The Department of Health and Human Services Announces Final Rule to Improve Regulations Protecting Human Research Subjects
On January 19, 2017, final revisions to the Federal Policy for the Protection of Human Subjects, i.e., the Common Rule, were released. The intent of the updated Common Rule is to enhance human subject protections while minimizing administrative burden for investigators.
The anticipated compliance dates, i.e., the dates on which regulated entities must comply with the revised Common Rule are as follows: The compliance date for the revised Common Rule, except for (cooperative research and use of single IRB) is January 19, 2018; the compliance date for cooperative research is January 20, 2020.
We emphasize anticipated given the uncertainty surrounding whether final revisions to the Common Rule will take effect due to a number of obstacles that can sideline eventual implementation of the revised Common Rule, e.g., potential Administrative Procedures Act (“APA”) challenges to the revised Common Rule brought by regulated research community stakeholders, the incoming Trump administration, its platform and its moratorium on informal rulemaking, the January 4, 2017 House of Representatives passage of bill (H.R. 21) that would allow Congress to repeal ‐ at once ‐ a slew of regulations issued in the last half of 2016, the appearance of proposed revisions to the Common Rule on the House Freedom Caucus Rules, Regulations and Executive Orders to Examine, Revoke and Issue, as well as the recent passage of the bipartisan 21st Century Cures Act which requires the Office of Management and Budget (“OMB”) to establish a Research Policy Advisory Board charged with advising on how to modify and harmonize federal research regulation requirements to minimize administrative burden. Any one of these potential obstacles, either individually or collectively, could undermine the future of the final rule.