News and information useful to Cleveland-Marshall College of Law students, faculty and staff.

Archive for January 30th, 2018


Protection of Human Subjects “Common Rule” Revision Delayed

The revision of the U.S. Federal Policy for the Protection of Human Subjects – the Common Rule – scheduled to become effective on 1/19/18, has been delayed by an interim final rule (see 83 Fed. Reg. 2885).  The effective date is now 7/19/18, but that date may be furthered delayed.  The Common Rule had been revised in a 2017 final rule, referred to as the “2018 Requirements” (see 82 Fed. Reg. 7149, 1/19/17, and 82 Fed. Reg. 43459, 9/18/17).  The Common Rule (see 45 C.F.R. 46) covers policy at 17 federal agencies, and those agencies “are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements.”  Research and industry leaders believe the delay(s) will allow time for the DHHS Office for Human Research Protections to develop and provide guidance for implementation.