IRB: Ethics & Human Research
Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule
At the federal level in the United States, development of regulations is governed by the Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies to develop rules with the force of law, under a process called “notice and comment rulemaking.” In 2011, the Department of Health and Human Services (HHS) published in the Federal Register an “Advanced Notice of Proposed Rule Making” (ANPRM) to begin the first public discussion in decades about amending the Federal Policy for the Protection of Human Subjects, also known as the “Common Rule.” Over 1,100 public comments were submitted. In 2015, HHS along with several other federal agencies issued a “Notice of Proposed Rule Making” (NPRM), the second step in the process toward revising the Common Rule. This time, the agencies received nearly 2,200 public comments. Courts have interpreted the APA to require that agencies consider public comments with an “open mind” susceptible to persuasion, although this does not require an agency to actually change what has been proposed. Given the relatively lax legal standard for engaging with public comments, it seems clear that despite widespread opposition to several key changes that have been proposed to the Common Rule, the agencies are free to finalize the rule essentially as set forth in the NPRM. In our view, this would be an extremely worrisome outcome, but one offering little to no legal recourse—and given the pace of change to the Common Rule over the past several decades, not one likely to be corrected any time soon.
Keywords: Common Rule, Federal Policy for the Protection of Human Subjects, Notice of Proposed Rule Making (NPRM)
In July 2011, the Department of Health and Human Services (HHS) published in the Federal Register an “Advanced Notice of Proposed Rule Making” (ANPRM)1 to begin the first public discussion in decades about amending the Federal Policy for the Protection of Human Subjects, also known as the “Common Rule.”2 The ANPRM listed a range of possible reforms, from altering the regulatory structure for research with biospecimens to mandating use of a single institutional review board for multisite domestic studies. Over 1,100 public comments were submitted, some expressing support, some concern, and some alternatives for the federal agencies proposing the rule change to consider.3 Four years later, in September 2015, HHS along with several other federal agencies issued a “Notice of Proposed Rule Making” (NPRM),4 the second step in the process toward revising the Common Rule. This time, the agencies received nearly 2,200 public comments. Analyses of these comments reveal vastly differing opinions about the proposed changes,5 with many voicing overwhelming opposition to specific provisions and one national committee even calling for the proposed rule to be withdrawn.6 The research community now waits in limbo as the agencies analyze the comments and other factors and decide whether or not to issue a final rule. Because they failed to act before the 2016 presidential election, what the outcome will be is now even less certain.
Uncertainty around the change in administration aside, do the public comments provide any insight as to what to expect from a final rule? Not necessarily. While those who offer comments in response to the agencies’ call for input presumably do so with the expectation that they will affect the final outcome, rulemaking is decidedly different from a public referendum, and the agencies have substantial discretion to proceed as they see fit.
Legal Standards for Federal Rulemaking
At the federal level, development of regulations is governed by the Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies to develop rules with the force of law, under a process called “notice and comment rulemaking.”7 The APA requires publication of an NPRM in the Federal Register, with an explanation of the agency’s plan and rationale, proposed regulatory text for consideration, and notice of the opportunity to submit comments. Courts have interpreted the APA to require that agencies consider public comments with an “open mind” susceptible to persuasion, although this does not require an agency to actually change what has been proposed. Indeed, public comments are only one piece of the agency’s decision-making process, to be considered in concert with expert opinion, facts, and accumulated data from a variety of sources.
In order to proceed with a final rule, an agency must conclude that its proposed solution will help accomplish the goals identified; of course, this is possible even if many public commenters disagree. If an agency determines that commenters have raised critical new points, or if additional consideration is needed, it may publish a new proposed rule instead of moving to finalization, or it may terminate the rulemaking process altogether. However, an agency is also free to make changes to the proposed rule prior to issuing a final rule and without issuing a new NPRM, so long as those changes reflect a “logical outgrowth” of what was previously presented. Thus, it would be premature for any regulated community to take steps to implement a proposed rule prior to finalization.
If and when a final rule is published, it must be accompanied by a “preamble” in which the agency must describe the basis and purpose of the rule and provide the facts and data relied upon, concise and general responses to major criticisms raised by commenters, and the rationale for not selecting alternative approaches. In other words, the agency must provide evidence of consideration of significant, relevant public comments, but is not required to provide an exhaustive explanation of its reasoning for adopting a rule.
Should an agency’s final rule be challenged in court, it generally will be upheld so long as it is not “arbitrary, capricious, an abuse of [an agency’s] discretion, or otherwise not in accordance with law.”8 From a legal standpoint, this is a very low threshold. Agencies need not prove that their approach is empirically superior to the status quo or supported by robust—or any—data. Notably, the mere existence of plentiful public comments opposed to a rule is not sufficient evidence that the rule is arbitrary or capricious. Instead, an agency may simply disagree with the comments in opposition, so long as it can reasonably articulate the basis for doing so. In particular, it may be expected that many public comments on any proposed rule will be in opposition, since it is likely that stakeholders who stand to be aggrieved will have greater motivation to submit comments than those who find the change agreeable. Moreover, an agency may have reason to protect a minority viewpoint or interests against those of a more vocal majority.
So, is notice-and-comment rulemaking a sham—a process that makes the public feel engaged but that, in reality, simply allows them to be ignored? Not quite. Although an agency may ultimately decide to disagree with those in opposition to its proposals, it cannot ignore them completely. The process does require engagement with alternative perspectives, which may at the very least provoke a more refined explanation of the agency’s goals and approach, and clarified understanding of why various alternatives are not preferred. Not everyone will be satisfied, but that is no less true of other types of lawmaking.
What Does This Mean for the Common Rule?
Given the relatively lax legal standard for engaging with public comments, it seems clear that despite widespread opposition to several key changes that have been proposed to the Common Rule, the agencies are free to finalize the rule essentially as set forth in the NPRM. In our view, this would be an extremely worrisome outcome, but one offering little to no legal recourse—and given the pace of change to the Common Rule over the past several decades, not one likely to be corrected any time soon.
To be fair, as evidenced by extensive categorization and analysis of the comments received (e.g., by type of commenter, which proposals were discussed, the extent of opposition or support, and alternatives offered),9 the federal agencies that have adopted the Common Rule are clearly doing more than paying lip service to the notice-and-comment process. However, the agencies have not articulated any principle(s) on which to determine whether a given comment is convincing enough to demand change to the approaches set forth in the NPRM. One would hope that they would give substantial weight to input by expert stakeholders, those offering empirical evidence about the likely effects of implementing the proposed changes, and those offering well-reasoned arguments for why the proposed changes may fail to achieve the agencies’ stated goals. But in an area where there is reasonable conceptual disagreement about the rights and interests of research participants and what would be most beneficial to the future of research itself, the federal agencies have substantial discretion to do what they think best. The regulated community, prospective and actual research participants, and the public in general should continue to engage with regulatory agencies about the nature and scope of human subjects protections—but as any administrative lawyer would warn, be prepared for disappointment in the final rule, if one is indeed issued.
Holly Fernandez Lynch, JD, M.Bioethics, 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; I. Glenn Cohen, JD, is a professor at Harvard Law School and the faculty director of the Petrie-Flom Center; and Barbara E. Bierer, MD, 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.
The views expressed in this essay represent those of the individual authors and should not be attributed to any organization with which the authors are affiliated. All three authors are affiliated with Harvard Catalyst, Harvard’s Clinical and Translational Sciences Center. Holly Fernandez Lynch is a member of the Secretary’s Advisory Committee for Human Research Protections (SACHRP), U.S. Department of Health and Human Services. Barbara E. Bierer is former chair of SACHRP (2008-2012) 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 Medicine’s Committee on Science, Technology, and Law. Each of these institutions has made or endorsed comments critical of the proposed changes to the Common Rule.
- Department of Health and Human Services. Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Advance notice of proposed rule making. Federal Register 2011;76(143):44512-44531. https://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.
- Department of Health and Human Services. Protection of Human Subjects. Subpart A. Basic HHS Policy for Protection of Human Research Subjects, 45 CFR 46.
- Department of Health and Human Services, Office for Human Research Protections. How to read ANPRM comments July 2011. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/how-to-read-anprm-comments/index.html.
- Department of Health and Human Services. Notice of Proposed Rulemaking. Federal Policy for the Protection of Human Subjects. Federal Register 2015;80(173):53933-54061.
- Council on Governmental Relations and Association of Public and Land-Grant Universities. Analysis of public comments on the Common Rule NPRM. https://www.cogr.edu/Human-Subjects-and-Animal-Research.
- National Academies of Sciences, Engineering, and Medicine. Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press, 2016. https://www.nap.edu/catalog/21824/optimizing-the-nations-investment-in-academic-research-a-new-regulatory.
- Administrative Procedure Act, 5 USC § 553. See, generally, Office of the Federal Register. A Guide to the Rulemaking Process. https://www.federalregister.gov/uploads/2011/01/the_rulemaking_process.pdf.
- See ref. 7, 5 USC at § 706.
- Hartsmith L, Office for Human Research Protections, Department of Health and Human Services. NPRM Update: Summary of Public Comments. Presentation to the public meeting of the Secretary’s Advisory Committee on Human Research Protections.May 2016.