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The Final* Final Rule (and opportunities for CRS credit)

It ain’t over until the … publication appears in the Federal Register, and sure enough, today’s Federal Register contains the final* Final Rule.

Since most people don’t have the daily Federal Register delivered to them at home, here’s a link to today’s publication. Note that much of this document is a discussion of the slow, painful, multiyear (anybody remember the Advanced Notice of Proposed Rulemaking back in 2011?) process of birthing a new regulation. The quickest way to find the actual rule, we’ve found, is to click on the PDF link at upper right, and then go to page 111 of 126 to find the text of the revised rule. (It appears as Federal Register page no. 7259). Those who are so inclined can then refer back to the previous 115 or so pages to find discussions of the thinking behind each section.

And why are we calling it the Final-with-an-asterisk Final Rule? First off, even Final Rules are subject to revision. Secondly, any change in presidential administration can lead to a review of any number of regulations adopted in previous administrations. So it will be interesting to see what sticks from this new version. Also, the Notice of Proposed Rulemaking also addressed several contentious issues that didn’t make it into the Final* Final Rule. There’s no telling if plans to incorporate some version of that draft language are still a thing.

Most rule provisions are slated to take effect in January 2018. A few have an implementation date of January 2020.

Some resources are available to help you make sense of the revised Common Rule. Public Responsibility in Medicine and Research (PRIM&R) has a web page on which it plans to post “additional resources and programmatic updates” about the rule. PRIM&R also has a webinar scheduled for January 26 that is free for PRIM&R members; a link is available at the above website. WIRB Copernicus Group also has a free webinar scheduled for Friday, January 20, regarding the new rule. We’re curious to which aspects of the new rule will be highlighted in each — and whether they’ll agree on topics they both discuss.

Certified Research Specialist education credit is available for both of these webinars. Email your completion certificate to Education Coordinator Catrice Banks-Johnson to earn your credit.