May 1, 2018: Proposal for 6-month Delay for Implementation of Revised Common Rule

On April 20, 2018, the Department of Health and Human Services and 15 other federal departments and agencies proposed a rule to delay both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). The Interim Final Rule initially announced a delay until July 19, 2018, and the new, proposed rule would delay by a further 6 months to January 21, 2019. This is intended to give institutions additional time to prepare to implement the revisions. Before January 21, 2019, institutions must comply with the pre-2018 Common Rule, except for these three proposed allowances, which are intended to reduce burden on regulated entities:

  1. Entities may use the 2018 definition of “research,” which deems certain activities not to be research,
  2. No annual continuing review is needed for certain categories of research, and
  3. Institutional review boards (IRBs) are not required to review grant applications related to research.

Comments on the proposal will be accepted until midnight EST on May 21, 2018, on the Federal eRulemaking Portal or through regular mail. To use the portal, search for “83 FR 17595” and click the box “Comment Now!”