A Wrinkle in Common Rule Time
January 18, 2018 - In an 11th hour—but nonetheless anticipated—move, the sixteen federal departments and agencies responsible for the Common Rule Final Rule that was slated to become effective tomorrow, January 19, 2018 ("Revised Common Rule"), have issued an Interim Final Rule ("IFR ") delaying the effective date and the general compliance date of the Revised Common Rule for six months, until July 19, 2018. The IFR does not alter the compliance date for the Revised Common Rule's provision on cooperative research (including its single IRB mandate); that date remains January 20, 2020.
The announcement provides a respite to those in the regulated community who have been working towards bringing their policies and procedures into compliance by January 19, 2018, despite the lack of any written guidance from the Office for Human Research Protections or others in the federal government regarding aspects of the Revised Common Rule that are ambiguous or otherwise challenging to implement.
The IFR acknowledges that "regulated entities need additional time for implementation and compliance, which would be furthered by the issuance of guidance by the Common Rule agencies" as part of its justification for issuing the delay through the IFR process without the normally required period for public notice-and-comment.
Serving as a "pause" button in what has been a perplexing process for many in the regulated community, the IFR contemplates that the federal departments and agencies will use the delay period to pursue additional rulemaking to extend further the effective date and compliance date for the Revised Common Rule to January 21, 2019.
One puzzling aspect of the IFR is its stated "effective date." Although the government is indicating that the delay outlined in the IFR serves to stay tomorrow's compliance and effective dates for the Revised Common Rule, the IFR states that the IFR itself has an effective date of July 19, 2018, which is the same day the Revised Common Rule would also become effective pursuant to the IFR. Our understanding is that the identification of this date may be driven by the fact that the delay is being issued prior to the Revised Common Rule going into effect, and because the IFR seeks to modify specific language in the "transition" provisions of the as-yet-effective Revised Common Rule at §___101(l) (which explicitly sets forth the effective and compliance dates). However, the express statements in the IFR that it does not take effect until the Revised Common Rule would already have been in effect for six months under the original Final Rule has caused some confusion in the regulated community and among regulatory attorneys. Again, all indications from the government are that the delay is effective immediately notwithstanding the IFR's stated effective date, and that this confusion is simply the result of a regulatory technicality.
Importantly, the regulated community should note that early compliance with the flexible aspects of the Revised Common Rule remains prohibited ahead of July 19. Institutions may elect to implement aspects of the Revised Common Rule that are more stringent than the current regulations (for example, the new elements of informed consent related to secondary uses), but may not take advantage of flexibilities, such as broad consent and the new categories of exempt research, at this time.
We have updated our 2018 Common Rule Implementation Checklist in light of the new effective date and compliance date, and have added some additional reflection on particular regulatory provisions since the checklist was originally circulated. We include this updated Implementation Checklist here for your reference. For more information about the delay or the ACRG's Implementation Checklist, or to discuss your institution's plans for compliance with the 2018 Common Rule, please feel free to contact the member of Verrill Dana's Academic and Clinical Research Group with whom you normally work, or email us at [email protected].
This communication is intended for general information purposes and as a service to clients and friends of Verrill Dana, LLP. This publication, which may be considered advertising under the ethical rules of certain jurisdictions, should not be construed as legal advice or a legal opinion on any specific facts or circumstances, nor does it create attorney-client privilege.