Focus Area: Clinical Trials & Research

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.

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Topic:

In September 2023, the MRCT Center’s R3 forum devoted a session entirely to issues that arise when conducting research involving the PRC.  Since that time, there have been several developments that affect research with a nexus to the PRC.  These include updates to the PRC’s requirements for processing sensitive personal data in the context of clinical trials, scrutiny of arrangements involving the PRC from an export control perspective, the implementation of the DOJ’s Bulk Data Rule, and reliance by different components of the U.S. Department of Health and Human Services on Executive Order 14117 (which served as the basis for the DOJ Bulk Data Rule) to make policy announcements regarding research involving the PRC.  

This session of the MRCT R3 will explore these latest developments and discuss additional changes that may be on the horizon.  Speakers will include Ropes & Gray partners Katherine Wang, who routinely counsels life sciences clients on PRC laws and regulations, Brendan Hanifin, who advises companies on customs/export controls and CFIUS, and David Peloquin, who advises clients on a wide range of clinical research and data protection matters.  

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

Deliverables

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

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.

Abstract: Congressional Investigations into Research Activities

In recent years, congressional investigations of biopharma companies, research institutions, and universities have frequently involved issues related to clinical research. We anticipate this trend to continue or even accelerate under the new Congress. During this session, we will begin with an overview of congressional investigations, including: (1) Congress’s authority to investigate; (2) the types of information requests that Congress sends private parties; and (3) the mechanics of congressional hearings. We will then provide key takeaways from recent congressional investigations involving clinical research and predict areas of focus in the coming years, taking into account recent actions of the Trump Administration. We will end with a discussion of the various risks of such investigations and provide best practices to mitigate such risk and effectively respond to investigations. Amish Shah, counsel at Ropes & Gray and former Senior Associate White House Counsel and congressional investigator, will lead the session.

Update on DOJ’s Restrictions on Sharing Bulk Sensitive Personal Data with China and Other Countries of Concern

On January 8, 2025, the U.S. Department of Justice published in the Federal Register a Final Rule entitled “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons.” Most provisions of the Final Rule will take effect on April 8, 2025, unless delayed by the administration of President Trump. The Final Rule imposes sweeping restrictions on providing access to health data, biometric data, human ‘omic data and biospecimens from which such data may be derived, as well as other categories of sensitive personal data, to the People’s Republic of China, certain other “countries of concern,” and “covered persons” that have ties to those countries. Notably, the Final Rule does not exempt de-identified, pseudonymized or anonymized data except in limited circumstances. During this session we will provide an overview of the Final Rule’s likely effect on research activities, including a discussion of the Rule’s research exemptions.

CLE credits will be available.

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

Deliverables