The Honorable Sylvia M. Burwell
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Ms. Burwell:
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 two subcommittees, the Subcommittee on Harmonization and the Subpart A Subcommittee, and were approved on October 25 and 26, 2016.
SACHRP’s charge to the Subcommittee on Harmonization (SOH) is to identify and prioritize areas in which regulations or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination. The Subcommittee develops recommendations for consideration and possible adoption by SACHRP to harmonize and simplify these guidelines and regulations. The goal of this subcommittee effort is to reduce unnecessary burdens on research efforts, thus resulting in better allocation of research resources and promoting the safety and welfare of human subjects.
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.
The goals of this review and assessment of subpart A of 45 CFR part 46 are threefold: (1) to enhance the protection of human subjects; (2) to reduce, where possible, regulatory burdens that do not contribute to the protection of subjects in a meaningful way; and (3) to promote scientifically and ethically valid research.
SACHRP approved the following recommendations on October 25 and 26, 2016:
1. Initial Considerations for Single IRB Review: Points to Consider (Attachment A)
2. Recommendations on Regulatory Issues in Cluster Randomized Studies (Attachment B)
3. Recommendations on Benchmarking (Attachment C)
4. Recommendations on Revisions to “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules,” Appendix M (Attachment D)
5. Recommendations on OHRP/FDA draft guidance “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs" (Attachment E)
On behalft 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.
Jeffrey R. Botkin, 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