)
SACHRP Recommendations
March 30, 2012 SACHRP Letter to the HHS Secretary
March 30, 2012
The Honorable Kathleen Sebelius
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Recommendation Letter
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.
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:
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:
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:
- How to apply 50.51 (404), 50.53 (406), and 50.52 (405) to controlled trials and specifically to placebo-controlled trials,
- How component analysis does or does not apply to social and behavioral research,
- How component analysis might impact parental permission and child assent, and
- 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.
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.
Sincerely,
/s/
Barbara E. Bierer, M.D .Chair, Secretary's Advisory Committee on Human Research Protections (SACHRP)
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRPJulia Gorey, J.D., Executive Director, SACHRP
Barbara E. Bierer, M.D .Chair, Secretary's Advisory Committee on Human Research Protections (SACHRP)
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRPJulia Gorey, J.D., Executive Director, SACHRP
Meeting Members:
Barbara Bierer, M.D.ChairHarvard Medical SchoolBrigham and Women's HospitalBoston, Massachusetts
Albert J. Allen, M.D., PhD.Eli Lilly & Co.Indianapolis, Indiana
Carl H. Coleman, J.D.Seton Hall Law SchoolNewark, New Jersey
Gary Chadwick, Pharm. D., MPH,CLP.University of RochesterRochester, New York
David G. Forster, J.D., M.A., cI.P.Western International Review BoardOlympia, Washington
Gary H. Gibbons, M.D.Morehouse School of MedicineAtlanta, Georgia
Albert J. Allen, M.D., PhD.Eli Lilly & Co.Indianapolis, Indiana
Carl H. Coleman, J.D.Seton Hall Law SchoolNewark, New Jersey
Gary Chadwick, Pharm. D., MPH,CLP.University of RochesterRochester, New York
David G. Forster, J.D., M.A., cI.P.Western International Review BoardOlympia, Washington
Gary H. Gibbons, M.D.Morehouse School of MedicineAtlanta, Georgia
Steven Joffe, M.D., MPHDana-Farber Cancer InstituteBoston, Massachusetts
Susan Krivacic, M.P. Aff.PBG Consulting LLCAustin, Texas
Suzanne M. Rivera, Ph.D., M.S.W.Case Western Reserve UniversityCleveland, Ohio
Lainie F. Ross, M.D., PhD.University of ChicagoChicago, illinois
Stephen O. Sodeke, Ph.D., M.A.Tuskeegee UniversityTuskegee, Alabama
Jerry Menikoff, M.D., J.D.Executive Secretary
Julia Gorey, J.D.Executive Director
Susan Krivacic, M.P. Aff.PBG Consulting LLCAustin, Texas
Suzanne M. Rivera, Ph.D., M.S.W.Case Western Reserve UniversityCleveland, Ohio
Lainie F. Ross, M.D., PhD.University of ChicagoChicago, illinois
Stephen O. Sodeke, Ph.D., M.A.Tuskeegee UniversityTuskegee, Alabama
Jerry Menikoff, M.D., J.D.Executive Secretary
Julia Gorey, J.D.Executive Director
Related Recommendations
Attachment D: Recommendation Regarding Oversight of Research Misconduct and Regulatory NoncomplianceAttachment C: Recommendation on Protocol DeviationsAttachment B: Recommendation on Single Patient Treatment UseAttachment A: Recommendation on Applicability of FDA Regulations for IRBs
Content created by Office for Human Research Protections (OHRP)Content last reviewed March 30, 2012