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Common Rule (45 CFR 46) Revisions Delayed by OMB

Earlier today, the Office of Management and Budget (OMB) approved aninterim final rule that delays the effective and compliance dates of the revised Common Rule (45 CFR 46) to July 19, 2018 (“the 2018 requirements”).  Please note that the interim rule explicitly bars regulated entities such as UCI and its researchers from complying with the 2018 requirements prior to July 19, 2018.  This means that UCI and its human subjects researchers must continue to comply with the pre-2018 requirements, as those are the requirements that will be enforced by federal agencies.

The federal government delayed implementation of – and compliance with – the 2018 requirements to provide additional time for federal agencies and regulated entities to prepare for implementation.  However, the interim rule also provides additional time for federal agencies to seek input from interested stakeholders through a notice and comment rulemaking process on a proposal to further delay implementation.

With the federal government delaying the implementation and compliance dates for the 2018 requirements, the Office of Research will continue its efforts to prepare the campus and its information systems for their eventual implementation.

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Human Research Protections

More news at https://news.research.uci.edu/