An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa

Motivations, Understanding, and Voluntariness in International Randomized Trials

“…4 For example, in a study in Haiti on HIV transmission, only three of 15 potential participants scored well enough on a true-false comprehension test to be enrolled, 5 and investigators in The Gambia found that 90% of participants in a vaccine trial knew the purpose of the vaccine, but only 10% understood placebos. 6 Autonomous decision-making, a standard goal of existing national and international research ethics guidelines, may be especially challenging for research conducted in international settings. It is expected that autonomous decision-makers voluntarily agree to participate in clinical trials.…”

Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review

“…23,34 Altruism also motivated participation, with the goal of contributing to science and providing hope for new therapies for future generations and the underprivileged. 43,47 Medical Mistrust: The community's mistrust of medical research was a barrier that researchers believed needed to be addressed sensitively. 22,40 A major concern in Africa was the perceived dangers of gathering blood samples.…”

“…40,41 The results of this systematic review show that there is scope for a common international ethical framework to be applied in LMICs with ethical reasoning of the moral application of these principles in these contexts. 47,64 Researchers supported the development of a pragmatic ethical framework for children's involvement in trials that is appropriate in LMICs. 22,65,66 Communities in LMICs place a greater emphasis on tangible research benefits and remuneration, which some stakeholders believe may be coercive and cloud the objective assessment of potential risks to participants.…”

An ethics-based approach to global child health research

“…The intricacies of proxy consent required in paediatric research is compounded by the challenge of obtaining valid informed consent in a non-Western context (35,36). The authors of a study of the informed consent process for a placebocontrolled Hemophilus influenzae B vaccine trial involving children in The Gambia concluded that the Western model for obtaining proxy consent was valid despite cultural differences (37). However, only 10% of the parents of participating children were aware of the concept of a placebo, an especially worrisome observation given that 93% of parents reported having joined the trial to receive the active vaccine.…”