This meeting was presented to the Bioethics Collaborative. The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials. Meetings convene individuals from academia, industry, patient/participant groups, ethics committees, government, and others.
Abstract: The lines between research and care continue to blur. Pragmatic research studies comparing accepted therapies are increasingly embedded seamlessly into clinical practice. More and more, participation in research deemed promising is offered to patients before standard therapies are exhausted, sometimes as a first-line option. While the concept of “therapeutic misconception”—in very broad strokes, the tendency for individuals to misapply attributes of clinical care to research—has been a mainstay of research ethics for over 40 years, these developments provide an occasion, and perhaps even an urgent need, to revisit it and related topics. How exactly should we understand the therapeutic misconception and what it involves, particularly in cases where the line between research and care really is vague and hard to determine? Even more basically, how should we understand the relationship between research and care in the first place? Are concerns over therapeutic misconception still important, or do they perhaps reflect naïve understandings of research and care and the relation between them–particularly in cases where current options are limited?
Topic: Digital Doppelgängers: Ethics of Digital Twins and Synthetic Data
Abstract: Clinical trial design, conduct, and analysis are benefiting from the increased use of AI, rendering it essential to address the ethical considerations that arise when new (or newer) modalities are introduced. In the last few years, AI-enabled synthetic data, retaining the characteristics of original individual-level datasets but containing no actual personal health information, has been used to conduct preliminary hypothesis generation and testing, to model eligibility criteria, and to overcome privacy concerns, particularly in rare disease research. Digital twins are AI-generated models of individual patients that simulate disease progression and treatment response, updated dynamically with real or inferred data from the physical (actual) twin. They have been used for predictive modeling and to modify trial design, the number of enrollees, and/or power calculations, increasing efficiency. They can be used prospectively (e.g., augmenting control arms) or for decision support. In both synthetic data and digital twin settings, key ethical questions arise, but each operates at a different level of abstraction.
Synthetic data are artificially generated datasets created to mimic the characteristics and distributions of patient populations statistically, but they do not correspond to identifiable individuals. Synthetic data can be used, for example, to train generative AI, minimizing privacy concerns early in AI development, and/or for trial simulation. Synthetic data, however, do not support inference at the individual level. The utility of synthetic data depends on the dataset from which it was generated; assessing bias in the source dataset is important but challenging in practice. In ultrarare diseases, for example, sufficient and representative data may not even be available. As a dataset becomes more limited and fails to capture the diversity of the patient population (as in rare and ultrarare diseases), the less generalizable its derivatives and outputs. Does the use of synthetic data reproduce and embed bias and perpetuate health inequalities? How certain are we that synthetic data are – and remain – anonymous?
In contrast, digital twins are constructed from individual participant data, are “personalized,” and acquire, ingest, and use real-time data to refine and update their attributes over time. Do participants have an implicit right to or expectation of consent to the use of their data for the construction of “their” digital twin? Does the creation of a digital twin increase the risk of reidentification and downstream privacy harms? What are the responsibilities for protecting the digital twin data, and the range of permissible future uses of digital twin data? For example, developing a digital twin may yield diagnostic, therapeutic, or other useful information about a person’s future health. Should that be disclosed or communicated? What degree of certainty is necessary for that disclosure to be warranted or permissible? Do the considerations or processes of ethics review bodies need to evolve for the review of protocols involving digital twins or synthetic data, or should additional protections be considered, as a condition of approval?
In clinical research, there is an expectation that the data that inform a trial’s results will be available for independent reanalysis and validation of the results, and to facilitate discovery. The future use of synthetic data and digital twin data, however, is complicated. At a minimum, the synthetic data represents a stable dataset that can benefit from a persistent data object identifier. But does the metadata always reflect that the dataset is derived, and should the original training dataset be available for query, reintroducing privacy risks? Digital twin data, however, is consistently updated based on the acquisition of dynamic, real-world data. How will that be reflected in the trial data? Should the original informed consent include permission for its potential secondary use, particularly as more mature digital twin data becomes increasingly identifiable?
This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Clinical trials are vital to advancing medical knowledge and care, yet participation can impose significant financial burdens on participants and their families—from travel and time away from work to uncovered medical and ancillary expenses.
This webinar examined the sources and impact of these costs and highlighted emerging strategies to reduce financial hardship for research volunteers. Presenters also introduced tools, checklists, and other resources developed through the EACT Project, a collaborative forum advancing financial neutrality in clinical research participation.
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.
Our international team of investigators, educators, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.
Join us on June 22, 2026, 9:00-11:00 AM ET for the Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting. This meeting will focus on two recent proposed revisions to the JTF Framework: the JTF-Patient Partner Project and an update to Domain 6. We will hear about the proposed updates, discuss them with users of the JTF Framework, and gather input on any further updates needed.
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.
Topic: Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues (continued). This is the continuation of a discussion first introduced at the April 9, 2026 R3 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 and select guests of the Research, Development, and Regulatory Roundtable.
Topic: Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues
Carolyn Chapman, Mena Shaikh, Ava Glazier, Andrew Creamer, and Barbara Bierer published Ethical, Legal, and Social Issues (ELSI) in Human Somatic Gene Therapy Clinical Research: A Scoping Review in Human Gene Therapy. Dozens of gene therapies have been approved, and hundreds more are in development, prompting the need to better characterize the ethical, legal, and social implications (ELSI) of this emerging therapeutic class. The authors conducted a scoping review to map these issues across the literature, identifying themes related to risk–benefit assessment, engagement and communication, justice and access, ethical trial design, and the influence of financial and regulatory decision-making. The article also discusses potential approaches to address these ELSI as gene-therapy research expands.
