Full Implementation of Common Rule Delayed through January 2019

On June 19, the Office of Human Research Protections (OHRP) within the U.S. Department of Health and Human Services issued a final rule adopting a proposal released in April to delay the compliance date for revisions to the Common Rule (the set of regulations governing research involving human participants) by six months. COSSA submitted comment on this proposal asking that the implementation of the new regulations not be delayed any further than is necessary. The new compliance date for the majority of the new regulations is now January 21, 2019. However, beginning on July 19, 2018, institutions (on a study-by-study basis) may choose to adopt three “burden-reducing” provisions early (so long as the studies move into full compliance with the new regulations after they go into effect in January 2019). The burden-reducing provisions include: the revised definition of research; the elimination of requiring annual continuing review for certain categories of research; and elimination of requiring IRBs to review grant applications and funding proposals. See COSSA’s previous summary of this proposal for a comparison of the text of the current and new provisions.

While the fate of the revisions to the Common Rule has been in limbo since the Presidential transition in 2017 (see COSSA’s previous coverage), barring some unforeseen intervention by the Administration, the issuance of this final rule appears to be the last step before the regulations can go into effect. In its response to comments submitted, OHRP notes, “We do not believe a delay of the general compliance date beyond January 21, 2019 is necessary.”

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Posted in Issue 13 (June 26), Update, Volume 37 (2018)

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