Abstract #359  -  Providing adapted information to participants in medical research : an experiment to move from advocacy towards experience-based implementation
Authors:   Presenting Author:   Mrs Caroline Desclaux - CRCF
Additional Authors:  Mrs Alice Desclaux, Mrs Marie De Cenival,
Aim: As health research is developing in resource-poor settings, advocacy for participants’ informed consent is claimed, particularly in international regulations. But the content of the information that should be delivered and its modes of transmission raise many questions, especially in populations with low literacy rates. Evidence- or experience-based practices are still lacking and practices are heterogeneous at field level. Based on an experimental information program using community participation in Senegal, this presentation aims at providing insights about the content and medium of information favored by research participants and adapted to their needs.
Method / Issue: In Centre Régional de Recherche et de Formation à la Prise en Charge Clinique de Fann (CRCF), Dakar, a study was held in 2008 regarding the needs for information of participants felt by medical, social and community teams and by participants in clinical research projects themselves. Several issues were identified regarding uses of blood, advantages and risks related to participation, conditions after the end of research projects, meanings of research. In 2009, an experimental project was proposed in CRCF to the participants of a cohort study on long-term use of ART. They could choose between an individual session of information, a collective session, or usual modalities of information provided by the physician during a medical encounter before discussing pre-inclusion consent. The content and shape of the information delivered were defined with a diversified team (medical doctors, ethics mediator, community agents, social scientists, association delegates, translator/linguist). At various stages of participants’ itineraries, evaluations were proposed in order to identify factors for choice and adherence, to follow improvement of knowledge and to identify elements that favor or hinder transmission of information and perception of agency in consent decision.
Results / Comments: The analysis of participants choices will be presented as well as declared reasons for choice amongst several information patterns. Results will be discussed in the light of advantages and difficulties identified for each pattern, regarding for instance confidentiality, interactive dimension of exchanges, issues of comprehension, organizational and structural challenges related to implementation of this intervention as related to a medical research project.
Discussion: This experiment reveals a set of issues and difficulties when moving from advocacy to intervention. However, ethical issues were less sharp in this long-term cohort study than they might be in clinical trials or prevention studies. These results provide an adequate basis for further studies in different research contexts, which conclusions might be compared.
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