Additional Delay of the Revised Common Rule Proposed

On April 20, 2018, OHRP proposed an additional delay to the Revised Common Rule. If finalized, the Revised Common Rule would require institutions to continue to comply with the requirements of the current Common Rule (hereafter the “pre-2018 Requirements”) until January 21, 2019. This would be a six-month delay of the effective and compliance date of July 19, 2018. This proposed delay is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements.

The proposal offers institutions the ability to implement on July 19, 2018 three provisions intended to reduce burdens on IRBs and researchers:

  1. Implement definition of “research,” which deems certain activities not to be research, hence not require IRB oversight.

  2. Eliminate the requirement for annual continuing review of certain categories of research.

  3. Eliminate the requirement that institutional review boards (IRBs) review grant applications related to the research.

If finalized, institutions will be given the liberty to determine whether or not to implement these three requirements prior to January 21, 2019. However, if implemented, those studies would have to comply with all of the 2018 Requirements beginning on January 21, 2019.

OHRP is seeking public comment about the proposed delay, due no later than May 21, 2018. The HRPP is currently gathering feedback from stakeholders and will submit a response. Submit your comments no later than May 14. Comments will be shared in aggregate through the federal register.