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SACHRP Recommendations
March 17, 2022 Letter to the HHS Secretary
March 17, 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. These recommendations were presented to SACHRP and approved at the meeting held March 10-11, 2022: The Protection of Non-Subjects from Research Harm and Recommendations on the NIH Genomic Data Sharing Policy.
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. These recommendations were presented to SACHRP and approved at the meeting held March 10-11, 2022: The Protection of Non-Subjects from Research Harm and Recommendations on the NIH Genomic Data Sharing Policy.
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
NIH Genomic Data Sharing Policy: NIH Request for Public CommentsThe Protection of Non-Subjects from Research Harm
Content created by Office for Human Research Protections (OHRP)Content last reviewed March 28, 2022