‘Even if they ask you to stand by a tree all day, you will have to do it (laughter)…!’: Community voices on the notion and practice of informed consent for biomedical research in developing countries

Pediatric Assent for a Study of Antiretroviral Therapy Dosing for Children in Western Kenya: A Case Study in International Research Collaboration

“…In a qualitative study examining opinions of Kenyan community members related to informed consent for research, Molyneux et al asked community focus groups whether consent should be sought from Kenyan children from whom blood samples would be requested (Molyneux et al, 2005b). They reported that all of the groups "reacted with surprise" to the question of considering consent for children, with "general agreement that children should not be asked, " and they further specified that investigators should not consider asking children aged ten to twelve years (Molyneux et al, 2005b). The study participants reported concerns that the children could not "reason things out" or understand why the samples were needed, and they felt that fear of pain would be the children's only consideration (Molyneux et al, 2005b).…”

“…They reported that all of the groups "reacted with surprise" to the question of considering consent for children, with "general agreement that children should not be asked, " and they further specified that investigators should not consider asking children aged ten to twelve years (Molyneux et al, 2005b). The study participants reported concerns that the children could not "reason things out" or understand why the samples were needed, and they felt that fear of pain would be the children's only consideration (Molyneux et al, 2005b). Even for children ages ten to thirteen years, the Kenyan community members felt that the researchers should discuss the project directly only with the parents, and then the parents could relay the information to the children (Molyneux et al, 2005b).…”

“…The study participants reported concerns that the children could not "reason things out" or understand why the samples were needed, and they felt that fear of pain would be the children's only consideration (Molyneux et al, 2005b). Even for children ages ten to thirteen years, the Kenyan community members felt that the researchers should discuss the project directly only with the parents, and then the parents could relay the information to the children (Molyneux et al, 2005b). We could not find any literature documenting how often or in what manner pediatric assent is incorporated in biomedical research in Kenya or in sub-Saharan Africa.…”

“…Of particular relevance is the perception of children by community members as competent decision makers, given the importance of capacity as a criterion for informed consent. A qualitative study by Molyneux et al suggests that children are viewed by the community as unable to "reason out things" for the purposes of informed consent and "cannot understand" what the risks and benefits of a study might be (Molyneux et al, 2005b). In this context, the child is not seen as a legitimate decision maker, a factor that further undermines their ability to fully assent or dissent.…”

Musings on participation in health research and the recruitment process: It is not always about the numbers

“…Consent forms sometimes generated additional anxiety and were perceived as protecting researchers instead of participants (6). Individuals who perceived research as being more risky were more inclined to want concrete benefits from the study (5).…”