Content created by Office for Human Research Protections (OHRP)
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. This set of recommendations was presented to SACHRP and approved at the meeting held March 20, 2024: Interpretation of the Best Interests Standard for the Retention of Subjects in Human Subjects Research that Has Been Suspended or Terminated.
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)
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
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