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.
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.
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.
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.
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.
Topics: (1) The HALT Fentanyl Act and its effect on research involving controlled substances; (2) Declaration of Taipei
HALT Fentanyl Act and Research. On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances Act (“CSA”), and much of the political commentary and media attention related to the legislation have focused on this specific provision and its potential impact on the nation’s fentanyl crisis. However, the HALT Fentanyl Act also contains numerous significant reforms related to research activities with controlled substances, including provisions streamlining the process for conducting research with any Schedule I controlled substance. We will discuss takeaways from the HALT Fentanyl Act that drug developers, academic medical centers, research institutions, and others involved in nonclinical or clinical research with controlled substances should consider for their ongoing and future research activities.
The Declaration of Taipei, an ethical guideline by the World Medical Association (WMA) and adopted in 2016, for the collection, storage, and use of health data, biological materials, and health databases and biobanks. A meeting is taking place in December 2025 in Taipei, Taiwan, to discuss revisions to the Declaration of Taipei. Barbara Bierer is attending this meeting and will lead a discussion of key changes to the Declaration that were discussed at the meeting.
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:
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.
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.
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.
Recent Developments in FDA Guidance on Real World Evidence
Subject-Directed Recruitment Materials and Testimonials
Abstract: Real World Evidence and Emerging Trends in Clinical Trial Subject Recruitment
Real World Evidence
In recent years, real-world evidence (“RWE”) has increasingly been incorporated into product development programs, spurred by greater access to RWE, legislative changes, and significant policy development at FDA. The use of RWE raises novel opportunities, as well as new challenges for regulators, clinical trial sponsors, and the life sciences and healthcare industry to set common standards for RWE to ensure it can be relied upon with confidence in regulatory decision-making.
During 2023, FDA released two draft and three final guidance documents concerning RWE. These included the following:
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (Draft, February 2023)
Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (Final, August 2023)
Use of Real-World Evidence to Support Regulatory Decision-Marking for Medical Devices (Draft, December 2023)
Data Standards for Drug and Biological Product Submissions Containing Real World Data (Final, December 2023)
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (Final, December 2023)
This session will provide an overview of key concepts from these guidance documents, focusing in particular on how they intersect with FDA’s existing regulations on clinical investigations and how they may change the regulatory landscape. In addition to focusing on these recent FDA guidance documents, the speakers will address the application of other U.S. regulatory regimes to RWE activities, including the Common Rule, the Information Blocking Rule, and HIPAA and other data privacy laws.
Clinical Trial Subject Recruitment Trends
Clinical trial sponsors are increasingly exploring different techniques to attract potential subjects to clinical trials, particularly in the context of rare disease studies for which subjects may be difficult to find. These techniques have included the following:
Use of testimonials featuring active clinical trial subjects in clinical trial advertisements
Inclusion of detailed scientific information gathered in pre-clinical or Phase 1 studies in subject-directed recruitment materials
Partnerships with electronic health record vendors to identify potential trial sites or subjects
Each of these techniques raise novel regulatory questions, including concerns about pre-approval promotion, data bias, need for institutional review board review and approval, and data privacy.
This session will analyze these trends and the attendant regulatory considerations for each.
Description: The FDA has recently issued several guidance documents as part of the Agency’s ongoing efforts to modernize its policies for the conduct of clinical trials. These include:
A final guidance on “Conducting Clinical Trials With Decentralized Elements” (the “DCT Final Guidance”);
A draft guidance on “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (the “DAP Draft Guidance”).
During this R3 session, we will provide an overview of each of these guidance documents, discuss thematic intersections between them, and address practical implications for study sponsors, investigators and sites. With respect to the DCT Final Guidance, we will also look at how the final guidance addressed the MRCT Center’s extensive comments on the draft guidance.
This meeting is open to sponsors of the Research, Development, & Regulatory Roundtable. To learn about how to become a sponsor, please contact us at mrct@bwh.harvard.edu
