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SACHRP Recommendations
April 4, 2023 Letter to the HHS Secretary
April 4, 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 March 23rd, 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 March 23rd, 2023:
- Recommendations on FDA draft guidance, Ethical Considerations for Clinical Investigations of Medical Products Involving Children
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 Bioethics and Emergency MedicineUniversity of WashingtonSchool of MedicineSeattle, Washington
Mary Ellen Allen, J.D.Genentech, Inc.South San Francisco, California
Robert Nelson, M.D., M.Div., Ph.D.Johnson & JohnsonPhiladelphia, Pennsylvania
Lois Shepperd, J.D.University of VirginiaCharlottesville, Virginia
Sandra Soo-Jim Lee, Ph.D.Columbia University
Mary Ellen Allen, J.D.Genentech, Inc.South San Francisco, California
Robert Nelson, M.D., M.Div., Ph.D.Johnson & JohnsonPhiladelphia, Pennsylvania
Lois Shepperd, J.D.University of VirginiaCharlottesville, Virginia
Sandra Soo-Jim Lee, Ph.D.Columbia University
New York City, New York
Walter L. Straus, M.D., M.P.H.Moderna, Inc.Doylestown, Pennsylvania
Kevin Weinfurt, Ph.D.Duke University School of MedicineDurham, North Carolina
Consuelo Wilkins, M.D., MSCIVanderbilt UniversityMedical Center and Meharry Medical CollegeNashville, Tennessee
Julie KaneshiroActing Director, OHRPRockville, Maryland
Julia Gorey, J.D.Executive DirectorRockville, Maryland
Walter L. Straus, M.D., M.P.H.Moderna, Inc.Doylestown, Pennsylvania
Kevin Weinfurt, Ph.D.Duke University School of MedicineDurham, North Carolina
Consuelo Wilkins, M.D., MSCIVanderbilt UniversityMedical Center and Meharry Medical CollegeNashville, Tennessee
Julie KaneshiroActing Director, OHRPRockville, Maryland
Julia Gorey, J.D.Executive DirectorRockville, Maryland
Related Recommendations
SACHRP Recommendations on Draft Guidance “Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs”
Content created by Office for Human Research Protections (OHRP)Content last reviewed May 4, 2023