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IRB Breakout Session #2: If I were in Charge, I would …..

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

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IRB Breakout Session #2: If I were in Charge, I would …..

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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 . . .”

  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?

  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 . . .”

  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?

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