On January 17, 2018, just two days before a final rule that revised the Common Rule was scheduled to take effect, the United States Department of Health and Human Services (“HHS”) announced a six-month delay in the final rule’s effective and compliance date. HHS has now issued an interim final rule whose effect is to postpone the compliance and effective dates of the revised Common Rule from January 19, 2018 to July 19, 2018. (Nevertheless, unchanged from the revised Common Rule, the requirement for single institutional review board (“IRB”) review of multisite research will take effect on January 20, 2020.) On January 18, 2017, HHS together with fifteen other federal departments and agencies, had issued a final rule intended to revise and modernize the federal Policy for the Protection of Human Subjects (the Common Rule), the set of federal regulations governing clinical research involving human subjects. We previously described the key changes contained in the revisions to the Common Rule here, here, and here.
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