VA Research: Health Sciences IRBs Policy for IRB Review of Human Participants Research that Falls Under VA Purview

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Policy Number:
UW-4082
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

The UW Health Sciences IRB (HS-IRB), through a Memorandum of Understanding (MOU), serves as the Institutional Review Board (IRB) of record for William S. Middleton Memorial Veterans Hospital (Madison VA) human participants research studies that are not otherwise reviewed by a central IRB of the VA or other federal agency. This policy documents requirements for research conducted under the purview of the Madison VA that add to or differ from those outlined in the UW-Madison Human Research Protection Program (HRPP) Toolkit Library for the review of human participant research.

Policy:

  1. Application of Veterans Affairs (VA) Regulations and Madison VA Policies

    1. Study teams engaged in Madison VA human participants research must follow, in addition to other applicable federal regulations and UW-Madison policies for the protection of human participants, all applicable policies found in Veterans Health Administration (VHA) and Department of Veterans Affairs (VA) Handbooks, related memoranda, and other guidance documents.
    2. The HS-IRB applies the Common Rule regulations at 38 CFR Part 16 to all Madison VA human participants research in addition to other applicable federal regulations governing human participants research, such as FDA and DOD regulations, and VA regulations and requirements.

  2. Definition of VA Research

    1. VA Research. VA research is research that is conducted by investigators (serving on VA compensated, WOC, or IPA appointments) while on VA time or on VA property. The research may be funded by VA, by other sponsors, or be unfunded. VA research must have Research and Development Committee (R&DC) approval before it is considered VA research and before it can be initiated. All research activities approved by the R&DC are considered VA research. NOTE: Any emergency use of a test article does not require R&DC approval but is VA research under VHA Directive 1200.05(2) and subsequent updates to the directive.
    2. The determination as to whether a particular research study falls under VA purview will be made by the Madison VA R&DC.
    3. Recruitment of veterans or limited use of VA facilities in non-VA research must follow the MOU between the Madison VA and UW Concerning Recruitment of Madison VA Veterans to Non-VA Studies, as well as the most recent VA and VHA memoranda or guidance regarding the issue, which can be found on the Office of Research and Development website here.

  3. Restrictions on VA Research

    1. Restrictions on VA research are outlined in HRP-318-WORKSHEET: Additional Federal Agency Criteria and HRP-103-Investigator Manual: Conducting VA Research.

  4. Madison VAH Officials and Human Participants Research

    1. Even if the HS-IRB approves a study, Madison VA Hospital (VAH) officials, including the R&DC and Madison VAH Director, or Office of Research Development (ORD) can disapprove the research.
    2. Madison VAH officials may not approve human participants research if it has not been approved by the HS-IRB nor can they overrule the HS-IRB’s determination to disapprove a study or require modifications to secure HS-IRB approval.
    3. In addition to the HS-IRB, the Madison VAH R&DC and the Madison VAH Director have the authority to suspend or terminate approval of Madison VAH research.

  5. Integration of IRB and R&DC Reviews and Oversight

    1. Non-exempt VA human participants research
      1. The HS-IRB ensures that Madison VAH R&DC endorsement is in place prior to submission to the IRB in the case of all initial reviews and convened IRB review of changes of protocols (aka amendments).
      2. If a new study is approved under expedited procedures or by the convened IRB or a change of protocol is approved by the convened IRB, an administrative hold is placed on the submission to ensure final VA R&DC approval for the study is obtained. Final consent documents are not released by the HS-IRB until final VA R&DC approval has been granted and the conditions of VA R&DC approval have been met.
    2. Exempt VA human participants research
      1. The HS-IRB reviewer ensures that Madison VAH R&DC endorsement is in place prior to formalizing a determination of exemption.
      2. The notification of exemption includes a statement that the research cannot commence until final VA R&DC approval has been granted.
      3. The VA R&DC is responsible for any further VA-required monitoring of exempted research.
    3. Not human participants research certifications
      1. The HS-IRB reviewer ensures that Madison VAH R&DC endorsement is in place prior to certifying a project as not human participants research.
      2. The VA R&DC is responsible for any further VA-required monitoring of certified projects.

  6. Notifications to the Madison VAH

    1. Generally, the HS-IRB notifies the Madison VAH R&DC through ARROW of its determinations, including approvals or disapprovals of research activities or of modifications required to secure IRB approval of a research activity.
      1. In the case of suspensions or terminations of research, a finding of serious and/or continuing noncompliance, or a determination that an unanticipated problem involving risks to participants or others has occurred, the HS-IRB notifies the Madison VAH Director, Associate Chief of Staff/Research &Development (ACOS/R&DC), and Research Compliance Officer (RCO) according to processes outlined in Toolkit documents HRP-024-SOP: New Information and HRP-052-SOP: Post-Review.
    2. For research approved under expedited procedures, the decision and the expedited review eligibility category are recorded in ARROW and available to the study team and VA R&DC.

  7. Integration of IRB and Madison VAH Privacy Officer (PO) and Information Systems Security Officer (ISSO) Reviews

    1. The Madison VAH PO and ISSO do not serve on the HS-IRB but act in an advisory capacity to the IRB. As nonvoting members of the R&DC, the ISO and PO will advise the committee as to whether all requested privacy and security issues were adequately responded to prior to final approval. The HS-IRB has the authority to waive or alter HIPAA authorization requirements when appropriate.
    2. The HS-IRB will consult with the VA PO and ISSO as needed.

  8. Access to IRB Records

    1. HS-IRB records are accessible for inspection and copying by authorized representatives of Madison VAH (including the RCO), Office of Research Oversight (ORO), Office for Human Research Protections (OHRP), FDA, and other authorized entities at reasonable times and in a reasonable manner.
    2. IRB records are described in the UW-Madison HRPP Toolkit Library.
    3. The content of IRB records for VA research is outlined in HRP-070-SOP: IRB Records.
    4. Retention and disposal of IRB records for studies that fall under VA purview are outlined in HRP-072-SOP: IRB Records Retention.
      1. The retention date for studies canceled without participant enrollment is calculated from the date that the study is closed with the IRB.
    5. The HS-IRB provides the RCO and Madison VAH R&DC access to unredacted IRB minutesthrough ARROW.

  9. IRB Minutes

    1. The HS-IRB makes required regulatory determinations in accordance with HRP-314-WORKSHEET: Criteria for Approval, HRP-410-CHECKLIST: Waiver or Alteration of Consent Process, HRP-411-CHECKLIST: Waiver of Written Documentation of Consent, HRP-441-CHECKLIST: HIPAA Waiver of Authorization.
    2. The HS-IRB documents regulatory determinations in accordance with HRP-043-SOP: IRB Meeting Minutes.

  10. IRB Rosters

    1. HS-IRB rosters are updated and these revisions are communicated to the Madison VA RCO for reporting to ORO and other VA offices when required.
    2. The rosters for HS-IRB members is outlined in HRP-601-DATABASE: IRB Roster.

  11. Collaborative Research Between the UW and Madison VAH (or Involving Other Non- VA Sites)

    1. Generally, whenever the Madison VHA participates in a collaborative human participants research study (i.e. one that will be conducted at both the Madison VAH and at the UW or other non-VA sites), separate IRB applications are required, one solely for the VA component of the study, and one for the non-VA component.
    2. VA research must be conducted in accordance with requirements outlined in HRP-103-Investigator Manual: Conducting VA Research, Collaborative Research.

  12. IRB Membership

    1. The HS-IRB includes representatives with the Madison VAH appointments to include perspectives of individuals who have experience working with or treating veterans.
    2. VA members of the HS-IRB are appointed by the Madison VAH Director in accordance with Madison VAH policies and procedures, and by the IRB in accordance with HRP-082-SOP: IRB Member Appointment.
    3. For the purposes of Madison VAH research, physicians, dentists, nurses, pharmacists, social workers, other clinicians, statisticians, and allied health professionals are considered to be scientists.
    4. The following personnel at the Madison VAH cannot serve as IRB members:
      1. Research office staff including, but not limited to, the ACOS/R&D and the Administrative Officer (AO/R&D)
      2. Madison VAH Director
      3. Other Madison VAH senior administrators such as Associate or Assistant Directors or Chief of Staff
      4. Administrative staff for any Madison VAH senior administrators
    5. The Madison VAH RCO acts as a consultant to the HS-IRB and may attend IRB meetings in that capacity, but does not serve as a voting or non-voting member of the IRB.
    6. The Madison VAH PO and ISSO serve as consultants to the HS-IRB and may attend IRB meetings in that capacity, but do not serve as a voting or non-voting member of the IRB.

  13. IRB Review

    1. In addition to the criteria for IRB approval for non-exempt research, the VA also requires the following criteria be met:
      1. Privacy and confidentiality provisions must take into consideration the requirements of the HIPAA Privacy Rule and other laws regarding protection and use of veterans’ and others information, including the Privacy Act of 1974, 5 U.S.C. § 552a; Confidentiality of Drug Abuse, Alcoholism and Alcohol Abuse, Infection with Human Immunodeficiency Virus (HIV), and Sickle Cell Anemia Medical Records, 38 U.S.C. § 7332; Confidentiality of Healthcare Quality Assurance Review Records, 38 U.S.C. § 5705.
      2. The research must be relevant to the mission of VA and the veteran population that it serves.
        1. The HS-IRB relies on the Madison VAH R&DC for this determination and does not approve human participants research that is not endorsed by the Madison VAH R&DC.
      3. If non-veterans will be included, the protocol and related materials must justify the inclusion of non-veterans.
    2. The HS-IRB reviews investigator financial conflicts of interest in accordance with HRP-055-SOP: IRB Review of Financial Conflicts of Interest.
      1. The HS-IRB relies, in part, on the Madison VAH’s research COI policies and review processes to help ensure that potential COIs that are financial in nature are addressed.
    3. Principal Investigators are responsible for the control of test articles in accordance with UW-Madison Policy UW-4078, Control of Test Articles Used in Research and in accordance with Madison VAH policies and procedures.
    4. Exempt research activities and limited IRB review is conducted in accordance with criteria in HRP-312-WORKSHEET: Exemption and Limited IRB Review.

  14. Informed Consent

    1. In addition to the elements of consent required under the Common Rule and FDA regulations, the VA requires the following additional consent language for research that involves more than minimal risk: A statement that VA will provide treatment for research-related injury in accordance with applicable federal regulations.
    2. When appropriate, the Madison VAH consent form should include additional consent document disclosures listed in HRP-318-WORKSHEET: Additional Federal Agency Criteria.
    3. The informed consent document must include information describing any photographs, video, and/or audio recordings to be taken or obtained for research purposes as outlined in HRP-103-Investigator Manual: Conducting VA Research, Photography, Video and/or Audio Recording for Research Purposes.

  15. Use of a Short Form

    1. The IRB cannot waive the requirement for a witness or witness signature when the short form consent is used as outlined in HRP-317-WORKSHEET: Short Form of Consent Documentation.

  16. Consent Documents

    1. The date of a UW Health Sciences IRB approval is documented on consent documents.
    2. Consent may be obtained electronically so long as the informed consent process meets all requirements in the VHA Directive 1200.05(2) and VA requirements for the use of electronic signatures.

  17. HIPAA Privacy Rule

    1. As part of its review of human participants research, including exempt human participants research, the HS-IRB is responsible for making determinations under the HIPAA Privacy Rule in regard to waivers or alterations of authorization for research uses of protected health information on behalf of the Madison VAH.
    2. The HS-IRB reviews VA HIPAA authorization forms to ensure that they are consistent with the consent documents, study protocol, and other research materials.
      1. The Madison VAH requires the written HIPAA authorization to be a standalone document using VA Form 10-0493: Authorization for Use and Release of Individually Identifiable Health Information Collected for VHA Research. In some cases, the VA RD&C may approve a combined consent and authorization form.
      2. All potential disclosures to a non-VHA entity must be listed within the written authorization.
    3. When a study team requests a waiver of HIPAA authorization, the HS-IRB reviews the request in accordance with HRP-441-CHECKLIST: HIPAA Waiver of Authorization, which is available in Arrow.
    4. The application of preparatory to research activities are outlined in HRP-103-Investigator Manual: Conducting VA Research, Use of Preparatory to Research.
    5. If a study team proposes to disclose PHI outside the Madison VAH and also requests a waiver of HIPAA authorization and signed consent, the Madison VAH PO must ensure and document the VA’s authority to disclose the PHI to another institution in order to ensure the requirements of other applicable privacy regulations such as the Privacy Act of 1974 (5 U.S.C. § 552a) are met.

  18. Participation of Non-Veterans in VA Research

    1. Non-veterans may be entered into a VA-approved research study that involves VA outpatient or VA hospital treatment, but only when there are insufficient numbers of veteran patients suitable for the study and not simply because a non-veteran population is easily accessible to the investigator.
      1. The HS-IRB requires research teams to justify including non-veterans in a VA research study.
      2. If the HS-IRB finds the inclusion of non-veterans in a study to be justified, the approval for recruitment of non-veterans is documented in the meeting minutes and/or study file.
    2. Other situations where non-veterans may be recruited include studies that will generally benefit veterans and their well-being but would not include veterans as participants, such as surveys of VA providers, studies involving veterans’ family members, or studies including active-duty military personnel.
    3. Active duty military personnel may be entered into VA research conducted jointly by VA and DoD or within DoD facilities.
    4. All VA regulations and policies related to veterans as research participants apply to non-veterans participating in VA research.

  19. Research Involving Special Populations

    1. Research involving special populations must be conducted in accordance with HRP-103-Investigator Manual: Conducting VA Research, Special Populations. The HS-IRB reviews VA research involving special populations in accordance with HRP-318-WORKSHEET: Additional Federal Criteria, in addition to those Toolkit documents listed below.
    2. The HS-IRB reviews research involving pregnant participants, human fetuses, and neonates in accordance with HRP-412-CHECKLIST: Pregnant Participants; HRP-413-CHECKLIST: Non-Viable Neonates; and HRP-414-CHECKLIST: Neonates of Uncertain Viability.
    3. The HS-IRB reviews research involving children in accordance with HRP-416-CHECKLIST: Children and HRP-013-SOP: LARs, Children, and Guardians.
    4. The HS-IRB reviews research involving prisoners in accordance with HRP-415-CHECKLIST: Prisoners.
    5. The HS-IRB reviews research involving adults with impaired decision-making capacity in accordance with HRP-417-CHECKLIST: Adults with Impaired Decision-Making Capacity and HRP-013-SOP: LARs, Children, and Guardians.

  20. Student and Trainee Research

    1. Students or trainees cannot serve as Principal Investigators on VA human participants research.
    2. In order for a student or trainee to participate as a study team member in Madison VAH research, they must be enrolled in an institution with an educational affiliation agreement with the Madison VAH facility or be directly appointed to a VA training program that has no external institutional sponsorship (e.g. VA Advanced Fellowship).
    3. If a student or trainee is involved in Madison VAH research, a VA investigator sufficiently experienced in the area of the trainee’s research interest must serve as PI and is responsible for oversight of the research and the trainee/student. The PI is responsible for ensuring the trainee/student complies with all applicable local, VA, and other federal requirements including those related to research, information security, and privacy.

  21. Recruitment of VA Employees

    1. VA Hospital employees, such as office staff, lab technicians, and post-doctoral fellows, are similar to students in that they are vulnerable to pressures, even if not intended, to appear cooperative and supportive of their supervisor’s work. Investigators should avoid recruiting employees from the investigator’s own lab or office unless approval for such recruitment is received from the IRB.
    2. Requirements for Surveys & Interviews: A list of general requirements for surveys and interviews conducted within the VA system is provided in the references. Please note that for studies which interview employees from facilities other than the WSMMVH, the R&DC may also request that approval be granted by the local Medical Center Director or Chief of Staff.

  22. Identification and Recruitment of Research Participants

    1. The HS-IRB is required to approve the use of identifiable information to recruit participants for VA research protocols and the approval must include approval of a waiver of HIPAA authorization in such instances.
    2. If a research repository from a previous study is used to identify participants and use of their information to recruit for future studies was not included in the authorization signed by participants, there must be an IRB-approved HIPAA waiver for this activity in the new IRB application.
    3. Posting of recruitment documents, flyers, and advertisements for research that is not VA research within or on the premises of a VA facility is not permitted unless approved by the Office of the VAH Director. If approved, such materials must include a disclaimer statement that the research is not VA research, will not be conducted by VA, has not been reviewed by VA’s Institutional Review Board, and is not endorsed by VA. VA is not responsible for any costs incurred by a Veteran if the Veteran enters the study as a research participants. The announcement is being provided for information only.
    4. Study team members can only make initial contact with potential participants for recruitment purposes in person or by letter, or email when such email recruitment is approved by the IRB and R&DC, prior to initiating any telephone contact unless there is written documentation that the participant is willing to be contacted by telephone about the study in question or a specific kind of research as outlined in the study.
    5. Initial participant contact also must follow the most recent VA and VHA memoranda or guidance regarding this issue, which can be found on the Office of Research and Development website here.
    6. Identifiable information cannot be used to re-contact individuals to obtain additional information unless approved by the IRB. The IRB will determine whether a waiver of consent and authorization is required for the study team to re-contact study participants.

  23. Expiration of IRB Approval

    1. Required actions related to expiration of IRB approval are outlined in HRP-103–Investigator Manual: Conducting VA Research, VA Requirements.

  24. Social Security Numbers

    1. Social Security Numbers (SSNs), real or scrambled, are considered identifiers.
      1. Scrambled SSNs are considered identifiers by the HIPAA Privacy Rule because they are unique to the individual and are derived from the SSN.
    2. The HS-IRB will confirm that investigators have obtained approval from the Madison VAH PO and VA R&DC to obtain real SSNs or scrambled SSNs to meet the specific aims of the research protocol.

  25. Use of Data and Data Repositories in VHA Research

    1. The HS-IRB applies VHA Handbook 1200.12 with respect to use of data and data repositories in VHA research, including criteria for re-identification of de-identified data.

  26. Apparent Serious or Continuing Noncompliance

    1. The HS-IRBs follows VHA Directive 1200.05(2) and VA Handbook 1058.01 for the identification, assessment, and reporting of apparent serious or continuing noncompliance.
    2. Reporting requirements for apparent serious or continuing noncompliance in VA research are outlined in HRP-103–Investigator Manual: Reportable Events, Reporting Requirements for VA Studies; HRP-024-SOP: New Information; and HRP-052-SOP: Post-Review.
    3. The HS-IRB evaluates reports of apparent serious or continuing noncompliance in VA research in accordance with HRP-321-WORKSHEET: Review of Information Items and HRP-024-SOP: New Information.

  27. Unanticipated Serious Adverse Events (SAEs) and Unanticipated Problems Involving Risks to Participants or Others

    1. The HS-IRB follows Handbook 1058.01 for the identification, assessment, and reporting of serious unanticipated problems and unanticipated SAEs.
    2. Reporting requirements for unanticipated problems, including for a local research death that is both unanticipated and related to the research are outlined in HRP-103–Investigator Manual: Reportable Events, Reporting Requirements for VA Studies.
    3. The HS-IRB evaluates reports of unanticipated problems occurring in VA research in accordance with HRP-321-WORKSHEET: Review of Information Items; HRP-024-SOP: New Information; and HRP-052-SOP: Post-Review.
    4. The Madison VAH Director is responsible for additional reporting to ORO and any other relevant agencies (e.g., FDA, OHRP) after receiving the IRB’s notification.

  28. Termination or Suspension of Human Participants Research

    1. Any termination or suspension of VA research by the HS-IRB related to concerns about the safety, rights, or welfare of human research participants, research staff, or others will be reported in writing directly (without intermediaries) to the Madison VAH Director within 5 business days after the termination or suspension occurs with simultaneous copies to the ACOS/R&DC and the RCO in accordance with HRP-024-SOP: New Information and HRP-026-SOP: Suspension or Termination Issued Outside of Convened IRB.
    2. The HS-IRB reviews any notifications of an external entity’s suspension or termination of research in accordance with HRP-026-SOP: Suspension or Termination Issued Outside of Convened IRB.
    3. The IRB will notify the Madison VAH Director, ACOS/R&D, and RCO within 5 business days after the determination if it finds either that the suspension or termination resulted from a local adverse event(s), local noncompliance, or another local issue(s) or required local action (in addition to the suspension/termination) to ensure the safety, rights, or welfare of local human research participants, personnel, or others, or the effectiveness of the local HRPP.
External References:

Policy Administration

Approval Authority:
Associate Vice Chancellor of Research Policy and Compliance
Policy Manager:
Associate Vice Chancellor of Research Policy and Compliance
Contact:
Associate Director, HRPP -- Travis Doran, TRAVIS.DORAN@WISC.EDU, (608) 890-4399
Date Issued:
08-07-2015
Revised Dates:

10-27-2023

Retrieved:
12-07-2024 07:54:54