Bioethics Forum Essay
Common Rule Revisions: Impact of Public Comment, and What’s Next?
On January 19, the day the final revisions to the Federal Policy for the Protection of Human Subjects were published in the Federal Register, our essay “Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule” was published in IRB: Ethics & Human Research. Of course, when we were drafting the essay last fall, we could not know the fate of the Notice of Proposed Rule Making to amend the Common Rule. The uncertainty stemming from 2,186 public comments, many of which opposed the rule, alongside calls for the proposed rule to be withdrawn, was only exacerbated by the historic upset of the presidential election, the subsequent lame duck period, and rumors that the regulatory agencies planned nonetheless to push the revisions to finalization before the change in administration – which they ultimately did.
The Rulemaking Process
But in the midst of that uncertainty, we realized that many of our colleagues in the human subjects research regulation community were uncertain about something else: precisely how their comments on the proposed rule could, should, or would be taken into account by the Common Rule agencies. For example, we heard questions about how the government could proceed if the vast majority of comments were negative, whether the final rule could be dramatically different from what had been proposed (and if so, whether there would be additional opportunity for comment), whether empirical evidence was needed to support the proposed changes, and whether comments from organizations and experts would be accorded more weight than others. Thus, we saw an important opportunity to clarify the regulatory process, the legal requirements for agency consideration of public comments, the range of options available to the regulators when engaged in rulemaking, and our view of the best outcome.
In our commentary in IRB, we explained the fundamental differences between notice-and-comment rulemaking under the Administrative Procedure Act and a public referendum – namely, that the regulatory agency need not be swayed by comments in opposition to what it has proposed, even if they make up the vast majority of comments received – as long as it considers them with an open mind and has a reasonable explanation for taking a different approach, i.e., one that is not arbitrary or capricious. The government is also limited, when finalizing a new rule, to changes that are a “logical outgrowth” of what had previously been provided for public comment; should more substantial changes be put forth, an additional opportunity for public comment must be provided.
Impact of Public Comments
Now that the final rule has been published, we can ask how it actually stacks up to these legal standards. We noted in the manuscript our hope that the regulators would give substantial weight to input by expert stakeholders and especially comments made by those concerned about the negative impact of the proposed rule. In particular, we were concerned with the possibility that the regulators would proceed to finalize proposals regarding research with biospecimens that would have required at least broad consent regardless of identifiability, despite serious concerns and opposition by patient groups and the research community, as well as a range of advisory committees.
We are happy to report that the regulators seem to have used the notice-and-comment process precisely as it was intended – to listen to the affected parties and change course accordingly. In 110 pages of the Federal Register accompanying the final rule, the regulators engaged deeply with the comments received. Based on those comments, as well as other expert analyses, the final rule differs in important ways from the NPRM, most importantly, rejecting proposals to require research with nonidentified specimens to be subject to the Common Rule and to make waiver of consent for research with identifiable specimens nearly impossible.
In that regard, the preamble explicitly notes (page 7168) that although those proposed changes were “based on the premise that continuing to allow secondary research with biospecimens collected without consent for research places the publicly funded research enterprise in an increasingly untenable position because it is not consistent with the majority of the public’s wishes, which reflect legitimate autonomy interests . . . . , the public comments on this proposal raise sufficient questions about this premise such that we have determined that the proposal should not be adopted in this final rule.”
Here we see open-mindedness and reconsideration – exactly what the comment process is intended to achieve (although it is important to remember that comments from stakeholders are decidedly not the same as robust, representative empirical data derived from well-designed survey research, for example). The rule also ultimately dropped the proposal to add a new category of excluded research and substantial changes to the exemption categories, which many commentators suggested would make the rules more complex than necessary.
The lesson: although the regulators had substantial discretion to finalize the NPRM’s proposals, public comments seem to have successfully impacted the outcome. But open questions remain. In particular, the final rule adopts a new requirement (§ .102(e)(7)(ii)) (page 7260) to periodically assess and develop a list of “analytic technologies and techniques that should be considered by investigators to generate identifiable private information or identifiable biospecimens.” Before a technology or technique can be placed on the list, notice and the opportunity for public comment will be provided; whole genome sequencing will likely be one of the first technologies evaluated. Given the number of public comments on how to treat research involving whole genome sequencing in relation to the NPRM, the regulated community should remain engaged. Further, although there is no specified requirement in the rule for notice and public comment when the regulators embark on the newly required (§ .102(e)(7)(i)) (page 7260) periodic reconsideration of the meaning of “identifiable” with regard to research with biospecimens and private information, the dramatic impact of a change to that definition suggests that regulators should nevertheless seek public input – and continue to consider comments received on this question already.
Public comments on the NPRM also heavily impacted what didn’t make its way into the final rule. In particular, the regulators dropped a number of proposals (page 7153) to which commentators had objected on the basis of lacking adequate opportunity to provide comment, as the specific proposals were not even provided in draft form with the NPRM. These included a tool that had been proposed to allow investigators to determine whether their own research was exempt from the regulations, a template for broad consent to research with biospecimens and identifiable private information, and new privacy and confidentiality standards for such research. These things still may be forthcoming, but will require a new rulemaking process at that time, unless they are offered only as nonbinding guidance.
So where do we go from here? After nearly six years of uncertainty about what the final rule would look like, the regulated community has largely been heard, and it is anxious to get to the hard work of implementation. But alas, procedural uncertainty remains. Unable to get the rule finalized until the very end of the Obama administration, the new rule was published the day before President Trump took office. Indeed, even before that, Congressional Republicans warned agencies “against finalizing pending rules or regulations in the Administration’s last days,” on pain of having “Congress scrutinize . . . your actions – and, if appropriate, overturn . . . them – pursuant to the Congressional Review Act.” The Congressional Review Act provides Congress a streamlined process to eliminate “major” new agency rules, via a 60-legislative-day review period triggered by publication of a final rule during which time Congress can pass a resolution of disapproval. Importantly, if a rule is repealed under this law, agencies are precluded from promulgating something substantially similar going forward unless authorized by a new statute, although it is unclear how different a new regulation must be to overcome this ban. “Major” is defined as having an annual impact of $100,000,000 or more, a major increase in costs, or significant adverse impact on competition or innovation. It is unclear whether the final rule would meet (page 7232) these thresholds, but it conceivably could.
To date, there has been no resolution of disapproval put forward for the Common Rule, but there are two other pieces of pending legislation in which the final rule could become entangled, if passed. First, the Midnight Rules Relief Act would amend the Congressional Review Act to allow Congress to disapprove multiple rules at once, e.g., everything finalized within the prior 60 legislative days, without individual consideration. Second, the REINS (Regulations from the Executive in Need of Scrutiny) Act would require that “major” rules get a joint resolution of Congressional approval within 70 session days after publication to take effect. Both pieces of legislation passed the House in early January, but to date the Senate has not acted on either.
In terms of the executive branch, on January 20, Reince Priebus, the President’s Chief of Staff, issued a memo to the heads of the executive departments and agencies freezing regulations pending review. With regard to regulations like the final rule, already published but not yet in effect, the memo asks department and agency heads “as permitted by applicable law” to postpone their effective date for 60 days to allow review of questions of law, fact, and policy. This may be a moot point for the Common Rule revisions, which are not effective for another year, but the memo also asks heads to consider initiating notice and comment rulemaking to delay the effective date of regulations beyond the 60-day review period, and to potentially consider further notice-and-comment rulemaking altogether.
So, what should we expect? Although there are clearly legal avenues to send the rule back to the drawing board, it is unclear whether they will be utilized. In the first few weeks of the new administration, it does not seem that the Common Rule is the subject of much Congressional or executive attention. There appears to be simply too much else going on for Congress to focus its attention on this, between plans to dismantle the Affordable Care Act, immigration policy, cabinet nominations, and a new Supreme Court justice on the horizon. Moreover, there has been no further action on either pending bill, but there’s still time and if that changes, the final Common Rule could become a casualty of legislative attention focused on other, potentially more controversial rules.
At the agency level, there is less concern that something might change without individual consideration. Moreover, it seems unlikely that a regulation explicitly intended to minimize burden and delay, and to facilitate and streamline research oversight, would be the sort of rule pegged for repeal. But even if it were (stranger things have happened!), the notice-and-comment rulemaking process would have to begin all over again to get rid of the rule now that it has been finalized. Considering that the final rule ended up precisely where many commenters wanted it to be – and that the most offending provisions inhibiting research with biospecimens were dropped – the legal grounds for repeal seem very weak indeed.
While we can’t say for sure what will happen next, our bet is that the regulated community – after spending all those hours drafting comments on the last few years of rulemaking, poring over proposals, assessing possible impacts, and pondering next steps – should be buckling down again, getting into the hard work of implementation. January 2018 will be here before you know it.
Holly Fernandez Lynch is the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and a faculty member at the Harvard Medical School Center for Bioethics. She is a member of the Secretary’s Advisory Committee for Human Research Protections (SACHRP), U.S. Department of Health and Human Services. I. Glenn Cohen is a professor at Harvard Law School and the faculty director of the Petrie-Flom Center. Barbara E. Bierer is a professor of medicine at Harvard Medical School, a senior physician in the Department of Medicine at the Brigham and Women’s Hospital (BWH), and a faculty cochair of the Multi-Regional Clinical Trials Center of BWH and Harvard. She is a former chair of SACHRP and a member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R); she was also a member of the National Academy of Sciences, Engineering, and Medicines Committee on Science, Technology, and Law. The views expressed here are only their own and should not be attributed to any organization of which they are a part.