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SACHRP Recommendations
January 5, 2016 SACHRP Letter to the HHS Secretary
January 5, 2016
The Honorable Sylvia M. Burwell
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Recommendation Letter
Dear Ms. Burwell:
On behalf of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your consideration recommendations pertaining to the Department‘s recent Notice of Proposed Rulemaking (NPRM) entitled “Federal Policy for the Protection of Human Subjects” that appeared in the Federal Register on September 8, 2015, Vol 80, No 173:53933. These comments were drafted by the SACHRP subcommittees (the Subpart A Subcommittee and the Subcommittee on Harmonization), and were revised and approved by SACHRP at their December 3-4, 2015 meeting.
The NPRM represents the first set of significant regulatory changes to the “Common Rule” in almost 25 years. SACHRP appreciates the opportunity to provide comments on this important set of proposals. SACHRP and its subcommittee members have taken this opportunity seriously and have spent hundreds of hours in efforts to understand the proposals, assess their ethical foundation, anticipate the consequences and potential adverse consequences of the proposals for a range of stakeholders, and to craft the following responses and recommendations.
On behalf of SACHRP, I would like to thank you for your consideration of this most important and timely report. We look forward to continuing this work to enhance human subjects protections for the benefit of all Americans.
On behalf of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your consideration recommendations pertaining to the Department‘s recent Notice of Proposed Rulemaking (NPRM) entitled “Federal Policy for the Protection of Human Subjects” that appeared in the Federal Register on September 8, 2015, Vol 80, No 173:53933. These comments were drafted by the SACHRP subcommittees (the Subpart A Subcommittee and the Subcommittee on Harmonization), and were revised and approved by SACHRP at their December 3-4, 2015 meeting.
The NPRM represents the first set of significant regulatory changes to the “Common Rule” in almost 25 years. SACHRP appreciates the opportunity to provide comments on this important set of proposals. SACHRP and its subcommittee members have taken this opportunity seriously and have spent hundreds of hours in efforts to understand the proposals, assess their ethical foundation, anticipate the consequences and potential adverse consequences of the proposals for a range of stakeholders, and to craft the following responses and recommendations.
On behalf of SACHRP, I would like to thank you for your consideration of this most important and timely report. 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
James Anderson, Ph.D.Merck Research LaboratoriesNorth Wales, Pennsylvania
Diana T. Chingos, M.S., M.F.A.Noreen Fraser FoundationLos Angeles, California
Thomas Eissenberg, Ph.D.Virginia Commonwealth UniversityRichmond, Virginia
Holly Fernandez-Lynch, J.D.,M. BioeticsHarvard Law SchoolCambridge, Massachusetts
Owen Garrick, M.D., M.B.A.Bridge Clinical ResearchOakland, California
Jonathan Green, M.D. Washington University School of MedicineSt. Louis, Missouri
James Anderson, Ph.D.Merck Research LaboratoriesNorth Wales, Pennsylvania
Diana T. Chingos, M.S., M.F.A.Noreen Fraser FoundationLos Angeles, California
Thomas Eissenberg, Ph.D.Virginia Commonwealth UniversityRichmond, Virginia
Holly Fernandez-Lynch, J.D.,M. BioeticsHarvard Law SchoolCambridge, Massachusetts
Owen Garrick, M.D., M.B.A.Bridge Clinical ResearchOakland, California
Jonathan Green, M.D. Washington University School of MedicineSt. Louis, Missouri
Nancy M.P. King, J.D.Wake Forest UniversityWinston-Salem, North Carolina
Pilar Ossorio, J.D.University of Wisconsin Law School Madison, Wisconsin
Reed E. Pyeritz, M.D., Ph.D.University of PennsylvaniaPhiladelphia, Pennsylvania
Stephen Rosenfeld, M.D., M.B.A.Quorum Review IRBSeattle, Washington
Jerry Menikoff, M.D., J.D.Executive SecretaryRockville, Maryland
Julia Gorey, J.D.Executive DirectorRockville, Maryland
Pilar Ossorio, J.D.University of Wisconsin Law School Madison, Wisconsin
Reed E. Pyeritz, M.D., Ph.D.University of PennsylvaniaPhiladelphia, Pennsylvania
Stephen Rosenfeld, M.D., M.B.A.Quorum Review IRBSeattle, Washington
Jerry Menikoff, M.D., J.D.Executive SecretaryRockville, Maryland
Julia Gorey, J.D.Executive DirectorRockville, Maryland
Related Recommendations
Attachment A: Recommendations NPRM
Content created by Office for Human Research Protections (OHRP)Content last reviewed January 5, 2016