August 12, 2020 - Letter to the HHS Secretary

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.

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 Harmoniz ation 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.
Chair,
Secretary’s Advisory Committee on Human Research Protections (SACHRP)

cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRP
     Julia Gorey, J.D., Executive Director, SACHRP