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November 1, 2017

A Framework for Readying Your Institution for Complying With the Revised Common Rule

By Jennifer Mallory, Carrie A. Hanger

Bloomberg Law Medical Research Law and Policy Report

Earlier this year, the long-awaited revision to the Federal Policy for the Protection of Human Subjects, known as the ‘‘Common Rule,’’ was published in the Federal Register (the ‘‘Final Rule’’). 82 Fed. Reg. 7149 (Jan. 19, 2017), available at https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf. The Final Rule, issued by 16 federal agencies and departments including the U.S. Department of Health and Human Services, seeks to modernize the regulations governing all research involving human subjects conducted, sponsored, or regulated by these federal government agencies and departments that have adopted the rule. The Final Rule fundamentally alters regulations that permeate institutions’ standard operating procedures (‘‘SOPs’’), training, and expectations regarding human subjects research. Indeed, the revisions impact even basic issues, ranging from the types of research actually subject to the Final Rule to informed consent.