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I would like to share my take on potential implications HHS rescinding public participation on rule making. As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
Let’s get started!
Revocation of Public Participation on Rule Making
The following rule entitled “Policy on Adhering to the Text of the Administrative Procedure Act” was posted on March 3, 2025. Per the Federal Register (2025-03300 (90 FR 11029)):
The Department of Health and Human Services’ Immediate Office of the Secretary is rescinding the policy on Public Participation in Rule Making (Richardson Waiver) and re-aligning the Department’s rule-making procedures with the Administrative Procedure Act (APA).
If you’d like to read about the Administrative Procedure Act, I strongly urge you to read this post: Federal Guidance Repository: Offset to Trumpโs EOs
What is the Richardson Waiver?
Per the Federal Register (36 FR 2532), the Richardson Waiver:
A policy that waived the APA’s statutory exemption from procedural rulemaking requirements for rules and regulations relating to public property, loans, grants, benefits, or contracts
This policy required HHS. to use the APA’s notice and comment rulemaking procedures for these types of matters. In plain English, this means that HHS no longer needs a โRequest for Commentโ from the public for proposed rules. Essentially, they will be able to follow the APAโs exemption of public comment due to โgood causeโ when the agency finds that the procedures are โimpracticable, unnecessary, or contrary to the public interest.โ 5 U.S.C. 553(b)(B). Further, the APA exempts from these requirements โmatter(s) relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.โ 5 U.S.C. 553(a)(2).
Potential Implications on HHS Recision
Letโs think about some of the agencies that fall under the HHS umbrella:
- Office of the Assistant Secretary for Health (OASH): This agency comprises of the Office of Human Research Protections (OHRP), which also consists of Secretaryโs Advisory Committee on Human Research Protections (SACHRP)
- The Food and Drug Administration (FDA) which ensures that food is safe, pure, and wholesome; human and animal drugs, biological products, and medical devices are safe and effective; and electronic products that emit radiation are safe
These are two critical agencies that protect human participants in research (e.g., clinical trials). They release guidance documents on how investigators should conduct research with human participants as well as considerations for specific research areas. Without the public comment requirement, HHS is potentially losing out on insights from industry folks and academia that are directly on the field conducting this critical research. Further, HHS will be forgoing essential feedback from folks who review research with human participants such as research compliance. Lastly, HHS will be losing out on folks who support these research endeavors (such as clinical research coordinators). Though this may feel like a time of uncertainty, all we can do as a community is to be vocal in avenues that we can be. We have to band together for the sake of safe and ethical human research.
I hope you found this post informative and useful!
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