[Healthy volunteers and clinical research in the South: a community-based approach].

BACKGROUND AND OBJECTIVES: The participation of healthy volunteers is essential for many clinical studies. However, their situation differs from that of patients, yet they are not subject to specific ethical recommendations. Unlike patients, healthy volunteers are not seeking treatment. They are exposed to the uncertainties of a clinical trial and face with an unfavorable risk/ benefit ratio. The VoIREthics charter, published by Inserm and its partners, outlines the protection principles that should protect healthy volunteers participating in clinical research. However, these principles are essentially based on Western morality and may therefore conflict with non-Western moral codes. The discussion presented here highlights the difficulties that may arise during clinical research depending on the cultural, legislative and regulatory context.

METHOD: The VolREthics charter's recommendations were examined based on the principles of autonomy, beneficence and justice. This examination was conducted in light of literature and personal experience, to illustrate the differences in perception that may exist between Western and non-Western societies.

RESULTS AND DISCUSSION: A person's place in society can limit their free will. In some societies, individual autonomy is replaced by dependence on the community. The perception of the benefit/risk balance must relate to the scale of the community, not the individual. In traditional medicine, therapeutic efficacy does not result from treatment alone, and therapeutic risk is not understood in the same way as in Western medicine. Furthermore, healthy volunteers must reflect the diversity of the population. If they are selected through a community consensus, the inclusion criteria cannot escape the investigator's or sponsor's control.

CONCLUSION: The principles set out in the VolREthics charter must be contextualized to ensure acceptance by the study stakeholders and to avoid conflict with local practices. Rather than applying recommendations that are difficult to adapt to all contexts systematically, it is essential to discuss their local relevance point by point to ensure the well-being of clinical trial participants and their adherence to the research protocol.