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RCA: Notice of Proposed Rulemaking for the Federal Policy for the Protection of Human Subjects (Common Rule)

September 18, 2015

Final

Record of Commission Action

(Briefing Package September 24, 2015, OS No. 3314)

Decision

The Commission voted (4-1) to approve publication in the Federal Register ("FR"), with anamendment, of the notice of proposed rulemaking ("NPR") that would amend the Commission's regulations at 16 C.F.R. part 1028, Protection of Human Subjects. Chairman Kaye,Commissioner Adler, Commissioner Buerkle and Commissioner Mohorovic voted to approvepublication of the NPR in the FR, with an amendment. (The approved amendment proposed byCommissioner Mohorovic is attached.) Commissioner Robinson voted to approve publication ofthe NPR in the FR, as drafted. The NPR would adopt the Federal Policy for the Protection ofHuman Subjects (referred to as the "Common Rule") as proposed to be amended by theDepartment of Health and Human Services ("HHS") through cross-reference to HHS 'sregulations at 45 C.F .R part 46, subpart A .

 

Commissioners Voting

Ballot vote due September 18, 2015

  • Chairman Elliot F. Kaye
  • Commissioner Robert S. Adler
  • Commissioner Ann Marie Buerkle
  • Commissioner Joseph P. Mohorovic
  • Commissioner Marietta S. Robinson

Attachment:

Approved Amendment of Commissioner Mohorovic

Type
Records of Commission Action and Commission Meeting Minutes
Date
Report an unsafe product