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 the recommendation for a 60 day extension of the public comment period posed in the Common Rule Notice of Proposed Rulemaking, docket ID Number: HHS-OPHS-2015-008. This recommendation was passed by SACHRP at their October 21-22, 2015 meeting.
On behalf of SACHRP, I would like to thank you for your consideration of this recommendation. 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 Committee
on Human Research Protections
(SACHRP)
cc: Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRP
Julia Gorey, J.D., Executive Director, SACHRP
Recommendation for a 60 day extension of the public comment period posed in the Common Rule Notice of Proposed Rulemaking, docket ID Number: HHS-OPHS-2015-008.
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
Richmond, Virginia
Holly Fernandez-Lynch, J.D.,
M. Bioetics
Harvard Law School
Cambridge, Massachusetts
Owen Garrick, M.D., M.B.A.Bridge Clinical Research
Oakland, California
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
Philadelphia, Pennsylvania
Stephen Rosenfeld, M.D., M.B.A.
Quorum Review IRB
Seattle, Washington
Jerry Menikoff, M.D., J.D.
Executive Secretary
Rockville, Maryland
Julia Gorey, J.D.
Executive Director
Rockville, Maryland