Chapitre 12. Consentement éclairé pour la recherche biomédicale dans les pays en développement : Procédures et attitudes parentales dans un essai randomisé de supplémentation alimentaire de nourrissons sénégalais

Abstract

Justification: The 52^nd World Health Assembly recently confirmed the importance of individual free informed consent for any research that involves human beings, and emphasised that medically and economically disadvantaged populations need particular attention.
Objectives: To describe the procedures and results of individual information sessions which took place at the homes of parents with a view to including their infant in a controlled food supplementation trial in Senegal.
Methods: The information about the study was written in the local language and the meaning was checked by translating back. It was given to the parents orally, since over 90% of the mothers had never been to school. Only oral consent was requested.
The hypothesis of the study was a positive effect of supplementation on the growth of the infant (from 4 to 7 months of age).
Results: Only the mother’s presence at the session was necessary, but the father and other members of the family frequently took part. Of the 148 mothers contacted, 141 gave their agreement to take part in the study. Refusals were more frequent in the North part of the zone (p < 0.01) and during the first 2 months of inclusion (p < 0.05, Fisher test). The existence of a control group with random distribution of the children was accepted easily, but most of the mothers wished to be part of the supplemented group. Some “disguised” refusals were suspected, such as travel plans by the mother, criterion for exclusion from the study (n = 2), or agreement to take part in the control group only (n = 2).
Conclusion: Poor illiterate parents in the Sahel are capable of making informed decisions to have their child take part in medical research, without reference to religious or traditional “authorities”. A criterion of non-inclusion such as plans to be absent from home could help some parents to avoid the participation of their child without having to refuse directly.