title: Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso.
abstract: BACKGROUND
  Over the last years, the number of clinical trials carried out in low-income countries with poor medical infrastructure and limited access to health care has increased. In these settings, the decision of participating in a clinical study may be influenced by factors related to participants' vulnerability that limit the efficacy of the informed consent.
  
  
  METHODS
  A mixed methods social science study, based on the triangulation of qualitative and quantitative data, was carried out in a socio-economically disadvantaged and semi-urban area of Bobo Dioulasso, Burkina Faso. The study aimed at assessing the relevance of the informed consent procedure on the decision-making process of the parents and/or guardians of potential participants in a pediatric malaria trial.
  
  
  RESULTS
  For most parents (70.4%), the decision of participating had already been taken before undergoing the informed consent process and was based on the information conveyed through the community. Access to free and good quality health care often inspired this decision. In addition, the parents' willingness to have their child included in the trial made them develop active strategies to achieve this purpose.
  
  
  CONCLUSIONS
  In a context of socio-economic vulnerability and poor access to free health care, the process of informed consent does not always accomplish its goal of informing people and enabling them to make a free and informed decision. This information role is somehow anticipated by the community and trial participation becomes a strategic action to secure otherwise unavailable health resources leading community members to decide on participation even prior to the informed consent process.
authors.affiliation: Institut de Recherche en Sciences de la Santé (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso.
authors.forename: Lea
authors.initials: L
authors.lastname: Paré Toe
authors.forename: Raffaella M
authors.initials: RM
authors.lastname: Ravinetto
authors.forename: Susan
authors.initials: S
authors.lastname: Dierickx
authors.forename: Charlotte
authors.initials: C
authors.lastname: Gryseels
authors.forename: Halidou
authors.initials: H
authors.lastname: Tinto
authors.forename: Noèl
authors.initials: N
authors.lastname: Rouamba
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Diallo
authors.forename: Yacouba
authors.initials: Y
authors.lastname: Cissao
authors.forename: Korotimi
authors.initials: K
authors.lastname: Bayala
authors.forename: Susanna
authors.initials: S
authors.lastname: Hausmann
authors.forename: Joan
authors.initials: J
authors.lastname: Muela
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
authors.forename: Koen
authors.initials: K
authors.lastname: Peeters Grietens
mesh_terms: D000293:Adolescent; D002050:Burkina Faso; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards*; D003657:Decision Making / Q000941:ethics*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007223:Infant; D007258:Informed Consent / Q000941:ethics*; D008288:Malaria / Q000188:drug therapy; D008297:Male; D010465:Perception; D011203:Poverty; D036301:Qualitative Research; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires