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SACHRP Meeting: Common Rule Update

Friday, May 20, 2016   (0 Comments)
Posted by: Whitney Lingafelter
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May 20, 2016

MEMORANDUM

TO:     Coalition for Clinical and Translational Science

FR:     Dale Dirks and Dane Christiansen

RE:     SACHRP Meeting on the Common Rule  

On Wednesday, May 18th, and Thursday, May 19th, the [HHS] Secretary’s Advisory Committee on Human Research Projections (SACHRP) convened for an open meeting. The meeting was opened by the Director of the HHS Office of Human Research Projections, Dr. Jerry Menikoff, and led by the SACHRP Chair, Dr. Jeffrey Botkin. The primary item for discussion was the Notice of Propose Rulemaking (NPRM) released by OHRP late last year entitled, Federal Policy for the Protection of Human Subjects (HHS-OPHS-2015-0008). Specifically, Dr. Botkin and members of SACHRP reviewed public comments on updating the “Common Rule” that were submitted to the docket.

Based on the analysis presented, general comments mirrored the CCTS position on many critical issues. Mainly, that the NPRM was too broad and loosely constructed, and that it was difficult to provide meaningful feedback when specific tools, regulations, and standards were left as to-be-determined. 

Attached to this e-mail, please find a slide deck providing an overview of NPRM feedback. 

A section by section summary of SACHRP’s view of the NPRM provisions is also available, but likely too large to transmit as a .pdf. We will cover the NPRM and ongoing efforts to update the Common Rule on the CCTS advocacy call this Monday at 4:00 PM (details below). 

See the SACHRP Slide Deck on Common Rule here.

Coalition for Clinical and Translational Science (CCTS)

Conference Call Agenda 
Monday, May 23rd, 2016
4:00 PM – 5:00 PM (Eastern Time)

Dial-in number: 1 (800) 944-8766
Participant Pass code: 79743#