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October 25, 2023 - Letter to the HHS Secretary

October 25, 2023

The Honorable Xavier Becerra, J.D.
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Recommendation Letter

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 October 19th, 2023:

  • SACHRP Recommendation on IRB Effectiveness, #GAO-23-104721

On behalf of SACHRP, I would like to thank you for your consideration of these recommendations relevant to the General Accounting Office’s report entitled, INSTITUTIONAL REVIEW BOARDS: Actions Needed to Improve Federal Oversight and Examine Effectiveness.  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

Meeting Members:
Alison Bateman-House, Ph.D.
New York University
New York, New York

Neal W. Dickert, M.D., Ph.D.
Emory University School of Medicine
Emory, Georgia

Douglas S. Diekema, M.D., MPH (Chair)
University of Washington
School of Medicine
Seattle, Washington

Eric C. Mah, Ed.D., M.H.S.
University of California San Diego
San Diego, California

Mindy Reeter, M.A., CIP
University of Illinois College of Medicine at Peoria
Peoria, Illinois



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

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

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

Ruqaiijah Yearby, J.D., M.P.H.
The Ohio State University
Columbus, Ohio

Julie Kaneshiro
Acting Director, OHRP
Rockville, Maryland

Julia Gorey, J.D.
Executive Director, SACHRP
Rockville, Maryland

Related Recommendations

SACHRP Recommendation on GAO-23-104721, INSTITUTIONAL REVIEW BOARDS: Actions Needed to Improve Federal Oversight and Examine Effectiveness
Content created by Office for Human Research Protections (OHRP)
Content last reviewed November 3, 2023
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