July 21, 2016 The Honorable Sylvia M. Burwell Secretary of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Recommendation Letter Dear Ms. Burwell: On behalf of the Secretary's Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your consideration two sets of comments relevant to the Department of Health and Human Services (HHS) human subjects protection regulations at 45 CFR part 46. These comments were passed by SACHRP at their May 2016 meeting. Recommendations from the Subpart A Subcommittee On October 5, 2004, SACHRP approved a recommendation establishing a Subpart A Subcommittee (SAS). SACHRP's charge to this subcommittee was 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 base on this review and ongoing assessment, to develop recommendations for consideration by SACHRP in three categories: (1) recommendations on interpretation of subpart A provisons; (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. Consistent with the goals of this subcommittee, on May 9, 2016 SACHRP approved recommendations on Minimal Risk Informed Consent Models (Attachment A) Recommendations from the Subcommittee on Harmonization On October 28, 2009, SACHRP approved a recommendation establishing a Subcommittee on Harmonization (SOH). SACHRP's charge to this subcommittee was to identify and prioritize areas in which regulations and/or guidelies for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity simplification and/or coordination. The Subcommittee will develop recommendations for considertion 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. On May 19, 2016, SACHRP passed the attached recommendation on Return of Individual Research Results (see Attachment B). On behalf of SACHRP, I would like to thank you for your consideration of this report. The committee, the Subpart A Subcommitte and the Subcommittee on Harmonization have been actively working in pursuit of their charges, and we look forward to continuing this work to enhance human subjects protections for the benefit of all Americans. Sincerely, /s/ Jeffrey R. Botkin, M.D. Chair, Secretary's Advisory Committee on Human Research Protections (SACHRP) cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRP Julia Gorey, J.D., Executive Director, SACHRP Enc.