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Holly Fernandez Lynch, I. Glenn Cohen & Barbara E. Bierer, Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule, 39 IRB: Ethics & Hum. Res. 17 (2017).

Abstract: 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.