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SACHRP Recommendations
July 31, 2023 - Letter to the HHS Secretary
July 31, 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 July 29-20, 2023:
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 29-20, 2023:
- OHRP draft guidance, “Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions”
- FDA draft guidance, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices - Guidance for Industry, Investigators, and Other Stakeholders”
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.
/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:
Douglas S. Diekema, M.D., MPH(Chair)Professor, Department of PediatricsAdjunct ProfessorDepartments of Bioethicsand Emergency MedicineUniversity of WashingtonSchool of MedicineSeattle, Washington
Eric C. Mah, Ed.D., M.H.S.Associate DeanClinical & Translational ResearchUniversity of California San Diego
Robert Nelson, M.D., M.Div., Ph.D.Johnson & JohnsonPhiladelphia, Pennsylvania
Mindy Reeter, M.A., CIPDirectorOffice of Human ResearchOversight & IRBUniversity of Illinois College ofMedicine at Peoria
Eric C. Mah, Ed.D., M.H.S.Associate DeanClinical & Translational ResearchUniversity of California San Diego
Robert Nelson, M.D., M.Div., Ph.D.Johnson & JohnsonPhiladelphia, Pennsylvania
Mindy Reeter, M.A., CIPDirectorOffice of Human ResearchOversight & IRBUniversity of Illinois College ofMedicine at Peoria
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.Kara J. Trott Professorin Health LawMoritz College of LawThe Ohio State University
Julie KaneshiroActing Director, OHRPRockville, Maryland
Julia Gorey, J.D.Executive Director, SACHRPRockville, Maryland
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.Kara J. Trott Professorin Health LawMoritz College of LawThe Ohio State University
Julie KaneshiroActing Director, OHRPRockville, Maryland
Julia Gorey, J.D.Executive Director, SACHRPRockville, Maryland
Related Recommendations
SACHRP Recommendations on OHRP Draft Guidance “Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions”SACHRP Recommendations on “Decentralized Clinical Trials for Drugs, Biological Products, and Devices - Guidance for Industry, Investigators, and Other Stakeholders”
Content created by Office for Human Research Protections (OHRP)Content last reviewed July 31, 2023