March 17, 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. These recommendations were presented to SACHRP and approved at the meeting held March 10-11, 2022: The Protection of Non-Subjects from Research Harm and Recommendations on the NIH Genomic Data Sharing Policy.

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

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

Lois 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

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