[Ethics of research: the freedom to withdraw].
Because they do not have universal access to health care, the poorest people in developing countries often have no other choice but to participate in medical research. In exchange for their contribution to a clinical trial and their adhesion to the study protocol, they receive a bare minimum of health services. Can the notion of informed and free consent be applied under these conditions? Does the provision of care actually constitute a powerful incentive to participate in biomedical research that contradicts the notion of free will? Suppressing this promise of care will not resolve issues for research participants in resource-limited countries. On the contrary the promise of care must be extended to all potential research participants who approach the investigators regardless of their participation in the research. Additionally, all participants should be able to withdraw the trial at any time when he/she considers that his/her interest is better dealt with outside the frame. An individual's consent could be continually renewed, informed by his/her experience throughout the course of the trial independently of the health services that are offered. A standard of care could be offered to those who decide to break the contract that connects them to researchers including the first day after the signature of the consent. Would the provision of care constitute an "even more powerful incentive" for participants to enter into trials and/or create a situation whereby research is no longer possible? Or would it be on the contrary a beneficial reform, forcing research to propose less restricting and heavy protocols, for the obvious potential direct benefits so that the participants would not be tempted to withdraw the programme? This article and the ideas put forward are directly inspired from dialogues presented on the EthicHIV discussion forum, set up by sidaCTlON as a part of their program on ethics in HIV-related research in developing countries.
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