de Cenival M
Sidaction, Programmes intemationaux, France.
Bull Soc Pathol Exot. 2008 Apr;101(2):98-101.
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.
由于无法普遍获得医疗保健服务,发展中国家最贫困的人群往往别无选择,只能参与医学研究。作为他们对临床试验的贡献以及遵守研究方案的交换,他们只能获得最基本的医疗服务。在这些情况下,能否适用知情且自由同意的概念?提供医疗服务实际上是否构成了参与生物医学研究的强大诱因,从而与自由意志的概念相矛盾?取消这种医疗服务的承诺并不能解决资源有限国家中研究参与者的问题。相反,医疗服务的承诺必须扩展到所有接触研究人员的潜在研究参与者,无论他们是否参与研究。此外,所有参与者在认为自己的利益在试验框架之外能得到更好处理时,应能够随时退出试验。个人的同意可以根据其在试验过程中的经历不断更新,而与所提供的医疗服务无关。对于那些决定违反将他们与研究人员联系起来的合同的人,包括在签署同意书后的第一天,都可以提供一种护理标准。提供医疗服务是否会构成参与者参与试验的“更强大诱因”和/或造成研究不再可行的情况?或者相反,这是否会是一项有益的改革,迫使研究提出限制更少、负担更轻的方案,因为显然有潜在的直接好处,这样参与者就不会轻易退出项目?本文及所提出的观点直接受到了EthicHIV讨论论坛上所呈现对话的启发,该论坛是由sidaCTlON设立的,作为其在发展中国家与艾滋病相关研究伦理项目的一部分。