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SACHRP Recommendations
October 21, 2022 Letter to the HHS Secretary
October 21, 2022
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, 2022:
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, 2022:
- Recommendations on 87 FR 58752: Institutional Review Boards; Cooperative Research
- IRB Considerations on the Use of Artificial Intelligence in Human Subjects Research (Revised)
- Use of Social Media by Research Subjects: Ethical and Regulatory Considerations
- Recommendations on 87 FR 58733: Protection of Human Subjects and Institutional Review Boards
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 Committeeon Human Research Protections(SACHRP)
Enc.
cc:Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRPJulia 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:Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRPJulia 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
Jerry Menikoff, M.D., J.D.Executive SecretaryRockville, 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
Jerry Menikoff, M.D., J.D.Executive SecretaryRockville, Maryland
Julia Gorey, J.D.Executive DirectorRockville, Maryland
Related Recommendations
IRB Considerations on the Use of Artificial Intelligence in Human Subjects ResearchUse of Social Media by Research Subjects: Ethical and Regulatory Considerations for the Protection of Human Research SubjectsRecommendations on 87 FR 58752: Institutional Review Boards; Cooperative ResearchRecommendations on 87 FR 58733: Protection of Human Subjects and Institutional Review Boards
Content created by Office for Human Research Protections (OHRP)Content last reviewed November 4, 2022