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Ready for Compliance with Revised Common Rule?
Health Law Perspectives
June 1, 2018

As entities subject to the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) know, the path to revising the Common Rule has been long and winding. Revised regulations were issued on the eve of the last day of the prior administration with a built-in delay until January 19, 2018.  Just days prior to that effective date, the general compliance date was then pushed back to July 19, 2018.  Now, with July around the corner, it remains uncertain as to whether that date will be further pushed back.  Further detail on the proposed delay and takeaways for regulated entities follows.

Proposal to Delay Compliance Date to January 21, 2019, and Related Regulatory History

On April 19, 2018, the U.S. Department of Health and Human Services and sixteen other federal departments and agencies announced a proposal to further delay the implementation of revisions to the Federal Policy for the Protection of Human Subjects, otherwise known as the Common Rule, in a notice of proposed rulemaking (the NPRM).[1]  Pursuant to the NPRM, the new general compliance date would be January 21, 2019. 

This delay is with respect to a final rule published on January 19, 2017, which was initially scheduled to become effective January 19, 2018.[2]  The provisions of the final rule, referred to as the 2018 Requirements in the NPRM, are intended to strengthen protections for research participants, as well as minimize regulatory burdens for investigators, research institutions and IRBs, especially in the context of low-risk research.[3]  For more information about the 2018 Requirements, see our firm’s February 22, 2017 advisory, Federal Agencies Issue Revised Common Rule.

However, just prior to the original effective date, the regulatory departments and agencies published an interim final rule delaying the effective and general compliance date until July 19, 2018.[4]  That delay was intended to provide additional time for regulated entities to prepare for implementation of the 2018 Requirements, as well as for the regulatory departments and agencies to seek input on a further delay and to issue additional guidance on some of the requirements. 

The NPRM now seeks to further delay implementation of the general compliance date until January 21, 2019, to provide additional time for regulatory entities to prepare for implementation.  The prior delay in the interim final rule and the proposed delay in this NPRM were anticipated, given the significance of the revisions to the Common Rule and the feedback provided from regulated entities.  The NPRM states that the proposed delay “is both an appropriate action to take at this juncture, and a reasonable time period to allow the regulated community to be prepared for compliance with the 2018 Requirements and for HHS and the other Common Rule agencies to develop implementation guidance.”[5] 

The NPRM sought comments through May 21, 2018, on whether regulated entities should be permitted to implement three of the 2018 Requirements in the interim, with respect to certain studies: (1) the revised definition of “research;” (2) the ability to not conduct annual continuing reviews for certain types of research; and (3) the elimination of the requirements that IRBs review grant applications or other funding proposals.  Pursuant to the NPRM, institutions would be required to continue to comply with the pre-2018 Requirements until January 21, 2019, except that an institution, by electing to transition certain research studies to comply with the 2018 Requirements on or after July 19, 2018, would be able to take advantage of these three burden-reducing changes in advance of the general compliance date of January 21, 2019. 

Takeaway for Regulated Entities

At the time this article went to press in early June 2018, it was unclear whether the further delay would go into effect.  A final rule that adopts some or all of the content in the NPRM may be issued, or nothing further may be issued and the compliance date will remain July 19, 2018.  Although federal regulators are engaging in this rulemaking process in part to benefit regulated entities, by providing additional time to prepare as well as to allow more time for regulators to issue additional guidance, this latest delay does create a “hurry-up-and-wait” environment that leaves regulated entities unsettled regarding how to proceed.  Given the uncertainty, regulated entities should continue to proceed as if compliance will be required in July 2018 so that they are ready, and continue to monitor regulatory developments closely.

Other Regulatory Developments to Watch

In the Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), released in May, the FDA signaled an intent to harmonize its regulations with the Common Rule by addressing the following topics: (1) IRB and informed consent requirements; (2) waiver of informed consent for minimal risk clinical investigations; and (3) single IRB review of multisite research in the U.S. and IRB recordkeeping requirements when the reviewing IRB is not the institutional IRB.  While at this stage the released agenda does not provide detail, developments on the FDA front should be closely monitored in the coming months given that research studies may be subject to both regulatory regimes.  At this point it is unknown how much overlap there will be between the regulations, or whether FDA regulations will be tailored differently for its regulated population, which may require further updates to a regulated entity’s research compliance efforts following on the heels of updates needed to comply with the revised Common Rule.

Hooper, Lundy & Bookman’s Academic Medical Center/Teaching Hospital Group provides assistance to health care providers and IRBs in all aspects of research and privacy compliance.  For assistance, please contact Amy Joseph in Boston at 617.532.2702; Paul Smith, Katrina Pagonis, or Andrea Frey in San Francisco at 415.875.8500; Kelly Carroll in Washington, D.C. at 202.580.7700; or Sandi Krul or Jennifer Siegel in Los Angeles at 310.551.8111. 

[1] Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period, 83 Fed. Reg. 17595 (Apr. 20, 2018); see also https://www.hhs.gov/ohrp/announcement-nprm-revisions-common-rule.html.

[2] Federal Policy for the Protection of Human Subjects, 82 Fed. Reg. 7149, 7150 (Jan. 19, 2017).

[3] Id. at 7150.

[4] Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects, 83 Fed. Reg. 2885, 2889 (Jan. 22, 2018); see also https://www.hhs.gov/ohrp/ifr-delays-revisions-common-rule-published-fr.html-1.

[5] 83 Fed. Reg. at 17596.

For media assistance, please contact Maura Fisher at 202-580-7714.