Delay to Common Rule Implementation Likely

On January 4, the Department of Health and Human Services submitted a final rule for approval by the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA), which would indefinitely delay implementation of revisions to the Common Rule, the set of regulations governing research involving human participants (see COSSA’s analysis of the changes, which were announced in the final days of the Obama administration). This rule replaces an earlier proposal to delay implementation that was submitted in October but never approved by OIRA (see COSSA’s discussion), which would have allowed certain “burden-reducing” provisions of the Rule to go into an effect as scheduled while delaying the remaining pieces of the revision for one year. The new rule would delay the entirety of the revisions to the Common Rule for an unspecified period of time.  The original implementation date for the revisions is January 18, 2018, so OIRA would need to approve the new rule by then in order to avoid the regulations taking effect. It is unclear what the impact would be if OIRA were to approve the delay after the January 18 deadline.

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