Compliance Date for Common Rule Revisions Delayed an Additional 6 Months

The US Department of Health and Human Services (HHS) and 16 other federal departments and agencies have published a final rule adopting the April 20, 2018, Notice of Proposed Rulemaking (NPRM) to delay the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”) for an additional 6 months. The compliance date for the revised Common Rule, also known as the “2018 Requirements,” is now extended to January 21, 2019.

Regulated entities are required to comply with all pre-2018 Requirements until January 21, 2019. However, institutions are permitted to implement the 3 burden-reducing provisions of the revised Common Rule for certain research during this delay. Institutions choosing to exercise this exception must still comply with all other pre-2018 Requirements during the delay period. If institutions choose to implement the 3 burden-reducing provisions for particular studies, those studies would be subject to the 2018 Requirements beginning on January 21, 2019.

The 3 burden-reducing provisions are: (1) the revised definition of “research,” which deems 4 categories of activities not to be research; (2) the allowance for no annual continuing review of certain categories of research; and (3) the elimination of the requirement that IRBs review grant applications or other funding proposals related to the research.

Advarra is prepared to comply with the revised Common Rule requirements and will notify clients of any policy and/or process changes necessary for compliance.

For more information, read the final rule here.

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