See All Projects

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

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

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

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

R3 meetings are open to organizations that sponsor R3. During the COVID-19 pandemic, R3 meetings have temporarily transitioned to a virtual format and the frequency of meetings has increased to five per year. 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. R3 meetings are open to organizations that sponsor the R3. Please contact mrct@bwh.harvard.edu if you are interested in sponsoring the R3.

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

  • Advarra
  • Dana-Farber Cancer Institute
  • Genentech, Inc.
  • International Society for Biological and Environmental Repositories
  • Johnson & Johnson
  • Merck & Co., Inc.
  • Sanofi
  • Takeda Pharmaceuticals International, Inc.
  • Washington University in St. Louis

Current status: Active

Impact: Non-partisan forum for discussing the impact of laws, regulations, policies, and guidance on drug and device development and regulatory oversight of clinical trials

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 TopicTopic SummaryMeeting Information
March 2021: Communicating with National Regulatory Authorities Regarding Research MisconductResearch 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 MisconductCommunication 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 IndustryAttendees 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 ResearchAttendees 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 ResearchAttendees 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 ResearchMeeting 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 TrialsAttendees 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) QuestionsAttendees 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
  • Walker Morrell, BSc, Project Manager

 Contact information:  wmorrell@bwh.harvard.edu