Healthy volunteers' protection around the world

Abstract

Healthy volunteers participating in biomedical research benefit from varying levels of protection in different parts of the world since they are too rarely identified as a specific subset of study participants with specific vulnerabilities and risks. These differences in protection can lead to unfair and ethically unacceptable situations. Healthy volunteers are subject to a number of risks, not only regarding the respect of their rights and of their health but they are also at risk of being exploited because of their financial situation, educational level and motivations. In the end, the scientific validity of the studies may also be called into question. Through its work, the VolREthics (Volunteers in Research and Ethics) initiative, set up by the Inserm ethics committee, outlines the ethical issues raised by the involvement of healthy volunteers in biomedical research, and highlights the need to improve their protection worldwide. Healthy volunteers are essential to scientific progress and society, and their potential vulnerabilities must be recognized and taken into account.