April 24, 2015 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 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 March 24th and 25th, 2015.

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 March 24th and 25th, 2015:

  1. Big Data and the Impact on Human Subjects Research, Attachment A
  2. Commentary on FDA Draft Guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products,” released December 9, 2014, docket number FDA-2013-D-1275-0002, Attachment B
  3. Commentary on FDA Draft Guidance, “Use of Electronic Informed Consent in Clinical Investigations, Questions and Answers, Guidance for Industry,” released March 9, 2015, docket number FDA-2015-D-0390-0002, Attachment C
  4. Recommendations Regarding Return of General Research Results, Attachment D
  5. Recommendations Regarding Research Uses of Newborn Dried Bloodspots and the Newborn Screening Saves Lives Reauthorization Act of 2014, Attachment E
  6. Recommendations Regarding the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research,  Attachment F

On behalf 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 (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

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

James Anderson, Ph.D.
University of Nebraska
Medical Center
Omaha, Nebraska

Gary Chadwick, PharmD., MPH.
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
Richmond, Virginia

Holly Fernandez-Lynch, J.D.,
M. Bioetics
Harvard Law School
Cambridge, Massachusetts

Owen Garrick, M.D., M.B.A.
Bridge Clinical Research
Oakland, California

Pilar Ossorio, J.D.
University of Wisconsin Law School
Madison, Wisconsin

Reed E. Pyeritz, M.D., Ph.D.
University of Pennsylvania
Philadelphia, Pennsylvania

Stephen Rosenfeld, M.D., M.B.A.
Quorum Review IRB
Seattle, Washington

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

Julia Gorey, J.D.
Executive Director
Rockville, Maryland
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