The Honorable Alex M. Azar II
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Mr. Azar:
On behalf of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your consideration 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 by the co-chairs of SACHRP’s Subpart A Subcommittee, and were approved at the meeting held July 30-31, 2019.
SACHRP’s charge to the Subpart A Subcommittee (SAS) is to review and assess all provisions of subpart A of 45 CFR part 46 (HHS’ codification of the Federal Policy for the Protection of Human Subjects, also known as the Common Rule) and relevant Office for Human Research Protections (OHRP) guidance documents, and based on this review and ongoing assessment, to develop recommendations for consideration by SACHRP in three categories: (1) recommendations on interpretation of subpart A provisions; (2) recommendations for development of new, or modification of existing, OHRP guidance; and (3) recommendations for possible revision of subpart A.
During the July SACHRP meeting, this committee approved a set of recommendations entitled, “Addressing Ethical Concerns Regarding Offers of Payment to Research Participants.”
On behalf of SACHRP, I would like to thank you for your consideration of these recommendations.
Both SACHRP subcommittees, the Subpart A Subcommittee and the Subcommittee on Harmonization, have been actively working in pursuit of their charges, and remain dedicated to continuing their work to enhance human subjects protections for the benefit of all Americans.
Stephen Rosenfeld, M.D.
Chair, Secretary’s Advisory Committee
on Human Research Protections
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRP
Julia Gorey, J.D., Executive Director, SACHRP