On 20 April 2018, the U.S. Department of Health and Human Services (HHS) and 16 other agencies released a Notice of Proposed Rulemaking (NPRM) to propose delaying the general compliance date of the revised Common Rule for six months while allowing for three burden-reducing provisions during the delay period.
This NPRM proposes to delay the general compliance date of the revised Common Rule until 21 January 2019, six additional months from the Interim Final Rule (that delayed the revised Common Rule to 19 July 2018).
Under this proposed rule, the current (also referred to as the “pre-2018 Rule”) regulation will remain in effect. However, the NPRM proposes to allow three provisions from the revised rule to be implemented during the delay period:
- 1. Revised definition of “research”
- 2. Elimination of continuing review for no more than minimal risk research
- 3. Elimination of the requirement for Institutional Review Boards (IRBs) to review grant applications
If an institution chooses to implement the three burden-reducing provisions to studies during the delay period, then the affected studies must comply with all of the 2018 rule requirements after the general effective date of the revised Common Rule.
During this delay, CITI Program can help organizations prepare for the Final Rule. We have developed a new Revised Common Rule course focused on the Final Rule revisions to the Common Rule. In addition, as a reminder, all CITI Program existing modules will be updated to reflect the revised regulations when they become effective.
CITI Program is monitoring regulatory developments and will update materials accordingly.