are members of the Institution’s medical staff in good standing and are credentialed and privileged to perform the procedures outlined in the studies.
- 4.2.4.1. Notify the external IRB of the termination, suspension, or modification of any clinical privileges of the Organization’s Medical Staff who are participating in the studies authorized by the external IRB.
- 4.2.5. Advise the external IRB of any allegations of noncompliance which are received by the ORA and which are found to be serious or continuing, or which represent an unanticipated problem involving risk. The external IRB, in conjunction with the ORA, will determine how best to handle the allegation in consideration of the need to maintain due process and protect the whistleblower.
- 4.2.6. Advise the external IRB of any complaint directly from subjects or others. The Research Subject Advocate Office will assist in the resolution of the complaint as necessary.
- 4.2.7. Advise the external IRB of any contact by the FDA, HHS, or any other persons or entities regarding the research within three business days of contact.
- 4.2.8. Notify the external IRB within three business days, in the event that the FDA or other governmental agency issues the relying Institution any “Notice of Inspectional Observations”, “Warning Letters”, or other communications citing improper or inadequate research practices with respect to the research specified above.
- 4.2.9. Ensure that UNMC applies its FWA to all research and ensure that the IRB review is consistent with the requirements of the UNMC’s FWA.
- 4.2.10. Ensure that, should termination of a reliance agreement occur, it is clear who will have the responsibility of continued oversight of study activities until closure or transfer of the study.
- 4.2.11. Ensure that all investigators participating in the research understand their responsibilities under applicable federal regulations (45 CFR 46 including subparts as applicable, 21 CFR 50, 56, 312, 812, and HIPAA Privacy Rule), state laws, institutional policies, and the protocol.
- 4.2.12. Ensure that all research personnel involved in the process of consent or assent are properly trained and are fully aware of their responsibilities relative to the obtainment of informed consent/assent according to institutional policies, applicable federal regulations, and state law.
- 4.2.13. Notify the reviewing IRB when local policies that impact IRB review are updated.
- 4.3. It is the responsibility of the UNMC PI to:
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4.3.1. Complete all requirements for submission of request to utilize the CIRB to the ORA.
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4.3.2. Complete all requirements for submission to the external IRB.
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4.3.3. Comply with all relevant UNMC HRPP policies, such as, but not limited to, those related to compensation, advertisement, ethical access, short form consent, process and documentation of consent.
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4.3.4. Comply with all determinations and requirements of the external IRB.
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4.3.5. Comply with the external IRB’s requirements for initial and continuing review, record keeping, and reporting in a timely manner.
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4.3.6. Promptly report the following to the external IRB (in accordance with their policies):
- 4.3.6.1. Any proposed changes to the research.
- 4.3.6.2. Conflict of interest (COI) management plans (in accordance with HRPP policy 1.25 Financial Conflicts of Interest). The UNMC PI and research staff must comply with all determinations.
Note: The external IRB may impose additional safeguards; however, the external IRB may not be less stringent than what is required by the UNMC COI management plan.
- 4.3.6.3. Incidents of noncompliance. Copies of all reports to the federal government (e.g., OHRP, FDA, federal sponsor or funding agency) must also be provided to the ORA.
- 4.3.6.4. Protocol deviations.
- 4.3.6.5. Any complaints from subjects or others. The UNMC Research Subject Advocate Office will assist in the resolution of the complaint as necessary.
- 4.3.6.6. Data Safety Monitoring Reports
- 4.3.6.7. Internal adverse events and other events which qualify as an unanticipated problem involving risk to the subject.
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4.3.7. Promptly report to the UNMC IRB
- 4.3.7.1. Any new or modified conflicts of interest of responsible personnel (per HRPP policy 1.25 Financial Conflicts of Interest), and any new or modified management plans.
- 4.3.7.2. Additional requirements by the external IRB to the UNMC COI management plan.
- 4.3.7.3. Incidents of non-compliance
- 4.3.7.4. Copies of all reports to OHRP and/or FDA.
- 4.3.7.5. Reports of internal adverse events
- 4.3.7.6. Changes in study personnel
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4.3.8. Ensure all investigators and research staff have the appropriate qualifications and expertise to conduct the research.
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4.3.9. Ensure that all research personnel understand their responsibility in enrolling participants in the research; including obtainment, documentation, and maintenance of records of consent for each subject/LAR.
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4.3.10. Conduct monitoring in addition to, or in cooperation with, the external IRB and the ORA.
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4.3.11. Notify the ORA when a study is completed
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- 4.4. There may be additional external IRB, UNMC IRB, and PI, responsibilities dictated by the IRB Reliance Agreement. The fully executed IRB Reliance Agreement must be maintained as documentation verifying the responsibilities of each organization to ensure compliance with the requirements of the Common Rule.
5.0 Procedures
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5.1. For all non-exempt human subject research, the PI must submit the Central IRB Application (CIRB) through RSS. The application must be accompanied by the following documents:
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5.1.1. Full protocol
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5.1.2. Sponsor’s template consent forms and/or information sheets
Note: It is recommended that the PI contact the ORA to determine if the proposed research will qualify for external IRB review prior to submission of the application. Acceptance of the application by the ORA does not signify that review will be ceded.
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5.2. The IRB Administrator must determine that the request to utilize an external IRB satisfies the requirements of Section 2 above. The administrator, in consultation with the Executive Chair, as appropriate, will then present to the IO the request to allow the UNMC IRB to cede IRB review to the external IRB.
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5.3. If the IO approves the request, the UNMC IRB Administrator will review the Central IRB Application to determine that:
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5.3.1. The research satisfies UNMC requirements including, but not limited to:
- 5.3.1.1. HRPP policies as described in addendum 2.
- 5.3.1.2. Review and approval by other components of the HRPP (including, as appropriate, Conflict of Interest Committee, Fred & Pamela Buffett Cancer Center Scientific Review Committee, Pharmacy & Therapeutics Committee, Investigational Device Review Committee, Pathology, IT Security if SSNs maintained)
- 5.3.1.3. Contract review by Sponsored Programs Administration or UNeHealth
- 5.3.1.4. Coverage analysis and matrix/study calendar
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5.3.2. Appropriate agreements are in place, including, but not limited to:
- 5.3.2.1. Executed sponsored agreement
- 5.3.2.2. Data Use, Data Transfer and/or Material Transfer Agreements
- 5.3.2.3. IRB Reliance Agreement between UNMC IRB and external IRB
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5.3.3. The UNMC IRB Administrator will issue a conditional acceptance letter to the investigator, with conditions based on Organizational requirements.
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5.3.4. The following items are available to investigators and may be provided to the external IRB:
- 5.3.4.1. UNMC Consent Form letterhead (use recommended but not required).
- 5.3.4.2. The UNMC required consent form language (addendum 1 to this policy).
- 5.3.4.3. Any COI management plan including any requirements for disclosure in the informed consent form.
- 5.3.4.4. Additional information related to local context issues, including state, local or institutional regulations or policies that may impact IRB review.
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5.3.5. Once all Organizational requirements have been met (as specified in HRPP policy 2.2 Section 8.0: Full IRB Review and HRPP policy 2.3 Section 13.0: Expedited Review) and the IRB Reliance Agreement is fully executed, the IRB Administrator will provide the PI with an acceptance letter granting acceptance of IRB oversight by the external IRB.
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5.3.6. The study may not be initiated until the acceptance letter has been provided to the PI.
Note: Once it has been determined that an external IRB will serve as the IRB of record for any given study, all communications from the PI and other study personnel regarding IRB review of the study or its status must be with the external IRB, except as specified in Sections 4.3.7 above. UNMC IRB staff do not have the authority to respond to questions or concerns on behalf of the external IRB.
Note: The external IRB policies and procedures for stamping (or not stamping) consent forms with the approval dates take precedence. The UNMC IRB will not review or provide an approval stamp on any consent forms or information sheets approved by an external IRB.
-
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5.4. For research exempt under 45 CFR 46.104, a copy of the protocol and application submitted to, and approved by the external IRB (or HRPP) will be accepted by the ORA in lieu of the Central IRB Application.
- 5.4.1. The IRB administrator will review submitted materials as described in HRPP Policy 2.6 Exempt Research.
- 5.4.2. If acceptable, the protocol will be designated ET and will otherwise be handled as an EX protocol.
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5.5. The ORA, the IRB and the IO retain the authority to suspend research conducted within the organization which has been ceded to an external IRB, if the ORA, IRB or IO believes such action is necessary to protect the rights and welfare of human subjects of the research. The suspension will be promptly reported to the external IRB.
Addendum 1: UNMC Required Consent Form Language
Title: As the IRB of record allows, the consent Form should appear on UNMC/ Nebraska Medicine letterhead for easy identification as a research consent form. The UNMC IRB number should appear in the consent.
Contraception/Pregnancy Language for FDA regulated research: Insert appropriate contraception language based on FDA Pregnancy and Lactation Labeling Rule and/or FDA Use-In-Pregnancy category, as per HRPP Policy 3.9 Contraception Requirements.
Category A and Some Category B Drugs (do not require contraception) It is possible that the medicines used in this study could injure a fetus if you or your partner becomes pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions. Category B, C and D Drugs It is possible that the medicines used in this study could injure a fetus if you or your partner becomes pregnant while taking them. You have already been told what is known about this possibility, and you are encouraged to ask further questions.
You may want to discuss this with others before you agree to take part in this study. If you wish, we will arrange for a doctor, nurse, or counselor who is not part of this study to discuss the potential risks and benefits with you and anyone else you want to have present.
Because of the potential risks, you or your partner must not become pregnant while participating in this study. Women must have a negative pregnancy test before entering the study (and before each treatment as appropriate).
If you are sexually active and can get pregnant, or can get your partner pregnant, you must use ONE (or TWO) appropriate method of birth control every time you have sex, or you must not have sex.
You can get additional information about methods to avoid pregnancy by calling the UNMC Research Subject Advocate's Office at (402) 559-6941.
You or your partner will need to continue to avoid pregnancy for X months after finishing the research.
Should you or your partner become pregnant while on this study, you should immediately notify the study personnel. The investigator will assist you in finding appropriate medical care. The investigator also may ask to be allowed to continue getting information about your pregnancy. You can refuse to provide this information.
Category X drugs: Since studies of the drug in humans, or investigational or post-marketing data, have demonstrated fetal risk, contraception is required and the language must be at least as protective as Category D language above. Often the sponsor and/or FDA require inclusion of specific language relating to fetal risk, monitoring for pregnancy and prevention of pregnancy in the consent form. The language cannot be modified.
The consent form should indicate how frequently pregnancy testing will be performed, how often subjects will be informed of results, and whether subjects will be removed from the study if they become pregnant. If the study involves minors, the consent form must disclose that the results of the pregnancy testing will be shared with the parents. For more information, please see UNMC HRPP policy 3.10 Pregnancy Testing.
Costs to Subject (required for all clinical trials): You will have to pay any insurance deductibles and co-payments. If you want to speak with someone about your insurance, just tell us.
Payment:
If SSN is required for payment, then use the following standard statement:
In order to pay you, you will have to provide your social security number. You can choose not to provide this and still participate in the research but we will be unable to pay you.
If this study has a tissue bank include this standard statement:
We do not plan to pay you if any new drugs or products are made using the sample(s) you donated. It is our policy that all donated samples belong to the organization.
Subject Injury Language for greater than minimal risk research Add the following to consent form subject injury language: Your health and safety is our main concern. If you are injured or have a medical problem because of this study call someone listed at the end of this consent form. You can get emergency medical treatment at Nebraska Medicine. You can also go to your doctor, the nearest emergency room or call 9-1-1.
{Insert the commercial sponsor language}
We have no plans to pay for your treatment or give you any other money or compensation. Signing this does not mean you have given up any of your legal rights. HIPAA Language:
We also will get medical information about you (like medical record number, medical history, or the results of physical exams, blood tests, x-rays or other medical or research procedures). We call this protected health information" or PHI. PHI is protected by a law called the HIPAA Privacy Rule. We will collect the smallest amount of PHI that we can. We will keep your PHI as confidential as possible.
By signing this consent form, you are letting us (the researchers listed on this consent form and other people involved in this research at the Organization) have access to your PHI. Your PHI will be used only for the purposes described in the section "What is the reason for doing this research study?"
You can change your mind and tell us to stop collecting your PHI for use in this research at any time by writing to the principal investigator. We can still use the PHI we have already collected. If you tell us to stop collecting your PHI, you will have to stop being in this research.
The UNMC Institutional Review Board (IRB) Institutional officials designated by the UNMC IRB The HHS Office for Human Research Protections (OHRP)
The Food and Drug Administration (FDA) {if study involves FDA regulated drug, device, or biologic} National Institutes of Health (NIH) {if study is funded by the NIH}
Researchers at insert the name of the institution(s) involved in the study if this is a multi-institution study where PHI will be shared with other researchers
Your health insurance company {if the Institution expects third party payers to pay for clinical procedures performed during the course of the research}
The Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC) {if the research involves patients with cancer}
{insert name of sponsor}, which sponsors this research and may pay the Organization to do this research
{insert name of CRO} which has been hired by the sponsor to help run the research
The Data and Safety Monitoring Committee (DSMC)
{name of NCI National Cooperative Group}
The National Cancer Institute's (NCI) Clinical Trial Reporting Program
NOTE: Choose one of the statements that appropriately represents your study:
You are letting us use and share your PHI for as long as the research is going on.
Or:
You are letting us use and share your PHI for as long as the sponsor needs so it can get approval from the FDA.
Or:
There is currently no plan to end this study. You are letting us use and share your PHI for as long as we want.
What are your rights as a research participant?
You have rights as a research subject. These rights have been explained in this consent form and in The Rights of Research Subjects that you have been given. If you have any questions concerning your rights, or want to discuss problems, concerns, obtain information or offer input, or make a complaint about the research, you can contact any of the following:
The investigator or other study personnel
Institutional Review Board (IRB) Telephone: (402) 559-6463. Email: IRBORA@unmc.edu
Mail: UNMC Institutional Review Board, 987830 Nebraska Medical Center, Omaha, NE 68198-7830 Research Subject Advocate Telephone: (402) 559-6941 Email: unmcrsa@unmc.edu
Addendum 2: UNMC HRPP Policies to be followed by institution investigators
Process of informed consent, including remote consent and electronic signature, documentation of consent and use of Short Form; per HRPP policies 5.1 (Obtaining Informed Consent From Research Subjects), 5.3 (Use of a Remote Consent Process), and 5.5 (Use of the Short Form Consent Document)
Research Data Privacy, Confidentiality, use of PHI, and Data Safety Monitoring; per HRPP policies 3.2 (Data and Safety Monitoring), 3.3 (Privacy Interests and Confidentiality of Research Data), and 3.4 (Use of Protected Health Information in Research).
Subject Identification and Recruitment, including Ethical Access; per HRPP policies 3.5 (Subject Recruitment through Advertisements), 3.6 (Subject Recruitment through Direct Invitation), 3.7 (Finder’s Fees and Recruitment Bonuses), and 3.12 (Ethical Access).
Subject payment; per HRPP policy 3.8 (Research Subject Compensation).
Pregnancy testing, pregnant partner, and contraception; per HRPP policies 3.9 (Contraception Requirements) and 3.10 (Pregnancy Testing).
Investigator and research staff training; per HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel).
Research involving subjects with impaired decision-making capacity; per HRPP policy 4.6 (IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity).
DOCUMENT HISTORY:
Written: not documented (Approved: not documented)
Revised: 5/30/2017 - revision not documented
Revised: 2/28/2018 - revision not documented
Revised: 10/21/2021 - Added organizational policy to comply with Common Rule and NIH requirements regarding use of a single IRB; deleted redundant policy statements; clarified requirements for accreditation of reviewing IRB; modified types of research not eligible for use of external IRB; moved list of UNMC policies that must be followed to addendum 2; clarified responsibilities of external IRB, UNMC IRB and investigators; clarified ORA and IRB procedures; clarified required documents to be submitted by PI; other minor reorganization of policy; added Addendum 1 and 2. Notification: not documented
Revised: 12/8/2022 - modified addendum 1 to correct inconsistencies with Consent Form template (Subject Injury, HIPAA, and Participant Rights sections)
Revised: 8/25/2023 – Added responsibility for UNMC HRPP regarding notification of reviewing IRB when local policies that impact IRB review are updated (section 4.2.11).
Revised: 1/22/2024 - added UNMC IRB and HRPP responsibility to ensure that UNMC applies its FWA to all research and ensure that the IRB review is consistent with the requirements of the UNMC’s FWA (section 4.2.9) and ensure that, should termination of a reliance agreement occur, it is clear who will have the responsibility of continued oversight of study activities until closure or transfer of the study (section 4.2.10).
1.5 Requirements for Research Conducted with International Sites
Last Revised: 5/9/2023
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for research conducted with international sites. For the purposes of this policy, “Research conducted with International Sites” (international research) is defined as (1) research conducted by a faculty member, staff, student, or other representative of the Organization at an international site, or (2) research conducted by external investigators under the direction of a faculty member, staff, student, or other representative of the Organization, or (3) research where an investigator receives identifiable private information or identifiable biospecimens from an international site.
2.0 Policy
It is the policy of the Organization that:
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2.1. The PI assumes responsibility for the safe and proper conduct of the research in full compliance with all applicable U.S. regulations, country specific laws and regulations, local IRB (IEC, REB, REC) requirements and UNMC HRPP policies.
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2.2. Non-exempt research conducted with an international site by the Organization’s faculty, staff, students, or other representative of the Organization, must be reviewed and approved by both the UNMC IRB, and by any local IRB at the international site which has review and oversight jurisdiction over the research. If there is no local IRB, an exception may be granted by the Institutional Official upon recommendation by the IRB Executive Chair.
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2.3. Exempt research conducted at an international site by the Organization’s faculty, staff, students, or other representative of the Organization, requires review and approval by both the ORA, and by any local IRB or official which has review and oversight jurisdiction. If there is no local IRB or official which has review and oversight jurisdiction, an exception may be granted by the IRB Executive Chair/designee.
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2.4. When reviewing research conducted entirely or in part in other countries, the IRB must have appropriate knowledge concerning the laws, regulations, guidance, and customs in that country either through the direct expertise by a member or by the use of consultants.
Note: The IRB may utilize as a resource the latest edition of the “OHRP International Compilation of Human Research Standards” as well as the information provided by the investigator in Addendum T of the IRB application.
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2.5. When conducting or participating in international research conducted entirely or in part in other countries, the investigator must have appropriate knowledge concerning the laws, regulations, guidance, and customs in that country either through the direct expertise or by the use of consultants.
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2.6. Protections of human subjects at the international site must be at least equivalent to HHS regulations at 45 CFR 46
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2.7. International research involving prisoners is not permitted.
3.0 Investigator Responsibilities
- 3.1. Non-Exempt International Research
- 3.1.1. In order for the Organization’s faculty, students, staff, or other representatives to conduct non-exempt research with an international site, the following must be submitted to the IRB for review:
- 3.1.1.1. The appropriate IRB application
- 3.1.1.2. Addendum T: International Research
- 3.1.1.3. A copy of the approval letter from the local IRB as required.
- 3.1.1.4. A copy of the ICF approved by the local IRB which has been translated into English.
- 3.1.1.5. A copy of the ICF approved by the local IRB in the native language.
- 3.1.1.6. An agreement between the international site and the investigator and/or institution which specifies the responsibilities of the local IRB/REB which includes, but is not limited to, the following:
- 3.1.1.6.1. Continuing review will be performed no less often than annually.
- 3.1.1.6.2. Post approval monitoring as appropriate will be conducted at the site.
- 3.1.1.6.3. Reports of complaints, serious or continuing noncompliance, protocol deviations, and unanticipated problems involving risk to the subject or others will be forwarded to the UNMC IRB.
- 3.1.1.6.4. Reports of other serious problems in the conduct of the research will be forwarded to the UNMC IRB.
- 3.1.1. In order for the Organization’s faculty, students, staff, or other representatives to conduct non-exempt research with an international site, the following must be submitted to the IRB for review:
- 3.2. Exempt International Research
- 3.2.1. In order for the Organization’s faculty, staff, students, staff, and other representatives to conduct exempt research with an international site, the following must be submitted to the ORA for review:
- 3.2.1.1. The appropriate IRB application
- 3.2.1.2. Addendum T: International Research
- 3.2.1.3. A copy of the approval letter from the local IRB or authorized official
- 3.2.1.4. A copy of the ICF approved by the local IRB (if a consent form is required) which has been translated into English.
- 3.2.1.5. A copy of the ICF approved by the local IRB (if a consent form is required) in the native language.
- 3.2.1. In order for the Organization’s faculty, staff, students, staff, and other representatives to conduct exempt research with an international site, the following must be submitted to the ORA for review:
- 3.3. When any international research involves the shipment of human biological materials, hazardous materials, or dangerous goods, the PI must comply with UNMC Hazardous Material/Dangerous Goods Shipping Plan. For more information contact the UNMC Biosafety Officer or the UNMC/Nebraska Medicine Department of Environmental Health & Safety, or the UNO Office of Research and Creative Activity (ORCA).
- 3.4. The PI must comply with UNMC policy 8005 (Export Control Policy) or with UNO Export Control policy. For more information contact the UNMC Export Control Office, the UNMC Chief Compliance Officer, or the UNO Office of Research and Creative Activity (ORCA).
- 3.5. The PI is responsible for ensuring all appropriate host country permissions to conduct research are in place (including as appropriate, institutional, governmental or ministerial, IRB or EC, local or tribal).
4.0 ORA Responsibilities
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4.1. Non-Exempt International Research
- 4.1.1. In addition to the criteria for approval under 45 CFR 46.111, when conducting its review, the IRB will consider whether:
- 4.1.2.1. The PI and research personnel are qualified to conduct research in the specified country, including knowledge of relevant laws, regulations, guidance, and customs.
- 4.1.2.2. The consent process and consent documents are appropriate for the languages of the subjects and communication with the subject population, and whether appropriate arrangements are considered to communicate with the subjects throughout the research.
- 4.1.2.3. The PI has in place an adequate process for handling:
- 4.1.2.3.1. Modifications to the research. The IRB and investigators should consider as many contingencies as possible when research is reviewed and approved.
- 4.1.2.3.2. Complaints, noncompliance, protocol deviations, and unanticipated problems involving risk to subject or others.
- 4.1.2.3.3. Post-approval monitoring of the research.
- 4.1.2.4. There is an adequate mechanism for communication between the IRB and the PI and research personnel when they at the international site.
- 4.1.3. The UNMC IRB will review the protocol in accordance with HRPP policies 2.2 (Full IRB Review) and HRPP 2.3 (Expedited Review).
- 4.1.4. Written documentation of informed consent may be waived by the IRB if the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, provided that the research presents no more than minimal risk of harm to subjects and there is an appropriate alternative mechanism for documenting informed consent was obtained (45 CFR 46.117(c)(1)(iii)).
- 4.1.5. If a conflict arises between country specific laws/regulations and applicable US regulations, the IRB will consult with legal counsel (per HRPP policy 1.11 HRPP Access to Legal Counsel), other legal consultants, OHRP, and FDA as necessary.
- 4.1.1. In addition to the criteria for approval under 45 CFR 46.111, when conducting its review, the IRB will consider whether:
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4.2. Exempt International Research
- 4.2.1. The ORA will review the protocol in accordance with HRPP policy 2.6 (Exempt Research).
- 4.2.2. As appropriate, the ORA will consider whether:
- 4.2.2.1. The PI and research personnel are qualified to conduct research in the specified country, including knowledge of relevant laws, regulations, guidance, and customs.
- 4.1.2.2. If informed consent is required, the consent process and consent documents are appropriate for the languages of the subjects and communication with the subject population, and whether appropriate arrangements are considered to communicate with the subjects throughout the research.
- 4.1.2.3. The PI has in place an adequate process for handling complaints, noncompliance, protocol deviations, and unanticipated problems involving risk to subject or others.
- 4.1.2.4. There is an adequate mechanism for communication between the IRB and the PI and research personnel when they are at the international site.
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4.3. If a conflict arises between country specific laws/regulations and applicable US regulations, the IRB will consult with legal counsel (per HRPP policy 1.11 HRPP Access to Legal Counsel), other legal consultants, OHRP, and FDA as necessary.
DOCUMENT HISTORY:
Written: 1/13/2016 (Approved: 1/13/2016) - original author not recorded
Revised: 2/9/2018 - revision not documented
Revised: 12/8/2022 – revised title to stress international research includes work with international sites in addition to work at those sites; added specific definition to include research where an investigator receives or sends human biological or data from or to an international site; corrected reference to UNMC policy shipping of Hazardous Materials; corrected reference to Department of Environmental Health & Safety; added UNO policies; deleted requirement for formal reliance agreement (section 5.1.1.6); deleted references to sections effective after the revision of the Common Rule; revised section 2.3 so that exception may be granted by the Executive Chair rather than IO.
Revised: 5/9/2023 – Revised definition of international research to remove sending human biological material or data; reformatted to separate investigator responsibilities and IRB/ORA responsibilities; clarified ORA responsibilities when considering exempt international research.
1.6 IRB Composition, Leadership, Qualifications, and Responsibilities
Last Revised: 2/15/2025
1.0 Purpose
The purpose of this policy and procedure is to describe the Organization’s requirements for IRB composition, leadership, member qualifications, and responsibilities.
2.0 Policy
It the policy of the Organization that the membership of its IRBs will satisfy requirements of 45 CFR 46.107 and 21 CFR 56.107, and will include an appropriately diverse mixture of backgrounds, gender, and race/ethnicity.
3.0 Composition of the IRBs
- 3.1. Each IRB will have at least five members.
- 3.2. Each IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
- 3.3. Each IRB shall include persons knowledgeable in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice to be able to ascertain the acceptability of proposed research.
- 3.4. The IRBs will include one or more members who are knowledgeable about or experienced in working with children, pregnant women and fetuses, and decisionally impaired individuals.
- 3.4.1. The IRB-04 will include a predominance of members who are knowledgeable about and experienced in working with children and neonates.
- 3.5. Every effort will be made to ensure that the IRB does not consist entirely of men or entirely of women. No appointment will be made to the IRB on the basis of gender alone.
- 3.6. The IRB shall not consist entirely of members of one profession.
- 3.7. Each IRB will include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. In order to qualify as a non-scientist member the individual must have little or no scientific training or experience.
- 3.8. Each IRB will include at least one member that is not affiliated with the Institution.
- 3.8.1. The unaffiliated member should be able to represent the general perspective of research subjects and/or of the community. These members should be particularly cognizant of the need to protect subjects vulnerable to coercion and undue influence.
- 3.8.2. The unaffiliated member must not have any professional relationship with the Institution as an employee, consultant, faculty (including voluntary faculty), or student, or have an immediate family member who has such a professional relationship with the Institution.
- 3.8.3. It is expected but not required that at least one unaffiliated member will be present at each meeting of each IRB.
- 3.9. Each IRB which reviews research conducted at NM, CN, or BMC, or conducted by personnel affiliated with those medical facilities, will include at least one nurse as a voting member.
- 3.10. When reviewing community-based participatory research, as necessary, a consultant (or a knowledgeable board member) will supply the IRB with information about the community and how it will be served by the research.
- 3.11. A member of the IRB may fill multiple membership position requirements (for example, an unaffiliated member may also serve as a non-scientist member).
- 3.12. In situations where prisoners will be or are involved in research under IRB review: 1) the majority of the Board (exclusive of the prisoner member) will have no association with the prison(s) involved, apart from their membership on the IRB; and 2) the Board will include a prisoner representative with appropriate background and experience to serve in that capacity. This individual must have a reasonable working knowledge, understanding, and appreciation of prison conditions and be able to act in the best interests of the prisoners who will participate in the research.
- 3.13. Any IRB member with a conflict of interest related to a specific study will be recused from participating in the discussion and vote except to offer information as requested by the IRB. This applies to both full board review and expedited review. A conflict of interest will be determined in accordance with HRPP policy 1.7 (IRB Member, Consultant, Staff COI Identification and Management).
- 3.14. When review of a proposal requires medical or scientific expertise or specific knowledge about vulnerable subjects that is not available on the Board, the IRB will request assistance from an expert consultant. Consultants will provide guidance and information in accordance with the following procedures:
- 3.14.1. Either before or during review of a protocol, the IRB Executive Chair/designee, assigned IRB reviewer, or the IRB itself may determine there is a need for appointment of one or more expert consultants, as per 45 CFR 46.107(e)) and 21 CFR 56.107(f).
- 3.14.2. Consultants may be selected from within or from outside the Organization, based upon the required expertise.
- 3.14.3. Consultants must certify in writing that they do not have any conflict of interest as described in HRPP policy 1.7 (IRB Member, Consultant, Staff COI Identification and Management).
- 3.14.4. Consultants will produce written reviews upon request which will be provided to IRB members in advance of, or at the IRB meeting.
- 3.14.5. Consultants may participate in the IRB’s discussion of the protocol but they may not vote and will leave the meeting before a vote is taken.
- 3.15. IRB alternate members are appointed according to discipline and membership category. They may represent more than one named IRB member. The alternate member’s professional specialty, qualifications, and experience must be comparable to those of the primary member to enable them to adequately fulfill the role of the member to be replaced. Alternate members may attend any IRB meeting; however, alternates are not permitted to vote unless the designated regular member is not present. All alternate members have access to IRB review materials regardless of whether or not they attend an IRB meeting.
- 3.16. Any Organizational representatives responsible for business development are prohibited from serving as an IRB member or in carrying out the day-to-day operations of the IRB review process. Organizational leadership may attend IRB meetings as necessary but will not vote.
- 3.17. When the IRB membership changes, the HHS/FDA IRB registration will be modified by the IRB Analyst responsible for membership documentation, in accordance with 45 CFR 46.505(b) and FDA regulations.
- 3.18. A full listing of IRB members will be maintained by the ORA. This list will include for each IRB member: name, earned degrees, scientific status (that is, scientist or non-scientist), representative capacity (for example, children, pregnant women, prisoners), indications of experience (that is, brief descriptors of relevant experiences that describe each member’s chief anticipated contributions to IRB), relationship to the organization, affiliation status, office (for example, chair or vice chair), membership status (member, alternate member, or non-voting), and, as applicable, alternate member for and list the members or class of members for whom the alternate member can substitute.
- 3.18.1. Roster will be updated at least annually.
- 3.19. The ORA will not release the names of any IRB members except as required by federal regulations or state law. However, the IRB will provide a list of members by specialty and role.
4.0 IRB Leadership
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4.1. IRB Executive Chair
- 4.1.1. The IRB Executive Chair is a senior faculty member and preferably is nationally recognized as an expert in the ethics and regulation of human subject research.
- 4.1.2. The IO will appoint an IRB Executive Chair to serve for renewable 3-year terms. Any change in appointment, including reappointment or removal, will require written notification.
- 4.1.3. The IRB Executive Chair reports directly to the IO on all matters pertaining to the IRB and related HRPP issues.
- 4.1.4. The IRB Executive Chair also has a direct line to the UNMC and UNO Chancellors, as well as Executive Leadership for Nebraska Medicine and Children’s Nebraska on all matters as necessary concerning compliance with HRPP policies and procedures.
- 4.1.5. The IRB Executive Chair performs all the duties of the IRB Chair as described in section 4.2 below.
- 4.1.6. The IRB Executive Chair is the Chair of the IRB Executive Committee, and may serve on ad hoc IRB subcommittees.
- 4.1.7. The IRB Executive Chair is a signatory for correspondence in accordance with HRPP policy 1.19 (IRB Signature Authority).
- 4.1.8. The IRB Executive Chair appoints qualified IRB members to perform expedited review, in accordance with HRPP policy 2.3 (Expedited Review).
- 4.1.9. The IRB Executive Chair advises the IO, on an on-going basis, about performance and competence of the IRB Chairs, Vice-Chairs, IRB members and ORA staff.
- 4.1.10. The performance of the IRB Executive Chair will be reviewed in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP).
- 4.1.11. The IRB Executive chair must satisfy continuing education requirements per HRPP policy 1.24 (HRPP Training Requirements for IRB Members).
- 4.1.12. The IRB Executive Chair must keep current with all updates in federal regulations and guidance, as well as attend regional and national conferences in human research subject protections.
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4.2. IRB Chairs
- 4.2.1. IRB Chairs are appointed by the IO, in consultation with the IRB Executive Chair, for a renewable 3-year term. The Chair must:
- 4.2.1.1. Have at least four years of IRB experience.
- 4.2.1.2. Be knowledgeable about regulatory and institutional requirements for protection of human subjects.
- 4.2.1.3. Be committed to serving in a leadership role.
- 4.2.2. The IRB Chair conducts the IRB meetings, performs expedited reviews, reviews adverse events, unanticipated problems involving risk to the subject or others, protocol deviations, noncompliance, provides continuing education of IRB members and investigators, and participates in the development of policies, procedures, IRB forms and checklists.
- 4.2.3. As needed, the IRB Chair may carry out the duties of an IRB member, as noted in section 4.5.4 below.
- 4.2.4. If the IRB Chair is an MD (or equivalent) he/she will review requests for emergency use of a test article under 21 CFR 56.104(c)
- 4.2.5. The IRB Chair is a member of the IRB Executive Committee, and may serve on ad hoc IRB subcommittees.
- 4.2.6. The IRB Chair is a signatory for correspondence in accordance with HRPP policy 1.19 (IRB Signature Authority).
- 4.2.7. The IRB Chair appoints qualified IRB members to perform expedited review, in accordance with HRPP policy 2.3 (Expedited Review).
- 4.2.8. The IRB Chair advises Executive Chair, on an on-going basis, about performance and competence of the IRB Vice-Chairs, IRB members and ORA staff.
- 4.2.9. The performance of the IRB Chair will be reviewed in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP).
- 4.2.10. The IRB Chair must satisfy continuing education requirements per HRPP policy 1.24 (HRPP Training Requirements for IRB Members).
- 4.2.11. The IRB Chair should keep current with all updates in federal regulations and guidance, as well as attend regional and national conferences in human research subject protections.
- 4.2.1. IRB Chairs are appointed by the IO, in consultation with the IRB Executive Chair, for a renewable 3-year term. The Chair must:
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4.3. IRB Vice Chairs
- 4.3.1. IRB Vice-Chairs are appointed by the IO, in consultation with the IRB Executive Chair, for a renewable 3-year term. The Vice-Chair must:
- 4.3.1.1. Have at least two years of IRB experience.
- 4.3.1.2. Be knowledgeable about regulatory and institutional requirements for protection of human subjects.
- 4.3.1.3. Be committed to serving in a leadership role.
- 4.3.2. The IRB Vice-Chair will serve in the capacity as IRB Chair when the Chair is unavailable (or recused).
- 4.3.3. As needed, the IRB Vice-Chair may carry out the duties of an IRB member, as noted in section 4.5.4 below.
- 4.3.4. If the IRB Chair is an MD (or equivalent) he/she will review requests for emergency use of a test article under 21 CFR 56.104(c)
- 4.3.5. The IRB Vice-Chair is a member of the IRB Executive Committee, and may serve on ad hoc IRB subcommittees.
- 4.3.6. The performance of the Vice-Chair will be reviewed in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP).
- 4.3.7. The IRB Vice-Chair must satisfy continuing education requirements per HRPP policy 1.24 (HRPP Training Requirements for IRB Members), section 5.0.
- 4.3.8. The IRB Vice-Chair should keep current with all updates in federal regulations and guidance, as well as attend regional and national conferences in human research subject protections.
- 4.3.1. IRB Vice-Chairs are appointed by the IO, in consultation with the IRB Executive Chair, for a renewable 3-year term. The Vice-Chair must:
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4.4. IRB Executive Committee
- 4.4.1. The IRB Executive Committee is comprised of the IRB Executive Chair, the IRB Chairs and Vice-Chairs, ORA Assistant Director, and Lead IRB Analyst responsible for the Executive Committee operations.
- 4.4.2. The IRB Executive Committee meets monthly, or more often if needed.
- 4.4.3. IRB Analysts may attend the IRB Executive Committee meetings as requested by the Committee.
- 4.4.4. The purpose of the IRB Executive Committee is to:
- 4.4.4.1. Perform ongoing assessment of the IRBs.
- 4.4.4.2. Assist in the development of HRPP policies and procedures.
- 4.4.4.3. Assist in the development of IRB forms.
- 4.4.4.4. Address concerns of any nature which impact the effectiveness of the HRPP in assuring the protection of the rights and welfare of research subjects.
- 4.4.5. All IRBs will be advised of Executive Committee deliberations that impact the HRPP.
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4.5. IRB Members
- 4.5.1. IRB members will normally be identified and recruited by the IRB Executive Chair, IRB Chairs and Vice-Chairs. However, unsolicited nominations may be submitted to the IRB Executive Chair or the ORA at any time.
- 4.5.2. Prior to appointment to the board, the prospective member will be interviewed by the IRB Executive Chair or designee, to determine the relevant experience of the prospective member that will describe his/her chief anticipated contribution to IRB deliberations (AAHRPP element II.1.A).
- 4.5.3. IRB members are appointed by the IO, in consultation with the IRB Executive Chair, for a renewable 3-year term.
- 4.5.4. Each IRB member is expected to be fully engaged in the HRPP and will be involved in carrying out the following responsibilities as assigned:
- 4.5.4.1. Participate in all assigned IRB meetings and subcommittees with full voting privileges.
- 4.5.4.2. Serve as a reviewer for new protocols.
- 4.5.4.3. Serve as a reviewer for applications for continuing review.
- 4.5.4.4. Serve as an expedited reviewer once they are sufficiently experienced.
- 4.5.4.5. Serve as a reviewer for unanticipated problems involving risk to the subject or others.
- 4.5.4.6. Serve as a reviewer for changes in protocol and/or consent documents.
- 4.5.4.7. Serve as a reviewer for incident reports.
- 4.5.4.8. Serve on IRB ad hoc subcommittees as needed.
- 4.5.4.9. Serve on a Post Approval Monitoring assessment team as needed.
- 4.5.5. IRB members are expected to attend the majority of scheduled meetings, and are required to attend all meetings for which they have been assigned reviews, unless prior arrangements have been made (e.g., written comments sent). IRB member attendance records will be maintained by the ORA in accordance with HRPP policy 1.22 (Assessment of the Effectiveness and Efficiency of the HRPP).
- 4.5.6. IRB members must satisfy initial and on-going education requirements as per HRPP policy 1.24 (HRPP Training Requirements for IRB Members).
- 4.5.7. The performance of all IRB members will be reviewed in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP).
- 4.5.8. Upon completion of a member’s term, the IRB Executive Chair, Chairs and Vice-Chairs, in consultation with the IRB Analysts, and based in part upon the performance evaluation (per HRPP policy 1.22: Assessment of the Effectiveness and Efficiency of the HRPP), will determine whether an additional term is offered.
- 4.5.9. An IRB Analyst may serve as a voting, or alternate voting, member of the IRB. Analysts are appointed as IRB members or alternate members by the IO, in consultation with the IRB Executive Chair, as noted above.
- 4.5.9.1. IRB Analysts serving as voting or alternate members will be classified as scientist or non-scientist based on specific degree, education, or experience.
- 4.5.9.2. IRB Analysts must have at least 2 years-experience with the ORA or another IRB, must be a voting member, and must be approved by the IRB Executive Chair, before they can act as an expedited reviewer.
- 4.5.9.3. An IRB Analyst serving as a voting or alternate member of the IRB will have the same responsibilities and requirements as noted in section 4.5.4 above, except they may not serve as primary reviewer for a new protocol for which they are the primary Analyst.
- 4.5.9.4. The term of appointment for an IRB Analyst serving as a voting or alternate member of the IRB will be indefinite.
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4.6. IRB Alternate Members
- 4.6.1. The appointment, responsibilities, training, evaluation and re-appointment of IRB alternate members is the same as that for regular IRB members.
- 4.6.2. The alternate member must qualify in terms of expertise and role in order to serve in place of the regular member.
- 4.6.3. The IRB roster identifies the type of member (for example, non-scientist, physician, oncologist, nurse, etc) for whom each alternate member may substitute.
- 4.6.4. The alternate member may serve as a voting member of the IRB when the regular member is unavailable to attend a convened meeting, or is conflicted.
- 4.6.5. When an alternate member substitutes for a regular member, the alternate member will receive and review the same materials prior to the IRB meeting that the regular member received or would have received.
- 4.6.6. The alternate member will not be counted as a voting member unless the regular member is absent or conflicted.
- 4.6.7. The IRB minutes will document when an alternate member replaces a regular member.
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4.7. Liability Coverage for IRB Members The Organization’s insurance coverage applies to employees and any other person authorized to act on behalf of the Organization within the scope of their employment or authorized activity.
ADMINISTRATIVE APPROVAL: Bruce Gordon, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS Russell McCulloh, MD
DOCUMENT HISTORY:
Written: 4/11/2016 (Approved: 4/11/2016) - original author not documented
Revised: 3/27/2018 - revision not documented
Revised: 7/29/2021 - Removed redundant material; removed references to pre-2019 Common Rule; clarified items included in roster of IRB members; clarified responsibilities of IRB chairs and Vice-Chairs.
Revised: 4/15/2022 - Clarified that an IRB administrator serving as a voting or alternate member of the IRB may not serve as primary reviewer for a protocol for which he/she primary administrator (section 4.5.9.2).
Revised: 7/14/2022 - Revised to clarify that consultants are not officially appointed by EC; removed reference to Compliance Officer as a consultant; clarified that IRB Administrators appointed as IRB members or alternate members by the IO, in consultation with the IRB Executive Chair; simplified designation of IRB administrators as scientists or non-scientists; specified that IRB administrators must have at least 2 years-experience with the ORA or another IRB, and must be approved by the IRB Executive Chairperson, before they can act as an expedited reviewer.
Revised: 10/11/2022 - Clarified that a consultant or a knowledgeable board member may provide information to the IRB regarding Community Based Participatory Research (section 3.9).
Revised: 4/3/2024 – clarified that assigned analyst may not be the primary reviewer for initial review, but may be for other actions (for example, CR, AE, incident reports) (section 5.4.9.3); deleted reference to “expedited review” in section 4.6.4.
Revised: 2/15/2025 – added requirement that each IRB which reviews research conducted at NM, CN, or BMC, or conducted by personnel affiliated with those medical facilities, will include at least one nurse as a voting member (section 3.9).
1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management
Last Revised: 9/25/2024
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for the identification and management of IRB member, consultant, staff and guest potential conflicts of interest. For the purpose of this policy, staff refers to IRB Analysts (whether voting members or not) and other employees of the ORA.
2.0 Policy
It is the policy of the Organization that:
- 2.1. All financial and non-financial interests which may represent a conflict of interest for an IRB member, consultant, staff or guest must be self-identified to the best of the individual’s knowledge, and appropriately managed to prevent such conflicts from interfering with the objectivity and validity of the review process.
- 2.2. Any financial interest of any monetary value by an IRB member, consultant, staff or guest at the meeting is considered a conflict of interest for the purposes of this policy.
- 2.3. Disclosure of the specifics of the conflict to the IRB and ORA is not required.
3.0 Definitions
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3.1. Covered Persons are IRB members, consultants, staff, or guests at an IRB meeting, and the immediate family members of a Covered Person (spouse, dependent children, parents or anyone that a Covered Person may claim as a dependent under the Internal Revenue Code).
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3.2. Conflicts of Interest are situations in which financial or non-financial interest may compromise, or have the appearance of compromising, a covered person’s professional judgment or objectivity in reviewing or evaluating research involving human subjects.
Note: In general, the covered person is not considered to have a conflict of interest if 1) the individual serves on the sponsor’s scientific advisory board for an area unrelated to the research under review; or 2) the individual serves on an NIH study section or FDA advisory committee, where it has been determined by the NIH/FDA that a conflict does not exist.
- 3.2.1. Financial Interest includes any of the following:
- 3.2.1.1. Salary, royalties (or a commitment for future royalties), consulting fees, honoraria, gift(s), or other payments that has been received in the last twelve months, will be received while the research is being conducted or will be received within twelve months after the research is completed.
- 3.2.1.2. An equity interest in the sponsor of the research (excluding mutual funds).
- 3.2.1.3. A position as director, officer, partner, trustee, or any other significant position in the company sponsoring the research or such position in the past twelve months.
- 3.2.1.4. Patent rights or royalties from such rights whose value may be affected by the outcome of the research, including royalties under any royalty-sharing agreements involving the Organization.
- 3.2.1.5. Financial interest (as defined above) in a company which has a marketed product, or is in the process of developing a new product which the covered person knows or would be reasonably expected to know, is, or will be, in direct market competition with the product in the protocol under IRB review.
- 3.2.2. Non-financial interest is a personal or professional circumstance that includes (but is not limited to):
- 3.2.2.1. Serving as an investigator, participating personnel, or coordinator for the protocol, or serving as a faculty advisor for a student as PI
- 3.2.2.1. Having a personal relationship, or a conflict, with any research personnel listed on the IRB application which would compromise, or have the appearance of compromising, a covered person’s professional judgment or objectivity in reviewing or evaluating research.
- 3.2.1. Financial Interest includes any of the following:
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3.5. Guests are persons attending the IRB meeting who are neither members, non-voting alternates, or IRB staff. Guests may be organizational officials (for example, Chief Compliance officer, or Privacy Officer), legal counsel, representatives of other components of the HRPP (for example, the FPBCC Scientific Review Committee) or other persons specifically invited to attend.
4.0 Procedures for identification and management of conflict of interest by members and consultants
- 4.1. IRB members (including IRB analysts serving as IRB members) must notify the ORA if they have a conflict related to any protocol being reviewed by the board at a which they are attending. If the member is assigned to review any action related to a protocol for which they have a conflict, they must notify the ORA in advance of the meeting so the protocol can be re-assigned to a non-conflicted member.
- 4.2. Consultants will be provided with this policy and must certify that they do not have a conflict of interest regarding the protocol on which they were asked to consult. They will be excluded from serving as a consultant if a conflict exists.
- 4.3. Prior to the beginning of each meeting, IRB members will be asked to declare the existence of any undisclosed conflicts, but are not required to describe the nature of the conflict.
- 4.4. An IRB member with a conflict of interest (other than serving as participating personnel; see below) must be absent from the meeting during discussion and voting for the protocol in question. The IRB member may not vote on any protocol where they have a conflict of interest. Upon request of the IRB, the member may provide information or respond to questions. The absent member is not counted towards determination of quorum during the vote on the protocol in question.
- 4.4.1. An IRB member whose only conflict is that they are participating personnel on a protocol may serve as an assigned protocol reviewer, and may participate in the discussion regarding the protocol, may remain in the meeting during the vote, but will abstain from voting.
- 4.4.2. If the conflicted member is attending the meeting by videoconference, “absent from the meeting” shall mean that the connection is terminated for the duration of the discussion and voting.
- 4.5. The IRB meeting minutes will specifically record when COI is the reason any IRB member is out of the room and did not vote.
- 4.6. An IRB member with a conflict of interest may not serve as an expedited reviewer for a protocol for which they have a conflict.
5.0 Procedures for identification and management of conflict of interest by IRB staff
- 5.1. IRB staff must notify the IRB Executive Chair/designee if a conflict exists with any proposed or active research study under the jurisdiction of the IRB.
- 5.2. IRB staff who have a conflict are excluded from serving as the primary IRB analyst assigned to process the study in question.
- 5.2.1. IRB staff who have previously served as study personnel for an active protocol may serve as the primary IRB analyst assigned to process the study; however, they may not be the sole expedited reviewer for any non-compliance, AEs or UPs in which they were directly involved during their tenure as study personnel.
- 5.3. IRB staff with a conflict of interest must be absent from the meeting during discussion and voting for the protocol in question.
6.0. Procedures for identification and management of conflict of interest by guests at the IRB meeting
- 6.1. Guests with a conflict of interest must be absent from the meeting during discussion and voting for the protocol in question.
DOCUMENT HISTORY:
Written: 12/29/2015 (Approved: 12/29/2015) - original author not recorded
Revised: 2/1/2018 - revision not documented
Revised: 10/10/2022 - Added identification and management of COI for a guest at IRB meeting; clarified that any financial interest by IRB members, consultants, staff and guests at the meeting is considered a significant financial interest within the context of this policy; clarified definitions of financial and non-financial COI; added definition of guest; clarified timing of disclosure of COI by IRB members; added IRB member whose only conflict is that he/she is participating personnel on a protocol may serve as protocol reviewer, and may participate in the discussion regarding the protocol, may remain in the meeting room during the vote, but will abstain from voting; added that IRB staff with COI must leave room during the discussion and voting phases of the review of the protocol in which they have a conflict; deleted option for member with COI to request exception from recusal; stylistic changes for clarity.
Revised: 9/25/2024 – stylistic changes
1.8 Investigational Activities Requiring IRB Review and Approval
Last Revised: 5/9/2023
1.0 Purpose
The purpose of this policy is to describe the investigational activities that require IRB approval.
2.0 Policy
It is the policy of the Organization that:
- 2.1. IRB review and approval is required for research involving human subjects which falls in the following categories regardless of the funding source:
- 2.1.1. Research conducted on the premises of any of the components of the Organization {defined in HRPP policy 1.1 Human Research Protection Program} by faculty, students, staff or other representatives of the Organization, or by any non-affiliated investigator.
- 2.1.2. Research performed elsewhere by faculty, students, staff or other representatives of the Organization, as a part of their institutional responsibilities. However, with approval of the IO an external IRB may be accepted as the IRB of record {in accordance with HRPP policy 1.4 UNMC Ceding Review to an External IRB}.
- 2.1.3. Research performed elsewhere by faculty, students, staff or other representatives of the Organization where the personnel are identified as being affiliated with the Organization (for example in research documents, publications, or clinical trial listings). However, with approval of the IO, an external IRB may be accepted as the IRB of record {in accordance with HRPP policy 1.4 UNMC Ceding Review to an External IRB}.
- 2.2. The IRB does not routinely review activities which do not meet the definition of human subject research, with the exception of research involving human fetal tissue and human embryonic stem cells
- 2.3. IRB review will be performed in accordance with the authorities granted by institutions within the Organization in {accordance with HRPP policy 1.2 Authority Granted to the IRB by the Organization]}.
3.0 Definitions
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3.1. HHS Regulations
- 3.1.1. Research is defined in the Federal Policy as, “any systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(l)). Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
- 3.1.1.1. The definition of “research” in the HIPAA Privacy Rule (45 CFR 164.501) is identical to that in the Federal Policy; that is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”)
- 3.1.1.2. Systematic investigation means an activity described in a protocol which includes a set of scientific aims or objectives, procedures to pursue the objectives (for example, interventions or interactions), analysis of the data, and conclusions drawn based upon the analysis.
- 3.1.1.3. The Belmont Report provides further clarification of “research” as follows: “… the term ‘research’ designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).”
- 3.1.1.4. Generalizable knowledge means conclusions, facts, or principles derived from the research which can be applied outside the specific study population and which enhance scientific or academic understanding. Generalizable knowledge usually includes one or more of the following concepts: Knowledge that contributes to a theoretical framework of an established body of knowledge; the primary beneficiaries of the research are other researchers, scholars, and practitioners in the field of study; dissemination of the results is intended to inform the field of study (though this alone does not make an activity constitute research “designed to contribute to generalizable knowledge”); the results are expected to be generalized to a larger population beyond the site of data collection; the results are intended to be replicated in other settings (after Emory University and UC Berkeley HRPP).
- 3.1.1.5. Certain activities described in section 6.0 are deemed not to be research, as per 45 CFR 46.102(l)
- 3.1.2. Human Subject is defined as “A living individual about whom an investigator (whether professional or student) conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens” (45 CFR 46.102(e))
- 3.1.2.1. Intervention means both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject’s environment that are performed for research procedures. The intervention was carried out either solely or partially for the purposes of research.
- 3.1.2.2. Interaction means communication or interpersonal contact between the PI and other study personnel with the subject. The interaction was carried out either solely or partially for the purposes of research.
- 3.1.2.3. Private information means information about behavior(s) of the subject that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical record).
- 3.1.2.4. Identifiable private information means private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- 3.1.2.5. Identifiable biospecimen means a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
- 3.1.3. Human subject research means research activities which involve human subjects.
- 3.1.4. Engagement in Human Subject Research. The UNMC HRPP follows the OHRP guidance (October 16, 2008) in determining whether an institution is engaged in human subject research. In general, the Organization will be considered engaged in research when its employees or agents (that is, individuals who act on behalf of the institution; exercise institutional authority or responsibility; or perform institutionally designated activities) for the purposes of research obtain:
- 3.1.4.1. Data about the subjects of the research through intervention or interaction with them; or
- 3.1.4.2. Identifiable private information about the subjects of the research; or
- 3.1.4.3. Informed consent of the human subjects of the research.
- 3.1.1. Research is defined in the Federal Policy as, “any systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(l)). Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
-
3.2. FDA Regulations
- 3.2.1. Human Subject is defined at 21 CFR 56.012(e) as “. . . an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.”
- 3.2.1.1. Under FDA’s current regulations governing the conduct of in vitro diagnostic device (IVD) studies, the definition of human subject includes individuals on whose tissue specimens, an IVD is used [21 CFR 812.3(p)]. However, if the specimen is not individually identifiable by the investigator or any other individuals associated with the investigation, including the sponsor, the FDA will exercise enforcement discretion with regard to the requirements for informed consent in accordance with guidance issued April 25, 2006 titled “Guidance on Informed Consent for In Vitro Diagnostic Device Studies using Leftover Human Specimens That Are Not Individually Identifiable.” The UNMC IRB will determine whether subjects can be individually identified and apply 21 CFR 50, 56 accordingly.
- 3.2.2. Clinical Investigation is defined at 21 CFR 56.102(c) as, “…any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under Section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.” “The terms research, clinical research, clinical study and clinical investigation are deemed to be synonymous for the purposes of FDA regulations.”
- 3.2.2.1. Experiments that must “meet the requirements for prior submission to the Food and Drug Administration under Section 505(i) of the Federal Food, Drug, and Cosmetic Act” means any use of a drug other than the use of an approved drug in the course of medical practice [21 CFR 312.3(b)].
- 3.2.2.2. Experiments that must “meet the requirements for prior submission to the Food and Drug Administration under Section 520(g) of the Federal, Food, Drug, and Cosmetic Act” means any activity that evaluates the safety or effectiveness of a device [21 CFR 812.2(a)]. Any activity in which results are being submitted to or held for inspection for FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research [21 CFR 50.3(c), 21 CFR 56.102(c)].
- 3.2.3. Test Article is defined at 21 CFR 56.102(l) as, “any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Act or under Sections 351 or 354-360F of the Public Health Service Act.”
- 3.2.4. Human drugs: The primary intended use of the product is achieved through chemical action or by being metabolized by the body.
- 3.2.4.1. A drug is defined as a substance recognized by an official pharmacopoeia or formulary:
- 3.2.4.2. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
- 3.2.4.3. A substance (other than food) intended to affect the structure or any function of the body.
- 3.2.4.4. A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. See http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm for further information.
- 3.2.5. Investigational new drug: An investigational new drug means a new drug or biological drug that is used in a clinical investigation.
- 3.2.6. Medical devices: A medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
- 3.2.7. Investigational Device: An investigational device means a device, including a transitional device, which is the object of a clinical investigation. As further defined, a device is any healthcare product that does not achieve its primary intended purpose by chemical action or by being metabolized.
- 3.2.8. Food additives: In its broadest sense, a food additive is any substance added to food. Legally, the term refers to “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.” This definition includes any substance used in the production, processing, treatment, packaging, transportation or storage of food.
- 3.2.9. Color additives: A color additive is any dye, pigment or substance which when added or applied to a food, drug, or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting color. http://www.fda.gov
- 3.2.10. Foods: Foods include dietary supplements that bear a nutrient content claim or a health claim.
- 3.2.11. Infant formulas: Infant formulas are liquid foods intended for infants which substitute for mother’s milk.
- 3.2.12. Investigator is defined 21 CFR 56.102(h) as, “an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.”
- 3.2.1. Human Subject is defined at 21 CFR 56.012(e) as “. . . an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.”
4.0 HRPP Classifications of Human Subject Research
- 4.1. Biomedical Research: Biomedical Research includes all human subject research performed with intent to develop or contribute to generalizable knowledge (i.e., test a hypothesis and draw conclusions) about human biological systems and processes, including efficacy and safety of preventative, diagnostic or therapeutic methods. Biomedical research usually falls into one of two categories:
- 4.1.1. “Therapeutic” research characterized as research which involves a drug, medical device, technique or other intervention or strategy (including non-physical means, like diet, cognitive therapy, etc.) to diagnose, treat, prevent or otherwise study a particular condition or disease
- 4.1.2. “Non-therapeutic" research characterized as research to study normal or abnormal physical or physiologic processes (for example, gait and balance testing, biomechanical assessments).
- 4.2. Human Biological Material Research: Human Biological Material (HBM) research includes the collection and/or use of human biological specimens obtained directly from human subjects or from other sources such as a biorepository (tissue bank) for purposes of research. The full range of human biological specimens includes sub-cellular structures (e.g., DNA); cells; tissues (e.g., blood, bone, muscle, connective tissue, teeth, and skin); organs; gametes (e.g., sperm and ova); and waste (e.g., hair, nail clippings, urine, feces, saliva, and sweat).
- 4.3. Medical Records Research: Medical Records Research utilizes individual medical or clinical records with subject identifiers for both retrospective and prospective studies.
- 4.4. Behavioral and Social Science Research: Behavioral and social science research includes all research performed with intent to study behaviors, attitudes and interactions and social processes among and between individuals, groups, and cultures. Generally this category of research has no intent of producing a diagnostic, preventive, or therapeutic benefit to the subject who is not seeking nor expecting a health benefit from the research.
5.0 Activities Which Are Not Human Subject Research
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5.1. Systematic investigation involving data or human biological materials (HBM) without investigator access to subject identifiers: A systematic investigation involving data or HBM obtained from living individuals where (1) there are no identifiers which would allow any of the investigators to readily identify the individual, and (2) where the specimen or data was not collected specifically for the purposes of the research does not constitute human subject research under this policy. Required de-identification (i.e., the number of identifiers which must be removed) before the data or HBM is given to the investigator depends on whether or not the research is subject to HIPAA.
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5.2. Innovative Therapy: Physicians and other health care professionals are free to engage in innovative therapy if the innovative procedure is applied solely to enhance the well-being of their patient and is based upon sound clinical judgment. However, when innovative therapy differs significantly from routine practice it should be viewed and treated as such with appropriate safeguards in place to protect the rights and welfare of the patients through formal IRB review of a promising therapy in the context of a clinical trial. Therefore, in order to validate innovative therapy, the innovative procedure should be subjected early on to IRB review as a formal research protocol.
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5.3. Quality Improvement Activities: QI activities take place in a particular localized health care setting, their design is expected to incorporate the specific features of the setting, they are led by people who work in that setting, and they incorporate rapid feedback of results to bring about positive change for the patients in that setting. Instead of a fixed protocol implemented for a time period that may last for years, QI methods often require repeated modifications in the initial protocol as experience accumulates over time and as the desired changes engage the local structures, processes, patterns, habits, and traditions.
It is often difficult to determine whether a particular activity constitutes QI or research; therefore, a conversation between the person designing the activity, and the IRB, is useful and encouraged.
In general Quality Improvement activities have the following characteristics:
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5.3.1. The activity is intended to improve the process/delivery of care while decreasing inefficiencies within a specific health care setting
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5.3.2. The activity is intended to evaluate current practice and/or attempt to improve it based upon existing knowledge
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5.3.3. There is sufficient existing evidence to support implementing this activity to create practice change
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5.3.4. The activity is conducted by clinicians and staff who provide care or are responsible for the practice change in the institutions where the activity will take place
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5.3.5. The methods for the activity are flexible and include approaches to evaluate rapid and incremental changes
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5.3.6. The activity will involve a sample of the population (patients/participants) ordinarily seen in the institution where the activity will take place
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5.3.7. The planned activity will only require consent that is already obtained in clinical practice, and could the activity be considered part of the usual care
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5.3.8. Future patients/participants at the institution where the planned activity will be implemented will potentially benefit from the project
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5.3.9. The risk to patients/participants is no greater than what is involved in the care they are already receiving OR participating in the activity can be considered acceptable or ordinarily expected when practice changes are implemented within a health care environment.
Note: Publishing or presenting the results of a quality improvement project does not necessarily mean the activity is research. Descriptions of non-research activities (e.g., an account of the quality improvement project) are often an expected outcome of the project. On the other hand, re-analysis of the data derived from the quality improvement project in order to prove or disprove a hypothesis is research. Depending on whether or not subject identifiers are maintained, it may qualify as exempt research.
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5.4. Program Assessment: Program assessment (or program evaluation) is a systematic collection of information about the activities, characteristics and outcomes of a specific program or model, to contribute to continuous program improvement, and/or to inform decisions about future program development https://www.cdc.gov/evaluation/php/about/?CDC_AAref_Val=https://www.cdc.gov/evaluation/. Program assessments do not constitute human subject research under this policy.
In general, Program Assessments have the following characteristics:
- 5.4.1. Intent of project is to evaluate a specific program, only to provide information for and about that program.
- 5.4.2. Activities are not designed to develop or contribute to generalizable knowledge; does not involve randomization of individuals, but may involve comparison of variations in programs.
- 5.4.3. Activities are mandated by the program, usually its funder, as part of its operations.
- 5.4.4. Findings of the evaluation are expected to directly affect the conduct of the program and identify improvements.
- 5.4.5. No benefit to participants expected; evaluation concentrates on program improvements or whether the program should continue. (Source: Oregon State University)
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5.5. Case Histories: Descriptive case histories which are published and/or presented at national or regional meetings are not considered research if the case is limited solely to a description of the clinical features and/or outcome of individual patients.
Note: When a physician or other health care professional authors a case history that is not research, ethical guidelines should, nevertheless, be taken into consideration; specifically, Informed consent should be obtained from the patient; and appropriate safeguards to protect confidentiality should be in place.
Note: If a case history involves multiple patients with concomitant analysis and correlation of data as part of a systematic investigation, it is considered research. Depending on whether or not subject identifiers are maintained, it may qualify as exempt research.
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5.6. Student Projects: A systematic investigation conducted by a student that involves living individuals but is performed solely to meet educational requirements of a single academic course is not considered human subject research providing the results of the investigation are presented only within the confines of the classroom or similar forum and to the students, their instructors, parents/family members, or a limited number of other invited guests. This does not include presentation in a student research fair or forum, where the public are invited or have easy access.
Note: It is recommended that the students’ supervisor and/or department exert appropriate review and oversight of the project, including, for example, completion of an IRB application without submission to the IRB.
Note: A systematic investigation conducted by a student with intent to present the results of the investigation outside of the confines of the institution does constitute human subject research.
Note: An investigation conducted to meet educational requirements with no intent to present the results of the investigation outside of the organization, but is then re-analyzed in order to prove or disprove a hypothesis does constitute human subject research.
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5.7. Pilot Testing: small investigations characterized as “pilot testing” prior to conduct of research are not considered human subject research provided the procedures meet the following conditions:
- 5.7.1. Pilot testing is limited to interventions intended to test the equipment or the methodology, or to refine the parameters of the protocol, or to train the student to use the equipment.
- 5.7.2. The pilot testing is not explicitly named as one of the aims of the research.
- 5.7.3. The data generated from the pilot testing is not retained after the completion of the specific goals of the pilot testing (as per 5.7.1 above)
- 5.7.4. The data generated from the pilot testing is not presented in any public format (abstract, poster, or publication) nor used as background material for a grant application or similar purpose.
- 5.7.5. The pilot testing will only involve healthy volunteers (preferably research staff) as participants.
- 5.7.6. The pilot testing procedures constitute no greater than minimal risk to participants.
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5.8. Secondary research involving non-identifiable newborn screening blood spots.
6.0. Other Activities Deemed Not Research
Other activities specifically defined in 45 CFR 46.102(l) are deemed “not research.” These activities include:
- 6.1. Scholarly and journalistic activities
- 6.1.1. This includes, but is not limited to, oral history, journalism, biography, literary criticism, legal research, and historical scholarship, including the collection and use of information that focuses directly on the specific individuals about whom the information is collected. There is no attempt to perform a systematic analysis of the data in order to draw conclusions or test a hypothesis for the purpose of developing or contributing to generalizable knowledge.
- 6.1.2. Studies using methods such as participant observation and ethnographic studies, in which investigators gather information from individuals in order to understand their beliefs, customs, and practices, and the findings apply to the studied community or group, and not just the individuals from whom the information was obtained fall with the scope of the definition of research.
- 6.2. Public health surveillance activities
- 6.2.1. The collection and testing of information or biospecimens conducted, supported, requested, ordered, required, or authorized by a public health authority.
- 6.2.2. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products).
- 6.3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- 6.4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
7.0 Determination of When an Activity Constitutes Human Subject Research
- 7.1. Individuals should contact the ORA for guidance in determining whether or not a proposed activity constitutes human subjects research. An IRB Administrator, in consultation with the IRB Executive Chair/designee as necessary, will determine whether or not the planned activities constitute human subject research, using the OHRP Human Subject Decision Charts, the criteria in sections 4, 5 and 6 of this policy, and if necessary consultation with OHRP.
- 7.2. Once a determination is made, the investigator will be so informed.
8.0 Type of Review
- 8.1. The type of IRB review required depends upon the proposal classification:
- 8.1.1. Full Board (FB) research will be reviewed by the IRB in accordance with HRPP policy 2.2.
- 8.1.2. Expedited (EP) studies will be reviewed by the IRB in accordance with HRPP policy 2.3.
- 8.1.3. Exempt (EX) research will be reviewed by the ORA in accordance with HRPP policy 2.6.
- 8.2. The IRB Administrators and/or the IRB Executive Chair/designee will use the OHRP Human Subject Decision Charts as necessary in determination of the type of review.
DOCUMENT HISTORY:
Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded
Revised: 9/27/2017 - revision not documented
Revised: 3/3/2018 - revision not documented
Revised: 2/18/2019 - revision not documented
Revised: 10/4/2022 - Removed references to “after effective date of revised regulations”; deleted redundant descriptions of activities deemed not research per 46.102(l); simplified section 7.0 to remove specific IRB and ORA procedures.
Revised: 2/8/2023 – revised section 7.0 to describe use of website NHSR Decision Tool.
Revised: 5/9/2023 – clarified characteristics of Student Projects (section 5.6); added description and defined parameters of Pilot Testing (section 5.7).
1.9 Resources Necessary to Protect Subjects
Last Revised: 1/16/2025
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for resources that are necessary for human subject protection, care of research participants, and safety during the conduct of research.
2.0 Policy
It is the policy of the Organization that
- 2.1. There must be adequate resources to protect human subjects during the conduct of research.
- 2.2. The Principal Investigator is responsible for ensuring the necessary resources are available to protect the rights and welfare of human subjects.
3.0 PI Responsibilities
- 3.1. The PI must describe in the IRB application resources that are available to safely conduct research at each study site specified in the IRB application. Such resources include (but are not limited to):
- 3.1.1. The PI and all investigators have the necessary qualifications, experience and credentials to conduct the research.
- 3.1.2. There are an adequate number of qualified, licensed and credentialed research personnel available and assigned to conduct the research.
- 3.1.3. The PI has adequate time (in consideration of other academic or employment obligations, and other research protocols in which they are participating) to conduct and complete the research.
- 3.1.4. The PI has, or will have, necessary the financial resources to conduct the research.
- 3.1.5. There is adequate physical space, clinical resources (as appropriate), laboratory equipment (as appropriate), clerical and administrative support, data analysis and storage capability, and other resources necessary to complete the research.
- 3.1.6. There is appropriate emergency equipment, personnel, or services necessary to respond promptly to adverse events or unanticipated problems involving risk to the subject or others.
- 3.1.7. For research protocols conducted solely by the Organization, investigators have ethical access to a sufficient number of potential subjects to meet the scientific aims of the research.
- 3.1.8. As appropriate based on the nature of and potential risks associated with the research, there are adequate available medical or psychosocial resources (for example, medical services, counseling, social support services).
- 3.1.9. As appropriate, there are adequate resources necessary to facilitate communication with individuals who do not speak English or who have additional needs or vulnerabilities.
- 3.2. Submission of the application by the PI constitutes an assurance that resources described in the application are, or will be, available for the expected duration of the protocol.
- 3.3. The PI must notify the IRB if, during the course of the research, there are significant changes in the availability of researchers or if the necessary resources become unavailable.
4.0 IRB Responsibilities
- 4.1. In accordance with HRPP policy 2.5 (Criteria for IRB Approval) the IRB or expedited reviewer will review resources available as described in the IRB application at initial submission and at continuing review.
- 4.2. Significant changes in availability of resources reported by the PI or research team will be reviewed by the IRB to determine if ethical and regulatory criteria for approval continue to be met, and if the research can continue to be safely conducted. If the necessary resources cannot be obtained and adequate protection of human subjects cannot be assured, the IRB may suspend or terminate the research, in accordance with HRPP policy 8.6 (Study Hold, Suspension, and Termination).
DOCUMENT HISTORY:
Written: 5/6/2016 (Approved: 5/6/2016) - original author not documented
Revised: 9/27/2017 - revision not documented
Revised: 3/3/2018 - revision not documented
Revised: 1/16/2025 – deleted requirement for certification by Departmental Chairperson/authorized delegate or appointed review committee that resources are available; added that PI or research team must report significant changes in the availability of resources (section 3.3); added that significant changes in availability of resources reported by the PI or research team will be reviewed by the IRB; stylistic changes.
1.10 Scientific and Other Committee Review of Research
Last Revised: 4/8/2025
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for scientific and scholarly merit review, and for review by other component committees of the HRPP, of all non-exempt human subject research conducted under the jurisdiction of the UNMC IRB.
2.0 Policy
It is the policy of the Organization that
- 2.1. All human subject research must undergo a substantive scientific and scholarly merit review, either by the Department, Division, School, College, or Institute (collectively, “Unit”) prior to submission to the IRB, or by the IRB (or expedited reviewer) if no such process exists within the Unit.
- 2.2. Human subject research under oversight of the UNMC IRB will also be reviewed by other component committees of the HRPP, as appropriate and as dictated by institutional requirements and policies.
- 2.3. All non-exempt human subject research conducted at the Organization under the oversight of an external IRB will be reviewed by other component committees of the HRPP as appropriate (as per HRPP Policy 1.4) before the research will be released.
- 2.4. All human subject research conducted at external sites where the UNMC IRB is the IRB of record will undergo review by component committees of the relying institution, in accordance with the policies of that institution.
3.0 Department, Division, School, College, or Institute (collectively, “Unit”) Review of Scientific Merit
- 3.1. The PI is responsible for obtaining scientific review of all human subject research prior to submission to the IRB, if a process for such review exists within the Unit. The person or committee responsible for this review will vary depending on the type of research, and the processes and requirements of the PI’s Unit. The scientific review should focus on assuring:
- 3.1.1. The research has a sound scientific design; that is, the research is designed using accepted principles, methods, and practices, the methods are practically feasible, the research has a clear scientific objective, the research has sufficient power to definitively test the objective, and the research offers a plausible data analysis plan.
- 3.1.2. The research has an acceptable level of scientific/scholarly merit and the knowledge to be gained from the research is sufficiently important.
- 3.2. The IRB will also evaluate the scientific and scholarly merit of all proposed studies, using the same criteria. If the IRB does not have the appropriate disciplinary expertise for review of the protocol, the Board will utilize a consultant. In its evaluation, the IRB will take into consideration review by the PI’s Unit, as well as other external reviews.
4.0 Reviews by Other Components of the HRPP
Depending upon the nature of the research, proposals may be subject to additional review and approval by one or more components of the HRPP. None of these components has the authority to approve human subject research that has not yet been approved by the IRB, or has been disapproved by the IRB, as per HRPP policy 1.2 (Authority Granted to the IRB by the Organization).
- 4.1. Fred & Pamela Buffett Cancer Center (FPBCC) Scientific Review Committee (SRC)
- 4.1.1. The FPBCC is a National Cancer Institute (NCI) designated cancer center. As such, a mandatory element of the cancer center is a functioning Scientific Review Committee (SRC).
- 4.1.2. The SRC reviews the scientific aspects of industry sponsored and investigator-initiated cancer-related research involving human subjects conducted by members of the UNMC faculty and students and members of the Fred & Pamela Buffett Cancer Center.
- 4.1.3. The SRC is responsible for:
- 4.1.3.1. Evaluating all new and amended clinical research protocols for scientific merit and to ensure that there are adequate resources available to successfully complete the proposed research.
- 4.1.3.2. Monitoring accrual to active protocols to ensure that studies meet their accrual goals and to require a reassessment of recruitment strategies and/or accrual goals when necessary.
- 4.1.3.3. Ensuring that there are no competing studies with overlapping eligibility criteria for a specific disease indication.
- 4.1.3.4. Establishing each protocol’s priority based on NCI guidelines and institutional priorities.
- 4.1.3.5. Performing annual scientific review of open cancer center protocols, as per SRC policies.
- 4.1.4. A designated IRB Analyst attends meetings of the SRC as the IRB representative, and a representative of the FPBCC SRC attends the meetings of IRB-01 and IRB-02.
- 4.1.5. New cancer related human subject research, and changes to approved cancer related protocols, will be reviewed by the SRC as per their policies. This review may occur before or following IRB review.
- 4.1.5.1. All UNMC investigator-initiated cancer related studies must be reviewed and approved by SRC prior to review by the IRB.
- 4.1.6. If SRC review occurs before IRB review, SRC review and approval letters are uploaded to RSS and are available to assigned IRB reviewers.
- 4.1.7. If SRC review follows IRB review, the designated IRB Analyst in consultation with the IRB Executive Chair, or one of the Chairs or Vice-Chairs, will be responsible for assuring that no substantive changes have been made to the protocol or the consent forms by the SRC. If substantive changes have been made, additional review by the convened IRB will be required.
- 4.1.8. The SRC has access to RSS including all relevant IRB reviews.
- 4.1.9. For human subject research subject to SRC review, the ORA will not issue final release of a protocol until it has received notice of approval from the SRC, stating that all scientific requirements for the study have been met.
- 4.2. Pharmacy and Therapeutics Committee (P&T Committee)
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4.2.1. The Nebraska Medicine P&T Committee will review new non-exempt human subject research protocols involving any drugs or biologics to assess (1) if the drugs are appropriate in consideration of the proposed protocol and population, (2) if the route of administration is appropriate and will be safely monitored, and (3) the drugs will be administered only by authorized personnel. In addition, upon request of the IRB, the P&T Committee will also review research involving the administration of agents such as vitamins or other chemicals not classified as drugs.
Note: The Nebraska Medicine P&T Committee does not review research conducted at Children’s Nebraska (CN). Review of research involving investigational and marketed drugs conducted at CN is accomplished by a designated CN pharmacist who is a member of IRB-04.
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4.2.2. P&T Committee review may occur before or following IRB review.
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4.2.3. If P&T Committee review occurs before IRB review, the P&T review and any required modifications are uploaded to RSS and are available to assigned IRB reviewers.
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4.2.4. If the P&T Committee review follows IRB review, the ORA staff, in consultation with the designated IRB Analyst and the IRB Executive Chair, or one of the Chairs or Vice-Chairs will be responsible for assuring that no substantive changes have been requested by the P & T Committee. If substantive changes have been requested, additional review by the convened IRB will be required.
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4.2.5. The P&T Committee has access to RSS including all relevant IRB reviews.
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4.2.6. For human subject research subject to P&T Committee review, the ORA will not issue final release of a protocol until it has received notice of approval from the P&T Committee.
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4.2.7. If a Protocol Modification involves a change in dosing or route of administration of a study drug, or addition of a new study drug, P&T Committee will review, as above. The IRB will not approve a protocol modification until P&T Committee review is completed.
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- 4.3. Nebraska Medicine Investigational Device Review Committee (IDRC)
- 4.3.1. The IDRC reviews use of devices in research conducted within the components of the organization to assure compliance with HRPP policies. This includes receiving, storing, dispensing, returning or destroying investigational devices.
- 4.3.2. The IDRC review and any required modifications are uploaded to RSS and are available to assigned IRB reviewers.
- 4.3.4. For human subject research subject to IDRC review, the ORA will not issue final release of a protocol until it has received notice of release from the IDRC.
- 4.4. Center for Clinical & Translational Research (CCTR)
- 4.4.1. The CCTR manages the OnCore Clinical Trial Management System (CTMS) and generates the Clinical Study Calendar for clinical trials utilizing CTMS. The study calendar records protocol-specific scheduling of research related procedures/treatments and details how these procedures/treatments will be billed. The Study Calendar is submitted to the IRB thru RSS for clinical trials conducted at NM, UNMC or BMC.
- 4.4.1.1. Studies conducted at CN may submit a manually prepared billing grid for the same purpose.
- 4.4.2. CCTR conducts Coverage Analysis (CA), of any study that includes clinical care activities conducted at Nebraska Medicine/UNMC, based on the CTMS Study Calendar. The Coverage Analysis verifies conventional “standard” care vs. research only costs to identify what can or cannot be billed to a third-party payer (either private insurance or Medicare).
- 4.4.3. The Clinical Study Calendar and CA, if required, are uploaded to RSS and used by the ORA and the IRB in the assessment of financial risk to subjects associated with the research.
- 4.4.1. The CCTR manages the OnCore Clinical Trial Management System (CTMS) and generates the Clinical Study Calendar for clinical trials utilizing CTMS. The study calendar records protocol-specific scheduling of research related procedures/treatments and details how these procedures/treatments will be billed. The Study Calendar is submitted to the IRB thru RSS for clinical trials conducted at NM, UNMC or BMC.
- 4.5. UNMC Institutional Biosafety Committee (IBC)
- 4.5.1. The purpose of the Institutional Biosafety Committee (IBC) is to review research involving recombinant DNA molecules, materials containing recombinant DNA (including gene transfer and some vaccine trials), or research involving biohazardous materials.
- 4.5.2. A designated IRB Analyst attends meetings of the IBC as the IRB representative.
- 4.5.3. For research subject to both IRB and IBC review, IBC review may occur before or following IRB review. The ORA will be given a copy of the IBC review.
- 4.5.4. If IBC review occurs before IRB review, IBC review and approval letters are uploaded to RSS and are available to assigned IRB reviewers.
- 4.5.5. If IBC review follows IRB review, the designated IRB Analyst in consultation with the IRB Executive Chair, or one of the Chairs or Vice-Chairs, will be responsible for assuring that no substantive changes have been made to the protocol or the consent forms by the IBC. If substantive changes have been made, additional review by the convened IRB will be required
- 4.5.6. The IBC has access to RSS including all relevant IRB reviews.
- 4.5.7. For human subject research subject to IBC review, the ORA will not issue final release of a protocol until it has received notice of approval from the IBC.
- 4.6. Radioactive Drug Research Committee (RDRC) The RDRC is currently registered with the FDA as inactive. However, should a human subject protocol involve research with radioactive drugs, the RDRC would be activated and IRB approval contingent upon RDRC approval.
- 4.7. Export Control
- 4.7.1. The Export Control Office provides guidance and assistance concerning export controls and the permitting, licensing, packaging and shipping of research materials and data when UNMC personnel are conducting or participating in transnational research, as per HRPP policy 1.5 (Requirements for Research Conducted with International Sites).
- 4.7.2. For transnational human subject research, the ORA will not issue final release of a protocol until it has received notice of approval from the Export Control.
- 4.7.2.1. Research conducted at UNO or by UNO investigators must be reviewed and approved by the Director of Research Compliance (or designee) at UNO.
- 4.8. Conflict of Interest Committee (COIC) Refer to HRPP policy 1.25 Financial Conflicts of Interest.
- 4.9. Sponsored Programs Administration (SPA) and UNeHealth Refer to HRPP policy 1.12 Sponsored Research.
- 4.10. In addition, review by other committees not listed may be required on a permanent or ad hoc basis, for any or all protocols, as dictated by the institution and/or the Institutional Official.
DOCUMENT HISTORY:
Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded
Revised: 2/12/2018 - revision not documented
Revised: 5/17/2021 - Clarified responsibility for, and process of, scientific review; clarified responsibilities of the P&T Committee, and process of review; simplified description of function and activities of IDRC; clarified responsibilities of the IBC regarding human subject research; updated description of activities of CCTR; added reference to “other committees as directed by institution and/or IO”; clarified responsibilities of ORA vs IRB
Revised: 8/1/2023 - Corrected typographic errors; changed “administrator” to “analyst” {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}
Revised: 3/11/2025 - Specified responsibility for ancillary review of CIRB and SIRB protocols; clarified that scientific review will be undertaken by the investigator’s unit, if such a process exists within the unit; clarified scope and timing of SRC, P&T, IDRC and IBC reviews; added Export Control as ancillary committee of the HRPP, and defined scope and timing; clarified that IRB members have access to reviews by ancillary committees; stylistic changes.
Revised: 4/8/2025 – clarified scope of IDRC review (section 4.3.1).
1.11 HRPP Access to Legal Counsel
Last Revised: 2/11/2025
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for HRPP access to legal counsel for the purpose of interpreting federal, state, and local law.
2.0 Policy
It is the policy of the Organization that
- 2.1. The HRPP will have ready access to legal counsel in order to ensure the correct interpretation and application of federal, state, and local law.
- 2.2. When laws or regulations are issued or amended, the appropriate component of the HRPP will be advised in a timely manner and any necessary actions taken in accordance with effective dates.
3.0 Organizational Responsibilities
- 3.1. The IRB and ORA have access to legal counsel. Depending upon the issue, consultation will be obtained from one or more of the following individuals:
- 3.1.1. UNMC Chief Compliance Officer
- 3.1.2. UNMC Office of the General Counsel (GC)
- 3.1.3. University of Nebraska (NU) Office of the General Counsel
- 3.1.4. Children’s Nebraska General Counsel or Assistant GC
- 3.1.5. Children’s Nebraska Compliance Director / Privacy Director
- 3.1.6. Nebraska Medicine General Counsel / Chief Legal and Compliance Officer
- 3.2. The UNMC Chief Compliance Officer and the CN General Counsel or Compliance Director may attend meetings of the various IRBs as guests at their convenience, or at the request of the IRB and/or the IRB Chair or Executive Chair.
- 3.3. The Assistant Vice-Chancellor for Regulatory Affairs and the UNMC Chief Compliance Officer are responsible for advising the IO, the IRB and other HRPP components of new applicable legislation, as well as changes in interpretation of laws that impact human subject protection.
DOCUMENT HISTORY:
Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded
Revised: 2/2/2018 - revision not documented
Revised: 1/22/2025 – clarified job descriptions of persons available for legal consultation; clarified that legal may not regularly attend IRB meeting but are available for consultation; stylistic changes.
Revised: 2/11/2025 – added NM General Counsel and Chief Legal & Compliance Officer.
1.12 Sponsored Research
Revised: 6/12/2024
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for research sponsored by an external funding agency or commercial sponsor for which the UNMC IRB is the IRB of record. Organization and Sponsor requirements when the UNMC IRB relies on an external IRB are described in HRPP policy 1.4 (UNMC Ceding Review to External Central IRB).
2.0 Policy
It is the policy of the Organization that in sponsored research, both the Sponsor and the Organization have obligations to protect research participants and ensure that the research is conducted in accordance with the Organization’s ethical standards, and in full compliance with all applicable HRPP policies, federal regulations for protection of human subjects, state and local laws and regulations, and University of Nebraska Board of Regents By-Laws.
3.0 Definitions
- 3.1. Sponsor is defined as the company (pharmaceutical, device or biotechnology), other non-federal agencies, non-profit foundations, or individual donors providing financial or other support for a research study. Where applicable, the term sponsor also includes agents of sponsors (for example, contract research organizations).
- 3.2. Contract is defined as a study agreement executed between a commercial Sponsor and the Organization and signed by authorized representatives of each of the parties.
- 3.3. A Federal Awarding Agency is defined as a Federal agency that provides a Federal award directly to the Organization.
- 3.4. A Notice of Award is the legal document issued to a non-Federal entity (which would include the Organization) for a Federal Awarding Agency that an award has been made to support the study or project at the non-Federal entity.
- 3.5. A Subaward is an award of financial assistance made under a Notice of Award by a non-Federal entity to the Organization to carry out part of the scope of work or study.
- 3.6. A Subcontract is an agreement made under a contract between a commercial, non federal agency, or foundation to another entity, which that entity is passing down financial assistance and the terms and conditions of that contract to the Organization.
4.0. Investigator Responsibilities
- 4.1. The investigator is responsible for assuring that all appropriate approvals are obtained from UNeHealth and/or SPA prior to initiating any research interventions, including screening of potential subjects.
- 4.2. The investigator is responsible for assuring all charges for research activities are billed appropriately to the cost center or work order associated with the Contract, Notice of Award, Subaward or Subcontract.
- 4.2.1. Non-routine patient care costs which result from procedures performed solely for research purposes must be supported by the study budget and not charged to the subject and/or their third-party payors.
- 4.3. The investigator is responsible for promptly reporting to the IRB if they are advised by the sponsor of (1) any findings that could affect the safety of subjects or the willingness of subjects to continue participation in the study (for example, serious adverse events), or (2) any findings that could influence the conduct of the study, or (3) any noncompliance, or (4) any other information important to the IRB’s continued approval of the study.
- 4.4. The investigator is responsible for promptly reporting to the IRB if they are advised by the sponsor of any results of on-site monitoring conducted by the Sponsor at UNMC or other sites under the jurisdiction of the UNMC IRB.
- 4.5. The investigator is responsible for promptly initiating any corrective action required by the sponsor.
- 4.6. The investigator will notify subjects if they are advised by the sponsor after completion of the study of any findings that may directly affect the safety or medical care of subjects.
- 4.7. The investigator will complete the Charge for IRB Review of Commercially Sponsored Projects (Full Board and Expedited Review) form within RSS.
5.0. Sponsor Responsibilities
- 5.1. The Sponsor must promptly (no longer than 30 days) report to the Organization and/or PI any findings that could affect the safety of subjects, the willingness of subjects to continue participation in the study (e.g., serious adverse events), influence the conduct of the study, noncompliance, or other information important to the IRB’s continued approval of the study.
- 5.2. The Sponsor must provide the Organization with data safety monitoring reports as well as other routine or urgent reports promptly as indicated in the data and safety monitoring plan approved by the IRB.
- 5.3. The Sponsor must report to the Organization and/or PI any results of on-site monitoring conducted by the Sponsor at UNMC or other sites under the jurisdiction of the UNMC IRB.
- 5.4. The Sponsor must have a plan in place to notify the Organization and/or PI of the results upon completion of the study when the findings may directly affect the safety or medical care of subjects.
6.0. Organization Responsibilities
- 6.1. All Contracts, Subcontracts, and Subawards are reviewed by UNeHealth, UNMC Sponsored Programs Administration (SPA) or UNO SPA.
- 6.2. In negotiating contracts with commercial sponsors, UNeHealth and SPA will utilize template language which is consistent with requirements in Addendum I (Contract or Funding Arrangement) below, and with AAHRPP accreditation standards.
- 6.2.1. If a sponsor is unwilling to utilize approved template language, UNeHealth and SPA, in consultation with the Office of Regulatory Affairs, and appropriate legal counsel as needed, will determine whether the substitute language is consistent with requirements in Addendum I below, and with AAHRPP accreditation standards.
- 6.3. The Organization will not enter into a contract or other funding arrangement that does not obligate the sponsor (and/or the investigator) to fulfils its responsibilities as detailed in this policy, or that does not satisfy the requirements of Addendum I (Contract or Funding Arrangement) below.
- 6.4. When the Notice of Award or Contract agreement includes human research activities that will be conducted by investigators who are not employees or agents of the Organization, a Subcontract/Subaward must be executed between the Organization and the collaborating institution.
- 6.4.1. The Subcontract/Subaward will include the requirement for the collaborating institution to assure compliance with federal regulations for the protection of human subjects in research and to provide documentation of current and ongoing IRB approval.
- 6.4.2. The collaborating institution must also ensure that key personnel involved in human subject research are in compliance with the NIH policy on education in the protection of human research subjects and provide documentation of education of key personnel to the Organization.
- 6.5. The Organization will comply with the detailed study protocol, HRPP policies, and all applicable federal regulations.
7.0. ORA and/or IRB Responsibilities:
- 7.1. Contract Specialists and the Clinical Research Financial Compliance Specialist interact with Sponsors, investigators, legal counsel, IRB Executive Chair/designee and the IRB analysts to resolve identified issues and concerns.
- 7.2. If the IRB has already reviewed the project and the Contract, Subaward or Subcontract requires a major modification of the IRB application and/or ICFs, the convened IRB will re-review the study. “Major modification” is defined as per HRPP policy 2.4 (Review of Changes in Approved Research).
- 7.2.1. Minor modifications to the IRB Application and/or ICFs may be reviewed as expedited per HRPP policy 2.3 (Expedited Review).
- 7.3. The IRB will not issue a final release of commercially sponsored research until a fully executed Contract or Subcontract has been concluded.
- 7.4. The ORA and SPA or UNeHealth will communicate via RSS message portal, email, or another mechanism as appropriate to advise (1) when the Contract or Subcontract is fully executed, and (2) when the ORA has issued final approval and release of the research.
Addendum I Contract or Funding Arrangement: The contract or funding arrangement must include a clear definition of whether the Sponsor is responsible for the payment of medical care for research participants who experience a research related injury, and if responsible, the non-exculpatory limitations the sponsor has imposed on the extent of payment for medical care, and the location(s) where medical care can be obtained. This statement of responsibility must be consistent with the “Compensation in Case of Injury” clause found in the ICF. Indemnification language in the contract must not compromise the rights and welfare of research subjects. The contract must not include a financial bonus or financial penalty specifically linked to subject recruitment efforts (HRPP policy 3.7 Finders Fees and Recruitment Bonuses). The contract must not include any direct personal payments or other form of compensation from the Sponsor to investigators and other study personnel. The contract must not include any requirements which would cause the Organization to violate the HIPAA Privacy Rule. When PHI is provided to the Sponsor the Sponsor must refrain from using PHI to recruit subjects or advertise additional studies to subjects, refrain from using the PHI for marketing or market research and place the same restrictions on any third party to whom the Sponsor discloses PHI. The contract must not include any prohibition from retaining a copy of the data generated during the study at UNMC or other study sites under the jurisdiction of the UNMC IRB. The contract must not include any restrictions on publication of the results of the research which violate the University of Nebraska Board of Regents Policy (RP-3.2.8 (section 7; page 103)).
DOCUMENT HISTORY:
Written: 5/6/2022 (Approved: 5/6/2016) - original author not recorded
Revised: 2/8/2018 - revision not documented
Revise: 8/17/2023 – added definitions and language regarding subawards and subcontracts; reorganized to define specific responsibilities; provided specific AAHRPP requirements regarding contracts.
Revised: 2/23/2024 – clarified in Addendum I that sponsor is not obligated to provide compensation, but that the contract must specify whether compensation will be provided.
Revised: 6/12/2024 – clarified that policy applies to sponsored research for which the UNMC IRB is the IRB of record. Organization and Sponsor requirements when the UNMC IRB relies on an external IRB are described in HRPP policy 1.4 (UNMC Ceding Review to External Central IRB).
1.13 Compliance with ICH-GCP Guidelines
Last Revised: 2/2/2018
1.0 Purpose
The purpose of this policy and procedure is to describe the Organization’s requirements for compliance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) E6 Guidelines.
2.0 Policy
- 2.1. It is the policy of the Organization that, in addition to all applicable HRPP policies, the Organization will apply ICH-GCP E6 guidelines to IRB review and the conduct of clinical research when the sponsored agreement specifies adherence to ICH GCP.
- 2.2. It is the policy of the Organization that clinical trials subject to ICH-GCP will be conducted in accordance with the ethical principles that have the origin in the Declaration of Helsinki and that are consistent with good clinical practice and the applicable regulatory requirements.
3.0 Procedures
- 3.1. Contract Specialists notify the IRB via IRBORA whether the trial is subject to ICH-GCP Guidelines. The assigned IRB administrator reviews the submission for compliance with ICH-GCP.
- 3.2. When the protocol requires ICH GCP compliance, the IRB Administrator will ensure that the submission includes all necessary information in section 4.0.
- 3.3. When the full IRB reviews research that requires ICH GCP compliance, the IRB will ensure that all requirements are met prior to final approval.
4.0 ICH GCP Requirements
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4.1. New research and substantive scientific modifications to approved research shall undergo scientific review (including review by outside experts as needed) and that the review is considered by the IRB in accordance with HRPP policy 1.10 (Scientific and Other Committee Review of Research).
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4.2. In order to satisfy the ICH-GCP requirements, the IRB must be assured of the following:
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4.2.1. The PI is qualified by education, training, and experience to assume responsibility for the proper conduct of the trial and should meet all the qualifications specified by the applicable regulatory requirement(s). (ICH-GCP 4.1.1)
Note: The IRB relies upon the Organization’s credentialing process and the peer review certification. However, when any questions arise concerning qualifications the IRB may request an up-to-date Curriculum Vitae (CV) and additional documentation.
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4.2.2. A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, will provide the medical (or dental) care given to, and medical (or dental) decisions made on behalf of, subjects (ICH-GCP 4.3.1)
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4.2.3. The available nonclinical and clinical information of an investigational product is adequate to support the proposed clinical trial. For purposes of this requirement, “investigational product” means a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use (ICH-GCP 1.33 and 2.4), and
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4.2.4. The clinical trials is scientifically sound; adequately designed to answer the research question, and described in a clear, detailed protocol (ICH GCP 2.5).
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4.2.5. In addition to the elements described in HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects), consent form disclosures provide the following additional elements of information to potential subjects:
- 4.2.5.1. The approval by the IRB.
- 4.2.5.2. The probability for random assignment to each treatment.
- 4.2.5.3. The participant’s responsibilities.
- 4.2.5.4. When applicable, the reasonably foreseeable risks or inconveniences to an embryo, fetus, or nursing infant.
- **4.2.5.5. For alternative procedures or treatment that may be available to the subject, include the important potential benefits and risks of alternative procedures or treatments that may be available to the subject. (ICH-GCP 4.8.10(i)).
- 4.2.5.6. The subject should be made aware if there is no intended clinical benefit to the subject.
- 4.2.5.7. That the monitor, the auditor, the IRB, and the regulatory authority will be granted direct access to the subject’s original medical records for verification of clinical trial procedures or data, without violating the confidentiality of the subject, to the extent permitted by applicable laws and regulations and that, by signing a written consent form, the subject or the subject’s legally authorized representative is authorizing such access. (ICH GCP 4.8.10(n))
- 4.2.5.8. The subject’s identity will remain confidential if the trial results are published.
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4.2.6. Except as described in section 4.2.7 below, non-therapeutic clinical trials (trials in which there is no anticipated direct benefit to the subject), should be conducted in subjects who personally give consent and who sign and date the written informed consent form (ICH-GCP 4.8.13).
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4.2.7. Non-therapeutic clinical trials conducted in subjects with consent of a legally authorized representative (LAR) fulfill the following additional requirements (ICH-GCP 4.8.14):
- 4.2.7.1. The objectives of the clinical trial cannot be met by means of a trial in subjects who can give consent personally.
- 4.2.7.2. The foreseeable risks to the subjects are low.
- 4.2.7.3. The negative impact on the subject’s well-being is minimized and low.
- 4.2.7.4. The clinical trial is not prohibited by law.
- 4.2.7.5. The opinion of the IRBs is expressly sought on the inclusion of such subjects and the written opinion covers this aspect.
- 4.2.7.6. Such trials, unless an exception is justified, should be conducted inpatients having a disease or condition for which the investigational product is intended. Subjects in these trials should be particularly closely monitored and should be withdrawn if they appear to be unduly distressed.
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4.2.8. In those situations where there is an exception for the requirements for informed consent for planned emergency research, the subject, or LAR, will be informed about the clinical trial as soon as possible and provide informed consent if the subject wishes to continue in the clinical trial.
Note: Currently there is no planned emergency research conducted within the Organization.
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4.3. In order to satisfy the ICH-GCP requirements, the PI must assure the following:
- 4.3.1. The PI must provide evidence of such qualifications through an up-to-date CV or other relevant documentation requested by the sponsor, the IRB, or the regulatory authority. (ICH GCP 8.2.10)
- 4.3.2. The PI must be thoroughly familiar with the appropriate use of the investigational products, as described in the protocol, in the current Investigator’s Brochure (IB), in the product information, and in other information sources provided by the sponsor. (ICH-GCP 4.1.2)
- 4.3.3. During and following a subject’s participation in a trial, the PI must ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the clinical trial. (ICH-GCP 4.3.2)
- 4.3.4. The PI must inform a subject when medical care is needed for other illnesses of which the investigator becomes aware. (ICH-GCP 4.3.2)
- 4.3.5. The PI must follow the trial’s randomization procedures, if any, and ensure that the code is broken only in accordance with the Protocol. If the trial is blinded, the PI will promptly document and explain to the sponsor any premature unblinding. (ICH-GCP 4.7)
- 4.3.6. When appropriate, the PI must inform the subject’s primary physician about the subject’s participation in the clinical trial if the subject has a primary physician and if the subject agrees to the primary physician being informed. (ICH-GCP 4.3.2)
- 4.3.7. Although a subject is not obliged to give his or her reasons for withdrawing prematurely from the clinical trial, the PI must make a reasonable effort to ascertain the reason, while fully respecting the subject’s rights. (ICH-GCP 4.3.4)
- 4.3.8. Where allowed or required, the PI may assign some or all duties for investigational articles accountability at the trial sites to an appropriate pharmacist or another appropriate individual who is under the supervision of the PI. (ICH-GCP 4.6.2)
- 4.3.9. The PI and the investigational pharmacist will, in accordance with hospital policy, maintain records of a drug or biological product delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused products. These records will include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational products and trial subjects. The PI will maintain records that document adequately that the subjects are provided the doses specified by the protocol and reconcile all investigational products received from the sponsor. (ICG-GCP 4.6.3)
- 4.3.10. The PI, or other designated individual, will maintain records of an investigational device, delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused products. These records will include dates, quantities, serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational device and trial subjects. The PI will maintain records that document adequately that the investigational device has been used as specified by the protocol and reconcile all investigational products received from the sponsor. (ICG-GCP 4.6.3)
- 4.3.11. The PI will permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority. (ICH-GCP 4.1.4)
- 4.3.12. The PI will ensure the accuracy, completeness, legibility, and timeliness of the data reports to the sponsor. (ICH-GCP 4.9.1)
- 4.3.13. The PI will report all serious adverse events (SAEs) or abnormal laboratory findings identified in the protocol as critical to safety evaluations to the sponsor according to the reporting requirements and within the time period specified by the sponsor in the protocol. The PI will follow regulatory requirements related to the reporting of unexpected serious adverse drug reactions to the regulatory authority and the IRB. (ICH-GCP 4.11.1)
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4.3.14. The PI will report to the sponsor, IRB, and, as applicable, the Organization (ICH GCP 4.10.2):
- 4.3.14.1. Any new information that may adversely affect the safety of the subject or the conduct of a clinical trial.
- 4.3.14.2. Any changes significantly affecting the conduct of the clinical trial, or increasing risk to subjects.
- 4.3.15. The PI will maintain the clinical trial documents as specified in Essential Documents for the Conduct of a Clinical Trial and as required by the applicable regulatory requirements. (ICH-GCP 4.9.4). Essential documents will be retained until at least two years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least two years have elapsed since the formal discontinuation of clinical development of the investigational product. (ICH-GCP 4.9.5)
- 4.3.16. If the PI terminates or suspends a clinical trial without prior agreement of the sponsor, the PI will inform the Organization, sponsor and the IRB. (ICH-GCP 4.12.1)
- 4.3.17. If the IRB terminates or suspends its approval of the clinical trial, the PI will promptly notify the sponsor. (ICH-GCP 4.12.3)
- 4.3.18. Upon completion of the trial, the PI will inform the IRB with a summary of the trial’s outcome, and the regulatory authority with any reports required. (ICH-GCP 4.13)
- 4.3.19. The PI will maintain a list of appropriately qualified persons to whom the PI has delegated significant trial-related duties. (ICH-GCP 4.1.5)
- 4.3.20. For reports of deaths, the PI will supply the sponsor and the IRB with any additional requested information (e.g., autopsy reports and terminal medical reports). (ICH-GCP 4.11.3)
DOCUMENT HISTORY:
Written: 1/25/2016 (Approved: 1/25/2016) - original author not recorded
Revised: 2/2/2018 - revision not documented
1.14 Research Subject to Department of Defense Regulatory Requirements
Last Revised: 1/10/2024
1.0 Purpose
The purpose of this policy and procedure is to specify the Organization’s requirements for the review, approval, conduct and oversight of human subject research funded by or involving the U.S. Department of Defense (DoD) and the U.S. Department of the Navy (DoN).
2.0 Policy
- 2.1. It is the policy of the Organization that it will comply fully with all approval requirements of DoD and DoN when its IRBs review, approve and provide oversight of human subjects research funded by or otherwise contractually subject to DoD or DoN regulations and requirements or uses a DoD/DoN property, facility or asset.
- 2.2. It is the policy of the Organization that the research specified in Section 2.1 above will comply with the following codes, regulations, and guidance:
- 2.2.1. The Belmont Report
- 2.2.2. 32 CFR 219, Department of Defense Regulations, “Protection of Human Subjects” (DoD adoption of the “Common Rule”)
- 2.2.3. Title 45 Code of Federal Regulations Part 46, (45 CFR 46) Department of Health and Human Services Regulations, “Protection of Human Subjects,” Subparts B, C, and D as made applicable by DoD Instruction (DoDI) 3216.02, 15 April 2020.
- 2.2.4. Title 21 Code of Federal Regulations 50, 56, 312, and 812, Food and Drug Administration (FDA) Regulations
- 2.2.5. DoDI 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and -Supported Research” April 15, 2020, Change 1, June 29, 2022.
- 2.2.6. Title 10 United States Code Section 980 (10 USC 980), “Limitation on Use of Humans as Experimental Subjects”
- 2.2.7. DoDD 3210.7, “Research Integrity and Misconduct”
- 2.2.8. DoDD 6200.2, “Use of Investigational New Drugs in Force Health Protection”
- 2.2.9. DoDI 1100.13, “DoD Surveys”, March 31, 2017.
- 2.2.10. When conducting research supported by the Department of the Navy
- 2.2.10.1. SECNAVINST 3900.39E of 29 May 2018
- 2.2.10.2. OPNAVINST 5300.8C of 24 April 2008
- 2.3. It is the policy of the Organization that research specified in Section 2.1 will comply with the following requirements, as applicable:
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2.3.1. Education and Training Requirements In addition to investigator and research staff training requirements as described in HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel), it is the Principal Investigator’s responsibility to ensure that research staff has completed all appropriate educational requirements as mandated by DoD policy. (per DoDI 3216.02, 15 April 2020, or later; http://www.onr.navy.mil/About-ONR/compliance-protections/Research-Protections/Research-Protection-Training-References.aspx.)
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2.3.2. Additional Protections for Pregnant Women, Prisoners, and Children {Subparts B, C and D) of 45 CFR 46) DoDD 3216.02, section 3.9}. In addition to protections described in HRPP policies 4.2 (Research Involving Pregnant Women, Human Fetuses, and Neonates), 4.3 (Research Involving Prisoners), 4.4 (Research Involving Children), and other policies as applicable, the following additional protections apply:
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2.3.2.1. Regarding Research Involving Pregnant Women and Human Fetuses: Research involving pregnant women, fetuses, or neonates as human subjects must comply with 45 CFR 46 subpart B except as below:
(1) For purposes of applying this section, the phrase “biomedical knowledge” is replaced with “generalizable knowledge.”
(2) The applicability of 45 CFR 46 subpart B is limited to research involving pregnant women as human subjects involved in HSR that is greater than minimal risk, and includes interventions, as defined in 32 CFR 219, or invasive procedures involving:
(a) The woman or the fetus; or
(b) Fetuses or neonates as human subjects.
(3) HSR using fetal tissue must comply with 42, U.S.C Chapter 6A, Subchapter III, Part H, 289g:
• Research or experimentation may not be conducted, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation:
• May enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or
• Will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
• The risk standard must be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.
• For human subject research that would not otherwise be approved but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates, written approval from the DOHRP must be obtained through the HPRO prior to research starting.
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2.3.2.2. Regarding Research Involving Prisoners Research involving prisoners as human subjects must comply with 45 CFR 46 subpart C except as below:
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2.3.2.2.1. In addition to the categories of permissible HSR involving prisoners identified in 45 CFR 46 subpart C two additional categories are permissible:
(a) Epidemiological research that meets the waiver criteria in accordance with Federal Register 68: 36929-36931, may be approved in accordance with the applicable requirements of 45 CFR 46 subpart C, DoDI 3612.02 and other applicable requirements.
(b) HSR that would otherwise meet exemption criteria may be conducted but must first be approved by an IRB and must meet the requirements in 45 CFR 46 subpart C, DoDI 3612.02, and other applicable requirements.
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2.3.2.2.2. When a previously enrolled human subject becomes a prisoner, and the protocol has not been reviewed and approved by the IRB in accordance with 45 CFR 46 subpart C, the PI must promptly notify the IRB and the Organization must notify the Human Research Protection Official (HRPO).
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2.3.2.2.2.1. All research interactions and interventions with the prisoner- subject (including obtaining identifiable private information) must cease until and unless:
• The IRB Executive Chair or designee determines that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner. In this case, the prisoner-participant may continue to participate until the convened IRB can review this request to approve a change in the research protocol and until the organizational official and DoD Component office review the IRB’s approval to change the research protocol.; or
• The convened IRB review and approves the protocol in accordance with 45 CFR 46 subpart C, DoDI 3612.02, and HRPP policy 4.3 (Research Involving Prisoners).
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2.3.2.2.3. Research may not involve detainees unless the research involves an investigational drug or device when the same product would be offered to members of the US military in the same location for the same medical condition.
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2.3.2.2.4. Research may not involve Prisoners of War.
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2.3.2.2.5. Research involving prisoners cannot be reviewed by the expedited review procedure.
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2.3.2.3. Regarding Research Involving Children: Research involving children as human subjects must comply with 45 CFR 45 subpart D. The DoD considers all active duty service members and all reserve component members in a Federal duty status to be adults; and therefore not subject to the protections of 45 CFR 46 subpart D. However, in the state of Nebraska, the age of majority is 19 years. Therefore, the Organization restricts participation in DoD research to 19 years of age or older.
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2.3.3. Additional Safeguards for Research Conducted with International Populations In addition to the requirements described in HRPP policy 1.5 (Requirements for Research Conducted at International Sites) the following apply:
- 2.3.3.1. Research involving human subjects who are not U.S. citizens or DoD personnel, conducted outside the United States, and its territories and possessions requires permission of the host country.
- 2.3.3.2. The institution shall confirm that all applicable national laws and requirements of the foreign country have been met. The IRB shall also consider the cultural sensitivities in the setting where the research will take place (SECNAVINST 3900.39E, section 3d).
- 2.3.3.3. Approval by the appropriate DoD component is required prior to research starting when human subjects research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens.
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2.3.4. Limitation of Waivers and Exceptions from Informed Consent
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2.3.4.1. Sections 219.116(e) and (f) of Title 32, CFR, identify conditions where an IRB may waive informed consent for DoD-conducted and DoD-supported HSR.
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2.3.4.2. Section 980 of Title 10, U.S.C. (1) Imposes limitations on waiving informed consent when DoD appropriated funds are used to finance the research; (2) Is applicable only to DoD-conducted and DoD-supported research when involving a human being as an experimental subject as defined in this issuance. Research involving a human being as an experimental subject, governed by Section 980 of Title 10, U.S.C., is a subset of research involving human subjects, regulated by Title 32, CFR; and (3) Is not applicable to exempt HSR.
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2.3.4.3. DoD component-level administrative review (CLAR) must be conducted when the research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b).
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2.3.4.4. For research involving a human being as an experimental subject to which Section 980 of Title 10, U.S.C., applies, informed consent must be obtained in advance from the experimental subject or the subject’s legal representative (consistent with Part 219 of Title 32, CFR, if the subject cannot consent). If consent is obtained from the subject’s legal representative, the intention of the key investigator must be for the research to be beneficial to the subject.
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2.3.4.5. For research governed by Section 980 of Title 10, U.S.C., that involves no more than minimal risk, as defined by Part 219 of Title 32, CFR, an IRB may alter or waive other required elements of informed consent pursuant to Part 219 of Title 32, CFR, so long as it still preserves informed consent of the subject (i.e., the consent indicates the subject’s participation in the research is completely voluntary and includes the requirement that the subject is informed of research risks).
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2.3.4.6. The advance informed consent requirement pursuant to Section 980 of Title 10, U.S.C., may be waived by the DOHRP or its delegate, if the following conditions are met:
(1) The research is to advance the development of a medical product necessary to the DoD;
(2) The research may directly benefit the individual experimental subject; and
(3) The research is conducted in compliance with all other applicable laws and regulations.
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2.3.5. Limitations on Compensation for U.S. Military Personnel
- 2.3.5.1. Federal employees while on duty (including military personnel) may be compensated for blood draws for research for up to $50 for each blood draw. Compensation is not allowed for general research participation.
- 2.3.5.2. Federal employees while off-duty (including military personnel) may be compensated for blood draws for research for up to $50 for each blood draw. Compensation is allowed for general research participation, as approved by the IRB; however, payment may not come directly from a federal source.
- 2.3.5.3. Non-Federal personnel may be compensated for blood draws for research for up to $50 for each blood draw. Compensation is allowed for general research participation, as approved by the IRB; payment may come from any federal or non- federal source.
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2.3.6. Requirements for Informed Consent Forms In addition to requirements described in HRPP policy 5.1 (Obtaining Informed Consent From Research Subjects) the following apply:
- 2.3.6.1. If the research includes any risks to the fitness for duty for DoD personnel (e.g., health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about these risks and that they should seek command or Component guidance before participating.
- 2.3.6.2. The informed consent document must include, if applicable, potential risks for the revocation of clearance, credentials, or other privileged access or duty
- 2.3.6.3. The informed consent document must include a statement that the DoD or a DoD organization is funding the study, and a statement that representatives of the DoD are authorized to review research records.
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2.3.7. Provisions for Research with Human Subjects using Investigational Test Articles (Drugs, Device and Biologics): PIs may not be sponsors for INDs and IDEs.
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2.3.8. Classified Research
- 2.3.8.1. Classified research must receive prior approval from the DoD Office for Human Research Protections.
- 2.3.8.2. Classified research will be conducted following the requirements of DoD Instruction 3216.02 section 3.13.
- 2.3.8.3. Classified research is not eligible for review under expedited review procedures, or for a waiver of consent.
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2.3.9. Undue Influence [DoDD 3216.02, para.4.4.4]
- 2.3.9.1. Superiors are prohibited from influencing the decisions of their subordinates regarding participation as subjects in research involving human subjects and shall not be present at any human subject recruitment sessions or during the consent process.
- 2.3.9.2. For research involving service members as human subjects that has been determined to be greater than minimal risk and when recruitment occurs in a group setting, the IRB shall appoint an ombudsman. The ombudsman shall not be associated in any way to the research and shall be present during the recruitment in order to monitor that the voluntary involvement or recruitment of the Service members is clearly and adequately stressed and that the information provided about the research is clear, adequate, and accurate.
- 2.3.9.3. For research involving service members as human subjects, that has been determined to be NO greater than minimal risk and when recruitment occurs in a group setting, and for research involving DoD civilians, the IRB shall determine when it is appropriate to appoint an ombudsman for the purposes described above. The decision to require the appointment of an ombudsman should be based in part on the human subject population, the consent process, and the recruitment strategy.
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2.3.10. Requirements for Research Related Injury
- 2.3.10.1. Consent for DoD-supported research that is greater than minimal risk must include information about available compensation or medical treatments if a research-related injury occurs.
- 2.3.10.2. For research subject to Department of the Navy (DON) requirements, every project involving greater than minimal risk shall include an arrangement for emergency treatment and necessary follow-up of any research-related injury. The IRB will determine whether research involving minimal risk also might include a similar arrangement for research-related injury.
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2.3.11. Requirements for Reporting
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2.3.11.1. When participating in DoD supported non-exempt human subject research, the organization must provide to the HRPO:
(1) documentation that the DoD- supported HSR has been reviewed and approved by an IRB, including scientific merit, amendments, and additional reviews;
(2) documentation of key investigators’ human research protection training;
(3) IRB-approved protocol documents; and
(4) current FWA and IRB registration numbers.
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2.3.11.2. When participating in DoD supported exempt human subject research, the organization must submit institutional documentation of the determination that the research is exempt HSR to the HRPO, to include all protocol documents.
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2.3.11.3. When participating in DoD supported non-exempt human subject research the Organization must promptly (within 30 days) notify the HRPO of the following:
- 2.3.11.3.1. IRB-approved changes to HSR that involve changes to key investigators or institutions; decreased benefit or increased risk to subjects in greater than minimal risk research as defined in 32 CFR 219; addition of vulnerable populations, or DoD-affiliated personnel as subjects.
- 2.3.11.3.2. Transfer of HSR oversight to a different IRB.
- 2.3.11.3.3. Notification by any federal body, State agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that the non-DoD institution’s DoD-supported HSR is under investigation.
- 2.3.11.3.4. Any unanticipated problems involving risks to subjects or others, suspension or termination of IRB approval, or any serious or continuing noncompliance pertaining to DoD-supported HSR.
- 2.3.11.3.5. The results of the IRB’s continuing review, if required.
- 2.3.11.3.6. Change in status when a previously enrolled human subject becomes pregnant, or when the researcher learns that a previously enrolled human subject is pregnant, and the protocol was not reviewed and approved by the IRB in accordance with 45 CFR 46 subpart B.
- 2.3.11.3.7. Change in status when a previously enrolled human subject becomes a prisoner, and the protocol was not reviewed and approved by the IRB in accordance with 45 CFR 46 subpart C.
- 2.3.11.3.8. A DoD-supported study’s closure.
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2.3.11.4. When participating in DoD supported non-exempt human subject research the Organization must make records that document compliance or noncompliance with DoDI 3612.02 accessible for inspection and copying, as determined by DoD Human Research Protection Program personnel, by authorized DoD representatives.
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2.3.11.5. When participating in DoN supported non-exempt human subject research, the organization must inform the Department of the Navy (DON) HRPP Office (within 30 days of the incident) of any of the following:
- 2.3.11.5.1. The initiation and results of investigations into allegations of noncompliance.
- 2.3.11.5.2. Serious adverse events; or audits, investigations, or inspections of research.
- 2.3.11.5.3. Audits, investigations, or inspections of the Organization HRPP conducted by outside entities.
- 2.3.11.5.4. Significant communication between institutions conducting research and other federal departments and agencies regarding compliance and oversight.
- 2.3.11.5.5. All restrictions, suspensions, or terminations of the Organization assurances.
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2.3.12. Requirements for a Medical Monitor: For DoD-supported research, prior to April 15, 2020, a named independent research monitor was required for greater than minimal risk research and was optional for minimal risk research. As of April 15, 2020, a research monitor is no longer required by the DoD for DoD-supported research, regardless of risk level.
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2.3.13. Requirements for Survey Research:
- 2.3.13.1. The Principal Investigator for any DoD-supported research involving surveys is responsible for arranging for the review of the survey by the appropriate DoD component. This review is in addition to review by the IRB. For DON funded survey research, a Privacy Act Statement must be displayed prominently on all Navy personnel surveys. The statement will identify the authority for survey administration (including OPNAV RCS), advise respondents of the purpose and routine uses of the survey, indicate that the survey is voluntary, explain the intended use(s) of the data, and describe measures used to safeguard confidentiality (OPNAVINST 5300.8C).
- 2.3.13.2. Surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD Information Management Control Officer (IMCO) after the research protocol is reviewed and approved by the IRB. When a survey crosses DoD components, additional review is required. The Principal Investigator is responsible for this process and should work with the DoD component to obtain approval.
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2.3.14. Requirements for DoD Oversight: The HRPP will support the oversight by the sponsoring DoD component, including communicating to the sponsoring DoD component about:
- 2.3.14.1. information needed to assure that the approval of the initial submission is in compliance with all applicable requirements; and
- 2.3.14.2. IRB-approved substantive changes, including a notification that the Principal Investigator is informed that the changes cannot be implemented prior to acceptance by the sponsoring DoD component; and
- 2.3.14.3. the results of the continuing review; and
- 2.3.14.4. other information reported as required by section 2.3.11 (Requirements for Reporting) above.
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2.3.15. Research involving Chemical or Biological Agents
- 2.3.15.1. The organization does not permit research involving chemical or biological agents.
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2.3.16. Confidentiality of Research Data
- 2.3.16.1. Data or information acquired by the DoD component under a pledge of confidentiality for exclusively statistical purposes must be used exclusively for statistical purposes and may not be disclosed in identifiable form for any other purpose, except with the informed consent of the respondent (per DoDI 3216.02 June 29, 2022)
- 2.3.16.2. All studies involving large scale genomic data collected on/from DoD- affiliated personnel will apply an DHHS Certificate of Confidentiality (per DoDI 3216.02 June 29, 2022).
-
3.0 Definitions
- 3.1. For DoD supported research, the following definitions apply (and supersede definitions in other HRPP policies) Research Involving a Human Being as an Experimental Subject - An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects. This definition relates only to the application of Section 980 of Title 10, U.S.C.; it does not affect the application of Part 219 of Title 32, CFR.
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3.1.1. Minimal Risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (32 CFR 219). This definition does not include the inherent occupational risks that certain subjects face in their everyday life, such as those:
(1) encountered by Service members, law enforcement, or first responders while on duty;
(2) resulting from or associated with high-risk behaviors or pursuits;
(3) experienced by individuals whose medical conditions involve frequent tests or constant pain (DoDI 3216.02 section 3.8b).
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3.1.2. DoD Components - refers collectively to the organizational entities within the DoD that are subject to the human subjects protections laid out in Department of Defense Instructions (DoDI) 3216.02. These entities include the Office of the Secretary of Defense (OSD), the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD.
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3.1.3. Support of a Study - funds or assistance that are provided by the DoD to non-DoD institutions for HSR through a grant, contract, or similar arrangement subject to the DFARS or other applicable DoD regulations, such as the DoD Grant and Agreement Regulations. Included in this definition is the DoD’s provision of assistance to non-DoD institutions, whether or not through collaboration between DoD and non-DoD institutions, such as facilities, equipment, personnel (investigators or other personnel performing tasks identified in the research protocol), access to or information about DoD-affiliated personnel for recruitment, or data or specimens.
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3.1.4. Detainee - any individual captured by, or transferred to the custody or control of, DoD personnel pursuant to the law of war. This does not include persons being held solely for law enforcement purposes, except where the United States is the occupying power. Detainees who are U.S. citizens or U.S. resident aliens will continue to enjoy all applicable rights and privileges under U.S. law and DoD regulations (DoDD 2310.01E).
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3.1.5. DoD Personnel - Service members, Reserve Service members, National Guard members, DoD civilians, and DoD contractors. (DoDI 3216.02).
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3.1.6. Service Members - Individuals appointed, enlisted, or inducted for military service under the authority of the DoD. The Military Services are the Army; the Navy, including the Coast Guard under circumstances involving the declaration of war; the Air Force; the Marine Corps; and the Reserve Components. Members of the Reserve Components are included when in a duty status.
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3.1.7. Human Research Protection Official (HRPO) - A federal employee designated by a DoD Component or institution to conduct administrative review of DoD-supported research and whose review of DoD-supported research is intended to ensure compliance with DoD HSR requirements.
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4.0 Procedures
- 4.1. When reviewing research subject to DoD regulatory requirements, IRB members will be provided with a copy of this policy (HRPP policy 1.14) along with the IRB application, consent form, protocol, and all other related documents.
- 4.2. The IRB will review the application and consult the Research Subject to Department of Defense Research Regulatory Requirements Checklist to ensure compliance with all applicable DoD requirements, DoN requirements, and requirements of this and all other HRPP policies.
- 4.3. As appropriate and required (per section 2.3.9 above) the IRB will appoint an ombudsman to protect the rights of service members.
- 4.4. The IRB Analyst responsible for the protocol will assure that the PI has:
- 4.4.1. Notified appropriate DoD entities, as described above, and confirmed that the DoD component has conducted an administrative review as required by DoDI 3612.02 section 3.5b.
- 4.4.2. Uploaded a copy of the DoD component approval and all applicable additional DoD approvals, including, but not limited to, those required for survey, waiver or international research in the RSS system. Research will not be released until the appropriate DoD approvals are on file.
- 4.5. The IRB Analyst responsible for the protocol will:
- 4.5.1. Assure the Organization has a valid FWA as required by DoDI 3612.02 section 3.4a.
- 4.5.2. Assure that the requirements of this policy are met.
- 4.5.3. Assure that the informed consent form complies with provisions of section 2.3.6 (Requirements for Informed Consent Forms) above.
- 4.5.4. Make reports to the DoD (or have the PI make reports to the DoD) as described above.
DOCUMENT HISTORY:
Written: 4/13/2016 (Approved: 4/13/2016) - original author not recorded
Revised: 3/3/2018 - revision not documented
Revised: 6/4/2021 - Reorganized; extensive revisions based on revisions to DoDI 3216.02, 15 April 2020, SECNAVINST 3900.39E, 29 May 2018
Revised: 8/7/2023 - added 2.3.15 and 2.3.16; revised 2.3.4 per DoDI 3216.02, April 15, 2020 Change 1, June 29, 2022.
Revised: 1/10/2024 - Revised section 2.3.2.1 to describe specific restrictions associated with 42 USC Chapter 6A, Subchapter III, Part H, 289g; revised section 2.3.3 to specify that approval by the appropriate DoD component is required prior to research starting when human subjects research is conducted in a foreign country; revised section 2.3.4 to specify that DoD component-level administrative review (CLAR) must be conducted when the research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b); revised section 2.3.13 to specify that surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD Information Management Control Officer (IMCO) after the research protocol is reviewed and approved by the IRB; revised section 4.4.2 to clarify that the IRB Analyst responsible for the protocol will assure that the PI has uploaded a copy of the DoD component approval and all applicable additional DoD approvals, and that research will not be released until the appropriate DoD approvals are on file; other minor wording changes for clarity.
1.15 Research Subject to Department of Justice Regulatory Requirements
Last Revised: 4/20/2016
1.0 Purpose
The purpose of this policy and procedure is to specify the Organizations requirements for the review, approval, conduct and oversight of human subject research funded by or involving the U.S. Department of Justice (DoJ) and the Federal Bureau of Prisons (BoP).
2.0 Policy
- 2.1. It is the policy of the Organization that it will comply fully with all approval requirements of DoJ and/or BoP when its IRBs review, approve and provide oversight of human subjects research funded by or otherwise contractually subject to DoJ regulations (28 CFR 46) and BoP regulations (28 CFR 512).
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2.2. The Organization requires that the research specified in Section 2.1 above will comply with the following DoJ requirements as applicable:
- 2.2.1. The Belmont Report.
- 2.2.2. Title 28 Code of Federal Regulations Part 46 (28 CFR 46), Department of Justice Regulations, “Protection of Human Subjects” (DoJ adoption of the “Common Rule”).
- 2.2.3. Title 28 Code of Federal Regulations Part 512 (28 CFR 512), Bureau of Prisons Regulations, “Research”.
- 2.2.4. Title 28 Code of Federal Regulations Part 22 (28 CFR 22), Confidentiality of Identifiable Research and Statistical Information.
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2.3. Education and Training
- 2.3.1. All research personnel must complete training in accordance with HRPP policy #1.23 (HRPP Training Requirements and Opportunities for Research Personnel).
- 2.3.2. Any other specific training related to DOJ requirements will be provided as necessary by the ORA.
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2.4. Responsibilities
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2.4.1. Research Funded by the Department of Justice [28 CFR 46]
- 2.4.1.1. It is the responsibility of the PI to ensure compliance with all additional DoJ requirements for human subject protection.
- 2.4.1.2. It is the responsibility of the IRB to ensure that all additional DoJ requirements for human subject protection have been met before IRB approval of the research project.
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2.4.2. Research Conducted Within the Bureau of Prisons
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2.4.2.1. Regulatory Compliance [28 CFR 512]
- 2.4.2.1.1. It is the responsibility of the PI to ensure compliance with all additional BoP requirements for human subject protection.
- 2.4.2.1.2. All research proposals must be reviewed and approved by the Bureau Research Review Board (BRRB).
- 2.4.2.1.3. It is the position of the Organization that the IRB of record should, whenever possible, be the IRB appointed by the warden of the facility where the research will be conducted in accordance with 28 CFR 512.14. When multiple facilities are involved, the UNMC IRB may accept IRB approvals from multiple facilities, as appropriate.
- 2.4.2.1.4. It is the responsibility of the IRB to ensure that all additional BoP requirements for human subject protection have been met before IRB approval of the research project.
- 2.4.2.2. Limitations on Research Projects [28 CFR 512.11(a)(3)]: Research involving human subjects conducted within the BoP must not involve medical experimentation, cosmetic research, or pharmaceutical testing.
- 2.4.2.3. Academic Preparation or Experience [28 CFR 512.11(a)(6)]: The PI must have academic preparation or experience in the area of study of the proposed research.
- 2.4.2.4. Personnel [28 CFR 512.11(a)(7)]: For all research conducted within the BoP, the PI assumes responsibility for actions of any person engaged to participate in the research study as an associate, assistant (i.e., personnel listed in Section I of the IRB application) or subcontractor(s).
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2.4.2.5. Limitations on Incentives for Inmate Subjects [28 CFR 512.11(a)(5)]
- 2.4.2.5.1. Incentives may not be offered to help persuade inmate subjects to participate in research. However, soft drinks and snacks to be consumed at the test setting may be offered.
- 2.4.2.5.2. Reasonable accommodations such as a nominal monetary recompense for time and effort may be offered to non-confined research subjects who are both: 1) No longer in BoP custody and 2) participating in authorized research being conducted by BoP employees or contractors.
- 2.4.2.6. For research conducted within the Bureau of Prisons, implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered research.
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2.4.2.1. Regulatory Compliance [28 CFR 512]
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2.4.1. Research Funded by the Department of Justice [28 CFR 46]
3.0 Definitions [28 CFR 46.102]
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3.1. Human subject is defined a living individual about whom an investigator (whether professional or student) conducting research obtains:
- 3.1.1. Data through intervention or interaction with the individual and/or
- 3.1.2. Identifiable private information.
- 3.2. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulation of the subject or the subject’s environment that are performed for research purposes.
- 3.3. Interaction includes communication or interpersonal contact between PI and contact.
- 3.4. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the PI or associated with the information) in order for obtaining the information to constitute research involving human subjects.
4.0 Procedures
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4.1. Research funded by the Department of Justice
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4.1.1. The IRB will review the application and complete the Department of Justice Checklist and ensure compliance with all applicable DoJ requirements, BoP requirements, and HRPP policies.
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4.1.2. Requirement for Privacy and Confidentiality [28 CFR 22]: All research funded by the DoJ must maintain the following documents:
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4.1.2.1. A privacy certificate approved by the National Institute of Justice (NIJ) Human Subjects Protection Officer. A Privacy Certificate Template and Privacy Certificate Guidance are available on the National Institutes of Justice Website.
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4.1.2.2. Signed employee confidentiality statements for the PI and research staff, which are maintained by the PI.
Note: “Research staff” is defined as anyone listed in Section I of an approved IRB application.
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4.1.3. Requirement for Informed Consent [28 CFR 46.116; 28 CFR 22]: Research involving human subjects funded by the DoJ must include the following information in the ICF:
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4.1.3.1. The name(s) of the funding agency(ies)
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4.1.3.2. A statement describing the extent to which confidentiality of records identifying the subject will be maintained. For studies sponsored by the NIJ, the subject should be informed that private, identifiable information will be kept confidential and will only be used for research and statistical purposes. If, due to sample size or some unique feature, the identity of the individual cannot be maintained, the subjects need to be explicitly notified. If the PI intends to disclose any information, the subject needs to be explicitly informed what information would be disclosed, under what circumstances, and to whom. The subject must be informed of any risks that might results from this disclosure and must explicitly provide written consent prior to participating in the research.
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4.1.3.3. Under a privacy certificate, PIs and research personnel do not have to report child abuse unless the subject signs another ICF to allow child abuse reporting.
Note: It is the position of the University of Nebraska that child abuse must be reported in accordance with Nebraska State Law. Therefore, the ICF must disclose this obligation.
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4.1.4. Requirement for Reporting: For research studies involving human subjects funded by the DoJ, a copy of all data must be de-identified and sent to the National Archive of Criminal Justice Data, including copies of the ICF, data collection instruments, surveys, or other relevant research materials.
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4.2. Research conducted within the Bureau of Prisons
- 4.2.1. The IRB will review the application and complete the Department of Justice Checklist and ensure compliance with all applicable DoJ requirements, BoP requirements, and HRPP policies.
- 4.2.2. The research design must be compatible with both the operation of prison facilities and protection of human subjects. The PI must observe the rules of the institution or office in which the research is conducted.
- 4.2.3. The research must have an adequate research design and contribute to the advancement of knowledge about corrections.
- 4.2.4. The selection of subjects within in one organization must be equitable.
- 4.2.5. Any researcher who is a non-employee of the BoP must sign a statement in which the researcher agrees to adhere to the provisions of 28 CFR 512.
- 4.2.6. For research conducted within the Bureau of Prisons, the researcher must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
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4.2.7. For all research conducted within the Bureau of Prison, the PI must provide the following information:
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4.2.7.1. A summary statement, which includes:
- 4.2.7.1.1. Names and current affiliations of the Researchers
- 4.2.7.1.2. Title of the study
- 4.2.7.1.3. Purpose of the study
- 4.2.7.1.4. Location of the study
- 4.2.7.1.5. Methods to be employed
- 4.2.7.1.6. Anticipated results
- 4.2.7.1.7. Duration of the study
- 4.2.7.1.8. Number of participants (staff or inmates) required and amount of time required from each
- 4.2.7.1.9. Indication of risk or discomfort involved as a result of participation
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4.2.7.2. A comprehensive statement, which includes:
- 4.2.7.2.1. Review of related literature.
- 4.2.7.2.2. Detailed description of the research method.
- 4.2.7.2.3. Significance of anticipated results and their contribution to the advancement of knowledge.
- 4.2.7.2.4. Specific resources required from the BoP.
- 4.2.7.2.5. Description of all possible risk, discomforts and benefits to individual participants or a class of participants, and a discussion of the likelihood that the risks or discomforts will actually occur.
- 4.2.7.2.6. Description of steps taken to minimize any risks.
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4.2.7.2.7. Description of physical or administrative procedures to be followed to:
- 4.2.7.2.7.1. Ensure the security of any individually identifiable data that are being collected for the study.
- 4.2.7.2.7.2. Destroy research records or remove individual identifiers from those records when the research has been completed.
- 4.2.7.2.8. Description of any anticipated effect of the research study in organizational programs and operations.
- 4.2.7.2.9. Relevant research materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules.
- 4.2.7.2.10. A statement regarding assurance and certification required by 28 CFR 46, if applicable.
- 4.2.7.3. The researcher must demonstrate academic preparation of experience in the area of study of the proposed research.
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4.2.7.1. A summary statement, which includes:
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4.2.8. Requirement for Confidentiality [28 CFR 512.11, 12, 13, 15]: For all research conducted with the BoP:
- 4.2.8.1. A non-employee of the BoP may receive records in a form not individually identifiable when an advance adequate written assurance that the record will be used solely as a statistical research or reporting record.
- 4.2.8.2. Except as noted in the consent statement to the subject, the PI must not provide research data that identifies the subject to any person without that subject’s prior written consent to release the information. For example, research information identifiable to a particular individual cannot be admitted as evidence or used for any purpose in any action, suit, or other judicial, administrative, or legislative proceeding without the written consent of the individual to who the data pertains.
- 4.2.8.3. Except for computerized data records maintained at an official DoJ site, records that contain non-disclosable information directly traceable to a specific person may not be stored in, or introduced into, an electronic retrieval system.
- 4.2.8.4. If the PI is conducting a study of special interest to the Office of Research and Evaluation (ORE), but the study is not a joint project involving the ORE, the PI may be asked to provide ORE with the computerized research data, not identifiable to individual subjects, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the study.
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4.2.9. Requirement for Informed Consent [28 CFR 512.16]: Research involving human subjects conducted within the BoP, must include the following elements of disclosure in the ICF:
- 4.2.9.1. Identification of the PI and research personnel listed in Section I of the IRB application.
- 4.2.9.2. Anticipated uses of the results of the research.
- 4.2.9.3. A statement that participation is completely voluntary and that the subject may withdraw consent and end participation in the study at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable).
- 4.2.9.4. A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, a PI may not guarantee confidentiality when the subject indicates intent to commit future criminal conduct or harm himself or herself or someone else, or, if the subject is an inmate, indicates intent to leave the facility without authorization.
- 4.2.9.5. A statement that participation in the study will have no effect on the inmate subject’s release date or parole eligibility.
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4.2.10. Documentation and Waiver of Signed Informed Consent [28 CFR 512.16(a)(12)]
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4.2.10.1. A PI who is a non-employee of the BoP, in addition to presenting the statement of informed consent to the subject, shall also obtain the subject’s signature on the statement of informed consent prior to initiating the research activity.
The PI may not be required to obtain the signature if the PI can demonstrate that:- 4.2.10.1.1. The only link to the subject’s identity is the signed statement of informed consent, or
- 4.2.10.1.2. That there is significantly more risk to the subject if the statement is signed.
- 4.2.10.2. The signed statement shall be submitted to the chairperson of the IRB of record.
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4.2.10.1. A PI who is a non-employee of the BoP, in addition to presenting the statement of informed consent to the subject, shall also obtain the subject’s signature on the statement of informed consent prior to initiating the research activity.
- 4.2.11. Request for Change [28 CFR 512.11(a)(14)]: The PI must submit planned methodological changes in a research study to the IRB for approval, and may be required to revise study procedures in accordance with the new methodology.
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4.2.12. Requirement for Reporting [28 CFR 512.19]: For research studies involving human subjects conducted within the BoP, the PI is responsible for the submission of the following:
- 4.2.12.1. A progress report of the research at least once a year to the Chief and ORE.
- 4.2.12.2. A copy of any report of findings, including an abstract, must be provided at least 12 days working days before it is to be released to the chairperson of the BRRB, the regional director and the warden of each institution which provided data or assistance.
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4.2.13. Requirement for Publication of Results [28 CFR 512.20]
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4.2.13.1. For all research conducted within the BoP, the publication of results of any research studies involving human subjects is permitted in book form and professional journals. In any publication, the PI is responsible for the following:
- 4.2.13.1.1. An acknowledgment of the BoP’s participation in the research study.
- 4.2.13.1.2. Expressly disclaiming approval or endorsement of the published material as an expression of the policies or views of the Bureau.
- 4.2.13.2. Prior to submitting for publication, the PI will provide two copies of the material, for informational purposes only, to the Chief, ORE, Central Office, Bureau of Prisons.
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4.2.13.1. For all research conducted within the BoP, the publication of results of any research studies involving human subjects is permitted in book form and professional journals. In any publication, the PI is responsible for the following:
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4.3. Additional Requirements
- 4.3.1. New research and substantive scientific amendments to approved research shall undergo scientific review (including review by outside experts as needed) and that the review is considered by the IRB in accordance with HRPP policy #1.10 (Scientific and Other Committee Review of Research).
- 4.3.2. Disclosure regarding the provisions for research-related injury follows the requirements of the DoJ component.
DOCUMENT HISTORY:
Written: 4/20/2016 (Approved: 4/20/2016) - original author not recorded.
1.16 ORA Record Keeping Requirements
Last Revised: 01/17/2024
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for maintenance of documentation of IRB and ORA activities. Retention of records by the investigator is described in HRPP policy 1.17 (Retention of Research Records).
2.0 Policy
It is the policy of the Organization that the ORA will maintain documentation of all IRB activities in accordance with 45 CFR 46.115 and 21 CFR 56.115 as applicable. Records for each protocol will be organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of the protocol.
3.0 Procedures
- 3.1. Format of Protocol Files: In accordance with 45 CFR 46.115 and 21 CFR 56.115, the ORA will maintain, in paper or electronic format:
- 3.1.1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, records of protocol modifications, and reports of injuries to subjects.
- 3.1.2. Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
- 3.1.3. Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in §46.109(f)(1).
- 3.1.4. Copies of all correspondence between the IRB and the investigators.
- 3.1.5. A list of IRB members in the same detail as described in §46.108(a)(2).
- 3.1.6. Written procedures for the IRB in the same detail as described in §46.108(a)(3) and (4).
- 3.1.7. Statements of significant new findings provided to subjects, as required by§46.116(c)(5).
- 3.1.8. The rationale for an expedited reviewer's determination under §46.110(b)(1)(i) that research appearing on the expedited review list described in §46.110(a) is more than minimal risk.
- 3.1.9. Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in §46.103(e).
- 3.2. Records of protocol related activities submitted electronically through RSS are maintained indefinitely in RSS.
- 3.3. Records of protocol related activities submitted on paper are maintained in UNMC storage in either CD-ROM or paper format. Files will be maintained by the ORA as described in HRPP 1.17 (Retention of Research Records).
- 3.4. Records of protocol related activities will be retained by the investigator as described in HRPP 1.17 (Retention of Research Records).
- 3.5. Copies of IRB agendas, minutes, IRB member Curriculum Vitae, and IRB membership rosters are maintained within RSS or as electronic or paper documents within the ORA.
- 3.6. Copies of all educational items given to the IRB members are maintained within RSS, or as electronic or paper documents within the ORA.
- 3.7. Copies of HRPP policies are maintained on the UNMC website, accessible directly or thru a link in RSS.
4.0. Availability of IRB and ORA records
All IRB records are accessible for inspection and copying at reasonable times and in a reasonable manner in accordance with 45 CFR 46.115 and 21 CFR 56.115.
DOCUMENT HISTORY:
Written: 4/7/2016 (Approved: 4/7/2016) - original author not recorded
Revised: 2/2/2018 - revision not documented
Revised: 10/11/2022 - typo corrected in 3.2.27.2/3.2.27.3 - rational to rationale {by Robert Lewis, IRB Assoc}
Revised: 7/22/2022 - Extensive revisions; removed list of items to be retained, and substituted appropriate regulatory language; specified location of retained records; clarified duration of retention of paper records (per HRPP 1.17).
Revised: 01/17/2024 – Modified 3.1.1 to specify that records of protocol modifications will be retained along with other documents.
1.17 Retention of Research Records
Last Revised: 6/30/2022
1.0 Purpose
The purpose of this policy is to describe the requirements for retention of research records by the investigator.
2.0 Policy
It is the policy of the Organization that all research records must be maintained and stored securely, in accordance with Nebraska State Law, for at least seven years beyond the termination of the study or longer as required by sponsors.
- 2.1. All records associated with non-exempt human subject must be retained securely, for at least seven years beyond the termination of the study or longer as required by sponsors. If records include subject identifiers, those identifiers must be retained with the research records.
- 2.1. All records associated with exempt human subject research must be retained securely for at least three years beyond the termination of the study.
3.0 Required Records
-
3.1. Research records include:
- 3.1.1. All applications, other forms, communications, reports and other documents created in, or stored in, RSS. For the purposes of this policy the presence of this information within RSS constitutes retention.
- 3.1.2. Subject files including original signed consent documents, case report forms, laboratory results and other applicable information.
- 3.1.3. All communications between the investigator and the sponsor or funder, or, for multisite studies, between the local investigator and other investigators or coordinating center(s).
- 3.2. For applications and reports generated within RSS (for example, the IRB Application, Request for Change, Continuing Review, Report of Protocol Deviation), a paper copy may be printed an retained as above, or the presence of the information within RSS constitutes “retention” of the record for the purpose of this policy.
4.0 Department Retention of Records
-
4.1. If the PI resigns or otherwise departs from the Organization before the end of the designated retention period, the PI’s department or college maintain the research records.
- 4.1.1. If the research is conducted by a student, the faculty advisor is responsible for assuring retention of records as above.
- 4.1.2. If the PI is volunteer faculty then the Dean or other person taking responsibility for assuring the PI fulfills his/her responsibilities (as described in HRPP 1.26 {PI Qualifications and Responsibilities}) must maintain the research records.
- 4.2. The PI may request a copy of the research records in accordance with applicable Organizational policies
ADDENDUM
Under the HIPAA Privacy Rule, subjects have the right to ask the Organization for an accounting of certain disclosures of their identifiable health information for a period dating 6 years from the date of the last covered disclosure. To ensure that the Organization can meet this accounting requirement, investigators must retain study records, along with records of all disclosures of study information, for at least 7 years after either of the following (whichever is later) (1) the last subject has completed his or her participation in the study; or (2) the date of the last disclosure of identifiable health information from study records, if disclosures continue after all subjects have completed the study. {45 CFR 164.528}
DHHS regulations require that, “records relating to research which is conducted shall be retained for at least 3 years after completion of the research.” {45 CFR 46.115(b)}
FDA requires that sponsors and investigators participating in research subject to IND regulations retain “records and reports required by this part for 2 years after a marketing application is approved for the drug; or if an application is not approved for drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA so notified.” {21 CFR 312.57(c)} FDA requires that sponsors and investigators participating in research subject to IDE regulations retain the records “for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated of completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.” {21 CFR 812.140(d)}
DOCUMENT HISTORY:
Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded (original policy #3.5)
Revised: 2/2/2018 - revision not documented
Revised: 2/18/2019 - revision not documented
Revised: 4/15/2022 - deleted reference to Nebraska law; clarified that records must retain identifiers; revised to delete list of items to be retained; specified responsibility of faculty advisor for student conduct research; added regulatory requirements as addendum.
Revised: 6/30/2022 - revised to state that records associated with exempt research only need to be retained for three years; added statement regarding records retention for volunteer faculty (section 4.1.2).
1.18 Review and Approval of HRPP Policies and Procedures
Last Revised: 11/13/2024
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for the review and approval of HRPP policies.
2.0 Policy
It is the policy of the Organization to continually assess the adequacy of existent policies in consideration of new information and Organizational requirements that may affect the HRPP, including federal, state, and local laws, regulations, and guidance, as well as emerging ethical and scientific issues.
3.0 Review of HRPP Policies
- 3.1. The IRB Analysts, the Assistant Vice-Chancellor for Regulatory Affairs, the IRB Executive Chair, and IO will review HRPP policies on a rolling basis, with a target of review of policies at least every three years. However, anytime a policy requires revision due to new or revised federal, state or local laws, federal regulations or guidance, changes in Organizational requirements, or identification of deficiencies, the policy will be revised accordingly.
- 3.2. New HRPP policies which are (1) regulatory in nature (that is, which are dictated by federal, state, and local laws, regulations, and guidance), or (2) which solely describe ORA processes, will be provided to the IRBs for their information, but do not require approval by the IRBs.
- 3.3. New HRPP policies which include substantive extra-regulatory issues will be reviewed and approved by the IRBs that have scheduled meetings, the IO, and in select cases, other Organizational officials.
- 3.4. Modifications to existing HRPP policies that are (1) regulatory in nature (that is, which are dictated by federal, state, and local laws, regulations, and guidance), or (2) which solely describe ORA processes, or (3) which are limited to stylistic changes and/or corrections of typographic or other minor errors, will be provided to the IRBs for their information, but do not require approval by the IRBs.
- 3.5. Modifications to existing HRPP policies which include substantive extra-regulatory changes will be reviewed and approved by the IRBs that have scheduled meetings, the IO, and in select cases, other Organizational officials.
- 3.6. New HRPP policies, or modifications to existing HRPP policies which represent substantive extra-regulatory changes, but which affect only one specific board (for example, the RR-IRB [IRB-03] or IRB-06) will be reviewed and approved only by that board.
- 3.7. All new and revised HRPP policies must be approved by the IO and the Assistant Vice-Chancellor for Regulatory Affairs. The Assistant Vice-Chancellor for Regulatory Affairs, in consultation with the IO, will determine when policies also should be reviewed by other Organizational Officials (for example, Compliance Officer, Privacy Officer, General Counsel, and/or Vice Chancellor for Research).
- 3.7.1. New and revised HRPP policies that do not require IRB approval as above will be approved by the IO prior to notification of the board. New and revised HRPP policies that require IRB approval (section 3.3) will be reviewed by the boards prior to approval of the IO.
4.0 Full IRB Review of Draft HRPP Policies
- 4.1. New and revised HRPP policies requiring review by the full IRB as above will either be (1) discussed at all regularly scheduled IRB meetings, or (2) subject to an email vote, as described below.
- 4.2. Review at convened IRB meetings
- 4.2.1. IRB members will receive a copy of the policy to be reviewed with the detailed meeting agenda in advance of the scheduled IRB meeting.
- 4.2.2. All IRB members may cast their vote (for, against, abstain) either at the IRB meeting or via e-mail. IRB members may provide written statements in support of their vote or ask other IRB members to express their opinions at the meeting.
- 4.2.3. For the vote to be valid, a majority of each affected board must cast a vote, either in person or by e-mail. For the policy to be approved, a majority of those voting must vote for approval.
- 4.2.4. If the motion to approve a policy fails to pass, the draft policy may be referred to the IRB Executive Chair or an IRB subcommittee for further discussion and revision before re-consideration.
- 4.3. Review by email
- 4.3.1. At the discretion of the IO, the Assistant Vice-Chancellor for Regulatory Affairs, or the IRB Executive Chair, voting procedure by e-mail alone will be allowed for consideration of a policy. In general, this procedure should be limited to new policies that represent existing IRB practices, non-major revision of existing policies, or instances where approval of a policy is necessary before the next regularly scheduled meeting.
- 4.3.2. IRB members will receive by email a copy of the policy to be reviewed, as well as a summary of key points in the new policy, or relevant changes to the existing policy. The email will also describe the deadline for response, and the interpretation of non-response (that is, non-response is considered a vote in favor).
- 4.3.3. IRB members may provide written statements in support of their vote or request that the policy be brought to a convened meeting for discussion. The IO has the authority to decide on such requests, based on the nature of the members’ concerns, and the urgency of the policy review.
- 4.3.4. For the vote to be valid, a majority of each affected board must cast a vote. For the policy to be approved, a majority of those voting must vote for approval.
- 4.3.5. If the motion to approve a policy fails to pass, the draft policy may be referred to the IRB Executive Chair or an IRB subcommittee for further discussion and revision before re-consideration.
5.0 Organizational Notification of Changes to HRPP Policies
- 5.1. Changes to HRPP policies will be communicated to the Organization’s research community by email, notification on the IRB website, and/or other media as appropriate.
- 5.2. IRB Analysts and staff will be notified by email or at a staff meeting.
DOCUMENT HISTORY:
Written: 1/25/2016 (Approved: 1/25/2016) - original author not recorded
Revised: 1/28/2018 - revision not documented
Revised: 6/30/2022 - Revised required frequency of policy review; revised number of IRBs; clarified order of review and approval of policies by boards and IO; removed requirement for “read receipt” for email votes; clarified mechanism for notifying ORA staff.
Revised: 11/13/2024 – modified to distinguish between new and modified policies; clarified which modifications to existing policies need to be reviewed by the IRBs; clarified that if a policy only affects a single board (eg, RR-IRB or IRB-06) only that board needs to approve; stylistic changes.
1.19 IRB Signature Authority
Last Revised: 10/7/2022
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for granting signature authority for Office of Regulatory Affairs (ORA) and IRB correspondence.
2.0 Policy
It is the Organization’s policy that the IRB Executive Chair, the IRB Chairs and Vice-Chairs and qualified IRB staff will have appropriate signature authority on behalf of the ORA and the IRB.
3.0 Procedures
The following individuals have signature authority as indicated below:
- 3.1. IRB Executive Chair has the authority to sign: 1) HRPP policies in conjunction with the Institutional Official (IO), 2) IRB authorization agreements after review and approval by the IO, 3) IRB review letters, 4) IRB approval letters, and 5) all other IRB correspondence as necessary.
- 3.2. IRB Chairs and Vice-Chairs have the authority to sign: 1) IRB review letters, 2) IRB approval letters, and 3) all other IRB correspondence as necessary.
- 3.3. IRB Expedited Reviewers (including IRB Analysts who are also voting IRB members) have the authority to sign: 1) IRB expedited review letters, and 2) other related IRB correspondence as necessary.
- 3.4. IRB Analysts have the authority to sign: 1) IRB review letters, 2) IRB approval letters, and 3) other IRB correspondence as necessary. In exercising this authority, the IRB Analysts will consult the IRB Executive Chair, chairs and vice-chairs or other IRB members as necessary and may refer IRB review letters or other correspondence to the IRB Executive Chair for signature.
- 3.5. IRB Associates have the authority to sign routine ORA correspondence, but not correspondence on behalf of the IRB (such as IRB review letters).
DOCUMENT HISTORY:
Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded
Revised: 1/2/2018 - revision not documented
Revised: 10/7/2022 – clarified that Exec Chair can sign authorization agreements after review and approval by the IO; stylistic changes; correct typos; rename Office Assistant as IRB Associate.
1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)
Last Revised: 1/17/2024
1.0 Purpose
The purpose of this policy is to describe the Organization’s outreach activities to enhance the public’s understanding of research, obtain feedback about any community concerns, disseminate results of research conducted by the Organization and encourage involvement of the community in the research process.
2.0 Policy
It is the policy of the Organization that:
- 2.1. Outreach activities will be undertaken through a variety of mechanisms and venues to enhance the understanding of research by both the communities the Organization serves, as well as the members of those communities.
- 2.2. Outreach activities will be undertaken to make the community aware of current and proposed research activities of the Organization, and to provide advice about the needs of the community.
- 2.3. As appropriate considering the nature of the research, the Organization will involve the communities the Organization serves, as well as the members of those communities, in the research process; including the design and implementation of studies, analysis of data, and the dissemination of results.
3.0. Outreach Activities for Education of the Community
- 3.1 The Organization utilizes the following established outreach activities for educational purposes, as well as the dissemination of research results:
- 3.1.1. Omaha Science Cafe: The Science Cafe involves both in-person and virtual conversations between the public and scientists within the Organization about current science topics. The science cafe is held multiple times per year at casual meeting places within the local community and online. Each meeting begins with a didactic presentation, followed by a question-and-answer period.
- 3.1.2. Nebraska Science Festival: The Nebraska Science Festival is an initiative of UNMC, which continues to administer the festival with the assistance of several organizations and individuals interested in the advancement of science literacy.
- 3.1.3. Talks and seminars in community settings: Faculty and administrators from the Organization give educational talks and seminars about research in local community settings (e.g., Rotary Club) and greater Nebraska. Results from completed research may also be presented in community forums.
- 3.1.4. Newspaper articles about research projects: Local Nebraska newspapers feature articles about research projects, which help educate and inform the community about general research topics, specific upcoming or active projects, as well as the results from completed research studies.
- 3.1.5 Social Media: Components of the Organization maintain Facebook, Instagram and/or Twitter sites, presenting information regarding general research topics and specific upcoming or active projects, and may serve as a platform for providing results from completed research studies
- 3.1.6 Websites: Websites maintained by components of the Organization are available containing information about the Organization and its research activities, including material pertinent to research. At the organizational level, the Office of Community Engagement website serves as a connector between the institution and community. In addition to sites related to specific components of the Organization (eg, UNMC, Nebraska Medicine, UNO, Childrens Hospital & Medical Center), there are sites related to specific programs (eg, Great Plains IDeA-CTR, Fred & Pamel Buffett Cancer Center, Child Health Research Institute, UNMC College of Public Health (CoPH) Center for Reducing Health Disparities)
- 3.2. Additional outreach activities specific to UNMC/Nebraska Medicine and BMC may include:
- 3.2.1. Research Subject Advocate Office: The Research Subject Advocate (RSA) office was created in part to provide community education about processes in place to safeguard research subject safety within clinical and translational research trials and programs. The RSA office gives presentations to community groups interested in learning more about research or who have concerns or questions about research subject safety. The RSA office maintains a record of all RSA community outreach activities.
- 3.2.2. "Nebraska Medicine Now”: Nebraska Medicine Media Relations publishes “Nebraska Medicine Now” on a daily basis which is available to the public electronically.
- 3.2.3. “Ask UNMC” on KETV Channel 7 and the UNMC YouTube page.
- 3.2.4. “Connect” magazine: UNMC Strategic Communications publishes “Connect” magazine annually, which is available to the UNMC campus and UNMC alumni both online and by physical distribution.
- 3.2.5. Community outreach groups: The Organization has several outreach groups which provide the public with the opportunity to convey special needs of the community in terms of medical care and other services, which can translate into research.
- 3.3. Outreach activities specific to CHMC may include:
- 3.3.1. “The Link”: The Marketing department at CHMC publishes “The Link” twice per year to internal and community providers.
- 3.3.2. “Just Kids”: The Marketing department at CHMC distributes “Just KIDS” twice per year to a catered audience.
- 3.3.3. “The Pulse”: The Marketing department at CHMC distributes “The Pulse” weekly to internal and community providers.
- 3.3.4. “The Connection”: The Marketing department at CHMC distributes “The Connection” twice per year to internal and community providers.
- 3.3.5. “Visions”: The Marketing department at CHMC distributes “Visions” twice per year in print to Children’s Foundation donors.
4.0. Outreach activities specifically directed at community education regarding current and proposed research studies.
- 4.1. In addition to activities described above, the UNMC Center for Clinical and Translational Research maintains a clinical trial database where the public can find information about available clinical trials by medical area.
5.0. Outreach activities directed at involvement of the community in Research Design, Implementation, and Analysis of Research Results (CBPR).
- 5.1. The Great Plains IDeA-CTR (GP IDeA-CTR) offers community engagement and outreach resources to ensure that research done by the Organization is relevant and filling the needs in rural and underserved areas served by the Organization and partner institutions. https://gpctr.unmc.edu/cores/community-engagement-outreach/
Activities conducted or supported by the GP IDeA-CTR include:
- 5.1.1. Seminars and workshops in partnership with the Professional Development Core and Community Engagement and Outreach Core to provide the tools and training for CTR investigators to improve community engagement practices and to help researchers and community partners understand and prioritize community concerns that might be addressed with CTR projects.
- 5.1.2. Promotion and expansion of regional Practice-Based Research Networks (PBRNs) that work to merge clinical practice with evidence-based research https://gpctr.unmc.edu/ctr-resources/pbrn/
- 5.1.3. Community-Academic Partnership (CAP) Program has the goal to provide funding and other supports for research proposals with a strong community focus to improve health and wellness in communities through the development or testing of programs and interventions that are impactful and sustainable in a community setting https://gpctr.unmc.edu/cores/community-engagement-outreach/cap-program/
- 5.1.4. GP IDeA CTR Community Advisory Board (CAB) includes representatives from across the state. The goals of the CAB include the identification and prioritization of health concerns in the region, contributing to the review process for proposed pilot and scholar applications, and helping distribute research findings to the communities.
- 5.1.5. The Health Priorities List, created and maintained by the Community Advisory Board, assists the GP IDeA CTR in making funding decisions for Pilots and Scholars.
- 5.1.6. Community-Engaged Research Interest Group (CEnRIG) serves to address the challenges and opportunities community-engaged researchers and community partners face https://gpctr.unmc.edu/cores/community-engagement-outreach/cenrig/
- 5.1.7. Community Engagement and Outreach Consultations are available through the Community Engagement and Outreach (CEO) Core, consisting of experienced community-engaged researchers and community partners who have successfully secured funding from federal agencies (including NIH & PCORI) with clinical and translational science expertise.
- 5.2. The UNMC College of Public Health Center for Reducing Health Disparities (CRHD) supports faculty and community researchers in community engagement including CBPR
- 5.2.1. The CRHD conducts and publishes research (e.g., African American Listening Sessions, Hispanic and Latinx Community Listening Sessions, colon cancer, cattle feed lots), Health Needs Assessments (e.g., refugee and migrant communities) , and social justice activities. They also train faculty and students on community engagement and serve the various communities throughout the state to assist with identifying and prioritizing their health needs and goals.
- 5.2.2. The College teaches graduate level courses on the foundations and application of the CBPR approach.
6.0. Evaluation of Outreach Activities
- 6.1. The UNMC Office of Community Engagement and The College of Public Health conduct a biennial Community Engagement Survey among faculty and staff of UNMC to provide insights regarding involvement in community organizations and activities, outreach and community service, community engaged education, and Community Based Participatory Research. The engagement survey is conducted by the OCE and is constructed via the Community Collaboration Council, which includes representation from all colleges, institutes, and other engaged departments.
- 6.2. The ORA, in conjunction with the IO, the Executive Chair of the IRB, the RSA and UNMC Strategic Communications, and CHMC Marketing, performs an ongoing evaluation of community outreach activities to identify the needs of the community and any concerns.
7.0. IRB Responsibilities
- 7.1. If a protocol submitted to the IRB for review is either self-identified as CBPR, or is recognized by the IRB analyst or IRB reviewer during pre-review as CBPR, the meeting to which the protocol is assigned will include, either as a member or consultant, an individual with expertise in community-based participatory research.
- 7.1.1. If a CBPR protocol is eligible for expedited review, the designated expedited reviewer will either have expertise in community-based participatory research, or the reviewer will consult with an individual with such expertise.
DOCUMENT HISTORY:
Written: 4/14/2016 (Approved: 4/14/2016) - original author not recorded
Revied: 2/12/2018 - revision not documented
Revised: 6/2/2023 – amended numbering of section 3.2, made formatting and syntax corrections, updated sections 3.2, 3.3, and 3.4 to reflect current materials.
Revised: 7/6/2023 – extensive modifications and additions to sections 3, 4, 5, and 6.
Revised: 1/17/2024 – added section 7.0 defining IRB responsibilities regarding review of CBPR research.
1.21 Post-Approval Monitoring of Research
Last Revised: 2/28/2018
1.0 Purpose
The purpose of this policy and procedure is to describe the Organization’s requirements for post approval monitoring of research.
2.0 Policy
- 2.1. It is the policy of the Organization that a Post Approval Monitoring Program will be conducted in order to measure, maintain, and improve human subject research protection effectiveness, quality and compliance with all applicable regulations and HRPP policies.
- 2.2. It is the policy of the Organization that the Post Approval Monitoring Program focuses on the education of investigators, staff, and students about ethical and regulatory responsibilities in the conduct of human subject research, as well as the identification and correction of problems and deficiencies.
3.0 Post Approval Monitoring Program Objectives
- 3.1. Determine if the PI and other study personnel adhere to the research protocol as approved by the IRB.
- 3.2. Determine if the PI has filed all required reports to the IRB.
- 3.3. Determine if the process of informed consent and the informed consent document(s) meet all federal, state, and local requirements, as well as HRPP policies.
-
3.4. Identify the educational and training needs of the research community and determine the best methods for meeting those needs through:
- 3.4.1. Individualized training to meet the specialized needs of specific PIs and their research personnel.
- 3.4.2. General education programs designed for the research community at the Organization.
- 3.5. Assess the completeness and accuracy of IRB files which are linked to studies selected for Post Approval Monitoring.
4.0 Procedures
-
4.1. Study Selection Criteria
-
4.1.1. Not-For-Cause Monitoring of Non-Exempt Research
-
4.1.1.1. Categories of non-exempt research that will be considered for Post Approval Monitoring will be randomly selected, in order of priority listed below:
- 4.1.1.1.1. Investigator-initiated research
- 4.1.1.1.2. Research which would meet the criteria for increased monitoring and/or interim continuing review per HRPP policy 3.1 (Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI).
- 4.1.1.1.3. Research involving vulnerable populations
- 4.1.1.1.4. Greater than minimal risk research
- 4.1.1.1.5. Research conducted under emergency waiver of informed consent (FDA regulations at 21 CFR 50.24)
- 4.1.1.1.6. Minimal risk research
- 4.1.1.2. Selected research must be currently IRB-approved and normally have been actively accruing subjects for at least one year.
-
4.1.1.1. Categories of non-exempt research that will be considered for Post Approval Monitoring will be randomly selected, in order of priority listed below:
-
4.1.2. For-Cause Post Approval Audit
-
4.1.2.1. “For-Cause” audit will generally be scheduled based upon recommendation by the IO, IRB Executive Chair, or the IRB. Indications for audit include, but are not limited to:
- 4.1.2.1.1. Noncompliance (as per HRPP policy 8.4: Review of Noncompliance Involving the PI and Study Personnel).
- 4.1.2.1.2. Errors, inconsistencies, omissions in continuing review (HRPP policy 2.7: Continuing Review of Research) or AE/UP reporting (HRPP policies 8.1: IRB Review of Adverse Events and Adverse Device Effects and 8.3: IRB Review of Unanticipated Programs Involving Risk to the Subject or Others).
- 4.1.2.1.3. Complaints (as per HRPP policy 8.2: IRB Review of Study Related Complaints).
-
4.1.2.1. “For-Cause” audit will generally be scheduled based upon recommendation by the IO, IRB Executive Chair, or the IRB. Indications for audit include, but are not limited to:
- 4.1.3. Monitoring reports issued by outside agencies (pharmaceutical sponsors, FDA, OHRP or others) that revealed or suggested problems areas.
-
4.1.1. Not-For-Cause Monitoring of Non-Exempt Research
-
4.2. Post Approval Monitoring Process
-
4.2.1. Post Approval Monitoring will generally be performed by a designated IRB Administrator. Other IRB representatives may be included as necessary.
-
4.2.2. “Not-For-Cause” Audits
- 4.2.2.1. It is expected that at least twelve non-exempt studies will be selected for “Not-For-Cause” audit per year, however the actual number of audits will be contingent on available manpower
- 4.2.2.2. The Post Approval Monitoring visit will be scheduled at a time mutually acceptable to the PI and the designated IRB Administrator. Unannounced visits will not occur.
- 4.2.2.3. Prior to the Post Approval Monitoring visit, the PI will be informed, in writing, that a Post Approval Monitoring visit has been scheduled, including the date, time, place, and protocol(s) selected for review. The PI will also be provided a description of the audit process and criteria, as well as a copy of the Checklist for Post Approval Monitoring of On-Going Research to be completed by the designated IRB Administrator during the visit.
- 4.2.2.4. The PI will be asked to complete the Investigator Assessment Checklist for Regulatory Documentation and submit it to the ORA prior to conduct of the Post Approval Monitoring visit.
- 4.2.2.5. Visits must occur within 30 days of notification, unless delay is approved by the IRB Executive Chair.
- 4.2.2.6. Failure to comply with the Post Approval Monitoring Request constitutes non-compliance subject to HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel).
- 4.2.2.7. The designated IRB Administrator will utilize the Checklist for Post Approval Monitoring of On-Going Research during review of investigator records.
- 4.2.2.8. If the assessment visit will include observation of the process of informed consent or interviews with subjects, the PI will be asked to arrange this in advance with one or more subjects. All subjects who have agreed must give written informed consent in advance by signing the Consent for IRB Observation of the Informed Consent Process. The designated IRB Administrator will utilize the IRB Observation of Consent Process Form to evaluate the process of consent.
- 4.2.2.9. Failure of the investigator or the research staff to cooperate with PAM, or interference with PAM by the investigator or the research staff, constitutes serious noncompliance subject to HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel).
- 4.2.2.10. Following completion of the Post Approval Monitoring visit, the designated IRB Administrator will present preliminary findings to the investigator and/or staff, obtain additional clarifications and corrections, and provide education concerning IRB requirements as needed.
- 4.2.2.11. The designated IRB Administrator will prepare a written report of the PAM visit, including, as needed, a request for a corrective action plan. The written report will be given to the investigator, the IRB Executive Chair, and the IO.
-
4.2.2.12. The designated IRB Administrator, in consultation with the IO and the IRB Executive Chair, will evaluate the PAM report and the investigator’s corrective action plan, if provided.
- 4.2.2.12.1. Reports which suggest serious noncompliance or other concerns will be referred to the IRB for review in accordance with HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel).
- 4.2.2.12.2. Reports which demonstrate few or no deficiencies, and/or the use of “best practices” will be reported to the IRB as a notification item, and will be communicated to the investigator.
- 4.2.2.13. The Post Approval Monitoring Program will include appropriate follow-up to ensure that deficiencies are corrected in a timely manner. This follow-up may include only a written report of corrective action(s) implemented by the PI, or it may require additional monitoring by the IRB. In some cases, the PI and/or other study personnel may be required to undergo specific training in order to assist in achieving the desired level of compliance.
-
4.2.3. “For-Cause” Audit
“For-Cause” audits will follow the same procedure as above, except that unannounced visits may occur if authorized by the IO, and all PAM reports will be reviewed by the convened IRB.
-
DOCUMENT HISTORY:
Written: 12/14/2015 (Approved: 12/14/2015) - original author not recorded (original title “QUALITY IMPROVEMENT ASSESSMENT FOR THE CONDUCT OF RESEARCH”)
Revised: 2/28/2018 - revision not documented
1.22 Assessment of the Effectiveness and Efficiency of the HRPP
Last Revised: 9/25/2024
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for assessment of the quality, effectiveness, efficiency and support of the Organization’s HRPP in carrying out its mission to ensure protection of human subjects and compliance with all applicable federal, state and organizational requirements.
2.0 Policy
It is the policy of the Organization that there will be an ongoing assessment of the HRPP, as well as a comprehensive annual HRPP assessment. These assessments are designed to ensure 1) that the HRPP is fully capable of protecting the rights and welfare of research subjects; and 2) the HRPP will continue to evolve and improve in its effectiveness and efficiency.
3.0 Procedures
- 3.1. On-going Assessment of the HRPP
- 3.1.1. HRPP Policies will be assessed on an ongoing basis by the IO, IRB Executive Chair and IRB/ORA staff.
- 3.1.2. Organizational officials may provide input regarding IRB/ORA processes to the attention of the IO and IRB Executive Chair.
- 3.1.3. The IO, IRB Executive Chair, and IRB/ORA staff will continually monitor the efficiency and effectiveness of the IRB/ORA, utilizing appropriate metrics and data from relevant QA/QI projects and input from stakeholders, in order to maintain and improve IRB/ORA processes.
- 3.1.4. One set of IRB minutes for each board will be randomly selected for audit quarterly (as available). The IRB will utilize HRPP policy 2.2 (Full IRB Review) and OHRP Draft Guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs” (dated November 2015).
- 3.1.5. PIs and other study personnel are provided an on-going opportunity to assess the effectiveness of the HRPP, including policies, quality and efficiency of IRB review, IRB staff support and other components of the HRPP through communication with the IRB Executive Chair, IO, IRB staff, and senior administration.
- 3.1.5.1. As appropriate, the IRB Executive Chair and IRB Analysts may schedule focus group discussions with Investigators from components of the Organization to discuss the effectiveness of the HRPP.
- 3.1.5.2. PIs and other study personnel may utilize the Investigator Feedback link on the IRB website to communicate their concerns, questions or suggestions to the IRB and/or ORA.
- 3.1.5.3. PIs and other study personnel may utilize the “Report a Research Problem or Complaint” tab on the UNMC IRB website, which provides access to the University of Nebraska EthicsPoint, and to the UNMC Human Subjects Research Comment Portal.
- 3.2. Evaluation of the IRB Executive Chair
- 3.2.1. The IO will evaluate the performance of the IRB Executive Chair on an annual basis utilizing a discussion format. The focus of the discussion will be on IRB leadership, accomplishments during the past year and goals for the future.
- 3.2.2. The IO will obtain feedback submitted from the IRB Members and IRB Analysts at least annually, via on-line questionnaires and surveys, and/or via focus group discussion (facilitated by the Research Subject Advocate or designee) as appropriate.
- 3.2.3. If the IRB Executive Chair’s performance is judged to be deficient, the IO will discuss his/her concerns with the Executive Chair and seek a satisfactory resolution. If the IRB Executive Chair’s performance continues to be deficient, the IO may remove the individual as the Executive Chair, in consultation with the Vice Chancellor for Research.
- 3.3. Evaluation of the Chairs and Vice-Chairs
- 3.3.1. The IRB Executive Chair will review the performance of the IRB Chairs and Vice-Chairs on an annual basis considering, but not limited to, the following criteria:
- 3.3.1.1. Meeting leadership
- 3.3.1.2. General regulatory knowledge
- 3.3.1.3. Active participation in IRB Executive Committee and involvement in activities of the ORA.
- 3.3.1.4. Attendance at meetings
- 3.3.1.5. Timeliness and completeness of IRB reviews
- 3.3.1.6. Participation in IRB discussions
- 3.3.1.7. Service on IRB subcommittees
- 3.3.1.8. Feedback submitted by IRB Members at least annually, via on-line questionnaires and surveys, and/or via focus group discussion (facilitated by the Research Subject Advocate or designee) as appropriate. In addition, the IRB Executive Chair will convene meetings with IRB Analysts to elicit feedback about Chair and Vice-Chair performance.
- 3.3.2. If an IRB Chair or Vice-Chair’s performance is judged to be deficient, the IRB Executive Chair will discuss his/her concerns with the Chair or Vice-Chair and seek a satisfactory resolution. Upon recommendation of the IRB Executive Chair, the IO at his/her discretion may remove the individual as an IRB Chair or Vice-Chair.
- 3.3.1. The IRB Executive Chair will review the performance of the IRB Chairs and Vice-Chairs on an annual basis considering, but not limited to, the following criteria:
- 3.4. Evaluation of IRB Members and Alternates
- 3.4.1. The IRB Executive Chair will convene meetings with the IRB Analysts and Chairs at least annually, to evaluate the IRB Members considering, but not limited to, the following:
- 3.4.1.1. Attendance at meetings for which they have been assigned review items
- 3.4.1.2. Timeliness and completeness of IRB reviews
- 3.4.1.3. Participation in IRB discussions
- 3.4.1.4. Service on IRB subcommittees
- 3.4.1.5. General regulatory knowledge
- 3.4.2. The IRB Executive Chair, IRB Analysts and Chairs will also evaluate IRB Alternates, using criteria similar to those described in 3.4.1 above, in consideration of the episodic nature of their participation.
- 3.4.3. IRB members and alternates will be provided feedback, by letter or in person, regarding their performance.
- 3.4.3.1. If service of an IRB member or alternate is judged to be satisfactory or exceptional, the IRB Executive Chair will so inform the member.
- 3.4.3.2. If service of an IRB member or alternate is judged to be significantly deficient, the IRB Executive Chair will discuss the concerns with the member and seek a satisfactory resolution.
- 3.4.4. Any IRB member or alternate whose contribution to the IRB is judged to be continually deficient despite feedback, may have their appointment terminated by the IO upon recommendation of the IRB Executive Chair.
- 3.4.5. Upon request of individual IRB members or alternates, the IRB Executive Chair and/or the IO will write letters of recommendation which attest to the quality and value of the member’s service on the IRB.
- 3.4.1. The IRB Executive Chair will convene meetings with the IRB Analysts and Chairs at least annually, to evaluate the IRB Members considering, but not limited to, the following:
- 3.5. Evaluation of IRB Analysts and Staff
- 3.5.1. The Assistant Vice-Chancellor for Regulatory Affairs will evaluate the performance of the IRB Analysts utilizing the UNMC Employee Evaluation Form and Feedback submitted from the IRB Members at least annually via on-line questionnaires and surveys, and/or via focus group discussion (facilitated by the Research Subject Advocate or designee) as appropriate.
- 3.5.1.1. The Assistant Vice-Chancellor for Regulatory Affairs will provide feedback verbally to each IRB Analyst during the annual review process, as well as written comments on the UNMC Performance Evaluation Form.
- 3.5.1.2. The Assistant Vice-Chancellor for Regulatory Affairs will also provide ongoing feedback about the performance of the IRB Analysts throughout the year.
- 3.5.2. A designated supervising IRB Analyst will evaluate the performance of the IRB staff utilizing the UNMC Employee Evaluation.
- 3.5.2.1. The supervising IRB Analyst will provide feedback verbally to each IRB staff during the annual review process, as well as written comments on the UNMC Employee Evaluation Form.
- 3.5.2.2. The supervising IRB Analyst will also provide on-going feedback about the performance of the IRB staff throughout the year.
- 3.5.1. The Assistant Vice-Chancellor for Regulatory Affairs will evaluate the performance of the IRB Analysts utilizing the UNMC Employee Evaluation Form and Feedback submitted from the IRB Members at least annually via on-line questionnaires and surveys, and/or via focus group discussion (facilitated by the Research Subject Advocate or designee) as appropriate.
- 3.6. Annual Evaluation of the HRPP
- 3.6.1. The evaluation of the HRPP will be conducted utilizing the HRPP Assessment Survey. Each component of the HRPP, IRB members, Office of Regulatory Affairs (ORA), investigators, and other research personnel will be invited to participate and provide feedback. The survey will assess the interactions between the IRBs, the ORA, investigators and other components of the HRPP, as well as the overall effectiveness of the HRPP. The IO in conjunction with the Assistant Vice-Chancellor for Regulatory Affairs and any other personnel deemed appropriate will review the Annual HRPP Assessment Form
- 3.6.1.1. A corrective action plan will be developed for items determined to be deficient. The plan will include set goals and a time frame for remediation based upon the seriousness of the deficiency.
- 3.6.1.2. At least one other item will be targeted for further improvement before the next evaluation, and to set specific goals dependent upon available staff and resources.
- 3.6.1.3. Accomplishment of the goals arising out of the HRPP Evaluation will be evaluated by the IO in conjunction with the appropriate personnel in accordance with the corrective action and specified time frame.
- 3.6.1. The evaluation of the HRPP will be conducted utilizing the HRPP Assessment Survey. Each component of the HRPP, IRB members, Office of Regulatory Affairs (ORA), investigators, and other research personnel will be invited to participate and provide feedback. The survey will assess the interactions between the IRBs, the ORA, investigators and other components of the HRPP, as well as the overall effectiveness of the HRPP. The IO in conjunction with the Assistant Vice-Chancellor for Regulatory Affairs and any other personnel deemed appropriate will review the Annual HRPP Assessment Form
DOCUMENT HISTORY:
Written: 4/14/2016 - original author not recorded
Revised: 2/2/2018 - revision not documented
Revised: 8/30/2022 - Changed title of policy; clarified frequency of assessments of minutes for various boards; revised and clarified methods of feedback to the ORA/IRB by stakeholders; clarified process and basis for evaluation of Chairs and Vice-Chairs, and IRB members; clarified process of evaluation of IRB administrators and staff; clarified process and goals of Annual HRPP Assessment.
Revised: 9/25/2024 – Revised to allow flexibility in assessments of HRPP quality, effectiveness, and efficiency, and in evaluation of members, chairs, and analysts.
1.23 HRPP Training Requirements
Last Revised: 8/17/2022
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements and opportunities for training for all personnel involved in conducting human subject research.
2.0 Policy
It is the policy of the Organization that all personnel involved in the conduct of human subject research under the oversight of the UNMC IRB will be qualified through initial and continuing education in order to fulfill their responsibility to protect the rights and welfare of human subjects.
3.0 Definitions
-
3.1. Biomedical Research is defined (as per HRPP policy 1.8 Investigational Activities Requiring IRB Review & Approval, section 4.1) as research performed with intent to develop or contribute to generalizable knowledge (i.e., test a hypothesis and draw conclusions) about human biological systems and processes, including efficacy and safety of preventative, diagnostic or therapeutic methods. Biomedical research includes:
- 3.1.1. Clinical trial using a drug, medical device, technique or other intervention or strategy (including non-physical means, like diet, cognitive therapy, etc.) to diagnose, treat or otherwise study a particular condition or disease
- 3.1.2. Non-clinical biomedical research to study normal or abnormal physical or physiologic processes (for example, gait and balance testing, biomechanical assessments).For the purpose of this policy “Biomedical Research” includes Human Biological Material Research and Medical Records Research (per HRPP policy 1.8 Investigational Activities Requiring IRB Review & Approval, sections 4.2 and 4.3 respectively)
- 3.2. Social Science and Behavioral Research is defined (as per HRPP policy 1.8 Investigational Activities Requiring IRB Review & Approval, section 4.4) as research performed with intent to study behaviors, attitudes and interactions and social processes among and between individuals, groups, and cultures. Generally this category of research has no intent of producing a diagnostic, preventive, or therapeutic benefit to the subject who is not seeking nor expecting a health benefit from the research.
4.0 Required Training
-
4.1. Collaborative Institutional Training Initiative (CITI)
-
4.1.1. Training in the protection of human subjects is primarily accomplished through completion of this web-based training program. CITI training is required for:
- 4.1.1.1. All investigators and research staff conducting non-exempt research who (a) participate in the process of consent, (b) have contact with subjects, or (c) have access to identifiable private information or identifiable biospecimens.
- 4.1.1.2. Faculty Advisors of student investigators.
- 4.1.2. The CITI Training Program is accessible via http://www.citiprogram.org, or through a link on the UNMC IRB website.
- 4.1.3. The Biomedical and the Behavioral and Social Science courses consist of a series of Basic (core) modules which must be completed by users, and additional modules (primarily related to specific types of research or research subject populations). The GCP course consists of a series of required modules.
-
4.1.4. CITI training course requirements
- 4.1.4.1. The Biomedical course must be completed by personnel described in section 4.1.1 who conduct non-exempt biomedical research (including medical records and human biological material {HBM}) within the Organization or at external sites where the UNMC IRB serves as the IRB of record.
- 4.1.4.2. The Behavioral and Social Science course must be completed by personnel described in section 4.1.1 who conduct non-exempt Behavioral and Social Science research within the Organization or at external sites where the UNMC IRB serves as the IRB of record.
-
4.1.4.3. The GCP (Good Clinical Practice) course must be completed by:
- 4.1.4.3.1. Personnel described in section 4.1.1 who conduct a clinical trial funded by NIH. For the purpose of this policy, “clinical trial” is defined as “a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes” (per NIH Policy NOT-OD-15-015)
- 4.1.4.3.2. Personnel described in section 4.1.1 who conduct research utilizing an FDA regulated drug, device or biologic.
-
4.1.5. All research personnel must be CITI trained prior to IRB approval of initial research applications.
- 4.1.5.1. Personnel described in section 4.1.1 must complete all Basic (core modules) appropriate for the type of research (as per 4.1.3.1 thru 4.1.3.3)
- 4.1.5.2. Personnel described in section 4.1.1 who are conducting research where the additional modules are relevant must attest that they have completed those additional modules before final release of the protocol by ORA.
- 4.1.6. New research personnel added to IRB-approved research via a Request for Change or Application for Continuing Review must complete CITI training as described above prior to involvement in the research.
- 4.1.7. The Organization will accept CITI Training records from other institutions if the other institution utilized the CITI training courses specified above. A copy of any training record must be provided to the ORA.
- 4.1.8. On a case by case basis, the Organization may accept other forms of Human Subject protection, or GCP training, instead of CITI, provided such training is substantively similar, was completed at a site that did not participate in the CITI Program, and has been completed in the previous three years. The Executive Chair, in consultation with the IO as needed, will have the sole authority to accept such training.
- 4.1.9. The Organization will accept other certificates of training from external organizations for external research personnel conducting non-exempt biomedical research at external sites where the UNMC IRB is the IRB of record. The PI must certify that all external research personnel have completed appropriate training.
- 4.1.10. CITI training (including GCP Training) must be renewed every three years from the original date of completion. Training must be up to date for the individual to be listed on new IRB applications or added to existing IRB-approved applications, in the roles defined in Section 4.1.1. However, personnel already listed on an active protocol whose CITI training expires may continue associated with that protocol.
-
4.1.1. Training in the protection of human subjects is primarily accomplished through completion of this web-based training program. CITI training is required for:
-
4.2. Conflict of Interest Training
Conflict of Interest Training is required in accordance with UNMC Conflict of Interest policy #8010 and HRPP policy 1.25 (Financial Conflicts of Interest).
5.0 Additional (Optional) Training
-
5.1. UNMC Websites
- 5.1.1. The HRPP Policy Manual is posted on the UNMC Guides website. When policies are updated, a Summary of Changes will be included with the HRPP Policy Manual.
- 5.1.2. The IRB website contains the links to OHRP, FDA, Office of Civil Rights and other websites where research personnel can access the federal regulations, guidance documents and other information pertinent to human subject research.
- 5.1.3. ORA Staff will periodically post access to relevant presentations and other educational materials on the IRB website.
-
5.2. Individual Training
- 5.2.1. The IRB Administrators provide individualized training to any research personnel on request. This training may be conducted in the ORA or at any requested location within the Organization.
- 5.2.2. Supervisors of new employees of the Organization may request IRB Introduction and Overview as mandatory training. This training is generally provided by an IRB Administrator.
- 5.3. UNMC IRB Workshops: Workshops are scheduled on various topics, such as the IRB online submission system, informed consent and how to work more effectively with the IRB. Research personnel within the Organization are notified in advance.
- 5.4. Student Education: Didactic classroom presentations are offered to UNMC and UNO students on topics pertaining to human subject protection by request.
- 5.5. Webinars: The ORA facilitates access to webinars sponsored by external organizations on topics relevant to Human Subject Research.
- 5.6. HRPP Regional Conference (“Hot Topics in the Protection of Human Subjects”): The regional conference, produced in collaboration with the Great Plains Health Research Consortium, and partially funded by the Great Plains IDeA-CTR Network, brings together national and local speakers to explore cutting edge topics in human research subject protection. The conference has occurred annually since 2010, though postponed in 2020 due to the Coronavirus pandemic. The target audience is IRB administrators and staff, IRB members, investigators and research coordinators.
6.0 Procedures for Assessing Training Requirements
- 6.1. At regular intervals, the Assistant Vice-Chancellor for Regulatory Affairs, the Executive Chair, the IO and the ORA will re-evaluate the content, specific requirements, and effectiveness of training for research personnel associated with the Organization. This assessment will take into consideration current literature and evolving federal guidance regarding various aspects of research ethics and human subject protection, feedback from research personnel regarding their training needs, assessment of the quality and completeness of IRB submissions by IRB members and the IRB Administrators.
7.0 Procedures for Maintaining Training Records
The ORA maintains all training records for CITI Training and didactic activities described above, and maintains copies of materials sent by mail or email or posted on the website.
DOCUMENT HISTORY:
Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded
Revised: 6/28/2018 - revision not documented
Revised: 8/31/2021 - Described basic vs additional modules for CITI courses; described requirement to complete additional modules based on type or research and subject population; clarified location of UNMC HRPP Policies manual; correction of references to sections within this and other policies; delineated required vs optional training; deleted training no longer offered; minor stylistic changes and clarification.
Revised: 6/30/2022 - clarification or requirements for CITI biomedical course (section 4.1.4.1).
Revised: 8/17/2022 - clarification regarding expiration of CITI training for personnel on an active protocol (section 4.1.10).
1.24 HRPP Training Requirements for IRB Members
Last Revised: 7/14/2022
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for training for IRB members and alternates.
2.0 Policy
It is the policy of the Organization that IRB members and alternates will be qualified through initial and continuing education in order to fulfill their responsibility to protect the rights and welfare of human subjects.
3.0 Definitions
- 3.1. CITI (Collaborative Institutional Training Initiative) available through www.citiprogram.org or through the IRB website.
4.0 Initial Training and Orientation
-
4.1. New IRB members, including alternate members, will meet with the IRB Executive Chair or designee, and appropriate IRB Administrators for orientation to cover the following items:
- 4.1.1. Overview of HHS and FDA regulations
- 4.1.2. HRPP overview
- 4.1.3. Structure of IRB meetings
- 4.1.4. Responsibilities of IRB members
- 4.1.5. Overview of the Research Support System (RSS).
- 4.2. New IRB members and alternates who also act as investigators or research personnel will be required to complete CITI training (including GCP as appropriate) as per HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel). For new IRB members and alternates who do not act as investigators or research personnel, orientation (as described above) will be considered the equivalent of initial CITI training.
- 4.3. New IRB members are invited to attend an IRB meeting as a guest during the orientation period.
- 4.4. Full orientation must be completed before the new IRB members may serve as a reviewer or count as a voting member. Prior to completion of orientation, agenda will record new IRB members as “non-voting”.
- 4.5. New IRB members are assigned an experienced IRB member as a mentor, to provide assistance as necessary.
5.0 Continuing Education
- 5.1. Continuing education for IRB members is required throughout service on the IRB in order to ensure ethical oversight of human subject research and compliance with current regulatory and policy requirements.
-
5.2. IRB members are expected to participate in continuing education which may be obtained through any or all of the following mechanisms:
- 5.2.1. In-service training at IRB meetings.
- 5.2.2. Training workshops/webinars.
- 5.2.3. Regional IRB conferences.
- 5.2.4. Review of publications distributed by the ORA at IRB meetings or via email.
- 5.2.5. Review of new information affecting the HRPP such as new laws and regulations, new OHRP/FDA guidance documents, and new or revised HRPP policies distributed by the ORA via email or at IRB meetings.
- 5.3. Completion of required continuing education will be assessed at the time of the annual evaluation of IRB members (see HRPP policy 1.22) in terms of general regulatory knowledge. Members who remain deficient after this review may have their appointment terminated.
DOCUMENT HISTORY:
Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded
Revised: 2/1/2018 - revision not documented
Revised: 7/14/2022 - Deleted list of specific documents to be supplied to new IRB members; added requirement that full orientation of new members must be completed before the new member may serve as a reviewer or count as a voting member; clarified that completion of required continuing education will be assessed at the time of the annual evaluation of IRB members in terms of general regulatory knowledge; deleted requirement that ORA maintain initial and continuing education training records.
1.25 Financial Conflicts of Interest
Last Revised 1/22/2024
1.0 Purpose
The purpose of this policy is to describe the Organization’s procedures for identification, management, and minimization or elimination of financial conflict of interest (COI) of responsible personnel, senior administrators, and the Organization itself that could influence the conduct of research or the integrity of the HRPP.
2.0 Policy
It is the policy of the Organization that:
- 2.1. All potential financial COIs of responsible personnel engaged in non-exempt research (1) within the premises of the Organization, or (2) by any faculty, students, staff or other representatives of the Organization, or by Organizational officials, must be identified and minimized through appropriate management in accordance with a) PHS regulations at 42 CFR 50, Subpart F; b) National Science Foundation (NSF) regulations; c) FDA regulations at 21 CFR 54; d) University of Nebraska Board of Regents Policies #3.2.8.10 and #4.4.2, e) UNMC policy #8010, f) UNO Academic and Research Financial Conflict of Interest Policy, g) Children’s Hospital & Medical Center policy #ADM100, and h) Children’s Hospital & Medical Center Board of Directors Conflict of Interest Policy.
- 2.2. The IRB will interact with the COI Officers, Conflict of Interest Committees (COICs), and/or senior administrators of the applicable components of the Organization who are responsible for compliance and/or COI, in accordance with the above specified regulations and policies to ensure that appropriate COI management plans are in place to protect the rights and welfare of human subjects when investigators, senior administrators, or the Organization itself has a COI.
- 2.3. Any changes in financial interest must be promptly disclosed and managed in accordance with Section 2.1 above.
- 2.4. The Office of Regulatory Affairs will ensure that the organization has adequate policies and procedures to ensure responsible personnel are appropriately trained concerning the identification, disclosure, and management of COI. This includes initial education, immediate re-education when there are policy changes and appropriate re-education when there is noncompliance with the COI policy.
3.0 Definitions
- 3.1. Responsible Personnel: any faculty, students, staff, or other representatives of the Organization listed in Section I of the IRB application who are responsible for the design, conduct, or reporting of research, or the development of proposals to conduct research. This includes: Principal Investigator, Secondary Investigator(s), Participating Personnel, and Protocol Coordinator(s). Data and Administrative Personnel are not considered Responsible Personnel for the purposes of this policy.
- 3.2. Covered Persons: Responsible Personnel, as defined above, and immediate family members of a Covered Person (spouse, dependent children, parents, or anyone that a Covered Person may claim as a dependent under the Internal Revenue Code).
- 3.3. Conflict of Interest (COI): situations when the Covered Persons’ direct or indirect personal financial interests or fiduciary duties owed to third parties may compromise, or have the appearance of compromising, a Covered Person’s professional judgment or behavior in carrying out his or her research obligations including the individual’s obligation to protect the rights and welfare of research subjects. This includes indirect personal financial interests of a Covered Person that may be obtained through third parties such as a Covered Person’s immediate family, business relationships, fiduciary relationships, or investments.
- 3.4. Significant Financial Interest: a financial interest of the Covered Person that reasonably appears to be related to the Responsible Person’s institutional responsibilities during the course of the research. An interest “related to the research” is one the COI Officer, COI committee, or the IRB reasonably determines could directly and significantly affect the design, conduct or reporting of research. A significant financial interest is defined as (1) anything of monetary value that exceeds $5,000 which the Covered Person has received in the past 12 months preceding the disclosure or intends to or had knowledge of earning during the reporting year; or (2) any equity in a non-publicly traded company.
- 3.4.1. Financial interests not considered in the determination of “significant financial interest include (1) salary or other remuneration from the Organization, (2) income from seminars, lectures, or teaching engagements sponsored by governmental entities, and (3) income from service on advisory committees or review panels for governmental entities
- 3.5. Non-Significant Financial Interest: any financial interest that does not qualify as a significant financial interest as defined in Section 3.4 of this policy.
- 3.6. Organizational COI: a situation when the Organization itself, or any of its component parts, or any of senior organizational officials, have a financial interest in the design, conduct, or outcome of human subject research. Organizational financial COI includes: a) licensing, technology transfer, patents; b) investments of the Organization; c) gifts to the Organization when the donor has an interest in the research; d) financial interests of senior administrators; e) other financial interests.
- 3.7. COI Committee (COIC): the Committee responsible for reviewing potential conflicts of interest which have been determined to be significant, developing the management plan, and providing the information to the IRB. If a component of the organization does not have a committee per se, COIC hereinafter will mean the Conflict of Interest Officer, or the senior administrator of the applicable components of the Organization who are responsible for compliance and/or COI.
4.0 Procedures for Disclosure of Potential COI
- 4.1. Any Responsible Personnel listed on the IRB application who has a COI must disclose that financial interest in accordance with the applicable policy specified in Section 2.1 above.
- 4.2. Responsible Personnel conducting FDA regulated research must disclose their financial interests in accordance with 21 CFR 54.4.
5.0 COI Management Plan
- 5.1. A COI Management plan will be developed for research where responsible personnel have a significant financial interest.
- 5.1.1. For multi-institution research where the UNMC IRB is the reviewing IRB, the COI Management plan may be generated by the relying institution, in accordance with the terms of the reliance agreement.
- 5.2. The COI management plan may include an appropriate disclosure of the presence of a financial COI of the Responsible Person(s) in the consent form, in any presentations, publications, or news articles regarding the research, and to all personnel involved in the research including students. Additional management strategies may include (but are not limited to) more frequent and/or independent monitoring of the research; modification of the research protocol to manage potential bias (for example, through blinding); monitoring of the consent process; divesting or appropriately reducing the financial interest giving rise to the COI; severing relationships existing between the Covered Person and the company or other entity that is the source of the COI; or disqualification of the Covered Person from participation in all or a portion of the research.
- 5.3. In addition to any features required by the COIC and the IRB, the COI management plan will prohibit:
- 5.3.1. Any arrangement where the value of ownership interests will be affected by the outcome of the research.
- 5.3.2. Any arrangement where the amount of compensation will be affected by the outcome of the research.
6.0 Review of COI Management Plans
- 6.1. Management plans for responsible personnel with non-significant financial interest will not be reviewed by the convened IRB. The ORA will be notified by the Compliance Office of the management plan, and the investigator’s agreement to abide by it.
- 6.2. Management plans for responsible personnel with significant financial interest will be reviewed by the convened IRB (for FB studies) or by an expedited reviewer (for EP studies).
- 6.3. For management plans reviewed by the convened IRB the following apply:
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6.3.1. The full IRB will be provided with the COI management plan approved by the COIC.
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6.3.2. The COI Officer, the IRB Executive Chair, the IRB chair or designee will verbally describe the nature of the financial interest, and the specifics of the management plan proposed by the COIC.
Note: Members of the full IRB are not provided written copies which detail the specifics of the financial interest but are given ranges of the financial interest (e.g., $5,000 to $9,999; $10,000 to $19,999).
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6.3.3. The full IRB must approve the COI Management Plan proposed by the COIC before the protocol is approved and released or may require a more stringent COI management plan. The IRB may not adopt a less stringent plan than that approved by the COIC.
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- 6.4. For management plans reviewed by an expedited reviewer, the reviewer may approve the plan, or may refer to the convened IRB if he/she believes that a more stringent COI management plan is required. The expedited reviewer may not adopt a less stringent plan than that approved by the COIC.
- 6.5. Management plans for responsible personnel with significant financial interest who are participating in a study where the Organization relies on an external IRB (CB) will not be reviewed by the convened IRB. The ORA will acknowledge receipt of the plan and will instruct the PI to notify the IRB of record.
- 6.4. In all cases, the COI Management plan may be reviewed by Organizational officials, who may require a more stringent COI management plan. The Organization may not adopt a less stringent plan than that approved by the IRB of record.
7.0 Management of COI in Research Conducted by Subgrantees, Contractors, and Collaborators
- 7.1. If the research is conducted at an external site and involves subgrantees, external contractors or collaborators with any financial interest related to the research, the PI must provide verification to the ORA that the individual(s) are in compliance with the external institution’s COI policy which meets the requirements of 42 CFR 50.604.
- 7.2. If the external site does not have a COI policy which meets the requirements of 42 CFR 50.604 the requirements of the applicable policy under Section 2.1 above must be met.
8.0 Documentation of COI Management
- 8.1. The COI Management Plan approved by the IRB will be maintained in the protocol file in the ORA for no less than seven years following cessation of the outside activity to which they relate.
9.0 Management of Organizational Financial COI
- 9.1. Organizational financial COI may occur when the Organization itself, or any of its component parts, or any senior organizational officials, have a financial interest in the design, conduct, or outcome of human subject research.
- 9.2. In accordance with Board of Regents Policies 3.2.8.10 and 4.4.2, the University of Nebraska may accept royalties, equity, or other forms of compensation when technology is licensed, or new companies are formed to commercialize University technology.
- 9.3. Every potential Organizational COI must be reported to the appropriate COI Officer as soon as it is identified.
- 9.4. Organizational COI may be identified through:
- 9.4.1. the required disclosure of financial interest of the Responsible Personnel at the time the IRB application is submitted.
- 9.4.2. the required annual disclosure of financial interest of senior administrators when it relates to human subject research.
- 9.4.3. review by technology transfer officials or other officials at organizational components.
- 9.5. If an Organizational COI is identified the COI Officer of the involved component shall convene a group of senior Organizational officials and unaffiliated individuals, appointed by the appropriate Chancellor, CEO or designee, to review the potential Organizational COI and propose any required management plans for approval.
- 9.6. Initial review of non-exempt human subject research for which an organizational COI has been identified will be performed by the convened IRB.
- 9.7. The COI Officer will provide the full IRB with the COI committee’s approved COI Management Plan.
- 9.8. The COI Officer or the IRB Executive Chair/designee will describe the nature of the financial interest, and the specifics of the management plan proposed by the COIC.
- 9.9. The IRB will review the management plan and if any concerns are identified, these will be conveyed to the COI officer for further consideration and action.
- 9.10. The IRB must be assured that any Organizational COI is appropriately managed in the interest of the safety and welfare of human subjects.
- 9.11. Organizational COI management plans approved by the IRB will be maintained in the ORA for no less than seven years following cessation of the activity.
DOCUMENT HISTORY:
Written: 4/14/2016 (Approved: 4/14/2016) - original author not recorded (previous policy #3.12)
Revised: 6/13/2018 - revision not documented
Revised: 12/8/2022 - Clarified that the ORA is only responsible for assuring the organization has adequate policies and procedures to ensure responsible personnel are appropriately trained (as opposed to the actual training); revised definition of covered persons to match that in HRPP 1.7; clarified definition of Organizational COI; delete specific FDA requirements under 21 CFR 54.4; clarified that, for multi-institution research where the UNMC IRB is the reviewing IRB, the COI Management plan may be generated by the relying institution; clarified that management plan may (but not “must”) include disclosure; clarified process for management plans associated with non-significant FCOI; deleted list of possible management options by COIC; clarified process for expedited review as opposed to convened IRB review; clarified process for review of management plans when organization relies on an external IRB; added requirement that initial review of non-exempt human subject research for which an organizational COI has been identified will be performed by the convened IRB; added “senior organizational officials” to definition of Organizational COI.
Revised: 6/1/2023 – added examples of possible management options by COIC (section 5.2) as per AAHRPP.
Revised: 8/31/2023 - updated CHMC COI policy name from #ADM100 to ID 13201440.
Revised: 1/22/2024 – clarified that an interest “related to the research” is one the COI Officer, COI committee, or the IRB reasonably determines could directly and significantly affect the design, conduct or reporting of research (section 3.4).
1.26 PI Qualifications and Responsibilities
Last Revised: 6/27/2022
1.0 Purpose
The purpose of this policy and procedure is to describe the qualifications and responsibilities of the PI during the conduct of research within the Organization and at external sites under the PI’s protocol.
2.0 Policy
It is the policy of the Organization that the PI and all other personnel involved in the conduct of research must possess the required experience, skill, and appropriate medical licensure to safely conduct the research in full compliance with all applicable regulatory and Organizational requirements specified in HRPP policy 1.1 (Human Research Protection Program).
3.0 Definitions
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3.1. Investigator is defined broadly by the Organization as an individual who actually conducts human subject research as either a Principal Investigator (PI) or a Secondary Investigator (SI).
Investigator is not specifically defined by HHS regulations. However, HHS guidance defines “investigator” as the individual performing various tasks related to the conduct of human subject research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subject research. Such involvement would include:
- 3.1.1. Obtaining information about living individuals by intervening or interacting with them for research purposes.
- 3.1.2. Obtaining identifiable private information about living individuals for research purposes.
- 3.1.3. Obtaining the voluntary informed consent of individuals to be subjects in research.
- 3.1.4. Studying, interpreting, or analyzing identifiable private information or data for research purposes.
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3.2. Principal Investigator (PI) is the individual under whose direction the research is conducted and who assumes overall responsibility for the safe and proper conduct of the research (single or multi-site) in full compliance with all applicable regulations and UNMC HRPP policies.
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3.3. Secondary Investigator (SI) is an individual who shares responsibility with the PI for the safe and proper conduct of the research in full compliance with all applicable regulations and UNMC HRPP policies.
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3.4. External Investigator (XI) is an investigator who is not employed by or otherwise representing the Organization who is engaged in research for which the UNMC IRB is the IRB of record.
A researcher employed or otherwise representing another institution who is under the jurisdiction of another IRB which has a reliance agreement with UNMC and for which the UNMC is acting as a central or single IRB is NOT considered an XI (per HRPP policy 1.28; External Investigator Assurance).
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3.5. Investigational New Drug is a new drug or biologic that is used in a clinical investigation (21 CFR 312.3(b))
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3.6. Investigation New Drug Application (IND) is an application submitted to FDA to conduct a clinical investigation with an investigational new drug.
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3.7. Investigational Device is a device, including a transitional device, which is the object of the investigation.
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3.8. Investigational Device Exemption (IDE) is an application submitted to FDA to conduct a clinical investigation with an investigational device that is classified as a significant risk device (SRD).
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3.9. Sponsor-Investigator is the individual, who initiates the research, assumes overall responsibility for the research as indicated in section 3.2 above and also fulfills the FDA-required responsibilities of a sponsor.
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3.10. External Investigator Assurance (XIA) is an assurance of compliance which must be completed by all XIs when the UNMC IRB is the IRB of record.
4.0 Qualification Requirements for the PI
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4.1. The PI must be an employee, faculty, or student of the Organization. Faculty shall include full- or part-time persons or emeritus faculty. Faculty include those with special faculty appointments, such as volunteer, adjunct, courtesy (without a UNMC faculty appointment) research or visiting faculty (collectively referred to as “volunteer faculty”).
- 4.1.1. Volunteer faculty may serve as PI only with the written permission of the appropriate UNMC Dean or his/her designee. The UNMC Dean may, at his or her discretion, place additional requirements (such as the concurrent approval of a department chairperson). The UNMC Dean or designee must accept ultimate responsibility to assuring the PI fulfills his/her responsibilities under this policy.
- 4.1.2. If the research involves any direct contact with human subjects on the facilities of the Organization, then volunteer faculty serving as PI must be present physically on the facilities of the Organization, or have a secondary investigator who is UNMC faculty present physically on the facilities, to allow them conduct and oversee research activities.
- 4.1.3. Volunteer faculty may not serve as PI on a protocol which requires review and approval of the Institutional Biosafety Committee.
- 4.1.4. Medical or dental practitioners or other allied health practitioners who have admitting privileges but do not have a faculty appointment as above may not serve as PI.
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4.2. Individuals other than employee, faculty, or student of the Organization may serve as PI only if a special memorandum of understanding exists between the Organization and another entity which sponsors that individual and that research (for example, faculty of University of Nebraska Lincoln for FDA regulated research, or faculty of National Strategic Research Institute).
- 4.2.1. When a student or trainee is the PI, a researcher sufficiently experienced in the area of the trainee’s research interest and satisfying the requirements of Section 4.1 above must serve as a co-investigator for research and be jointly responsible for oversight of the research.
- 4.2.2. A student may not serve as the PI of a study which involves the administration or use of an FDA regulated drug, device or biologic.
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4.3. The PI must be qualified by education, training, experience and licensure (as applicable) to assume overall responsibility for the safe and proper conduct of the research in full compliance with all applicable regulations and UNMC HRPP policies.
- 4.3.1. When a student or trainee is the PI, a researcher sufficiently experienced in the area of the trainee’s research interest and satisfying the requirements of Section 4.1 above must serve as a co-investigator for research and be jointly responsible for oversight of the research.
- 4.3.2. A student may not serve as the PI of a study which involves the administration or use of an FDA regulated drug, device or biologic.
5.0 Responsibilities of the PI During the Conduct of Research
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5.1. The PI will conduct protocols with sound research design consistent with current methods and ethical standards. The PI will seek independent review and consultation by other experts prior to submission to the IRB when appropriate.
Note: Research designed and conducted by students and trainees must be thoroughly reviewed by the faculty advisor and exhibit sound research design.
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5.2. The PI is responsible for obtaining IRB approval (or exempt determination) prior to initiating the research. Documentation of this approval must be written and dated.
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5.3. The PI is responsible for conducting research in compliance with the detailed protocol, the IRB application, and any other documents approved by the IRB.
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5.4. The PI will ensure compliance with applicable regulatory and HRPP requirements specified in HRPP policy 1.1 (Human Research Protection Program).
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5.5. The PI must oversee and be responsible for ensuring all research personnel comply with all applicable requirements, including, but not limited to, implementing the research in accordance with the IRB-approved protocol and completing all educational requirements as specified in HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel).
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5.6. The PI is responsible for ensuring that research is conducted in accordance with the terms of any grant, contract, and/or signed agreement.
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5.7. The PI will ensure all secondary investigators (sub-investigators) and other study personnel conducting the research are qualified by education, training, experience, and medical licensure (as applicable) to safely conduct the research in full compliance with the applicable federal regulations, HRPP policies and the protocol.
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5.8. The PI will provide all secondary investigator(s) conducting the research and other study personnel (as appropriate) with a copy of the: a) UNMC IRB-approved application and ICF(s)/information sheet(s), b) detailed protocol, c) Investigator’s Brochure, and d) other necessary documents.
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5.9. The PI will ensure that all secondary investigator(s) and other study personnel fully understand the study and their obligations consistent with assigned responsibilities.
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5.10. The PI will disclose, and assure that responsible personnel and other covered persons disclose potential financial COI, in accordance with HRPP policy 1.25 (Financial Conflicts of Interest) and Organizational policies.
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5.11. The PI will ensure risks to subjects and others have been minimized to the greatest extent possible, as per HRPP policy 3.2 (Data and Safety Monitoring).
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5.12. The PI will ensure the protocol contains a plan for just, fair, and equitable recruitment and selection of subjects.
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5.13. The PI will ensure the protocol contains adequate provisions for monitoring the data collected to ensure the safety of subjects.
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5.14. The PI will ensure there are adequate provisions to protect the privacy of subjects and the confidentiality of data, as per HRPP policy 3.3 (Privacy Interests and Confidentiality of Research Data).
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5.15. The PI will ensure there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment and space.
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5.16. The PI may not make any changes in the research without IRB approval, except in accordance with 45 CFR 46.108(a)(3)(iii) and 21 CFR 56.108(b) where necessary to eliminate apparent immediate hazards to human subjects or provide the subject/LAR with critical information that is vital to the subject’s continued participation in the research in accordance with HRPP policy 2.4 (IRB Review of Changes in Previously Approved Research).
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5.17. Any change to the research, which is made to eliminate immediate hazards to subjects without prior IRB approval, shall be reported promptly to the IRB in accordance with HRPP policy 2.4 (IRB Review of Changes in Previously Approved Research).
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5.18. The PI is responsible for informing all study personnel and participating sites (as applicable) of IRB approved modifications in the protocol, IRB application, and/or consent form.
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5.19. The PI will ensure that when some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects in accordance with HRPP policy 4.1 (Additional Protections for Vulnerable Populations).
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5.20. The PI is ultimately responsible for ensuring that legally effective informed consent is developed, obtained and documented in accordance with, and to the extent required by 45 CFR 46.116, 45 CFR 46.117, 21 CFR 50 (as applicable) and HRPP policy 5.1 (Obtaining Informed Consent From Research Subjects).
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5.21. When consent is obtained by other authorized study personnel, the PI will ensure the individual is appropriately trained to obtain valid informed consent. In addition, the PI will exert ongoing supervision of all authorized study personnel.
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5.22. The PI will ensure that all secondary investigator(s) and other study personnel promptly report to the PI the following as applicable:
- 5.22.1. Internal Adverse Events which are unexpected and related, or possibly related, to the study interventions, and Unanticipated Adverse Device Effects, per HRPP policy 8.1 (IRB Review of Adverse Events and Adverse Device Effects).
- 5.22.2. Unanticipated problems involving risk to the subject or others, per HRPP policy 8.3 (IRB Review of Unanticipated Problems Involving Risk).
- 5.22.3. Noncompliance, per HRPP policy 8.4 (Review of Noncompliance)
- 5.22.4. Complaints, per HRPP policy 8.2 (IRB Review of Study Related Complaints)
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5.23. The PI will ensure that all of the incidents listed under Section 5.20 above are reported to the IRB in accordance with the applicable HRPP policies.
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5.24. The PI will permit and facilitate monitoring and auditing of research, at reasonable times, by the IRB, funding agencies, and other authorized federal and state regulatory agencies.
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5.25. The PI, or a qualified person(s) designated by the PI, shall conduct periodic audits of research records.
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5.26. The PI is responsible for the accuracy, completeness, legibility, and timeliness of the data recorded and reported in presentations and publications about the research.
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5.27. The PI will fulfill registration and reporting requirements of ClinicalTrials.gov in compliance with HHS regulations at 42 CFR 11 (Final Rule for Clinical Trials Registration and Results Information Submission), and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.
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5.28. The PI will maintain records after the study ends for at least seven years or longer as required by applicable FDA, HIPAA, state, or sponsor requirements and should take measures to prevent accidental or premature destruction of these documents.
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5.29. The PI is responsible for submitting continuing review reports to the IRB in accordance with the approval period specified by the IRB. The PI should fulfill the requirements for continuing review in time for the IRB to carry out the review prior to the expiration date of the current IRB approval.
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5.30. Upon completion of the research (or premature closure of the study), the PI will provide the IRB with the Study Completion Report and will provide the funding and regulatory agencies with any required reports.
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5.31. Once a study has been completed or closed, the PI must continue to honor any confidentiality protections of the data as well as other commitments agreed to as part of the approved research.
6.0 Responsibilities of the PI for the Conduct of PI-Initiated Multicenter Research
- 6.1. The PI will fulfill all the applicable responsibilities described in Section 5.0 above.
- 6.2. The PI assumes overall responsibility for the safe and proper conduct of the research at all sites (within the Organization and external sites) in full compliance with all applicable regulations and UNMC HRPP policies.
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6.3. The PI must have a process in place to coordinate and communicate issues related to the protection of human subjects to all performance sites including:
- 6.3.1. IRB initial review
- 6.3.2. IRB continuing review
- 6.3.3. IRB review of amendments
- 6.3.4. Consent requirements
- 6.3.5. HIPAA requirements
- 6.3.6. Information security including the confidential collection and transmission of data
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6.3.7. Reporting requirements for:
- 6.3.7.1. Unanticipated problems involving risks to the subject or others
- 6.3.7.2. Adverse events
- 6.3.7.3. Noncompliance
- 6.3.7.4. Complaints
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6.4. The PI will ensure that all external investigators promptly report to the PI the following (as applicable):
- 6.4.1. Adverse Events which are unexpected, related or possibly related to the research.
- 6.4.2. Unanticipated Adverse Device Effects
- 6.4.3. Unanticipated problems involving risk to the subject or others
- 6.4.4. Noncompliance
- 6.4.5. Complaints
- 6.4.6. Audits by sponsors, CRO’s, FDA, OHRP, or other federal authorities,
- 6.4.7. Study reports as required by the protocol,
- 6.4.8. Continuing review reports
- 6.4.9. Interim results
- 6.4.10. DSMB results
- 6.5. The PI, or a qualified person(s) designated by the PI, shall conduct periodic audits of research records maintained by external investigator(s) at all sites.
- 6.6. If the PI determines the research presents an unreasonable risk to subjects, the PI will discontinue the study immediately and notifications shall be sent immediately to all investigators, the IRBs of record for all sites, the sponsor and FDA (as required).
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6.7. When the external performance site(s) utilize(s) their own local IRB for oversight of the research, the PI must assure:
- 6.7.1. The IRB application identifies the external sites.
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6.7.2. A copy of all of the following documents from the external sites are maintained in the research records:
- 6.7.2.1. A copy of the external IRB approval letter(s) and approved ICF(s)/information sheet(s).
- 6.7.2.2. The external site’s FWA number (required for HHS funded research)
- 6.7.2.3. The external site’s IRB Registration number (required for FDA registered research)
- 6.7.2.4. The external site’s HRPP accreditation status
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6.8. When the external performance site(s) utilize(s) the UNMC IRB for oversight of research. The PI must assure:
- 6.8.1. Compliance with HRPP policy 1.3 (UNMC IRB Serving as Central IRB).
- 6.8.2. The IRB application identifies the external site(s).
- 6.8.3. An ICF is developed for each site deferring to UNMC IRB review.
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6.8.4. The research records contains:
- 6.8.4.1. Signed copies of each signed External Investigator Assurance (XIA).
- 6.8.4.2. A copy of each external investigator’s Curriculum Vitae (CV).
- 6.8.4.3. Copies of all signed ICFs obtained from subjects enrolled in the research by the external investigator(s) when the UNMC IRB is the IRB of record.
7.0 Additional Responsibilities of the PI during the Conduct of Research under the Oversight of an External IRB
- 7.1. The PI will fulfill all applicable requirements of the external IRB.
- 7.2. The PI will fulfil all applicable requirements specified in HRPP policy 1.4 (UNMC IRB Ceding Review to an External IRB), and as described in the Reliance Agreement.
8.0 Additional Responsibilities of the PI During Conduct of FDA Regulated Research
Note: FDA guidance regarding investigator responsibilities can be found in “Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects” (October 2009)
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8.1. For clinical investigations involving an investigational drug, the PI is responsible for ensuring that the conditions of 21 CFR 312.60, 61, 62, 64, 66, 68, and 69, are met:
- 8.1.1. Ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation (21 CFR 312.60).
- 8.1.2. Ensure that informed consent is obtained in accordance with the provisions of 21 CFR 50. (21 CFR 312.60)
- 8.1.3. Ensure control of the investigational drug in accordance with 21 CFR 312.61.
- 8.1.4. Prepare, maintain and retain records in accordance with 21 CFR 312.62 and Nebraska State Law per HRPP policy 1.17 (Retention of Research Records).
- 8.1.5. Report to sponsor in accordance with 21 CFR 312.64.
- 8.1.6. Assure that the IRB complies with 21 CFR 56 (21 CFR 312.66)
- 8.1.7. Report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others; and not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects (21 CFR 312.66)
- 8.1.8. Allow inspection of investigator's records and reports by FDA, in accordance with 21 CFR 312.68.
- 8.1.9. Handle controlled substances in accordance with 21 CFR 312.69.
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8.2. For clinical investigations involving an investigational device the PI is responsible for ensuring that the conditions of CFR 812.100 and 110 are met:
- 8.2.1. Ensure that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator’s care, and for the control of devices under investigation (21 CFR 812.100)
- 8.2.2. Ensure that informed consent is obtained in accordance with the provisions of 21 CFR 50 (21 CFR 812.100).
- 8.2.3. Not request the written informed consent of any subject to participate, and not allow any subject to participate before obtaining IRB and FDA approval (21 CFR 812.110(a)).
- 8.2.4. Conduct the investigation in accordance with the signed agreement with the sponsor, the investigational plan, applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA (21 CFR 812.110(b))
- 8.2.5. Permit use of the investigational device only with subjects under the investigator’s supervision (21 CFR 812.110(c)).
- 8.2.6. Disclose financial information to sponsor, as required per 21 CFR 54 (21 CFR 812.110(d)).
- 8.2.7. Dispose of remaining devices per 21 CFR 812.110(e).
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8.3. For clinical investigations subject to ICH GCP the investigator is responsible for requirements of ICH E6 (Guideline for Good Clinical Practice) section 4.
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8.4. The PI is responsible for ensuring all study personnel:
- 8.4.1. Read and understand the information in the Investigator’s Brochure, including the potential risks and side effects of the drug or device.
- 8.4.2. Ensure that a clinical investigation is conducted according to the signed investigator statement for clinical investigations of drugs, including biological products, or agreement for clinical investigations of medical devices, the investigational plan and other applicable FDA regulations and any conditions of approval imposed by the IRB or FDA.
- 8.4.3. Control drugs, biological products, and devices according to FDA regulations.
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8.5. The PI must maintain a list of the appropriately qualified persons to whom significant trial-related duties have been delegated. This list should also describe the delegated tasks, identify the training that individuals have received that qualifies them to perform delegated tasks (e.g., CV, certifications), and identify the dates of involvement in the study. The PI should maintain separate lists for each study conducted by the investigator.
Note: PIs who conduct clinical investigations of drugs and devices under the FDA regulations commit themselves to personally conduct or supervise the investigation. When certain study-related tasks are delegated by a PI, the PI is responsible for providing adequate supervision of those to whom the tasks are delegated.
9.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IND
- 9.1. When the investigator also acts as a sponsor for a clinical investigation involving an investigational drug he/she must submit a signed assurance that he/she understands and accepts his/her obligations per FDA regulations (21 CFR 312) (see Addendum O).
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9.2. When the investigator also acts as a sponsor for a clinical investigation involving an investigational device, in addition to all responsibilities as investigator as above, he/she is also responsible for ensuring that the following regulatory obligations are met:
- 9.2.1. General responsibilities, including select qualified investigators, provide them with the information they need to conduct an investigation properly, ensure proper monitoring of the investigation(s), ensure that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintain an effective IND with respect to the investigations, and ensure that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug (21 CFR 312.50).
- 9.2.2. Select qualified investigators and monitors, who make the required assurances and commitments as per 21 CFR 312.53.
- 9.2.3. Keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use, as per 21 CFR 312.55.
- 9.2.4. Monitor the progress of the clinical investigation (21 CFR 312.56)
- 9.2.5. Monitor the compliance of investigators and respond accordingly, including ending the investigator’s participation in the clinical investigation, in accordance with 21 CFR 312.56.
- 9.2.6. Review and evaluate the evidence relating to the safety and effectiveness of the drug, and make reports to the FDA regarding the safety of the drug and the progress of the investigation (21 CFR 312.56
- 9.2.7. Discontinue the investigation if he/she determines that the investigational drug presents an unreasonable and significant risk to subjects, and notify FDA, all institutional review boards, and all investigators, and assure the disposition of all stocks of the drug outstanding (21 CFR 312.56)
- 9.2.8. Maintain and retain adequate records as described in 21 CFR 312.57, and allow FDA access to such records, as per 21 CFR 312.58.
- 9.2.9. Handle controlled substances in accordance with 21 CFR 312.59.
- 9.3. The PI shall ensure there is on-going review and evaluation of evidence relating to the safety and effectiveness of the drug, and report such evaluation to (a) FDA in accordance with 21 CFR 312.33, and (b) the UNMC IRB when there is a safety concern.
- 9.4. If the PI determines the investigational drug presents an unreasonable risk to subjects, the PI will discontinue the study immediately and notifications shall be sent immediately to all external investigators, the IRBs of record for all sites and FDA.
10.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IDE
- 10.1. When the investigator also acts as a sponsor for a clinical investigator involving an investigational device he/she must submit a signed assurance that he/she understands and accepts his/her obligations per FDA regulations (21 CFR 812) (see Addendum P).
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10.2. When the investigator also acts as a sponsor for a clinical investigator involving an investigational device, in addition to all responsibilities as investigator as above, he/she is also responsible for ensuring that the following regulatory obligations are met:
- 10.2.1. General Duties (21 CFR 812.40), including submitting an IDE to the FDA in accordance with the requirements of 21 CFR 812.20.
- 10.2.2. Selection of Investigators (21 CFR 812.43)
- 10.2.3. Monitoring (21 CFR 812.46)
- 10.2.4. Controlling Distribution and Disposition of Devices. The sponsor-investigator must take proper measures to ensure that devices are not diverted outside of legally authorized channels, may ship investigational devices only to qualified investigators participating in the clinical investigation (21 CFR 812.43(b)), must maintain complete, current, and accurate records pertaining to the shipment and disposition of the investigational device (21 CFR 812.140(b)), take appropriate measures to instruct investigators regarding their responsibilities with respect to recordkeeping and device disposition per 21 CFR 812.140(a).
- 10.2.5. Prohibition of Promotion and Other Practices (21 CFR 812.7)
- 10.2.6. Supplemental Applications [21 CFR 812.35(a) and (b)]
- 10.2.7. Maintaining Records [21 CFR 812.140(b)]
- 10.2.8. Submitting Reports [21 CFR 812.150(b)]
- 10.2.9. Inspections [21 CFR 812.145]
- 10.3. The PI shall ensure there is on-going review and evaluation of evidence relating to the safety and effectiveness of the device and report such evaluation to (a) FDA, and (b) the UNMC IRB when there is a safety concern.
- 10.4. If the PI determines the investigational device presents an unreasonable risk to subjects, the PI will discontinue the study immediately and notifications shall be sent immediately to all investigators participating in the research, the IRBs of record and FDA, in accordance with 21 CFR 812.45.
DOCUMENT HISTORY:
Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded
Revised: 9/27/2017 - revision not documented
Revised: 3/3/2018 - revision not documented
Revised: 9/5/2018 - revision not documented
Revised: 10/11/2019 - revision not documented
Revised: 12/10/2019 - revision not documented
Revised: 6/27/2022 - "Clarification of definition of "volunteer faculty; inclusion of emeritus faculty; inclusion of individuals operating under a special memorandum of understanding; clarification of requirement that volunteer conducting research with direct subject contact be present physically on campus, or have UNMC co-investigator physically on campus; faculty".
1.27 Research Personnel Qualifications and Responsibilities
Last Revised: 2/18/2019
1.0 Purpose
The purpose of this policy and procedure is to describe the qualifications and responsibilities of personnel conducting research within the Organization and at external sites under the jurisdiction of the UNMC IRB.
2.0 Policy
It is the policy of the Organization that personnel involved in the conduct of research must possess the required experience, skill, education and (as appropriate) licensure to safely conduct the research in full compliance with all applicable regulatory and Organizational requirements specified in HRPP policy 1.1 (Human Research Protection Program).
3.0 General Requirements
- 3.1. Research personnel who are Responsible Personnel per HRPP policy 1.25 (Financial Conflicts of Interest) must comply with the Organizational Conflict of Interest Policy as described in that policy.
- 3.2. Research personnel who (a) participate in the process of consent, (b) have contact with subjects, or (c) have access to identifiable private information or identifiable biospecimens, and Faculty Advisors of student investigators, are required to comply with HSP subject protection training as described in HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel)
- 3.3. For FDA regulated research, research personnel must comply with applicable FDA requirements, including completion and submission of FDA Form 1572 to the sponsor if applicable.
4.0 Definitions of Research Personnel and Specific Requirements
-
4.1. Principal Investigator (PI):
- 4.1.1. The PI assumes overall responsibility for the conduct of the research. Specific responsibilities are described in HRPP policy 1.26 (PI Qualifications & Responsibilities).
- 4.1.2. Only one PI can be named on the IRB application. Co-PIs (for example, on NIH grants) must be listed as Secondary Investigators.
- 4.1.3. The PI must be an employee, faculty, or student associated with the Organization.
- 4.1.4. The PI must be qualified by education, training, experience and licensure (as applicable) to assume overall responsibility for the safe and proper conduct of the research in full compliance with all applicable regulations and UNMC HRPP policies.
- 4.1.5. If the PI is a student, resident, or house officer, a faculty advisor or program director must be identified on the IRB application. The faculty advisor/program director assumes responsibility for overall supervision of the student’s research and must sign off on the IRB application before submission to the IRB.
-
4.2. Secondary Investigator(s) (SI):
-
4.2.1. Secondary Investigator(s) responsibilities may include (but are not limited to):
- 4.2.1.1. Development of the research plan (in conjunction with the PI and other investigators)
- 4.2.1.2. Obtainment of legally effective informed consent/assent from prospective subjects.
- 4.2.1.3. Performance of research interventions or tests, or analysis of data or biospecimens
- 4.2.1.4. Presentation or publication of the data (in conjunction with the PI and other investigators).
- 4.2.2. The SI shares responsibility with the PI for assure safe conduct of the research in full compliance with the protocol, HRPP policies, IRB requirements, HHS or other Federal regulations, applicable FDA regulations and state law.
- 4.2.3. More than one SI may be named on the IRB application.
- 4.2.4. The SI is not required to be associated with the Organization; however an unaffiliated investigator must sign an external investigator agreement unless he/she does not have access to subjects or identifiable private information or identifiable biospecimens
- 4.2.5. The SI must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.
-
4.2.1. Secondary Investigator(s) responsibilities may include (but are not limited to):
-
4.3. Participating Personnel:
- 4.3.1. Participating Personnel are not involved in the development and submission of the Application to the IRB.
-
4.3.2. Participating Personnel responsibilities may include (but are not limited to):
- 4.3.2.1. Obtainment of legally effective informed consent/assent from prospective subjects, if authorized by the PI in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).
- 4.3.2.2. Performance of research interventions or tests in the course of providing clinical care or routine services to the patient/subject, or analysis of data or biospecimens
- 4.3.2.3. Presentation or publication of the data (in conjunction with the PI and other investigators).
- 4.3.3. More than one PP may be named on the IRB application.
- 4.3.4. Participating personnel are not required to be associated with the Organization; however unaffiliated personnel must sign an External Investigator Agreement unless they do not have access to subjects or identifiable private information or identifiable biospecimens
- 4.3.5. Participating personnel must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.
-
4.4. Lead Coordinator:
- 4.4.1. The Lead Coordinator is directly involved with working with the PI in the submission of all applications and reports to the IRB.
- 4.4.2. The Lead Coordinator serves as the primary regulatory contact point for the ORA. All correspondence from the IRB will be directed to both the PI and Lead Coordinator.
- 4.4.3. The Lead Coordinator may be authorized by the IRB to obtain informed consent/assent in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).
- 4.4.4. Performance of research interventions or tests in the course of providing clinical care or routine services to the patient/subject, or analysis of data or biospecimens.
- 4.4.5. Only one Lead Coordinator may be named in a study.
- 4.4.6. A Lead Coordinator is not required for all research. The PI will serve as the single contact when a Lead Coordinator is not identified.
-
4.5. Coordinator
- 4.5.1. Coordinators may be authorized to obtain informed consent/assent in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).
- 4.5.2. Coordinators may be involved with performance of research interventions or tests in the course of providing clinical care or routine services to the patient/subject, or analysis of data or biospecimens.
- 4.5.3. More than one coordinator may be named on the IRB application.
- 4.5.4. Coordinators must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.
-
4.6. Administrative and Data Management Personnel:
- 4.6.1. Administrative and Data Management Personnel generally handle the data collected during the course of the research.
- 4.6.2. Administrative and Data Management Personnel may be involved in preparation of IRB applications and required paperwork under the direction of the Lead Coordinator and PI.
- 4.6.3. Administrative and Data Management Personnel do not have direct subject contact, but may have access to subject's identifiable private information, or protected health information (PHI).
DOCUMENT HISTORY:
Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded
Revised: 2/18/2019 - revision not documented
1.28 External Investigator Assurance
Last Revised: 12/3/2022
1.0 Purpose
The purpose of this policy is to describe the Organization’s requirements for initiating an External Investigator Assurance (XIA) (also referred to as a “Collaborating Institutional Investigator Agreement”).
2.0 Policy
It is the policy of the Organization that:
- 1.1. An XIA is required when the UNMC IRB is the IRB of record for non-exempt research conducted at any site by an external investigator (XI) who is not faculty, employee or student of the Organization, and who is not under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC.
3.0 Definitions
- 3.1. An External Investigator (XI) means an investigator who is not faculty, employee or student of the Organization who is engaged in research for which the UNMC IRB is the IRB of record.
- 3.1.1. The Organization considers the criteria for “engagement” of an individual in the same manner as for an institution, as described in “OHRP Guidance: Engagement of Institutions in Human Subjects Research (2008).” In general, an External Investigator is “engaged in research” when he/she obtains (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.
- 3.1.2. An investigator who is employed by or otherwise representing another institution and who is under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC and for which the UNMC is acting as the IRB of record, is NOT considered an XI for the purpose of this policy. The reliance agreement which exists between UNMC and the relying institution obligates that institution to hold investigators at that institution to the same standards as the XIA.
- 3.2. An External Site means a facility not under the jurisdiction of the Organization where research for which the UNMC IRB is the IRB of record is performed, and which is not subject to the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC.
- 3.2.1. In general, the Organization considers a facility “performing research” as equivalent to the criteria for “engagement” of a facility as described in “OHRP Guidance: Engagement of Institutions in Human Subjects Research (2008).”
4.0 Requirements for, and Content of, an External Investigator Agreement (XIA)
- 4.1. An XIA between the Organization and the XI is required when an XI is engaged in research under a UNMC IRB approved research protocol and is not subject to the jurisdiction of an external IRB with which the UNMC IRB has an IRB Reliance Agreement in place.
- 4.2. An XIA between the Organization and the external site is required when an external site is engaged in research under a UNMC IRB approved research protocol for which there is not an IRB reliance agreement in place between UNMC and the site.
- 4.3. The XIA must be in effect before any research activities may be performed at that site.
- 4.4. An XIA must be in effect for each XI at that site and a copy maintained on file with the UNMC PI
- 4.5. The XIA describes responsibilities of the XI including, but not limited to, assuring compliance with 45 CFR 46 including subparts as applicable, 21 CFR 50, 56, 312, 812, and HIPAA Privacy Rule, state laws, HRPP policies, and the protocol.
- 4.6. An XIA is effective for all studies that the XI conducts under the oversight of the UNMC IRB; therefore only one XIA is required.
- 4.7. The Organization, ORA, the UNMC IRB or the UNMC investigator may revoke the XIA at any time, it there is reason to believe that the XI is not satisfying responsibilities as described in the XIA.
DOCUMENT HISTORY:
Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded (previous policy #3.14)
Revised: 2/6/2018 - revision not documented
Revised: 12/3/2022 - Clarified that XIA is synonymous with “Collaborating Institutional Investigator Agreement”; revised definition of XI to include an investigator who is “not faculty, employee or student of the Organization, and who is not under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC”; clarified that an XIA is required for an XI conducting research at any site (including sites operated by the Organization), not just an external site; revised definitions for clarity; provided definition of “external site”; clarified that XIA is required between the Organization and the external site when an external site is engaged in research under a UNMC IRB approved research protocol for which there is not an IRB reliance agreement in place between UNMC and the site.
1.29 ClinicalTrials.gov Reporting
Last Revised: 3/20/2023
1.0. Purpose
The purpose of this policy is to describe the requirements for registration and compliance with ClinicalTrials.gov.
2.0. Policy
It is the policy of the Organization that:
- 2.1. FDA regulated trials that meet the definition of an "applicable clinical trial" (ACT) will be registered and updated on ClinicalTrials.gov in compliance with HHS regulations at 42 CFR 11 (Final Rule for Clinical Trials Registration and Results Information Submission).
- 2.1.1. Investigators are required to adhere to the statutory provisions of 42 CFR 11 (rather than the abbreviated provisions described in this policy when there are discrepancies), as well as clarifications and definitions found at www.clinicaltrials.gov.
- 2.2. All NIH funded clinical trials will be registered and updated as required on ClinicalTrials.gov in compliance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.
- 2.3. All Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS) will be registered and updated on ClinicalTrials.gov as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1.
- 2.4. If an investigator voluntarily registers a study on ClinicalTrials.gov even though registration is not required, all ClinicalTrials.gov requirements and UNMC HRPP policies related to ClinicalTrials.gov reporting apply.
3.0. Definitions
- 3.1. Clinical Trial:
- 3.1.1. Per 42 CFR 11.10(a) a clinical trial is a “clinical investigation (or clinical study) in which human subject(s) are prospectively assigned, according to a protocol, to one or more interventions (or no intervention) to evaluate the effect(s) of the intervention(s) on biomedical or health-related outcomes”
- 3.1.2. Per NIH Policy NOT-OD-16-149 a clinical trial is a "research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health- related biomedical or behavioral outcomes.”
- 3.1.2.1. For the purposes of this Policy, the regulatory definition at 42 CFR 11.10(a) and the definition in NIH policy are treated as synonymous. The NIH definition of "clinical trial" is, however, broader than the term "applicable clinical trial" as defined in 42 CFR 11 (below).
- 3.1.2.2. The NIH definition of a clinical trial includes “Basic Experimental Studies involving Humans” (BESH) that meet both the definition of basic research and the NIH definition of a clinical trial. BESH are subject to NIH clinical trials policies such as registration and results reporting.
- 3.1.3. Per ICJME a clinical trial is “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.”
- 3.2. Applicable Clinical Trial (ACT):
- 3.2.1. An applicable device clinical trial means a clinical trial or study that meets the conditions listed in 42 CFR 11.22(b).
- 3.2.2. ACTs generally include interventional studies (with one or more arms) of FDA- regulated drugs, biological products, or devices that meet one of the following conditions:
- 3.2.2.1. The trial has one or more sites in the United States.
- 3.2.2.2. The trial is conducted under an FDA investigational new drug application or investigational device exemption.
- 3.2.2.3. The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research.
- 3.2.3. ACTs include the following:
- 3.2.3.1. Trials of drugs and biologics: Controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to Food and Drug Administration (FDA) regulation.
- 3.2.3.2. Trials of devices: 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric post-market surveillance required by FDA.
- 3.3. Responsible Party:
- 3.3.1. The sponsor of the trial will be considered the responsible party unless and until a principal investigator has been designated the responsible party in accordance with 42 CFR 11.4(c)(2).
- 3.3.2. If an ACT or clinical trial is being conducted under an IND or IDE, then the holder of the IND or IDE is the responsible party regardless of how the clinical trial is being funded.
- 3.3.3. For clinical trials not conducted under an IND or IDE:
- 3.3.3.1. If the clinical trial is being conducted under a grant or sponsored research agreement, the funding recipient is generally considered to be Responsible Party.
- 3.3.3.2. If the clinical trial is being conducted under a contract, the funder is generally considered to be the responsible party
- 3.3.3.3. If there is no funding agreement supporting the clinical trial, the person or entity who initiated the clinical trial by preparing and/or planning the clinical trial, and has authority and control, is considered to be the responsible party.
- 3.3.4. The sponsor of the clinical trial may designate the principal investigator to be the responsible party, if the PI satisfies the requirements of 42 CFR 11.4(c)(2).
- 3.3.5. For NIH funded clinical trials, the awardee is usually the Responsible Party. If he/she is not the Responsible Party, then he/she is still obligated to coordinate with the responsible party to ensure that all regulatory requirements are met.
- 3.4. Record Owner: ClinicalTrials.gov Protocol Registration and Results System (PRS) account holder who creates a study record in PRS and is authorized by the Responsible Party to enter information into the PRS.
4.0. Investigator Responsibilities
The following describes the responsibilities of the PI if he/she is the Responsible Party. If he/she is not the Responsible Party, then the PI is responsible only for assuring the IRB Application correctly reflects that the research study is registered with clinicaltrials.gov and that the NCT number is accurate. Otherwise, this section does not apply.
- 4.1. The PI must ensure the following trials are registered in the ClinicalTrials.gov PRS system:
- 4.1.1. FDA regulated trials that meet the definition of an "applicable clinical trial" (ACT) as above.
- 4.1.1.1. The following types of studies are generally excluded from the registration and results submission requirements of 42 CFR 11. This is not a complete list.
- 4.1.1.1.1. Phase 1 drug trials, including studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes
- 4.1.1.1.2. Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices, where the primary outcome measure relates to feasibility and not to health outcomes
- 4.1.1.1.3. Trials that do not include drugs, biologics, or devices (such as behavioral interventions)
- 4.1.1.1.4. Non-interventional (observational) clinical research (such as cohort or case-control studies)
- 4.1.1.2. FDA regulated trials that do not meet the definition of ACT, or that do not otherwise require registration per 42 CFR 11 may still require registration if they are an NIH funded clinical trial, or are a qualifying clinical trial which will render claims for items and services to the CMS (per section 2.0 above).
- 4.1.1.1. The following types of studies are generally excluded from the registration and results submission requirements of 42 CFR 11. This is not a complete list.
- 4.1.2. All NIH-funded clinical trials
-
4.1.2.1. All NIH-funded awardees and investigators conducting clinical trials will register and report the results of their trial in Clinicaltrials.gov regardless of study phase, type of intervention, or whether they are subject to 42 CFR 11.
Note: For example, NIH-funded phase 1 clinical trials of an FDA-regulated product are covered by this policy as are clinical trials studying interventions not regulated by the FDA, such as behavioral interventions.
-
4.1.2.2. The investigator is responsible for submitting to the ORA a copy of the award letter or other documentation from the NIH which specifies whether the trial constitutes a clinical trial subject to NIH Policy NOT-OD-16-149.
-
- 4.1.3. All Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS) will be registered and updated on ClinicalTrials.gov as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1.
- 4.1.4. Though not a requirement of the Organization, investigators should be aware that the International Committee of Medical Journal Editors (ICMJE) requires and recommends that all clinical trials be registered in a public registry at or before the time of first participant enrollment as a condition of consideration for publication. ICJME accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP), including ClinicalTrials.gov. A listing of non-ICJME journals that follow ICJME’s recommendations is available on the ICJME website.
- 4.1.5. Though not a requirement by the Organization, investigators should be aware that funding sources, such as international non-governmental organizations (NGOs) or private funders, may require registration and compliance with a publicly available registry.
- 4.1.1. FDA regulated trials that meet the definition of an "applicable clinical trial" (ACT) as above.
- 4.2. The PI is responsible for assuring that the IRB Application correctly reflects that a research study is registered with clinicaltrials.gov and that the NCT number is accurate. If registration is done after initial approval, a change request will be required.
- 4.3. If a research study which does not require registration is voluntarily registered with clinicaltrials.gov, then the responsible party is obligated to satisfy all requirements noted in this policy.
- 4.4. If the clinical trial is not registered with ClinicalTrials.gov the PI must provide justification why the trial is not registered.
- 4.5. The PI must update the ClinicalTrials.gov record in accordance with Section 801 of FDAAA (https://clinicaltrials.gov/ct2/manage-recs/fdaaa) and 42 CFR 11.64. This may apply to some changes, study status, and annual update.
- 4.6. The PI is responsible for uploading required documents in accordance with 42 CFR 11.48(a)(5).
- 4.7. The PI is responsible for ensuring the submission of all appropriate study results as defined in 42 CFR 48 at the conclusion of the study, in accordance with in 42 CFR 11.42.
- 4.8. Should the PI leave the Organization, the PI is responsible for assuring that the record is transferred to a new Responsible Party, the record is resolved (completed, terminated, or withdrawn) with all applicable information entered, or the record is transferred to the PI’s new Institution (applicable only to on-going studies).
- 4.9 If a study subject to this policy is completed (that is, when the investigator files a completion report), the IRB protocol must remain open and active until the ClinicalTrials.gov record is resolved.
5.0. ORA responsibilities
The following describes the responsibilities of the ORA where faculty, student or employee of the Organization is the Responsible Party for a record on ClinicalTrials.gov; otherwise, the UNMC HRPP Policies do not apply.
- 5.1. For studies where registration on ClinicalTrials.gov is required, ORA will not issue full approval of any protocol where the Responsible Party is part of the Organization until the trial is registered and NCT number is issued.
- 5.1.1. Under certain limited circumstances, full approval may be granted before issuance of the NCT number, provided registration has been completed (for example, if a Letter of Award or grant funding is dependent on IRB approval). In those circumstances, a letter of IRB approval will be provided, but subject enrollment may not begin, and funds may not be spent, until the NCT number is provided as a Request for Change in protocol.
- 5.2. Approval of any subsequent IRB submissions will not be issued until the ClinicalTrials.gov record is in compliance. The IRB ORA Analyst serving as the PRS Administrator will communicate the problems with the Responsible Party and Record Owner, and ensure the problems are resolved appropriately.
- 5.3. The PRS Administrator will routinely review the Organization’s ClinicalTrials.gov records for problems and will notify the Responsible Party and Record Owner, and ensure the problems are resolved appropriately.
- 5.4. The PRS Administrator will review the ClinicalTrials.gov record when a protocol amendment is submitted and will ensure that applicable changes are appropriately updated on the record.
- 5.5. Investigators who are non-compliant with ClinicalTrials.gov requirements or this HRPP Policy may be subject to disciplinary actions as per HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel), and per the Office of the Vice-Chancellor for Research.
DOCUMENT HISTORY:
Written: 5/31/2018 (Approved: 5/31/2018) - original author not recorded
Revised: 1/6/2023 - Added requirement that CMS qualifying clinical trials must be registered and updated as required on ClinicalTrials.gov; specifically noted that BESH constitute clinical trials subject to this policy; added recommendation that clinical trials that meet the clinical trial definition of The International Committee of Medical Journal Editors (ICMJE) be registered and updated as required on ClinicalTrials.gov; clarified that if an investigator voluntarily registers a study on ClinicalTrials.gov even though registration is not required, all ClinicalTrials.gov requirements and UNMC HRPP policies related to ClinicalTrials.gov reporting apply; added that should the PI or the Record Owner leave the Organization, the PI is responsible for assuring that the Responsible Party and/or Record Owner are updated in the PRS database; revised ORA responsibilities and processes; added that investigator is responsible for submitting documentation from NIH specifying whether the trial constitutes a clinical trial; text reorganized and stylistic changes made for clarity.
Revised: 3/20/2023 - Provided regulatory reference for designation of “applicable clinical trials”; simplified “ORA Responsibilities” and deleted specific procedures; simplified “Investigator Responsibilities”; added that “If a study subject to this policy is completed ... the IRB protocol must remain open and active until the ClinicalTrials.gov record is resolved” (section 4.9); stylistic changes.
1.30 Use of the Rapid Response IRB
Last Revised: 10/17/2024
1.0 Purpose
The purpose of this policy is to describe the constitution of, the criteria for use of, and the procedures for review by, the Rapid Response IRB (RR-IRB; IRB-03).
2.0 Policy
It is the policy of the Organization that
- 2.1. The Rapid Response IRB (RR-IRB) will be utilized as appropriate to facilitate the review of human subject research that meets criteria listed below.
- 2.2. The standard procedures for full IRB review (as per HRPP policy 2.2 {Full IRB Review}) may be modified as described below, to facilitate rapid and meaningful IRB review, in accordance with federal regulations at 45 CFR 46 and 21 CFR 56.
3.0 Constitution
- 3.1. The RR-IRB is a fully constituted and registered IRB (IRB00002686) operating under FWA 00002939.
- 3.2. The RR-IRB is composed of at least 8 members (at least one of whom is a non-scientist and one who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution), and a variable number of alternates.
- 3.3. The RR-IRB will include one Chair and at least one Vice-Chair.
- 3.4. Members and alternates will represent a variety of colleges, departments and medical and academic disciplines, including but not limited to, College of Public Health, Infectious Disease, Pharmacy, and ethics.
- 3.5. The RR-IRB shall include a prisoner representative with appropriate background and experience to serve in that capacity, as per 45 CFR 46.304(b).
- 3.6. Membership will satisfy requirements of HRPP policy 1.6 (IRB Composition, Leadership, Qualifications, & Responsibilities).
4.0 Criteria for Use
- 4.1. The RR-IRB may be activated by the Executive Chair or designee for rapid review of new protocols, previously tabled protocols, requests for change in approved research or continuing reviews of approved research.
- 4.1.1. In order for the RR-IRB to review a previously tabled protocol, one member of the convened RR-IRB must also have been present at the IRB meeting during which the protocol was tabled, or a member of the board that tabled the protocol must be present at the RR-IRB meeting, as a non-voting observer, to answer questions regarding the issues raised by that board.
- 4.2. Activation is at the discretion of the Executive Chair or designee, in consultation, if necessary, with the IO. In general, the RR-IRB will review research which fits ALL of the following criteria:
- 4.2.1. The research provides the potential for meaningful benefit to potential subjects that cannot be obtained outside the context of the specific research protocol, OR the research provides the potential for significant benefit to the Organization.
- 4.2.2. Review is urgent; that is, there is insufficient time to wait for a scheduled meeting of IRB-01, IRB-02 IRB-04, or IRB-05.
- 4.2.3. The research is not eligible for expedited review, per HRPP policy 2.3 (Expedited Review).
- 4.3. In general, the RR-IRB will not review research where the urgency arises from delays on the part of the investigator.
5.0 Process of IRB review and ORA release
- 5.1. Upon activation, one or more IRB Analysts will be responsible for contacting members in order to identify a quorum, and an appropriate meeting day/time. Once a quorum and meeting time are identified, the investigator will be notified.
- 5.2. The investigator will begin the process of completing the IRB application online
- 5.3. The RR-IRB will review as per HRPP policy 2.2 (Full IRB Review), except as noted below.
- 5.4. Depending on the urgency of the review, as determined by the Executive Chair and/or the RR-IRB Chair, in consultation as appropriate with the IO, any or all of the following modifications in the process of IRB review and/or ORA release may be utilized:
- 5.4.1. The investigator and the IRB Analyst, Executive Chair and/or the RR-IRB Chair may discuss issues related to the protocol, IRB application and CF in an iterative fashion during the completion of the online application, in order to proactively address potential concerns.
- 5.4.2. The primary and secondary reviewers may begin review of the draft IRB application and CFs as they become available prior to the meeting; they will be supplied with any revisions of these documents as they are available.
- 5.4.2.1. All RR-IRB members will be supplied with the complete IRB application, full protocol, and CFs at the time of the meeting.
- 5.4.3. RR-IRB review may occur concurrently with review by other committees (for example, Pharmacy and Therapeutics, IBC).
- 5.4.3.1. The Executive Chair and/or RR-IRB Chair or designee will be responsible for assuring that changes (if any) required by those other committees do not require further review by the IRB.
- 5.4.4. The investigator or their designee may be present at the IRB meeting during the presentation of the protocol and discussion by the board, in order to interactively address concerns or questions raised by the RR-IRB. The RR-IRB will be provided adequate time for further discussion and vote without the investigator or designee present.
- 5.4.5. The IRB analyst assigned to the protocol may make modifications to the IRB Application and the CF based on discussion with the investigator during the RR-IRB meeting, and the investigator’s responses to IRB directed comments following the meeting.
- 5.4.6. The Executive Chair and/or RR-IRB Chair, in consultation with the IO as appropriate, may waive the requirements that some or all of the ancillary committee reviews be completed prior to ORA release.
- 5.5. Following review of the protocol by the RR-IRB, the IRB Analyst assigned to the protocol (in consultation with the Executive Chair or RR-IRB Chair as needed) will review the investigator’s written responses, and revised application and CFs, and grant approval if the conditions placed by the full RR-IRB have been satisfied.
DOCUMENT HISTORY:
Written: 2/5/2018 (Approved: 2/5/2018) - original author not recorded
Revised: 10/17/2024 – clarified the size and composition of the RR-IRB (sections 3.2 and 3.4); deleted requirement that RR-IRB include representatives from UNMC, NM and CN (section 3.4); clarified the role of the non-voting observer when the RR-IRB reviews protocols tabled by another board (section 4.1.1); when RR-IRB review occurs concurrently with review by other committees specified who is responsible for assuring that those reviews do not raise conflicts with the IRB review (section 5.4.3.1); added that Executive Chair and/or RR-IRB Chair may waive the requirements that some or all of the ancillary committee reviews be completed prior to ORA release (section 5.4.6); stylistic changes.
1.31 Observers at IRB Meetings
Last Revised: 2/26/2018
1.0 Purpose
The purpose of this policy and procedure is to describe the Organization’s requirements for allowing observers at convened IRB meetings.
2.0 Policy
- 2.1. It is the policy of the Organization that non-members who have a legitimate reason, may be allowed to observe convened IRB meetings.
- 2.2. It is the policy of the Organization that an investigator whose protocol is being reviewed by the IRB at that convened meeting may attend that portion of the meeting for the purpose of providing information to, and answering questions of, the convened board.
3.0 Justification for Attendance
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3.1. With appropriate justification, the full IRB, the IRB Executive Committee, or the IRB Executive Chair has authority to permit an observer at a convened meeting of any of the IRBs
- 3.1.1. In general, adequate justification would include a legitimate job related interest in the process of IRB review, or an academic interest in research ethics and the functioning of IRBs in general.
- 3.1.2. Persons who are being considered as potential IRB members may observe one or more convened IRB meetings.
- 3.2. In deciding whether to allow a particular observer, the full IRB, the IRB Executive Committee, or the IRB Executive Chair will consider whether the same or similar benefit could be obtained from alternate experience (for example, an IRB orientation or didactic presentation).
- 3.3. The full IRB may invite an investigator whose protocol is being reviewed by the IRB at that convened meeting to attend that portion of the meeting, for the purpose of providing information to, and answering questions of, the convened board.
4.0 Procedure
- 4.1. The IRB Administrator responsible for coordinating the meetings will arrange for the appropriate meeting for the observer to attend.
- 4.2. The observer will be required to sign a confidentiality agreement prior to the scheduled meeting.
- 4.3. The presence of an observer will be recorded in the IRB minutes, as per HRPP policy 2.2 (Full IRB Review).
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4.4. For observers:
- 4.4.1. In general, observers will not participate in the discussion of agenda items.
- 4.4.2. The observer may be required to leave the room during any discussion or vote as determined by the Chair or Executive Chair, or at the request of any board member.
- 4.4.3. No observer will be permitted to attend a portion of the meeting where he/she has a COI, as per HRPP policy 1.7 (IRB Member, Consultant, Staff COI Identification and Management).
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4.5. For invited investigators:
- 4.5.1. An invited investigator may only attend during the review of his/her protocol.
- 4.5.2. An invited investigators may provide information to, and answer questions of, the convened board. He/she may, at the request of the board, participate in the discussion regarding his/her protocol.
- 4.5.3. The invited investigator will leave the room after he/she has provided the requested information, before final discussion or vote.
DOCUMENT HISTORY:
Written: 2/26/2018 (Approved: 2/26/2018) - original author not recorded
1.32 Confidentiality of the Review Process
Last Reviewed: 1/12/2018
1.0 Purpose
The purpose of this policy and procedure is to describe the Organization’s requirements and practices for assuring confidentiality of the process of review of human subjects research
2.0 Policy
- 2.1. It is the policy of the Organization that the deliberations of the IRB in a convened meeting or subcommittee meeting, or of an expedited reviewer, are confidential, and details of such discussions and deliberations may not be shared with the investigator or any other person outside the IRB or the ORA.
- 2.2. It is the policy of the Organization that findings and decisions of the IRB, or of a subcommittee of the IRB, or of an expedited reviewer, will be shared with the investigator or with the investigator’s staff verbally, by email or by letter, following that meeting or review. The details of the deliberations will not be shared as per section 2.1 above.
- 2.3. It is the policy of the Organization that violation of this policy, and especially the deliberate communication of the details of the deliberation of the IRB, the subcommittee or the expedited reviewer, is cause for action against that IRB member, ORA staff member or other responsible party as described below.
3.0 Process
- 3.1. IRB members will sign a Confidentiality Agreement at the time they are appointed to the board, and again at every re-appointment. The signed agreement will be retained by the ORA.
- 3.2. ORA Staff will sign a Confidentiality agreement at the time they are hired. The signed agreement will be retained by the ORA.
- 3.3. Guests to the IRB meeting will sign a Confidentiality agreement prior to attending the meeting in accordance with HRPP policy 1.31 (Observers at IRB Meetings). The signed agreement will be retained by the ORA.
- 3.4. Consultants to the IRB will sign a Confidentiality Agreement prior to attending the meeting. The signed agreement will be retained by the ORA.
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3.5. Allegations of violation of this policy will be handled and investigated as described in HRPP policy 8.5 (Noncompliance by the IRB or Other Components of the HRPP).
- 3.5.1. The event, however, will not be considered “non-compliance” as per that policy, and is not reportable outside the Organization.
- 3.6. Violation of this policy may lead to actions against the IRB member, the ORA Staff, or other responsible party, as determined by the IO. These actions could include, but are not limited to, dismissal from the board, disciplinary actions, or termination of employment.
DOCUMENT HISTORY:
Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded
1.33 Posting of Clinical Trial Consent Forms
Last Revised: 9/18/2019
1.0 Purpose
The purpose of this policy and procedure is to describe the Organization’s requirements for posting of clinical trial consent forms, per requirements of 45 CFR 46.116(h).
2.0 Policy
- 2.1. It is the policy of the Organization that, for clinical trials conducted or supported by a Common Rule department or agency, the awardee of a grant will post one IRB approved informed consent form used to enroll subjects on a publicly available Federal Web site that will be established as a repository for such informed consent forms. Posting shall occur after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
3.0 Definitions
- 3.1. Clinical Trial (for the purpose of this Policy) means a "research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
4.0 Investigator Responsibilities
- 4.1. If the UNMC/UNO/CHMC/BMC investigator is the awardee of the grant from a Common Rule agency or department, or is the principal investigator of a clinical trial conducted by a Common Rule agency or department, then he/she is responsible for posting the consent form as described in this policy.
- 4.2. The PI must notify the ORA when the clinical trial is closed to recruitment.
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4.3. The PI must post one IRB approved unsigned consent form to ClinicalTrials.gov (or other website as designated by OHRP) after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol (per 45 CFR 46.116(h)). In practice, the ORA requires that the consent form be posted within 30 days of enrollment of the last subject.
- 4.3.1. The consent form need not be the current version.
- 4.3.2. If there are multiple consent forms, only one must be posted. That is, if there are different consent forms for different classes of subjects (for example, for adults and for minors), or for different phases of the research (for example, screening and intervention) or for different interventions in different groups (for example, for an investigational group and a control group) only one needs to be posted.
- 4.3.3. If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (for example, confidential commercial information), such Federal department or agency may permit or require redactions to the information posted. Without such permission or requirement, the consent form must be posted as it had been approved.
- 4.4. The PI must notify the ORA when the consent form has been posted.
5.0 ORA Procedures
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5.1. At the time the ORA is notified that the clinical trial is closed to recruitment, the administrator will log the date into the RA database, and the ORA will notify the investigator of the requirements and advise that consent form must be posted within 30 days.
- 5.1.1. Notification of the ORA can come from the investigator (in the form of a completion report, or direct communication); from the Clinical Trial Management System (in the form of an automated notification when the last subject is accrued); or at the time of Continuing Review when status changes to “Subject Accrual Completed.”
- 5.2. After 30 days the ORA will query the investigator to verify that the consent form has been posted. In addition, the ORA may choose to review CT.gov to determine if consent form has been posted.
- 5.3. Failure to report relevant events (per section 4.2 and 4.4), or to respond the ORA queries, constitute non-compliance subject to disciplinary actions as per HRPP policy #8.5.
- 5.4. Failure to post consent forms as per section 4.3 constitutes serious non-compliance subject to disciplinary actions as per HRPP policy #8.5, and per the Office of the Vice-Chancellor for Research.
DOCUMENT HISTORY:
Written: 2/27/2019 (Approved: 2/27/2019) - original author not recorded
Revised: 9/18/2019 - revision not documented
1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs
Last Revised: 8/31/2023
1.0 Purpose
The purpose of this policy is to describe the Emergency Preparedness and Continuity of Operations Plan (EP/COOP) for the HRPP. This policy and accompanying documents focus on the Office of Regulatory Affairs (ORA) and the IRB; the Organization maintains plans for other components of the HRPP.
2.0 Policy
It is the policy of the Organization that:
- 2.1. The HRPP has an Emergency Preparedness and Continuity of Operations Plan, appropriate to the size and complexity of the HRPP, that addresses how continuity of operations will be maintained to ensure human participant protections during an emergency.
- 2.2. The HRPP Emergency Preparedness and Continuity of Operations Plan is periodically evaluated and, when necessary, adjusted to ensure continuity of operations.
- 2.3. Education about the HRPP Emergency Preparedness and Continuity of Operations Plan will be provided to IRB members and staff, researchers and research staff, and other persons in the HRPP as appropriate.
3.0. General Comments
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3.1. The purpose of the attached Emergency Preparedness /Continuity of Operations Plan (EP/COOP) is to provide the framework for restoring essential functions to the ORA and the UNMC IRBs as components of the HRPP in the event of an emergency that affects its operations. It is a supporting document to the UNMC/Nebraska Medicine (NM) enterprise COOP Plan.
The attached document establishes the EP/COOP procedures for any operational disruption, including but not limited to:
-Loss of access to a facility (such as damage to the building),
-Loss of service due to a reduced workforce (such as due to pandemic virus) and
-Loss of service due to protracted equipment or systems failure (such as IT systems failure).
The intent of this HRPP EP/COOP is to lay out procedures to allow the ORA and IRBs, as components of the HRPP in the event of an emergency, to implement actions to promptly begin continuity operations and to maintain essential functions until full operative capacity can be resumed.
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3.2. Depending on the nature of the risk and the potential impact to the HRPP and the institution, the AVCRA, in consultation with the IO, the Executive Chair and IRB Chairs, and representatives from components of the HRPP as appropriate, will determine which actions need to be undertaken to minimize the impact on research activities and mitigate risk to research participants, study team members, and the institution.
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3.3. The ORA and IRBs, as components of the HRPP, will work with the appropriate Institutional personnel (Director of UNMC Office of Emergency Management and Nebraska Medicine Executive Director of Emergency Management and Biopreparedness) to coordinate activities as appropriate with Institutional plans already in place to address the event (as per the institutional COOP plan on file with the UNMC Office of Emergency Management).
- 3.3.1. If the emergency only affects the ORA or IRBs, the ORA will assure that appropriate Institutional personnel (Director of UNMC Office of Emergency Management and Nebraska Medicine Executive Director of Emergency Management and Biopreparedness) are informed.
4.0. Specific Responsibilities in the Event of an Emergency
- 4.1. Specific responsibilities are described in the attached EP/COOP document.
5.0. Specific Actions by the ORA and/or IRBs in the Event of an Emergency
- 5.1. Specific actions are described in the attached EP/COOP document.
6.0. EP/COOP Maintenance
- 6.1. The Associate Vice-Chancellor for Regulatory Affairs will periodically review (at least biennially) and update the UNMC HRPP EP/COOP based on legislative changes, UNMC/NM guidance, departmental or personnel changes, and procedural changes based on lessons learned from exercises and actual events.
7.0. Training and Education
The ORA will provide targeted communications and education/training regarding the UNMC HRPP EP/COOP to researchers and research staff, IRB Chairs and IRB members, study team members and PIs. As appropriate, the ORA, in collaboration with the UNMC and NM Office of Emergency Management will conduct periodic exercises to assure validity and operability of the plan.
Addendum
DOCUMENT HISTORY
Written: 8/31/2023 (Approved: 9/1/2023)