Archives: January 2018

A Wrinkle in Common Rule Time

In an 11th hour—but nonetheless anticipated—move, the sixteen federal departments and agencies responsible for the Common Rule Final Rule that was slated to become effective tomorrow, January 19, 2018 (“Revised Common Rule”), have issued an Interim Final Rule (“IFR ”) delaying the effective date and the general compliance date of the Revised Common Rule for six months, until July 19, 2018. The IFR does not alter the compliance date for the Revised Common Rule’s provision on cooperative research (including its single IRB mandate); that date remains January 20, 2020.

The announcement provides a respite to those in the regulated community who have been working towards bringing their policies and procedures into compliance by January 19, 2018, despite the lack of any written guidance from the Office for Human Research Protections or others in the federal government regarding aspects of the Revised Common Rule that are ambiguous or otherwise challenging to implement. (more…)

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