December 4, 2013 SACHRP Letter to the HHS Secretary

The Honorable Kathleen Sebelius
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Ms. Sebelius:

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, originating in the Subcommittee for Harmonization, were passed by SACHRP at their July 2013 meeting.

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 11 SACHRP passed the attached comment regarding the June 4, 2013 FDA Request for Comment relating to the availability of masked and de-identified non-summary safety and efficacy data.

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

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

Albert J. Allen, M.D., PhD.
Eli Lilly & Co.
Indianapolis, Indiana

Carl H. Coleman, J.D.
Seton Hall Law School
Newark, New Jersey

Gary Chadwick, Pharm. D., MPH, C.I.P.
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

Steven Joffe, M.D., MPH
Dana-Farber Cancer Institute
Boston, Massachusetts

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

Lainie F. Ross, M.D., PhD.
University of Chicago
Chicago, Illinois

Jerry Menikoff, M.D., J.D.
Executive Secretary

Julia Gorey, J.D.
Executive Director
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