13
Jan2017

Update: The Office of the Federal Register pre-published the revisions to the Common Rule on January 18.

There has been a lot of anticipation and uncertainty in the research oversight community during the 16 months since the release of the Notice of Proposed Rulemaking to revise the Common Rule. We learned last week that the process is, in the final days of the Obama Administration, officially moving forward.

On January 4, a revised Common Rule was submitted to the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA). OIRA’s review is the last stop before a regulation is finalized and published in the Federal Register with an effective date. Although this signifies we're closer than ever to a new Common Rule, the outcome is still far from certain; OIRA may approve the proposed rule, but they may also return it to the submitting agency—in this case HHS—for further work and consideration.

There is, of course, a second layer of uncertainty about the fate of a revised Common Rule, given the fact that a new presidential administration takes over the reins of the federal government on Friday, January 20. If the final Rule is not published before that date, efforts to revise the Rule are not necessarily dead. HHS could, under the new administration, continue with efforts to push through, or perhaps amend, the current version of the Rule. But most people agree this outcome is unlikely.

If a new Rule is released before January 20, its ultimate fate is still uncertain. The Trump administration could leave the Rule in place, but there are options available for President-elect Trump and the Republican Congress to overturn some of the Obama administration’s most recently published regulations. And while it is unclear whether the Common Rule would be specifically targeted for such repeal, there is a bill making its way through Congress that would allow Congress to undo, in one action, any and all regulations issued in the “last 60 legislative days of a session of Congress during the final year of a President's term.” If passed, this would apply to regulations enacted since June 2016. In other words, rather than targeting individual regulations, this bill would allow a wholesale repeal of all regulations promulgated during that period of time. The timeline for possible passage of this bill is also unknown.

What does all of this mean? It means we still don’t know the fate of the nearly five-and-a-half year attempt to revise the Common Rule. Nor will we know, until it is published, what a new Rule will look like, and how much it does, and doesn’t, resemble the NPRM. We also don’t know what the timetable will be for implementing changes to the regulations under a new Rule, assuming it remains in effect long enough to implement.

In spite of all this uncertainty, these proposed revisions and the issues they raise are immeasurably important to the future of the oversight community. PRIM&R is keeping a close eye on all of this, and we will keep you updated on any and all new developments. If a new Rule is released, just as we did with the NPRM, we are prepared to provide you with focused, clear, and comprehensive information and resources. Watch our Common Rule webpage for blog posts like this one, quick-reference resources, and links, as well as a late-breaking summary webinar presented by experts in the field, to guide you in understanding the content and implications of any new regulations that may emerge.

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2 thoughts on “Revised Common Rule

  1. Pingback: Revised Common Rule - Bioethics Research Library

  2. Pingback: From the Director: Reflections on the Revised Common Rule - Ampersand