July 31, 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 July 29-20, 2023:

• OHRP draft guidance, “Frequently Asked Questions:
  Limited Institutional Review Board Review and Related
  Exemptions”
• FDA draft guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices - Guidance for Industry, Investigators, and Other Stakeholders”

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