July 3, 2014 SACHRP Letter to the HHS Secretary

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 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 March 2014 meeting.

Recommendations from the Subpart A Subcommittee

On October 5, 2014, 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. To that end, SACHRP approved the attached recommendations on Assurances and Engagement from this subcommittee on March 12, 2014:

Recommendations on Assurances and Engagement (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 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 March 12 and 13, 2014, SACHRP passed the attached comments regarding the use of Certificates of Confidentiality and informed consent issues in clustered randomized trials:

Recommendations on Certificates of Confidentiality (Attachment B)

Recommendations on Regulatory Issues in Cluster Studies (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.



Jeffry 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
Meeting Members:
Jeffrey R. Botkin, M.D., M.P.H.
University of Utah
Salt Lake City, Utah
James Anderson, Ph.D.
University of Nebraska
Medical Center
Albert J. Allen, M.D., PhD.
Eli Lilly & Co.
Indianapolis, Indiana
Gary Chadwick, PharmD., MPH,
University of Rochester
Rochester, New York
Thomas Eissenberg, Ph.D.
Virginia Commonwealth University
Richmond, Virginia
Owen Garrick, M.D., M.B.A.
Bridge Clinical Research
Oakland, California
Susan Krivacic, M.P. Aff.
PBG Consulting LLC
Austin, Texas
Pilar Ossorio, J.D.
University of Wisconsin Law School
Madison, Wisconsin
Suzanne M. Rivera, Ph.D., M.S.W.
Case Western Reserve University
Cleveland, Ohio
Stephen Rosenfeld, M.D., M.B.A.
Quorum Review IRB
Jerry Menikoff, M.D., J.D.
Executive Secretary
Julia Gorey, J.D.
Executive Director
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