April 4, 2023 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.

Recommendations on the following issues were presented to SACHRP and approved at the meeting held March 23rd, 2023:

1. Recommendations on FDA draft guidance, Ethical Considerations for Clinical Investigations of Medical Products Involving Children

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.

/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