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This update provides an overview of the recent developments in research and development as it pertains to the Institutional Review Board (IRB) processes at USUHS, including the implications of Title 32 CFR 219 and Title 21 CFR 56. Attention is drawn to the cooperation between the Office of the Staff Judge Advocate, MRMC, and Fort Detrick in managing Congressionally Directed Funding under USAMRMC for projects related to PTSD, TBI, and tropical diseases. Also discussed are the mechanisms of FDA vouchers for priority reviews of tropical disease products.
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Research and Development Update Jay B. Winchester 20-22 MAY 2009 USUHS Office of the Staff Judge Advocate, MRMC & Fort Detrick
Rogue IRB • Second IRB review? • Title 32 CFR 219.112: “. . .may not approve. . .if it has not been approved. . . • Title 21 CFR 56.109,.112, and .113. & FDA Information Sheet # 26. Office of the Staff Judge Advocate, MRMC & Fort Detrick
Congressionally Directed Funding Managed By USAMRMC PTSD, TBI, etc. Earmark—E.O. 13,457 (still good) PRMRP Office of the Staff Judge Advocate, MRMC & Fort Detrick
Congressionally Directed Funding Managed By USAMRMC USAMRAA PAN 09-02 Clinic/VA Center participation No Grant and CRADA together Solution: Cooperative Agreement Office of the Staff Judge Advocate, MRMC & Fort Detrick
FDA Vouchers for Tropical DiseasesTitle 21 USC 360n US has IP in tropical diseases(tp) Sponsor who gets approval for a tp product receives priority review voucher Voucher can be used or sold for any product review Office of the Staff Judge Advocate, MRMC & Fort Detrick
