Global Efforts to Protect Healthy Volunteers.

Abstract

Clinical trials on healthy volunteers generate unique ethical challenges both because participants accept potential physical risks without the possibility of direct medical benefit and because participants' financial motivations to enroll in trials could lead to their exploitation. Despite the large volume of published empirical studies and ethical analyses of healthy volunteer research, there has been little concerted effort to change how healthy-volunteer research is overseen or regulated. A new collaborative effort to do so is the VolREthics (Volunteers in Research and Ethics) Initiative. Launched in 2022, this initiative brings together an international community to engage questions about how healthy volunteers could best be protected from the risks of harm and exploitation while the validity of clinical trials is optimized.