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A (Temporary) Sigh of Relief: Delay of the Revised Common Rule

on Friday, 2 February 2018 in Health Law Alert: Erin E. Busch, Editor

On January 17, 2018, just two days before the revised Federal regulations governing the protection of human subjects (the “Revised Common Rule”) were set to go into effect, the U.S. Department of Health and Human Services and fifteen other Federal departments and agencies announced a six month delay of the effective date and general compliance date – until July 19, 2018. The delay comes as welcome news to many organizations, researchers, and institutional review boards (“IRBs”) that were scrambling to implement the significant changes included in the Revised Common Rule.

The Revised Common Rule applies to research that is conducted, supported, or regulated by the Federal government. The goal of the Revised Common Rule is to reduce administrative burdens associated with modern human subject research. Announced in January 2017, the new rules included significant changes to requirements for informed consent to participate in a research study; the categories of exempt research; criteria for initial IRB review; ongoing IRB review of research; and single IRB review for cooperative research studies. The complexity of the changes means that IRBs, researchers, and institutions conducting or sponsoring research studies must review and overhaul policies, procedures, and processes regarding human subject research.

Between now and July 19, 2018, organizations may elect to implement some of the new Revised Common Rule requirements, as long as they do not conflict with the existing (pre-2018) rules. For example, institutions may choose to implement the new informed consent requirements now. When the Revised Common Rule takes effect on July 19, 2018, all new research studies will be subject to the Revised Common Rule. For existing (pre-2018) research studies that were previously approved, institutions may decide whether the studies will continue to be subject pre-2018 regulations or transition to the new Revised Common Rule provisions.

Institutions that sponsor, conduct, or review research studies should educate investigators, staff, and IRB members about the new provisions. In addition, institutions should review and revise existing policies and procedures addressing human subject research in advance of the new compliance date.

Michael W. Chase

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