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Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

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.

R3 meetings are open to organizations that sponsor R3. Each R3 meeting focuses on one or two timely discussion topics related to the domestic and global impact of new legislation, regulations, guidance, and policies on research community stakeholders. At the end of each R3 meeting, we will consider whether the topic warrants further discussion or development as a publication, position paper, case study analysis, or commentary. In order to promote open dialogue, the meetings are run by ‘Chatham House Rule,’ by which commentary will not be attributed to any individual nor to their institutional affiliation.

The MRCT Center and Ropes & Gray LLP are grateful to the following R3 sponsors:

• Advarra
• Amgen
• Dana-Farber Cancer Institute
• Eli Lilly and Co.
• Genentech, Inc.
• International Society for Biological and Environmental Repositories
• Johnson & Johnson
• Mayo Clinic
• Merck, known as MSD outside of U.S. and Canada
• Sanofi
• Takeda Pharmaceuticals International, Inc.
• Vertex
• Washington University in St. Louis
• WCG IRB

Objectives:

• Facilitate open and collaborative discussion of non-proprietary issues in research and development
• Promote a deeper understanding of the laws and regulations governing therapeutic innovation, product approval, and the protection of human research participants on the global stage

Please contact mrct@bwh.harvard.edu if you are interested in sponsoring the R3.

Upcoming:

See our Events page.

Key Milestones:

Date and Topic	Topic Summary	Meeting Information
Dec 2022, The Impact of International Privacy Laws on Research	In an increasingly connected world, clinical trials and other research activities are no longer state- or country-specific. Not surprisingly, the globalization of research activities creates any number of legal and compliance challenges for stakeholders involved in the development, authorization, and commercialization of medicinal products, including under data privacy regulations that continue to evolve. This hybrid meeting addressed some of the most pressing of these challenges. We addressed issues that go to the heart of the General Data Protection Regulation (“GDPR”) of the European Union (“EU”), such as what constitutes a restricted international data transfer, the appropriate lawful basis to legitimize the processing of personal data in the context of clinical trials and secondary research, and the designations of parties participating in research as controllers and processors. We also discussed potential solutions to problems that continue to challenge the research community. The research community has been awaiting further guidance on the topic of the GDPR and research from the European Data Protection Board (“EDPB”) for several years. The research community must thus navigate several complex issues in the absence of relevant regulatory guidance. This meeting consisted of a series of panels made up of experts from the life sciences industry, government, and academia to address key challenges faced by the research sector under the GDPR and data privacy regulations in other geographies, including the Personal Information Protection Law of the People’s Republic of China (“PIPL”).	Meeting
Sept 2022, Part 1: Legal and Regulatory Perspectives on For-Profit Research Sites	The core activities of clinical trials are typically conducted at physical locations referred to as “sites.” Traditionally, these sites are hospitals or academic medical centers. While these traditional sites remain important fixtures in the clinical trial landscape, new models including “decentralized” or even “site-less” clinical trials have emerged. David Peloquin, MRCT Center Senior Advisor and Partner at Ropes & Gray LLP, provided an overview of the clinical trial site landscape and how it has changed over time, with a particular focus on the emergence of stand-alone sites, as such sites present unique regulatory issues. He then provided several examples of these stand-alone sites and presented a handful of recent regulatory enforcement cases before moving into a discussion of the relevant legal risks and considerations.	Meeting
Sept 2022, Part II: The Regulation of Research Involving Cannabis	As more states move to legalize marijuana, the regulatory landscape is becoming increasingly complex. The number of sponsors and researchers inquiring about these regulations has also increased. Clinical research involving cannabis is subject to both federal and state regulations. Key regulatory frameworks include DEA regulations on the use of controlled substances in research studies, FDA IND regulations, and state law. Proposed federal legislation may also affect the conduct of research involving cannabis. David Peloquin, MRCT Center Senior Advisor and Partner at Ropes & Gray LLP, provided an overview of DEA and FDA regulations relating to research involving cannabis, reviewed recent legislative developments, and discussed state-level policies and challenges using New York state as an example.	Meeting
June 2022: Recent Developments in the Trans-Atlantic Processing and Shipment of Personal Data for Research Purposes	The European Union (“EU”) General Data Protection Regulation (“GDPR”) and its effect on research activities was the first topic addressed by the R3 at its initial meetings in 2018. In the four years since those meetings, there have been many developments that have continued to cause complications for trans-Atlantic research. These have included, among others, the invalidation of the EU-U.S. Privacy Shield in June 2020 by the Schrems II decision, Brexit, the release in 2021 of new Standard Contractual Clauses by the European Commission, and the introduction of data transfer impact assessments as a prerequisite for many cross-border transfers of personal data. On March 25, 2022, the European Commission and the United States announced that they have agreed in principle on a new Trans-Atlantic Data Privacy Framework, intended to foster trans-Atlantic data flows and address the concerns raised by the Court of Justice of the European Union in the Schrems II decision. The discussion at the convened R3 considered these recent developments and identified potential solutions to ease trans-Atlantic research while complying with GDPR.	Meeting
March 2022: "Investigator" Designation and "Engagement" Status in Decentralized Clinical Research	Research that is executed in part or in whole through remote modalities, such as telemedicine and health care providers who visit participant homes, is increasingly commonplace yet complicated. Decentralized research raises novel questions regarding whether and which institutions are engaged in research under the Common Rule and who is a subinvestigator according to United States Food and Drug Administration (FDA) regulations. Mark Barnes, MRCT Center Faculty Director, overviewed the concept of engagement in research subject to the Common Rule and proposed a model to redefine the concept of engagement. David Peloquin, MRCT Center Senior Advisor, overviewed the investigator and subinvestigator designations in research subject to FDA regulations.	Meeting
November 2021, Part I: The Regulation of Digital Health Tools and Software as a Medical Device	In recent years, FDA has increasingly focused on honing its approach to regulating digital health tools and technologies, including those used in the research setting. This presentation focused on the Agency’s risk-based approach to regulation in the digital health space, with a focus on when clinical decision support and artificial intelligence/machine learning software may be considered a medical device subject to FDA regulation.	Meeting
November 2021, Part II: Update on the Application of the European Union’s General Data Protection Regulation (GDPR) to Research	In the past 18 months there have been several important developments related to the GDPR, including the Schrems II decision, the resulting European Data Protection Board guidance on cross-border data transfers, and the issuance of revised Standard Contractual Clauses. This presentation addressed how each of these items affects researchers.	Meeting
September 2021, Part I: Legal and Regulatory Challenges with Diagnostic Tests in the United States (US), including Laboratory Developed Tests (LDTs)	Meeting attendees overviewed and discussed the history of LDT regulation, shifting approaches to LDT regulation before and during the COVID-19 pandemic, strategies for navigating LDT regulation, and the relevance of FDA’s investigational device exemption framework to the regulation of LDTs.	Meeting
September 2021, Part II: The Impact of Emerging US State Privacy Laws on Research	Some state privacy laws apply to specific types of data that might be used in research. Other state privacy laws, sometimes referred to as omnibus privacy laws, regulate the collection and use of personal data throughout the economy. Meeting attendees reviewed and discussed both types of laws in several states, including their applicability to organizations involved in research, exemptions for research activities, and overall impact on research.	Meeting
May 2021, Part I: Direct Interactions Between Sponsors and Research Participants: A Legal Perspective	There has been an increase in sustained interactions between sponsors of clinical research or their designees and potential and enrolled study participants and their families. Sponsor interactions with study participants and their families raise certain legal and regulatory concerns when sponsors perform the functions of investigators, such as taking medical histories or securing records from third-party health care providers, or when interactions contribute to inaccurate participant perceptions regarding who is responsible for their participation in a study, among other things.	Meeting
May 2021, Part II: Rethinking the Workforce for Decentralized Clinical Trials: Who is Engaged and Regulatory Requirements	Decentralized clinical trials (DCTs) are clinical trials that are executed in part or in whole through remote modalities, such as telemedicine, smart phone applications, and health care providers who visit participant homes. Vendors engaged in DCTs may be subject to unfamiliar compliance and regulatory obligations, such as those set forth by the Common Rule or the FDA. Common Rule obligations extend beyond federally funded research if the site’s internal policy or state law require compliance with the Common Rule regardless of the funding source for the study. Part II of the meeting drew from both OHRP and FDA requirements to determine the regulatory requirements for a third-party partner who provides services in connection with a research protocol.	Meeting
March 2021: Communicating with National Regulatory Authorities Regarding Research Misconduct	Research misconduct allegations may trigger reporting obligations to domestic and international funding agencies, health regulatory authorities, and others. R3 attendees, which included representatives from U.S. funding and regulatory agencies, academia, and biopharmaceutical companies, discussed the challenges of varying reporting requirements, including timing, content, and need for confidentiality. Attendees clarified the different responsibilities of the different entities during investigations into research misconduct and identified strategies and solutions to mitigate these challenges.	Meeting
January 2021: Communicating with Journal Editors and Publishers Regarding Research Misconduct	Communication between journals, publishers, and institutions on questions of research misconduct is often lacking due to several reasons, including the speed with which journals seek to resolve these questions and institutional hesitancy to breach the confidentiality of an investigation into research misconduct. Representatives of academic journals, journal publishers, and institutions gained an appreciation for how the other parties manage questions of research misconduct and identified strategies to facilitate increased collaboration and communication between journals and institutions.	Meeting
November 2020: Legal Perspectives on Research Misconduct in Academia and Industry	Attendees discussed the most vexing problems in complex research misconduct cases, especially those that lie at the intersection of industry and academia. For example, how should an academic institution investigate research misconduct allegations in research collaborations between in-house industry labs/scientists and academic investigators? What are the attendant liability risks for informing or not informing the successor employer of a scientist who has been found to have engaged in research misconduct?	Meeting
Jul 2020, Part I: Foreign Influence in Clinical Research	Attendees learned about the NIH and DoD investigations into foreign influence in clinical research and discussed how research activities within academia and industry may have to adapt to accommodate the government's concerns.	Meeting
Jul 2020, Part II: Impact of Fraud and Abuse Laws on Clinical Research	Attendees learned about the impact of fraud and abuse laws on clinical research, overviewing research situations that may violate these laws and discussing how these laws relate to recruitment, compensation, and financial aid for research participants.	Meeting
Jul 2020, Part III: Legal and Regulatory Issues Related to COVID-19 in Human Subjects Research	Meeting attendees discussed the clinical research regulatory landscape during the COVID-19 pandemic, identifying areas that could be improved upon to foster less burdensome and higher-quality research.	Meeting
Nov 2019, Part I: Regulatory Challenges for Decentralized Clinical Trials	Attendees identified the potential benefits of decentralized clinical trials before reviewing the regulatory challenges. These challenges often stem from long-standing regulations that vary across state and national borders and are often incongruent with virtual care and research.	Meeting
Nov 2019, Part II: Revised Common Rule and Single IRB (sIRB) Questions	Attendees focused on regulatory ambiguities surrounding sIRB usage as research enterprises prepare to transition to full compliance with the Revised Common Rule. Attendees also addressed interpretations of the phrase 'key information' and examined how much authority an IRB retains after designating research for limited review.	Meeting
Aug 2019, Part I: Exporting from China for Research: Biospecimens, DNA, and Data	Participants reviewed updates to China’s Human Genetic Resources (HGR) regulation and discussed how the changes will alter work with Chinese biospecimens and biospecimen data. The HGR updates were contextualized within China’s broader evolving legislation that aims to protect national security by protecting data.	Fourth Meeting
Aug 2019, Part II: Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and Students in Research Studies	Attendees identified the ethical concerns with an institution conducting research on its own employees or students- undue influence, coercion, and risk to privacy. Relevant legislation was introduced, and participants were provided with a set of recommendations for conducting this type of ethically complex research.	Fourth Meeting
Mar 2019, Secondary Uses of Health Care Data for Clinical Recruitment: Legal and Regulatory Ambiguities	The use for clinical trial recruitment purposes of data that were originally collected for another business purpose raises several legal and regulatory questions, including whether the companies have authority to use healthcare data for these secondary purposes; whether health care providers may receive payment for permitting secondary uses of their data or for the results of these secondary uses; the extent to which third-party payors, or agents of those payors, may be involved in research recruitment; and which contact patients directly to discuss possible enrollment in a clinical trial. During this session, we discussed each of these issues from a legal and regulatory perspective, noting the many issues for which there is legal ambiguity.	Third Meeting
Nov 2018, Expanded Access: Practical, Legal, and Regulatory Considerations	Attendees discussed the advantages and drawbacks of the two pathways by which patients may now request access to investigational therapies. Among other things, we considered the impact of each avenue on long-term drug development, the resources necessary for handling requests in a timely and consistent manner, and the optimal contents of organizational policies, considering the perspectives of both pharmaceutical companies and large academic healthcare facilities.	Second Meeting
Jul 2018, Application of General Data Protection Regulations to Research: Legal, Practical, and Strategic Implications	Convening representatives from academia, industry, and government, this conference explored the impact of the EU GDPR on human subjects research, highlighting the challenges posed by the GDPR to clinical research, biobanking and databanking, and big data research, particularly in light of the limited guidance available to date from EU and EU member state authorities.	Initiated workgroup to draft a Code of Conduct for the EU GDPR Inaugural Meeting

Project Leadership:

• Mark Barnes, JD, LLM, Faculty Co-Director, MRCT Center
• Barbara E. Bierer, MD, Faculty Director, MRCT Center
• Sarah Evenson, MBE, Project Manager
• David Peloquin, JD, Senior Advisor, MRCT Center

 Contact information:  sevenson@bwh.harvard.edu