By Holly Fernandez Lynch
This morning, the Federal Register posted for public inspection the final rule revising the Federal Policy for the Protection of Human Subjects (AKA “The Common Rule”). This has been a long, long road, beginning with an ANPRM in 2011 and a massive NPRM in 2015. The agencies clearly wanted to slide this in before the administration change on Friday, but substantial uncertainty remains.
I’ve copied the preamble’s articulation of key changes – and key proposals that have been dropped – below the fold. But I want to briefly address the “what now?” question. The incoming Trump administration will have its hands full with ACA “repeal and something,” so it’s hard to imagine this regulatory change will be high on the priority list, especially with some of the most worrisome proposals having been nixed already. But the Congressional Review Act provides Congress a streamlined process to eliminate new agency rules. Under the Act, agencies must notify Congress of new regulations, triggering a 60 legislative day review period in which Congress can pass a resolution of disapproval for presidential signature (or veto). So that’s a possibility here.
In addition, two bills have passed the House that could impact these regulations. First, the Midnight Rules Relief Act would amend the Congressional Review Act to allow Congress to disapprove multiple rules at once. In other words, Congress could pass a resolution of disapproval of ALL regulations that had been recently passed to get rid of them all in one fell swoop without individual consideration. Second, the REINS (Regulations from the Executive in Need of Scrutiny) Act, if passed, would require that “major” rules get a joint resolution of Congressional approval within 70 session days to take effect – “major” is defined as having an annual impact of $100M or more, a major increase in costs, or significant adverse effects on innovation.
Point being, don’t get too comfortable with the new rule just yet. Key changes – and things that are staying the same – are listed below (from the Fed. Reg. notice). And I’ll be presenting on these matters at Petrie-Flom’s upcoming conference, Health Law Year in P/Review, on Monday 1/23/17.