Rescinding of Public Comments; Certificates of Confidentiality - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.

Topic 1: 

Trump Administration Changes to Notice and Comment Rulemaking at the U.S. Department of Health and Human Services

The notice-and-comment rulemaking process is a cornerstone of U.S. administrative law under the Administrative Procedure Act (APA).  The APA, however, exempts from notice-and-comment rulemaking certain regulations that pertain to “agency management or personnel or to public property, loans, grants, benefits, or contracts.”  The APA also contains a “good cause” exception that permits rulemaking to occur absent notice and comment in certain situations.  In 1970, the U.S. Department of Health and Human Services adopted a policy through memorandum referred to as the “Richardson Waiver” that required HHS as a matter of policy to follow voluntarily the notice-and-comment requirements of the APA even in cases in which the subject matter of the rule could fall within an APA exception.  HHS Secretary Robert F. Kennedy rescinded the Richardson Waiver in March 2025. 

This session will explore the history of the Richardson Waiver and what its rescission means for future rulemaking by HHS, including a discussion of which types of rules may fall within one of the APA exceptions.

Topic 2:

Certificates of Confidentiality:  Background and Practical Implications

Certificates of Confidentiality are a tool created by Congress that prevent the disclosure of research records and biospecimens containing identifiable, sensitive information except when certain conditions set forth in statute are satisfied.  Notably, CoCs prevent the disclosure of such research records and biospecimens in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding.  CoCs are issued automatically for all National Institutes of Health-supported research and must be issued by the U.S. Department of Health and Human Services (HHS) for other federal government-funded research.   CoCs can also be applied for by persons conducting privately-funded research and in such cases can be issued by HHS on a discretionary basis.  

In this session we will explore the history of CoCs, the contours of the protections offered by CoCs, and certain unanswered questions that remain regarding the extent to which law enforcement and courts will respect the protections offered by CoCs.  

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For more information, please email at MRCT@BWH.HARVARD.EDU

Deliverables