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SACHRP Recommendations
August 12, 2020 - Letter to the HHS Secretary
August 12, 2020
The Honorable Alex M. Azar II
Secretary of Health and Human Services
200 Independence Avenue S.W.
Washington, D.C. 20201
Recommendation Letter
Dear Mr. Azar:
On behalf of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your consideration recommendations relevant to the Department of Health and Human Services (HHS) human subjects protection regulations at 45 C FR part 46. These recommendations were presented to SACHRP by SACHRP’s Subcommittee on Harmoniz ation and Subpart A Subcommittee, and were approved at the meeting held July 22-23, 2020.
On behalf of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your consideration recommendations relevant to the Department of Health and Human Services (HHS) human subjects protection regulations at 45 C FR part 46. These recommendations were presented to SACHRP by SACHRP’s Subcommittee on Harmoniz ation and Subpart A Subcommittee, and were approved at the meeting held July 22-23, 2020.
1. Implications of the NIH Draft Policy for Data Management and Sharing on Data Derived from Human Participants (Attachment A)2. Issues Surrounding Deceased Donor Intervention Research under 45 C FR part 46 (Attachment B)
On behalf of SACHRP, I would like to thank you for your consideration of these recommendations. The committee, the Subpart A Subcommittee and the Subcommittee on Harmonization have been actively working in pursuit of their charges, and remain dedicated to continuing this work to enhance human subjects protections for the benefit of all Americans.
Sincerely,
/s/
Stephen Rosenfeld, M.D.ChairSecretary's Advisory Commitee on Human Research Protections (SACHRP)
Enc.
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRPJulia Gorey, J.D., Executive Director, SACHRP
Stephen Rosenfeld, M.D.ChairSecretary's Advisory Commitee on Human Research Protections (SACHRP)
Enc.
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRPJulia Gorey, J.D., Executive Director, SACHRP
Related Recommendations
Attachment B - Deceased Donor Intervention Research 45 CFR part 46Attachment A - NIH Data Sharing Policy
Content created by Office for Human Research Protections (OHRP)Content last reviewed September 17, 2020