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SACHRP Recommendations
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-23-104721On 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.
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-23-104721On 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 Committeeon Human Research Protections(SACHRP)
Enc.
cc:Julie Kaneshiro, M.A., Acting Director, OHRPJulia Gorey, J.D., Executive Director, SACHRP
Douglas S. Diekema, M.D., M.P.H.Chair, Secretary’s Advisory Committeeon Human Research Protections(SACHRP)
Enc.
cc:Julie Kaneshiro, M.A., Acting Director, OHRPJulia Gorey, J.D., Executive Director, SACHRP
Meeting Members:
Alison Bateman-House, Ph.D.New York UniversityNew York, New York
Neal W. Dickert, M.D., Ph.D.Emory University School of MedicineEmory, Georgia
Douglas S. Diekema, M.D., MPH (Chair)University of WashingtonSchool of MedicineSeattle, Washington
Eric C. Mah, Ed.D., M.H.S.University of California San DiegoSan Diego, California
Mindy Reeter, M.A., CIPUniversity of Illinois College of Medicine at PeoriaPeoria, Illinois Lois Shepperd, J.D.
Neal W. Dickert, M.D., Ph.D.Emory University School of MedicineEmory, Georgia
Douglas S. Diekema, M.D., MPH (Chair)University of WashingtonSchool of MedicineSeattle, Washington
Eric C. Mah, Ed.D., M.H.S.University of California San DiegoSan Diego, California
Mindy Reeter, M.A., CIPUniversity of Illinois College of Medicine at PeoriaPeoria, Illinois Lois Shepperd, J.D.
University of VirginiaCharlottesville, Virginia
Sandra Soo-Jim Lee, Ph.D.Columbia UniversityNew York City, New York
Kevin Weinfurt, Ph.D.Duke University School of MedicineDurham, North Carolina
Ruqaiijah Yearby, J.D., M.P.H.The Ohio State UniversityColumbus, Ohio
Julie KaneshiroActing Director, OHRPRockville, Maryland
Julia Gorey, J.D.Executive Director, SACHRPRockville, Maryland
Kevin Weinfurt, Ph.D.Duke University School of MedicineDurham, North Carolina
Ruqaiijah Yearby, J.D., M.P.H.The Ohio State UniversityColumbus, Ohio
Julie KaneshiroActing Director, OHRPRockville, Maryland
Julia Gorey, J.D.Executive Director, SACHRPRockville, 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