March 30, 2012 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:

In accordance with the provisions of the charter for 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, stemming from the SACHRP subcommittee on Harmonization, were passed by SACHRP at their February 2012 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 ofthis 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 approved the following recommendations and comment from this subcommittee on February 28 and 29, 2012:

  • Recommendation  on Applicability  of FDA Regulations for  IRBs (Attachment A)
  • Recommendation on Single Patient Treatment Use (Attachment B)
  • Recommendation on Protocol Deviations (Attachment C)
  • Recommendation Regarding Oversight of Research& Misconduct& and Regulatory Noncompliance (Attachment D)

Recommendation on Component Analysis

In addition to the recommendations contained in the above attachments, SACHRP addressed the topic of component analysis and heard from experts regarding the historical basis, ethical underpinning, and IRB considerations surrounding this important issue. Although component analysis is generally understood to mean the individual assessment of benefit and risk of each intervention or procedure in a study, the literature on the topic is sparse and complicated, and the regulatory status of the concept is not clear.

SACHRP recommends that FDA and OHRP issue joint guidance, or if that is not feasible, consistent guidance, explaining how to perform component analysis in the application of Subpart D. Such guidance should include:

  1.  How to apply 50.51 (404), 50.53 (406), and 50.52 (405) to controlled trials and specifically to placebo-controlled trials,
  2.  How component analysis does or does not apply to social and behavioral research,
  3.  How component analysis might impact parental permission and child assent, and
  4.  What documentation from the IRB must be or should be included.

Furthermore, SACHRP recommends that education and training materials for IRB members and investigators be made available and a communication plan developed.

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 the charges, and we look forward to continuing this work to enhance human subjects protections for the benefit of all Americans.



Barbara E. Bierer, 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:
Barbara Bierer, M.D.
Harvard Medical School
Brigham and Women's Hospital
Boston, Massachusetts

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,
University of Rochester
Rochester, New York

David G. Forster, J.D., M.A., cI.P.
Western International Review Board
Olympia, Washington

Gary H. Gibbons, M.D.
Morehouse School of Medicine
Atlanta, Georgia

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

Susan Krivacic, M.P. Aff.
PBG Consulting LLC
Austin, Texas

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

Stephen O. Sodeke, Ph.D., M.A.
Tuskeegee University
Tuskegee, Alabama

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

Julia Gorey, J.D.
Executive Director
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