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[Healthy volunteers' protection around the world].
Med Sci (Paris)
October 2023
Comité d'éthique de l'Inserm, 101 rue Tolbiac, 75013 Paris, France.
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.
View Article and Find Full Text PDFClinical 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.
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