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.
Summary of the Major Changes in the Final Rule
The final rule differs in important ways from the NPRM. Most significantly, several proposals are not being adopted:
- The final rule does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.
- To the extent some of the NPRM proposals relied on standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance.
- The final rule does not expand the policy to cover clinical trials that are not federally funded.
- The final rule does not adopt the proposed new concept of “excluded” activities. Generally, activities proposed to be excluded are now either described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
- The proposed revisions to the exemption categories have been modified to better align with the long-standing ordering in the final rule. The final rule does not include the proposed requirement that exemption determinations need to be made in specified ways.
- The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. Aspects of proposals that relied on those safeguards have been modified or are not being adopted.
- The final rule does not adopt the most restrictive proposed criteria for obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.
The final rule makes the following significant changes to the Common Rule:
- Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
- Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
- Establishes new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
- Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective 3 years after publication of the final rule.
- Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.
Other minor changes have been to improve the rule and for purposes of clarity and accuracy.