Common Rule Revisions: Impact of Public Comment, and What’s Next? image

The Hastings Center Blog, February 8, 2017
By Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director) and Barbara E. Bierer

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From the blog post:

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stemming from 2,186 public comments, many of which opposed the rule, alongside calls for the proposed rule to be withdrawn, was only exacerbated by the historic upset of the presidential election, the subsequent lame duck period, and rumors that the regulatory agencies planned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. [...]

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bioethics fda health law policy holly fernandez lynch human subjects research i. glenn cohen regulation research