[Analysis of the ethical issues raised by a ten-year epidemiology program in French Guiana: limitations of the current legal framework and solutions adopted].
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.
Unité d'Epidémiologie et Physiopathologie des Virus Oncogènes, URA CNRS 3015, Département de Virologie, Institut Pasteur, Paris Cedex 15, France.
P
P
Tortevoye
G
G
Moutel
P
P
Tuppin
S
S
Plancoulaine
M
M
Joubert
C
C
Hervé
A
A
Gessain
D003256:Community Participation / Q000331:legislation & jurisprudence; D004522:Educational Status; D016021:Epidemiologic Studies; D026689:Ethical Analysis; D032984:Ethics, Research; D005006:Ethnicity / Q000706:statistics & numerical data; D005602:France; D005616:French Guiana / Q000453:epidemiology / Q000208:ethnology; D015490:HTLV-I Infections / Q000453:epidemiology* / Q000208:ethnology; D006293:Health Promotion / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D015459:Leukemia-Lymphoma, Adult T-Cell / Q000453:epidemiology / Q000208:ethnology; D011203:Poverty