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Second Delay Issued for Revisions to the Common Rule

The US Department of Health and Human Services (HHS) and 16 other federal departments and agencies have announced a Notice of Proposed Rulemaking (NPRM) proposing 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. Under the NPRM proposal, the compliance date would change from July 19, 2018, to January 21, 2019.

In addition to the 6-month delay, regulated entities would be required to comply with all pre-2018 Requirements during the period that the general compliance date is delayed. However, institutions would be excepted from this if they choose to substitute the 3 burden-reducing provisions of the 2018 Requirements for the comparable provisions of the pre-2018 Requirements. As proposed, 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 four 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 full NPRM here.

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