The Honorable Xavier Becerra, J.D.
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Mr. Becerra:
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 CFR part 46. These recommendations were presented to SACHRP by SACHRP’s Subcommittee on Harmonization and Subpart A Subcommittee, and were approved at the meeting held March 23-24, 2021.
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 CFR part 46. These recommendations were presented to SACHRP by SACHRP’s Subcommittee on Harmonization and Subpart A Subcommittee, and were approved at the meeting held March 23-24, 2021.
1. IRB Authority to Restrict Use of Data Collected and Developed in Research (Attachment A)
2. New Challenges in Interactions among Sponsors, Clinical Trial Sites, and Study Subjects (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/
Douglas S. Diekema, M.D., M.P.H.
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
