Version Date: August 1, 2011
Guidance on obtaining VA R&D endorsement and approval of VA research
Human subjects research that may be considered in whole or in part as “VA research” and is conducted under the purview of the Madison VA (Wm. S. Middleton Memorial Veterans Hospital in Madison, Wisconsin) must undergo an approval process involving both the UW-Madison Health Sciences IRBs and the Madison VA Research and Development (VA R&D) Committee. Additionally, all research submitted to the VA R&D Committee must have either a VA principal investigator or a VA Responsible Investigator.
For VA research, the Health Sciences IRBs serve as subcommittees of the VA R&D Committee. Review and written approval of all appropriate subcommittees of the R&D Committee is required before research involving the VA can be undertaken. Therefore, final approval of VA research will be given by the VA R&D Committee only after the appropriate IRB has determined that the research is approvable and this approval information has been provided to the VA R&D Committee.
All VA human subjects research projects must be reviewed by either the Health Sciences IRB (HS-IRB) or the Minimal Risk IRB (MR-IRB). No other UW-Madison campus IRB may review VA research projects. (The only exceptions to the need for UW-Madision Human Subjects IRB review and VA R&D review would be VA research that is undergoing VA Central IRB review. This research will need VA R&D review, but will not be reviewed by the University IRB system.)
The VA Responsible Investigator:
- Potential VA research projects may be initiated at the VA or at the UW
- If the PI on the study is not a VA employee qualified to conduct research at the Madison VA then a VA Responsible Investigator must be appointed as part of the study team
- The VA Responsible Investigator shall serve as the principal investigator for the project in the eyes of the VA
- The VA Responsible Investigator or the Principal investigator if that person meets the VA qualifications must take an active part in the conduct of the research
- The VA Responsible Investigator is responsible for assuring that the project meets and follows all relevant VA regulations and guidelines