Tortevoye P, Moutel G, Tuppin P, Plancoulaine S, Joubert M, Hervé C, Gessain A
Unité d'Epidémiologie et Physiopathologie des Virus Oncogènes, URA CNRS 3015, Département de Virologie, Institut Pasteur, Paris Cedex 15, France.
Rev Epidemiol Sante Publique. 2007 Dec;55(6):413-21. doi: 10.1016/j.respe.2007.09.002. Epub 2007 Nov 26.
This paper discusses the ethical aspects of a large research program in virology, conducted since 1994 and which has evolved in parallel with the elaboration of bioethics laws in France. This research, which involved the collection of a considerable amount of epidemiological data in the field, focused on epidemiological determinants (mother to child transmission, genetic susceptibility/resistance) of the human oncogenic retrovirus human T cell lymphotropic virus type 1 (HTLV-1). Data were collected from a specific population (Noirs Marrons) living in remote areas in French Guiana (South America). This ethnic group of African descent is highly endemic for HTLV-1 and associated adult T cell leukemia/lymphoma. The population has lived for two centuries on either side of the Maroni river, which constitutes the frontier between French Guiana and Surinam. The low socioeconomic and education levels of a large part of this population are mainly explained by a recent housing/residence fixation on the French side of the Maroni river. It is also linked to significant immigration from Surinam due to the civil war, which lasted for five years in the late 1990s, in this country. Conducting epidemiological surveys in this peculiar context illustrates the limitations of the available current legal framework in France for such studies. Indeed, several important ethical issues arose concerning not only individual and population benefits, but also specificities of the given information and of the informed consent. Another question concerns individual information feed-back in such a context of persistent viral infection, with a very low disease incidence, in a population with a relatively low education level. The goal of this work was mainly to report several of the ethical issues encountered and to discuss possible ways of achieving better information deliver and consent procedures in such a context. Indeed, these procedures should include new ideas and regulations promoting a real partnership, in order to conduct long-term epidemiological studies in populations with a low education level.
本文讨论了自1994年以来开展的一项大型病毒学研究项目的伦理问题，该项目是在法国制定生物伦理法的同时发展起来的。这项研究涉及在实地收集大量流行病学数据，重点关注人类致癌逆转录病毒1型（HTLV-1）的流行病学决定因素（母婴传播、遗传易感性/抗性）。数据收集自居住在法属圭亚那（南美洲）偏远地区的一个特定人群（黑马龙人）。这个非洲裔族群HTLV-1及相关成人T细胞白血病/淋巴瘤的流行率很高。该人群在构成法属圭亚那和苏里南边界的马罗尼河两岸生活了两个世纪。该人群很大一部分社会经济和教育水平较低，主要原因是最近在马罗尼河法国一侧定居。这也与20世纪90年代末苏里南因内战持续五年导致的大量移民有关。在这种特殊背景下进行流行病学调查，说明了法国现行法律框架在此类研究中的局限性。事实上，出现了几个重要的伦理问题，不仅涉及个人和群体利益，还涉及所提供信息及知情同意的特殊性。另一个问题是，在这样一个病毒持续感染、疾病发病率很低且教育水平相对较低的人群中，如何进行个人信息反馈。这项工作的目标主要是报告遇到的几个伦理问题，并讨论在这种背景下实现更好的信息传递和同意程序的可能方法。的确，这些程序应包括促进真正伙伴关系的新思想和新规定，以便在教育水平较低的人群中开展长期流行病学研究。
