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 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.
Jeffrey R. Botkin, M.D.
Chair, Secretary’s Advisory Committee
on Human Research Protections
Attachment A: Recommendations on the NPRM
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRP
Julia Gorey, J.D., Executive Director, SACHRP
Jeffrey R. Botkin, M.D., M.P.H.
University of Utah
Salt Lake City, Utah
James Anderson, Ph.D.
Merck Research Laboratories
North Wales, Pennsylvania
Diana T. Chingos, M.S., M.F.A.
Noreen Fraser Foundation
Los Angeles, California
Thomas Eissenberg, Ph.D.
Virginia Commonwealth University
Holly Fernandez-Lynch, J.D.,
Harvard Law School
Owen Garrick, M.D., M.B.A.Bridge Clinical Research
Jonathan Green, M.D.
Washington University School of Medicine
St. Louis, Missouri
Nancy M.P. King, J.D.
Wake Forest University
Winston-Salem, North Carolina
Pilar Ossorio, J.D.
University of Wisconsin Law SchoolMadison, Wisconsin
Reed E. Pyeritz, M.D., Ph.D.
University of Pennsylvania
Stephen Rosenfeld, M.D., M.B.A.
Quorum Review IRB
Jerry Menikoff, M.D., J.D.
Julia Gorey, J.D.