FDA Guidance: Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations

Today the FDA issued a brief guidance titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations” that is intended to provide sponsors, investigators, and IRBs with direction as the implementation date for the revised Common Rule regulations is now three months away.

While there have always been minor differences between the Common Rule regulations and the FDA Human Subject Regulations at 21 CFR parts 50 and 56, the gulf between the two grows much wider under the new Common Rule.  Since the rule was announced in January of 2017 there have been questions about how FDA-regulated clinical research would be impacted by the revised rule.

It has long been recognized that the difference between the FDA human subjects research rules and those of the Common Rule can be confusing to the research community.  The 21st Century Cures Act, which was passed by Congress in 2016 attempted to address this by requiring that the U.S. Department of Health and Human Services “harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations” with a timeline for completion of December 2019.  It is not clear if HHS will be provided with additional time to comply with this requirement as a result of the delayed implementation of the Common Rule.

The guidance issued today primarily serves as a stop-gap with two primary messages.  First, research that is subject to FDA regulation must continue to adhere to the FDA regulations, even when they are more restrictive than the Common Rule. Second, the new Common Rule requirements for the structure and contents of informed consent documents may be applied, as they do not conflict with any FDA requirements for informed consent documents.  While this document serves to formalize this message, it is entirely consistent with comments made by FDA representatives in multiple public forums.

The guidance concludes by noting that “FDA is actively working to harmonize its human subject protection regulations consistent with the Cures Act.”  Hopefully more substantive guidance will be issued in the coming months, as well as guidance from OHRP, which has yet to issue any final guidance related to the implementation of the revised Common Rule.

About the Author

David Borasky, MPH, CIP, VP of IRB Compliance

In addition to his compliance oversight responsibilities at WCG, Mr. Borasky also serves as Co-Chair of the Subpart A Subcommittee of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) former member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R).

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