Section 1: General Human Research Protection Program Policies

1.1 Human Research Protection Program (HRPP)

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

4.0 HRPP Mission

5.0 Ethical Principles

6.0 Regulatory Compliance

7.0 Federalwide Assurance (FWA)

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.

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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/19/2023

1.2 Authority Granted to the IRB by the Organization

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:

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

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:

3.0 Definitions

4.0 UNMC IRB, Relying Institution, and Lead PI Responsibilities

5.0 Procedures

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). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 11/13/2024 – clarified which UNMC HRPP policies must be complied with by participating sites (section 5.7); corrected typographic errors; stylistic changes. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.4 UNMC Ceding Review to an External Central IRB

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

3.0 Definitions

4.0 External IRB, UNMC IRB, and PI Responsibilities

5.0 Procedures

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.

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.

We may share your PHI with other groups listed below:

The UNMC Institutional Review Board (IRB) Institutional officials designated by the UNMC IRB The HHS Office for Human Research Protections (OHRP)

We may share your PHI with other groups listed below. The HIPAA Privacy Rule requires these groups to protect your PHI.

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}

We may share your PHI with other groups listed below. These groups are NOT required by HIPAA to protect your PHI. If we share your PHI with these other groups they may share it with others who also do not have to protect it under HIPAA:

{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.

Information related to subject rights should include the UNMC IRB and Research Subject Advocate Contact information

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) {Approved Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.5 Requirements for Research Conducted with International Sites

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:

3.0 Investigator Responsibilities

4.0 ORA Responsibilities

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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 12/12/2022

 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. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

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

4.0 IRB Leadership

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). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/15/2022

 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. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management

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:

3.0 Definitions

4.0 Procedures for identification and management of conflict of interest by members and consultants

5.0 Procedures for identification and management of conflict of interest by IRB staff

6.0. Procedures for identification and management of conflict of interest by guests at the IRB meeting

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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Boards voted to approve: 11/22/22; 12/1/22; 12/9/22; 12/15/22

 Revised 9/25/2024 – stylistic changes {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.8 Investigational Activities Requiring IRB Review and Approval

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:

3.0 Definitions

4.0 HRPP Classifications of Human Subject Research

5.0 Activities Which Are Not Human Subject Research

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.

6.0. Other Activities Deemed Not Research

Other activities specifically defined in 45 CFR 46.102(l) are deemed “not research.” These activities include:

7.0 Determination of When an Activity Constitutes Human Subject Research

8.0 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 {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/16/2022

 Revised: 2/8/2023 – revised section 7.0 to describe use of website NHSR Decision Tool. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 2/15/2023

 Revised: 5/9/2023 – clarified characteristics of Student Projects (section 5.6); added description and defined parameters of Pilot Testing (section 5.7).{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.9 Resources Necessary to Protect Subjects

1.0 Purpose

The purpose of this policy and procedure 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

3.0 PI and Certifier Obligation

4.0 IRB Review of Resources

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

1.10 Scientific and Other Committee Review of Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for scientific and scholarly merit review, and review by other component committees of the HRPP, of all human subject research protocols (see HRPP policy 1.9 Review of Resources Necessary to Protect Subjects) conducted under the jurisdiction of the UNMC IRB.

2.0 Policy

3.0 Department, Division, School, College, or Institute Review of Scientific Merit

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 of the following groups. None of these committees has the authority to approve human subject research to begin that has not yet been approved, or has been disapproved, by the IRB, as per HRPP policy 1.2 (Authority Granted to the IRB by the Organization).

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)}

1.11 HRPP Access to Legal Counsel

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for HRPP access to legal counsel for the purpose of interpreting federal, state, and local law as needed.

2.0 Policy

It is the policy of the Organization that the HRPP will have ready access to legal counsel in order to ensure the correct interpretation and application of federal, state, and local law. 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 Procedures

DOCUMENT HISTORY:

 Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

1.12 Sponsored Research

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

4.0. Investigator Responsibilities

5.0. Sponsor Responsibilities

6.0. Organization Responsibilities

7.0. ORA and/or IRB Responsibilities:

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. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.13 Compliance with ICH-GCP Guidelines

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

3.0 Procedures

4.0 ICH GCP Requirements

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

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

3.0 Definitions

4.0 Procedures

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 {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.15 Research Subject to Department of Justice Regulatory Requirements

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

3.0 Definitions [28 CFR 46.102]

4.0 Procedures

DOCUMENT HISTORY:

 Written: 4/20/2016 (Approved: 4/20/2016) - original author not recorded

1.16 ORA Record Keeping Requirements

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

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). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/10/2022

 Revised: 01/17/2024 – Modified 3.1.1 to specify that records of protocol modifications will be retained along with other documents. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.17 Retention of Research Records

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.

3.0 Required Records

4.0 Department Retention of Records

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 {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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) {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/14/2022

1.18 Review and Approval of HRPP Policies and Procedures

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

4.0 Full IRB Review of Draft HRPP Policies

5.0 Organizational Notification of Changes to HRPP Policies

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. {Approved: 7/2/2022 Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/14/2022

 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 {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.19 IRB Signature Authority

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:

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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/14/2022

1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)

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:

3.0. Outreach Activities for Education of the Community

4.0. Outreach activities specifically directed at community education regarding current and proposed research studies.

5.0. Outreach activities directed at involvement of the community in Research Design, Implementation, and Analysis of Research Results (CBPR).

6.0. Evaluation of Outreach Activities

7.0. IRB Responsibilities

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.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 7/6/2023 – extensive modifications and additions to sections 3, 4, 5, and 6.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 1/17/2024 – added section 7.0 defining IRB responsibilities regarding review of CBPR research. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.21 Post-Approval Monitoring of Research

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

3.0 Post Approval Monitoring Program Objectives

4.0 Procedures

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

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

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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/30/2022

 Revised 9/25/2024 – Revised to allow flexibility in assessments of HRPP quality, effectiveness, and efficiency, and in evaluation of members, chairs, and analysts. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.23 HRPP Training Requirements

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

4.0 Required Training

5.0 Additional (Optional) Training

6.0 Procedures for Assessing Training Requirements

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) {Approved: 7/2/2022 - Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 8/17/2022 - clarification regarding expiration of CITI training for personnel on an active protocol (section 4.1.10) {Approved - Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/16/2022

1.24 HRPP Training Requirements for IRB Members

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

4.0 Initial Training and Orientation

5.0 Continuing Education

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. {Approved: Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/15/2022

1.25 Financial Conflicts of Interest

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:

3.0 Definitions

4.0 Procedures for Disclosure of Potential COI

5.0 COI Management Plan

6.0 Review of COI Management Plans

7.0 Management of COI in Research Conducted by Subgrantees, Contractors, and Collaborators

8.0 Documentation of COI Management

9.0 Management of Organizational Financial COI

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.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board voted and approved: 12/27/2022, 1/13/2023, 1/19/2023, 2/2/2023

 Revised: 6/1/2023 – added examples of possible management options by COIC (section 5.2) as per AAHRPP {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised:8/31/2023 - updated CHMC COI policy name from #ADM100 to ID 13201440. {Robert Lewis - IRB Assoc}

 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). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.26 PI Qualifications and Responsibilities

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

4.0 Qualification Requirements for the PI

5.0 Responsibilities of the PI During the Conduct of Research

6.0 Responsibilities of the PI for the Conduct of PI-Initiated Multicenter Research

7.0 Additional Responsibilities of the PI during the Conduct of Research under the Oversight of an External IRB

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)

9.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IND

10.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IDE

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" {Approved: 6/27/2022 Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.27 Research Personnel Qualifications and Responsibilities

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

4.0 Definitions of Research Personnel and Specific Requirements

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

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:

3.0 Definitions

4.0 Requirements for, and Content of, an External Investigator Agreement (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

 Revision 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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified - 12/29/2022

1.29 ClinicalTrials.gov Reporting

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:

3.0. Definitions

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.

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.

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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/16/2023

 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.{Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.30 Use of the Rapid Response IRB

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

3.0 Constitution

4.0 Criteria for Use

5.0 Process of IRB review and ORA release

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. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

1.31 Observers at IRB Meetings

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

3.0 Justification for Attendance

4.0 Procedure

DOCUMENT HISTORY:

 Written: 2/26/2018 (Approved: 2/26/2018) - original author not recorded

1.32 Confidentiality of the Review Process

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

3.0 Process

DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded

1.33 Posting of Clinical Trial Consent Forms

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

3.0 Definitions

4.0 Investigator Responsibilities

5.0 ORA Procedures

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

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:

3.0. General Comments

4.0. Specific Responsibilities in the Event of an Emergency

5.0. Specific Actions by the ORA and/or IRBs in the Event of an Emergency

6.0. EP/COOP Maintenance

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

See UNMC HRPP EP/COOP plan

DOCUMENT HISTORY

 Written: 8/31/2023 (Approved: 9/1/2023) {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}