July 25, 2022 Letter to the HHS Secretary

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:

  1. OHRP’s draft guidance on Use of Single Institutional Review Board for Cooperative Research (Attachment A)
  2. Draft supplemental information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data (Attachment B)
  3. The Interpretation of “HHS support” in the Application of 45 CFR part 46 (Attachment C)
  4. A Re-interpretation of “Engagement” in Human Subjects Research in the Application of 45 CFR part 46 (Attachment D)     
  5. 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

Meeting Members:
Douglas S. Diekema, M.D., MPH (Chair)
Professor, Department of Pediatrics
Adjunct Professor
Departments of Bioethics and Emergency Medicine
University of Washington School of Medicine
Seattle, Washington

Mary Ellen Allen, J.D.
Genentech, Inc.
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.
Yale University
New Haven, Connecticut

Janet Freeman-Daily, MSc, ENG
Patient Advocate
Seattle, Washington

Robert Nelson, M.D., M.Div., Ph.D.
Johnson & Johnson
Philadelphia, Pennsylvania

Louis Shepperd, J.D.
University of Virginia
Charlottesville, Virginia

Sandra Soo-Jim Lee, Ph.D.
Columbia University
New York City, New York

Walter L. Strauss, M.D., M.P.H.
Moderna, Inc.
Doylestown, Pennsylvania

Kevin Weinfurt, Ph.D.
Duke University School of Medicine
Durham, North Carolina

Consuelo Wilkins, M.D., MSCI
Vanderbilt University
Medical Center and Meharry Medical College
Nashville, Tennessee

Jerry Menikoff, M.D., J.D.
Executive Secretary
Rockville, Maryland

Julia Gorey, J.D.
Executive Director
Rockville, Maryland
Content created by Office for Human Research Protections (OHRP)
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