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SACHRP Recommendations
December 4, 2013 SACHRP Letter to the HHS Secretary
December 4, 2013
The Honorable Kathleen Sebelius
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Recommendation Letter
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.
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.
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.
Sincerely,
/s/
Jeffrey R. Botkin, M.D.Chair, Secretary’s Advisory Committeeon Human Research Protections(SACHRP)
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRPJulia Gorey, J.D., Executive Director, SACHRP
Jeffrey R. Botkin, M.D.Chair, Secretary’s Advisory Committeeon Human Research Protections(SACHRP)
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRPJulia Gorey, J.D., Executive Director, SACHRP
Meeting Members:
Jeffrey R. Botkin, M.D., M.P.H.University of UtahSalt Lake City, Utah
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, C.I.P.University of RochesterRochester, New York
Thomas Eissenberg, Ph.D.Virginia Commonwealth UniversityRichmond, Virginia
Owen Garrick, M.D., M.B.A.Bridge Clinical ResearchOakland, California
Steven Joffe, M.D., MPH
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, C.I.P.University of RochesterRochester, New York
Thomas Eissenberg, Ph.D.Virginia Commonwealth UniversityRichmond, Virginia
Owen Garrick, M.D., M.B.A.Bridge Clinical ResearchOakland, California
Steven Joffe, M.D., MPH
Dana-Farber Cancer InstituteBoston, Massachusetts
Susan Krivacic, M.P. Aff.PBG Consulting LLCAustin, Texas
Pilar Ossorio, J.D.University of Wisconsin Law SchoolMadison, Wisconsin
Suzanne M. Rivera, Ph.D., M.S.W.Case Western Reserve UniversityCleveland, Ohio
Lainie F. Ross, M.D., PhD.University of ChicagoChicago, Illinois
Jerry Menikoff, M.D., J.D.Executive Secretary
Julia Gorey, J.D.Executive Director
Susan Krivacic, M.P. Aff.PBG Consulting LLCAustin, Texas
Pilar Ossorio, J.D.University of Wisconsin Law SchoolMadison, Wisconsin
Suzanne M. Rivera, Ph.D., M.S.W.Case Western Reserve UniversityCleveland, Ohio
Lainie F. Ross, M.D., PhD.University of ChicagoChicago, Illinois
Jerry Menikoff, M.D., J.D.Executive Secretary
Julia Gorey, J.D.Executive Director
Related Recommendations
Attachment A: SACHRP 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
Content created by Office for Human Research Protections (OHRP)Content last reviewed December 4, 2013