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November 3, 2015 SACHRP Letter to the HHS Secretary

November 4, 2015

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 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.

Meeting Members:
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
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
Content created by Office for Human Research Protections (OHRP)
Content last reviewed November 3, 2015
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