Hot Topics in Research Ethics: Ethics of Decentralized Clinical Trials by Effy Vayena, PhD

Decentralized clinical trials involve an array of digital tools to facilitate research without physical contact among research teams and participants such as recruitment, enrollment, informed consent, administering study interventions, obtaining patient reported outcome measures, and safety monitoring. These approaches can provide ways of ensuring participant safety and research integrity while sometimes reducing participant burden and trial cost. At the same time these novel designs also raise ethical issues in relation to participants’ safety and rights, the scientific validity of the study and ethics oversight. In this talk, Professor Vayena will describe these issues and offer suggestions of how they could be addressed.