Skip to main content

1.4 UNMC Ceding Review to an External Central IRB

Last Revised: 5/15/2025

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the UNMC IRB to cede review to an external IRB.

2.0 Policy

It is the policy of the Organization that:

  • 2.1. 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. 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. Select independent commercial IRBs may serve as the IRB of record for new commercially sponsored clinical trials, with the exceptions specified under Section 2.5 below.
  • 2.4. 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).
  • 2.5. 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 is part of an accredited HRPP or has completed the OHRP QA Self-Assessment Tool, or, with specific approval of the IRB Executive Chair , in consultation with the IO as appropriate. Reviewing IRB must have appropriate systems to review the research 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.
    • 2.5.3. The external Institution has a valid FWA, and the external IRB is registered with OHRP and FDA (as applicable).
  • 2.6. 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 of any type to an external IRB.
  • 2.7. The Organization will not rely on a non-domestic IRB or Ethics Committee.
  • 2.8. 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:
    • 2.8.1. Clinical trials initiated by a UNMC investigator.
    • 2.8.2. Use of a Humanitarian Use Device (HUD) subject to 21 CFR 814.124(a).
    • 2.7.3. Research that involves the use of vaccines developed or manipulated at UNMC.
    • 2.7.4. Emergency use of a test article subject to FDA regulations at 21 CFR 56.102(d) and 21 CFR 56.104(c).
    • 2.7.5. Research involving prisoners as subjects.
    • 2.7.6. Research involving fetal tissue or HESCs, or their derivatives.
  • 2.9. The IO, in consultation with the IRB Executive Chair as appropriate, has the sole authority to allow exceptions to the exclusions above.
  • 2.10. The research may not begin at the Organization until there is a fully executed Reliance Agreement between UNMC and the external IRB for all non-exempt research and all institutional requirements described in HRPP 1.10 (Scientific and Other Committee Review of Research) have been completed.
    • 2.10.1. The IO and Executive Chair have the authority to allow exceptions to institutional requirements described in HRPP 1.10.
  • 2.11. The Organization will accept the review and approval of an external IRB for human subject research exempt under 45 CFR 46.104 and 21 CFR 56.104; however, the Organization will not require the execution of a Reliance Agreement.
  • 2.12. The research may not commence until approval has been granted by the external IRB, and acceptance has been issued by UNMC Office of Regulatory Affairs (ORA).
  • 2.13. 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. Investigators must comply with Organizational policies as described in Addendum 2.
  • 2.15. All research conducted under an external IRB is subject to post approval monitoring per HRPP policy 1.21 (Post-Approval Monitoring of Research).
  • 2.16. 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.

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 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, and responsibilities of the organizations.
  • 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: 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.
  • 3.5. Office of Regulatory Affairs (ORA); UNMC office responsible for the support of the IRBs and the day-to-day operations of the HRPP.

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 and to 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 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 ORA and HRPP (on behalf of the relying institution) to:
    • 4.2.1. Review the submitted CIRB application to ensure that (1) there is review and approval of appropriate other committees as described in HRPP 1.10; (2) the research will comply with certain HRPP policies related to the conduct of the research at the organization (as described in addendum 2; (3) the final CFs are accurate regarding required institutional boilerplate language; and (4) advertisements and recruitment methods are acceptable (as per HRPP 3.5 and 3.6).
    • 4.2.2. Assure that appropriate agreements are in place, including, but not limited to (1) Executed sponsored agreement; (2) Data Use, Data Transfer and/or Material Transfer Agreements; (3) Business Associate agreements as appropriate; and (4) IRB Reliance Agreement between UNMC IRB and external IRB
    • 4.2.3. 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 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 qualified by education, training, experience and licensure (as applicable) to conduct the research in accordance with all applicable regulations and UNMC HRPP policies.
      • 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 may be serious, continuing and/or may represent an unanticipated problem. 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 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 under review by the external IRB.
    • 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. Should termination of a reliance agreement occur, ensure that 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 regarding 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.
    • 4.2.14. Make determinations required by HIPAA Privacy Rule (45 CFR Parts 160 and 164) when the reviewing IRB does not accept the responsibility to make those determinations,
  • 4.3. It is the responsibility of the UNMC PI to:
    • 4.3.1. Complete all requirements for submission of request to utilize the CIRB to the ORA. PI must submit the Central IRB Application (CIRB) through RSS. 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. The application must be accompanied by all supporting documents (protocol, investigator’s brochure, consent templates, surveys, and any other study documents).
    • 4.3.2. Complete all requirements for submission to the external IRB. Cooperate with the external IRB to include UNMC required consent form language (addendum 1 to this policy) in final consent forms. Cooperate with external IRB to include any COI disclosure language in final consent forms.
    • 4.3.3. Comply with all relevant UNMC HRPP policies described in addendum 2 below (including, but not limited to, those related to compensation, advertisement, ethical access, short form consent, process and documentation of consent).
    • 4.3.4. Comply with all determinations and requirements of the external IRB.
    • 4.3.5. Comply with the external IRB’s requirements for initial and continuing review, record keeping, and reporting in a timely manner.
    • 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 as defined by the reviewing IRB policies.

      • 4.3.6.4. Protocol deviations.

      • 4.3.6.5. Any complaints from subjects or others.

      • 4.3.6.6. Data Safety Monitoring Reports

      • 4.3.6.7. Internal adverse events and other events which may qualify as an unanticipated problem involving risk to the subject.

    • 4.3.7. Promptly report to the UNMC ORA
      • 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 that have been determined to be serious and/or continuing, or an unanticipated problem, by the reviewing IRB.
      • 4.3.7.4. Copies of all reports to OHRP, FDA and sponsoring agency.
      • 4.3.7.5. Copies of internal adverse event reports that the reviewing IRB determines are unexpected, AND related to, or possibly related to, the research intervention or procedures.
        • 4.3.7.5.1. Reported events will be reviewed by the ORA but not referred to the convened IRB.
      • 4.3.7.6. Changes in study personnel
    • 4.3.8. Ensure all investigators and research staff are qualified by education, training, experience and licensure (as applicable) to conduct the research in accordance with all applicable regulations and UNMC HRPP policies.
    • 4.3.9. Ensure that all research personnel involved in the process of consent or assent are properly trained and are fully aware of their responsibilities regarding the obtainment of informed consent/assent according to institutional policies, applicable federal regulations, and state law.
    • 4.3.10. Conduct monitoring in addition to, or in cooperation with, the external IRB and the ORA.
    • 4.3.11. Notify the ORA when a study is completed
  • 4.4. There may be additional external IRB, UNMC ORA, 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. Exempt Research

  • 5.1. The Organization will accept the review and approval of an external IRB for human subject research exempt under 45 CFR 46.104 and 21 CFR 56.104
    • 5.1.1. In addition to completing the CIRB application in RSS, the protocol, all supporting documents, and the letter of approval by the external IRB or institution must be uploaded into RSS.
  • 5.2. The Organization does not enter into reliance for studies determined to be exempt per 46 CFR 46.104.
  • 5.3. When determining whether research relying on an external IRB is exempt, the organization will use the definition of exempt research as per HRPP policy 2.6 (Exempt Research). The organization will require review by the UNMC IRB/ORA regardless of the determination of the external IRB.

Addendum 1: UNMC Required Consent Form Language

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).

 Revised 5/15/2025 - Revised globally to focus on responsibilities of the various components and delete procedures more appropriate for SOPs; clarified the additional requirements for use of a non-accredited IRB as the CIRB (section 2.5.2); clarified that the organization will not rely on a non-domestic IRB or Ethics Committee (section 2.7); removed the restriction on use of a CIRB for (1) emergency research subject to FDA regulations at 21 CFR 50.24, (2) research that involves the use of vaccines developed or manipulated at UNMC, and (3) research involving gene transfer (section 2.8); clarified that research may not begin at the Organization until all institutional requirements been completed, but that the IO and Executive Chair have the authority to allow exceptions to institutional requirements (section 2.10); clarified that research may not commence until acceptance has been issued by ORA (section 2.12); moved to section 2.16 (as a policy item) the statement that the ORA, the IRB and the IO retain the authority to suspend research; added definition of ORA (section 3.5); clarified that the responsibility of the UNMC ORA and HRPP to ensure investigators are qualified includes investigators who are not medical staff (section 4.2.4); clarified responsibility for making determinations required by the HIPAA Privacy Rule (section 4.2.14); clarified policies related to CIRB review of Exempt Research (section 5.0), specifically that the Organization will accept the review and approval of an external IRB for exempt human subject research, but will not enter into reliance for those studies; deleted specific contraception language from addendum 1 (reference to text present on IRB website); removed redundancies; stylistic changes and correction of typographic errors.

Back to top