Details: The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.
The public is invited to attend virtual biannual meetings, which happen twice a year.
Key topics discussed at this meeting:
Integrating JTF Framework into Takeda’s R&D’s Knowledge Development Academy (KDA)
Update on Translations
JTF Competency Survey in Low and Middle Income Countries: Initial Analysis of Results
Clinical Research Core Competencies: An Adaptation of the JTF Framework to Switzerland
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) Executive Order on Increasing Medical Marijuana and Cannabidiol Research; (3) 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.
Executive Order on Increasing Medical Marijuana and Cannabidiol Research. On December 18, 2025, President Donald Trump signed an executive order that may breathe new life into efforts to move marijuana to a less restrictive schedule under the Controlled Substances Act (“CSA”). Executive Order 14370, entitled “Increasing Medical Marijuana and Cannabidiol Research” (the “EO”), recognizes that marijuana’s historical position in schedule I—the most restrictive of the CSA’s schedules—has hampered research, and it urges the Attorney General to complete the ongoing rulemaking process to move marijuana to schedule III. The EO also directs further action by the administration to facilitate medical research and improve access to certain hemp products. We will discuss the specifics of the Executive Order and what it may mean for researchers conducting research on marijuana and cannabidiol products. The discussion will be led by Ropes & Gray partners Josh Oyster and David Peloquin, who co-authored a short alert on the topic earlier this year.
The Declaration of Taipeiis an ethical guideline by the World Medical Association (WMA) and was 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.
The Principles of Post-Trial Responsibilities: Continued Access to an Investigational Product are 12 principles that guide the shared responsibilities and actions to provide continued access to an investigational product at the conclusion of a patient’s participation in a clinical trial. The principles, accompanied by an analysis, should be read as a whole.
The principles are designed to be used in coordination with the Framework of Responsibilities (Medicines) and (Devices), a framework of milestones, specific scenarios, and considerations that organizations can utilize to make equitable and fair decisions related to continued access to an investigational product.
To celebrate Health Literacy Month, the MRCT Center presented three engaging and informative webinars to provide practical tools and discussions to incorporate health literacy and accessibility best practices into communicating participant-facing clinical research information.
