Enhancing VHA Policy for Effective IRB and R&D Functions

Explore the potential VHA policy changes that can streamline IRB and R&D committee responsibilities to better serve veterans while upholding the VA's mission. Delve into questions concerning beneficial and challenging policy changes, the need for a single R&D committee model, and considerations on the appropriateness of a single IRB for research.

• VHA policy
• IRB
• R&D committee
• Research program
• Veterans

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1. IRB Breakout Session #2: If I were in Charge, I would .. August 21, 2019

2. What VHA Policy Changes Would Assist in Accomplishing Critical Functions and Clarify Responsibilities of the IRB and R&D Committee While Still Protecting Veterans and Upholding VA s Mission? If I was in Charge I Would . . . 2

3. Questions What policy changes in VHA Directive 1200.05 or VHA Directive 1200.01 have been most beneficial to your research program? What policy changes in VHA Directive 1200.05 or VHA Directive 1200.01 have been most challenging to your research program? Federal agencies have the ability to determine when single IRB is not appropriate for research it supports or conducts when it is not appropriate for a given context. What should be put in policy for reasons or circumstances when use of a single IRB is not appropriate? Should ORD allow VA Facilities participating in multi-site research to determine whether they wish to rely on a single IRB? What justification should VA Facilities be able to apply or use? Should a VA Facility be allowed to be an IRB of Record for a non-federal institution? What are the advantages and disadvantages? 3

4. R&D Breakout Session #2: If I were in Charge, I would .. August 21, 2019

5. What VHA Policy Changes Would Assist in Accomplishing Critical Functions and Clarify Responsibilities of the IRB and R&D Committee While Still Protecting Veterans and Upholding VA s Mission? If I was in Charge I Would . . . 5

6. Questions What policy changes in VHA Directive 1200.05 or VHA Directive 1200.01 have been most beneficial to your research program? What policy changes in VHA Directive 1200.05 or VHA Directive 1200.01 have been most challenging to your research program? Is there a need to develop a single R&D Committee model for approval of multi-site research? What are the advantages and disadvantages with having a single R&D Committee approve multi-site research? Federal agencies have the ability to determine when single IRB is not appropriate for research it supports or conducts when it is not appropriate for a given context. What should be put in policy for reasons or circumstances when use of a single IRB is not appropriate? Should ORD allow VA Facilities participating in multi-site research to determine whether they wish to rely on a single IRB? What justification should VA Facilities be able to apply or use? 6