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SACHRP Recommendations
July 25, 2022 Letter to the HHS Secretary
July 25, 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 July 20th and 21st, 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 July 20th and 21st, 2022:
- OHRP’s draft guidance on Use of Single Institutional Review Board for Cooperative Research (Attachment A)
- Draft supplemental information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data (Attachment B)
- The Interpretation of “HHS support” in the Application of 45 CFR part 46 (Attachment C)
- A Re-interpretation of “Engagement” in Human Subjects Research in the Application of 45 CFR part 46 (Attachment D)
- Considerations for IRB review of Research Involving Artificial Intelligence (Attachment E)
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 Washington School of MedicineSeattle, Washington
Mary Ellen Allen, J.D.Genentech, Inc.South San Francisco, California
Jyoti Angal, D.S., M.P.H.Avera McKennan Hospitaland University Health CenterSioux Falls, South Dakota
Linda Coleman, J.D.Yale UniversityNew Haven, Connecticut
Janet Freeman-Daily, MSc, ENGPatient AdvocateSeattle, Washington
Robert Nelson, M.D., M.Div., Ph.D.Johnson & JohnsonPhiladelphia, Pennsylvania
Mary Ellen Allen, J.D.Genentech, Inc.South San Francisco, California
Jyoti Angal, D.S., M.P.H.Avera McKennan Hospitaland University Health CenterSioux Falls, South Dakota
Linda Coleman, J.D.Yale UniversityNew Haven, Connecticut
Janet Freeman-Daily, MSc, ENGPatient AdvocateSeattle, Washington
Robert Nelson, M.D., M.Div., Ph.D.Johnson & JohnsonPhiladelphia, Pennsylvania
Louis Shepperd, J.D.University of VirginiaCharlottesville, Virginia
Sandra Soo-Jim Lee, Ph.D.Columbia UniversityNew York City, New York
Walter L. Strauss, 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
Sandra Soo-Jim Lee, Ph.D.Columbia UniversityNew York City, New York
Walter L. Strauss, 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
Considerations for IRB Review of Research Involving Artificial IntelligenceA New Interpretation of the “Engaged in Research” StandardInterpretation of the Definition of “Support” in the HHS RegulationsDRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant DataRecommendations on the Draft Guidance for Use of Single Institutional Review Board for Cooperative Research
Content created by Office for Human Research Protections (OHRP)Content last reviewed August 26, 2022