Pharmaceutical & Life Sciences News

Muddy Steps to Revise Research Rule May Finally Have Clarity

April 19, 2018, 2:05 PMUpdated: April 19, 2018, 8:23 PM

A rule to protect research volunteers could be pushed back to next January, ultimately providing research institutions an extra year from the original start date.

The proposed rule, issued April 19 before publication in the Federal Register April 20, would make Jan. 21, 2019, both the effective and compliance date for revisions to human subject regulations known as the Common Rule. The Department of Health and Human Services, along with the nearly 20 federal agencies that administer the rule, also is considering letting institutions that are ready now to comply with three provisions designed to reduce burdens.

If implemented,...

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