Effective Date and General Compliance Date for Revised Common Rule Delayed 6 Months
The Department of Health and Human Services (HHS) and 15 other agencies have issued an Interim Final Rule (IFR) that applies a 6 month delay to the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).
The IFR was published in the Federal Register on January 19, 2018, and delays the effective date and general compliance date from January 19, 2018, until July 19, 2018. The single IRB review mandate remains as scheduled, effective January 20, 2020.
Per the IFR, “…Studies initiated prior to July 19, 2018…would, as a default, continue to be subject to the pre-2018 Requirements for their duration.” This allows IRBs to maintain consistent regulatory oversight standards for studies approved before July 19th, although after July 19th IRBs may choose to shift these legacy studies to follow the provisions in the revised Common Rule.
This delay provides both the government and research community with more time to issue guidance documents and to update policies and processes in accordance with the changes to the Common Rule. In addition, the 21st Century Cures Act requires FDA to harmonize its regulations with those of the rest of HHS, and this delay provides time for FDA to take the steps necessary to align with the changes reflected in the revised Common Rule.
The Advarra team is ready to implement the changes reflected in the revised Common Rule as soon as it is effective. Advarra can provide resources to assist clients with their implementation efforts.