Abstract
The participation of children in the context of research is encouraged by international recommendations specific to children and/or to the regulation of research. In the studies about paediatric HIV, few data are available about the way international regulation is applied through approaches that allow to involve children. The demands of ethics committees considerably vary regarding this issue, leading to a diversity of practices.This thesis has for principal objective to describe and analyse ethical and social questions at stake in the participation of children living with HIV-1 in a cohort study led in Senegal in order to propose recommendations concerning the adaptation of ethical procedures in paediatric research in global South.Methods : Two studies were carried out in 2013 and 2015 combining quantitative and qualitative methods. À first survey focused on three aspects : 1/ the feasibility and acceptability of an experimental information process for research in the contexts of two sites of the cohort Maggsen ANRS 12279, 2/ the experience of children and parents involved in the paediatric HIV research, 3/ the points of view of concerned agents (children, parents, carers, members of associations) about the participation of children in health-related research. À second study analysed the key aspects connected to the ethics of paediatric research in Senegal by studying research protocols submitted to the CNERS between 2000 and 2013 ; the study focussed on information and decision-making process.The experimental information process for research carried out in this context proved to be feasible and acceptable. It allowed giving basic information to children about the essential aspects of the cohort, despite the fact that the collective session, open to 52 children who knew their HIV status, was only attended by 29 % of them, with a significant difference between research sites (85 % vs. 15 %). The obstacles to the setting up of the information process were linked to its novel character for little experienced teams caught in time constraints, to the important daily workload of the carers, and to the demands of research. À good preparation of carers appeared necessary in order to stimulate their engagement in the research process and improve their abilities to communicate with the children. The children who did not know their HIV status could not access global and detailed information on the research. The analysis of children’s experiences of the cohort showed a positive perception of their participation despite their difficulty to understand the meaning of the research project and distinguish it from care. In addition, family relationships and care relationships encouraged or limited children’s involvement. All of the agents were in favour of an information given to children regarding the research gradual from the age of 7 and depending on their knowledge of their HIV status ; their disagreements related to the practical modalities of participation. The analysis of health research protocols implicating children in Senegal (2000-2013), mainly concerned epidemiological research (58 %) and malaria (36 %). It showed that ethical considerations were focused on the consent of legal representative. Practices regarding children’s participation in submitted projects were very heterogeneous, and they included interesting initiatives which had not been evaluated. The analysis confirmed that the experimental information process for research tried out in the Maggsen ANRS 12 279 cohort study with the objective to reinforce children participation, was in tune with measures experimented in previous research projects.This work identifies favourable interventions, modalities and conditions of information and support that reinforce children and their parents’s involvement in paediatric research.