Lecture: Ethical Issues in Decentralised Clinical Trials

This lecture is co-sponsored by the Research Ethics Consultation Unit of the Division of Clinical Research at Massachusetts General Hospital and the Harvard Medical School Center for Bioethics. The aim of this series is to provide the opportunity for interdisciplinary discussions of bioethical issues pertinent to the broad clinical research community. We hope to offer the chance to understand the clinical, regulatory, and policy issues that currently impact clinical and social science researchers, to elucidate the ethical and bioethical concerns of a topic in an accessible manner, and to offer points to consider and/or solutions to address concerns.

The landscape of clinical trials is evolving with the emergence of decentralized approaches. Such methodologies harness an array of digital technologies to offer new possibilities in recruitment and enrollment, informed consent, intervention administration, and safety monitoring. While these approaches present potential benefits, they also introduce complex ethical considerations. This talk will identify and analyze the ethical challenges in decentralised clinical trials, discuss the implications for research participants, scientific integrity, and regulatory frameworks, and propose strategies for addressing these ethical concerns.

Speaker: Effy Vayena, PhD, professor of bioethics at the Swiss Federal Institute of Technology Zürich (ETH Zürich) and associate vice president for Digital Transformation & Governance.