Research Involving Veterans Affairs

Dual Review and Single IRB Exceptions

Because the U.S. Department of Veterans Affairs (VA) is a signatory to the Common Rule, non-exempt research engaging multiple VA sites is always subject to the Common Rule single IRB requirement, regardless of funding. Additionally, research involving the VA may be funded by NIH, and therefore also subject to the NIH single IRB policy. However, due to limitations arising from VA policy directives, the UW IRB does not review on behalf of any VA entities and VA IRBs cannot review on behalf of the UW. This means that all research engaging both UW and any VA entities must typically obtain dual IRB review, in other words, review from the UW IRB (or a non-UW IRB authorized by HSD) for the portion of the research engaging UW, and review from a VA IRB for the portion engaging the VA. The only exception to this is when the single IRB selected is an IRB that both VA and UW can rely on (e.g., a third-party IRB allowed by the VA). In this case, dual review is not necessary.

Because of this dual review situation, when UW and VA are both engaged in non-exempt research, the PI may need to obtain a formal exception from the single IRB requirement to allow UW IRB (or a non-UW IRB authorized by HSD) and the VA IRB to conduct dual review.

Key Information about Exceptions:

• Only the VA Office of Research & Development (ORD) can approve the exception request for research engaging the VA.
• VA facility research leadership (not the investigators) for the engaged VA facility must submit the request to ORD.
• Only one exception is submitted to ORD. The VA IRB leadership at the engaged VA entities must decide amongst themselves who will submit the request to ORD.
• If ORD grants a single IRB exception, it applies to all VA sites in the study.
• ORD never grants an exception to use of a single IRB because of site preferences. Exception requests must be based on another rationale. UW IRB’s inability to review for the VA is typically a sufficient rationale.
• NIH (and other non-VA federal funding agencies) will accept determinations by the VA ORD that the use of a single IRB is not appropriate for VA sites participating in NIH-funded multisite studies. However, all remaining sites in an NIH-funded multisite study are expected to comply with the single IRB requirement unless they have received an exception issued by NIH (or the other non-VA funding agency). This means that the non-VA sites must be reviewed by single IRB review for those sites, unless the PI has obtained a separate exception from the funding agency. The VA does not facilitate seeking this kind of exception. The PI should work with the Program Officer at the funding agency to determine how to seek an exception.

How to obtain an exception from VA ORD:

• For research involving VAPSHCS: Work with the VAPSHCS IRB or Seattle Institute for Biomedical and Clinical Research (SIBCR) grants management staff to develop a request. VAPSHCS IRB leadership will then submit the request to ORD.
• For research involving another VA entity: Work with that VA entity to submit the exception request.

When exceptions are required:

Not federally funded, and only UW and VAPSHCS are engaged in the research: No exception required from ORD. UW IRB and VAPSHCS IRB conduct their own reviews.

Federally funded, and only UW and VAPSHCS are engaged in the research: Exception required from ORD only. UW IRB and VAPSHCS IRB conduct their own reviews.

Federally funded, and VAPSHCS, UW and another non-VA entity are engaged: Exception required from ORD for VA to conduct its own review. UW and the other non-VA entities must use a non-VA single IRB, unless an exception is issued by the funding agency.

Not federally funded and VAPSHCS, UW and another non-VA entity are engaged: No exception required. VAPSCHS will conduct its own review and the other entities can conduct their own reviews or choose to rely on one another.

Federally funded, and multiple VA and non-VA entities (including UW) are engaged, and the single IRB is a commercial IRB (i.e., Sterling, WCG, or Advarra) that all of the VA locations can rely on. No single IRB exception typically needed.

Federally funded and multiple VA and non-VA entities (including UW) are engaged, and the single IRB for the VA locations will be the VA Central IRB. A single IRB exception from ORD is needed for the non-VA locations to conduct their own IRB review. The non-VA locations must still arrange for single IRB review using a non-VA IRB unless they obtain a separate exception from the funder.

When to Submit for Reliance on a non-UW IRB

When either:

• A non-VA IRB will serve as the single IRB for all institutions engaged in the research, or
• A VA IRB will review for one or more VA entities and another non-VA IRB will review for the non-VA institutions engaged in the research. UW will rely on the non-VA IRB.

Follow the instructions on how to request reliance.

When to Submit for Dual Review by UW IRB

A VA operated IRB will review for the VA portion of the research, and any of the following is true:

• Regardless of funding, when UW is the only non-VA institution engaged in the research in the U.S.
• The research is not federally funded and there are multiple non-VA institutions engaged. UW will review for itself, unless another non-VA institution has agreed to be the sIRB.
• For federally funded research, when UW has agreed to serve as the single IRB for all non-VA institutions in the U.S. UW may agree to serve as the single IRB under its Single IRB policy.
• For federally funded research, if VA facility research leadership has obtained an exception from ORD and you have obtained an exception from any non-VA funding agencies.

What aspects of the study does the UW IRB Review for Dual Review?

Per HSD policy, for projects that are also reviewed by a VA IRB, UW IRB reviews all activities for the proposed research project, including those conducted at VA sites, that the UW is engaged in.

Special considerations about VA appointments and UW engagement

VA has several unique staffing appointments that can impact whether or not UW is engaged in the research and dual review is required.

Without Compensation (WOC) appointments are personnel appointments by which a non-VA individual contributes effort to VA activities but receives no monetary compensation from the VA. WOC appointments allow flexibility for staffing and collaboration on research studies while enabling the VA to ensure credentialing, qualification, and trainings of collaborators and staff. WOC status also enables the VA to ensure compliance with VA policies such as intellectual property, data security, privacy of subjects, security of individually identifying information of subjects, etc. VA considers WOC’s to be Federal employees.

Interagency Personnel Agreements (IPA) and Joint Personnel Agreements (JPA) are funding mechanisms that allow the VA to reimburse other organizations for a portion or all of an employee’s salary and benefits. IPA and JPAs can be used to temporarily assign personnel between the VA and other eligible organizations, such as colleges and universities, state and local governments, and federally funded research centers.

When individuals will obtain consent, perform research procedures, administer study interventions, obtain, use or analyze identifiable data and/or specimens, and or have other protocol directed interaction with subjects, consider what appointment they are working under for the research and review the following to determine whether or not UW is engaged.

Other individuals working on a contract from the VA are not considered to be federal employees or agents. Consider what appointment they are working under for the research and review the following to determine whether or not UW is engaged.

Appointment for the research	Is UW engaged, requiring dual review or a reliance.
Paid directly by UW with internal funds (e.g., Royalty Research Fund, bridge funds, departmental funds, gift to UW).	Yes, unless the individual is working on the research for the VA entity under a WOC appointment.
Paid directly by UW with money from a UW-administered grant or contract, or subaward (for example, a service agreement by which a UW employee is contracted by his/her unit to work for a non-UW person). This includes UW employees who are working at any VA entity under a WOC appointment, or a contract from the VA. This does not include JPAs or IPAs. Example: a UW study coordinator who works on a VA study and whose salary is paid for by a grant administered through the UW. The study coordinator is given a WOC by VA.	Yes, unless: either: The individual is working on the research for the VA entity under a WOC appointment, or there is other substantial justification that their involvement will not be used to address or fulfill requirements associated with their UW role.
Paid directly by UW with money transferred to the UW via an IPA or JPA from VA.	No, unless: Their involvement in the research will also be used to address or fulfill requirements associated with their UW role.
Unpaid by UW. This includes individuals who may be paid by UW for other purposes and who have a WOC at the VA, but for the research under question are working “on their own time.” Example: a UW graduate student is involved in research as a volunteer at VA with WOC status. Note that if the student obtains class credit, UW is engaged. If the student uses the study data for their thesis, that use may be considered a separate project requiring separate IRB review, typically only from UW.	No, unless: Their involvement will be used to address or fulfill requirements associated with their UW role

References

• VA Office of Research & Development
• SMART Talk: VA Specific Requirements

Version History

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Keywords: Internal reliance; Multi-site