EPA Issues Final Rule Delaying Compliance Date for Human Subjects Policy by Six Months; Institutions

By Timothy D. Backstrom and Lisa M. Campbell On June 19, 2018, sixteen federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing studies with human subjects that are sponsored or utilized for regulatory purposes by the federal government (83 Fed. Reg. 28497).  These revisions to the human testing policy were adopted on January 19, 2017, in a final rule (82 Fed. Reg. 7149) that amended and expanded the “Common Rule” governing human testing originally promulgated in 1991.  The 2017 revisions to the human testing policy were originally scheduled to take effect on January 19, 2018, but the agencies published an interim final rule on January 22, 2018, that delayed the effective date for the new policy until July 19, 2018.  Thereafter, on April 20, 2018, the same 16 agencies published a proposed rule (83 Fed. Reg.…

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