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 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 20th and 21st, 2022:
- OHRP’s draft guidance on Use of Single Institutional Review Board for Cooperative Research (Attachment A)
- Draft supplemental information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data (Attachment B)
- The Interpretation of “HHS support” in the Application of 45 CFR part 46 (Attachment C)
- A Re-interpretation of “Engagement” in Human Subjects Research in the Application of 45 CFR part 46 (Attachment D)
- Considerations for IRB review of Research Involving Artificial Intelligence (Attachment E)
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.
Douglas S. Diekema, M.D., M.P.H.
Chair, Secretary’s Advisory Committee
on Human Research Protections
Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRP
Julia Gorey, J.D., Executive Director, SACHRP
Professor, Department of Pediatrics
Departments of Bioethics and Emergency Medicine
University of Washington School of Medicine
Mary Ellen Allen, J.D.
South San Francisco, California
Jyoti Angal, D.S., M.P.H.
Avera McKennan Hospital
and University Health Center
Sioux Falls, South Dakota
Linda Coleman, J.D.
New Haven, Connecticut
Janet Freeman-Daily, MSc, ENG
Robert Nelson, M.D., M.Div., Ph.D.
Johnson & Johnson
Louis Shepperd, J.D.
University of Virginia
Sandra Soo-Jim Lee, Ph.D.
New York City, New York
Walter L. Strauss, M.D., M.P.H.
Kevin Weinfurt, Ph.D.
Duke University School of Medicine
Durham, North Carolina
Consuelo Wilkins, M.D., MSCI
Medical Center and Meharry Medical College
Jerry Menikoff, M.D., J.D.
Julia Gorey, J.D.