March 21, 2024 - Letter to the HHS Secretary

Dear Mr. Becerra:

On behalf of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your review recommendations relevant to the Department of Health and Human Services (HHS) human subjects protection regulations at 45 CFR part 46.  This set of recommendations was presented to SACHRP and approved at the meeting held March 20, 2024: Interpretation of the Best Interests Standard for the Retention of Subjects in Human Subjects Research that Has Been Suspended or Terminated.

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/

Douglas S. Diekema, M.D., M.P.H.
Chair, Secretary’s Advisory Committee
on Human Research Protections
(SACHRP)

Enc.

cc: 
Julie Kaneshiro, M.A., Acting Director, OHRP
Julia Gorey, J.D., Executive Director, SACHRP