From: BNA
The final revisions to human research regulations arrived at the OMB, an indication that the first-ever overhaul of the so-called Common Rule will likely be released before President Barack Obama leaves office Jan. 20.
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No Guarantees
The OMB Office of Information and Regulatory Affairs has up to 90 days to review the final rule, so there is no guarantee a new Common Rule will move forward by Jan. 20. The OIRA/OMB review is the last required step before final rules can be published in the Federal Register, Gary Chadwick, a senior consultant with HRP Consulting Group, told Bloomberg BNA. Chadwick previously served as the associate director for human subject protections for both the OHRP and the FDA.