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 three 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 July 2015 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 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.
Consistent with the goals of this subcommittee, on July 21, 2015 SACHRP approved recommendations entitled Recommended Guidance on Minimal Risk Research and Informed Consent (see attachment A), and Application of the Common Rule to Clinical Data Registries (see attachment B).
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 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 will develop 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.
On July 22, 2015, SACHRP passed the attached recommendation on the Return of Research Results and Emergent CLIA and HIPAA Issues (see attachment C).
On behalf of SACHRP, I would like to thank you for your consideration of this report. The committee, the Subpart A Subcommittee 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.
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
University of Utah
Salt Lake City, Utah
Albert J. Allen, M.D., PhD.
Eli Lilly & Co.
James Anderson, Ph.D.
University of Nebraska
Gary Chadwick, PharmD., M.P.H.
University of Rochester
Rochester, New York
Diana T. Chingos, M.S., M.F.A.
Noreen Fraser Foundation
Los Angeles, California
Thomas Eissenberg, Ph.D.
Virginia Commonwealth University
Holly Fernandez-Lynch, J.D.,
Harvard Law School
Owen Garrick, M.D., M.B.A.
Bridge Clinical Research
Pilar Ossorio, J.D.
University of Wisconsin Law School
Reed E. Pyeritz, M.D., Ph.D.
University of Pennsylvania
Stephen Rosenfeld, M.D., M.B.A.
Quorum Review IRB
Jerry Menikoff, M.D., J.D.
Julia Gorey, J.D.