Important Information for all Research Involving the VA
As of July 1, the University of Washington IRB no longer provides the IRB review for research activities involving the VA Puget Sound Health Care System (VAPSHCS) and the Boise VA Medical Center (Boise VA).
The VAPSHCS has its own independent IRB which now provides IRB review for all research activities involving VAPSHCS and Boise VA.
Dual IRB review
National VA policy does not allow VA IRBs to have cooperative agreements with other IRBs. Therefore, any UW research that involves the VA in certain ways will require dual IRB review - that is, review by both the UW IRB and the VAPSHCS IRB. Similarly, VA research that involves the UW in certain ways will require dual IRB review. To assist in determining if this is the case, read  UW Engagement in VA Research (VA-854) - 06/11/2009.
The primary IRB review is by the home institution of the principal investigator (PI) who is initiating the research. The second institution is required to review only those activities that involve the second institution, though its IRB may decide in some cases to review the entire study.
Identifying the need for dual review
UW principal investigator (PI) who is not a VA employee
If any of the following circumstances are true for the UW research, then the VA is involved in a way that requires dual review.
- A grant, contract, sub-contract, or financial cooperative agreement that supports or partially supports the research and is for activities considered to be "human subjects research" is administered through the VA or the Seattle Institute for Biomedical and Clinical Research (SIBCR).
- VA employees perform research procedures with the subjects or with identifiable subject data or specimens. It does not matter whether the VA employee has a UW faculty appointment or other UW affiliation.
- VA employees obtain the informed consent of some or all subjects.
-
VA employees receive or obtain identifiable private information or identifiable biological specimens for research purposes (even if they do not directly interact or intervene with the subjects).
Exception: If the VA employee's time spent on the research is paid for by money coming from or through the UW, then the VA is not considered to be involved in a way that requires dual review.
VA principal investigator (VA employee)
Refer to the document UW Engagement in VA Research (VA-854) - 06/11/2009 to determine whether the research involvement of the UW requires dual review. Having a UW affiliation (such as a faculty appointment) is not sufficient reason for requiring dual review.
The process for obtaining dual review
Research initiated by UW principal investigators who are not VA employees
| |
Action |
Who is responsible for the action |
1 |
Identify an appropriate VA employee for the role of "VA PI"
- The VA PI will be held fully responsible for the conduct and oversight of the research activities involving the VA, including compliance with all applicable federal ,state, and VA regulations and policies. It also includes responsibility for all interactions with the VA IRB.
|
UW PI |
2a |
Prepare and submit the UW IRB application
- Use the forms and procedures listed on the UW Human Subjects Division website.
- The IRB application should describe all research activities but should clearly distinguish the VA involvement in the research.
- Use UW templates for consent forms and HIPAA authorization for all subjects except VA patients who will be subjects. For any VA patients who will be subjects, use VA templates for consent forms and HIPAA authorization.
|
UW PI |
2b |
Prepare and submit the VA IRB application
- Use the forms and procedures listed on the VA R&D Committee website.
- The IRB application should briefly describe the overall research study in the Background/Purpose section but the rest of the application should focus exclusively on those research activities involving the VA.
- Use UW templates for consent forms and HIPAA authorization for all subjects except VA patients who will be subjects. For any VA patients who will be subjects, use VA templates for consent forms and HIPAA authorization.
|
VA PI |
3a |
Obtain any other required UW approvals, such as Radiation Safety or Significant Financial Interest review.
|
UW PI |
3b |
Obtain any other required VA approvals, such as Radiation Safety or Significant Financial Interest review.
|
VA PI |
Research initiated by VA principal investigators
This assumes that the VA PI has a UW affiliation, such as a faculty appointment, which allows the VA PI to fill the role of UW PI on the UW IRB application.
| |
Action |
Who is responsible for the action |
1a |
Prepare and submit the UW IRB application.
- Use the forms and procedures listed on the UW Human Subjects Division website.
- The IRB application should describe all research activities but should clearly distinguish the VA involvement in the research.
- Use UW templates for consent forms and HIPAA authorization for all subjects except VA patients who will be subjects. For any VA patients who will be subjects, use VA templates for consent forms and HIPAA authorization.
|
VA PI |
1b |
Prepare and submit the VA IRB application.
- Use the forms and procedures listed on the VA R&D Committee website.
- The IRB application should briefly describe the overall research study in the Background/Purpose section but the rest of the application should focus exclusively on those research activities involving the VA.
- Use UW templates for consent forms and HIPAA authorization for all subjects except VA patients who will be subjects. For any VA patients who will be subjects, use VA templates for consent forms and HIPAA authorization.
|
VA PI |
2a |
Obtain any other required UW approvals, such as Radiation Safety or Significant Financial Interest review.
|
VA PI |
2b |
Obtain any other required VA approvals, such as Radiation Safety or Significant Financial Interest review
|
VA PI |
When both IRBs have granted approval, the research activities involving the VA may begin.
|
