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®: CRE Regulatory Action of the Week

Protection of Human Research Subjects: Proposed Six Month Delay of the General Compliance Date
In a final rule published on January 19, 2017, most federal departments and agencies made revisions to the Federal Policy for the Protection of Human Subjects The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). Most federal departments and agencies have also published an interim final rule delaying the effective date and general compliance date for the 2018 Requirements for six months, to cover the time period of January 19, 2018 until July 19, 2018. As per the interim final rule, the effective date of the 2018 Requirements is now July 19, 2018. Most federal departments and agencies have jointly proposed delaying the general compliance date for the 2018 Requirements for an additional six months, for the time period of July 19, 2018 until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements. Comments on this proposal must be received by one of the participating federal departments and agencies no later than 11:59 p.m. Eastern Standard Time on May 21, 2018.

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