Comparing the Understanding of Subjects Receiving a Candidate Malaria Vaccine in the United States and Mali

Abstract

Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali ( P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries

The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries

“…Sample sizes ranged from 33 to 700 research participants. Seven studies interviewed a parent of a participating child,18 21 22 24 26 29 33 and of those seven, three interviewed only the mothers 22 24 33. Thirteen studies19–21 23 26–33 35 used structured or semi-structured interviews, while five used questionnaires 18 22 24 25 34.…”

“…Seven studies interviewed a parent of a participating child,18 21 22 24 26 29 33 and of those seven, three interviewed only the mothers 22 24 33. Thirteen studies19–21 23 26–33 35 used structured or semi-structured interviews, while five used questionnaires 18 22 24 25 34. In nine studies, participants were interviewed close to the time of consent18 23 24 26 28 29 33–35 and in eight others interviews were conducted 1–14 months or longer after the participant gave consent 19–22 25 27 30 31.…”

“…Thirteen studies19–21 23 26–33 35 used structured or semi-structured interviews, while five used questionnaires 18 22 24 25 34. In nine studies, participants were interviewed close to the time of consent18 23 24 26 28 29 33–35 and in eight others interviews were conducted 1–14 months or longer after the participant gave consent 19–22 25 27 30 31. In one study, the timing was not specified 32…”

“…Six studies surveyed the parents of children in paediatric trials 40 42 45 48 54 57. Sixteen studies used structured interviews,19 38 39 42 45 47 48 50 54 57 58 60–64 nine used mailed surveys,37 41 43 46 49 51–53 59 and six used questionnaires 18 36 40 44 55 56. In eight studies, questions were asked close in time to when consent was given, in each case within 48 h of consent18 39 40 42 48 55 60 64; the remaining 23 studies surveyed participants weeks to months after consent 19 36–38 41 43–47 49–54 56–59 61–63…”

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

“…Os resultados deste estudo demonstram que, assim como em outros países 15,31,33,34,35 , o TCLE é insuficiente para expressar uma decisão autônoma, sugerindo que este é um desafio ético para a condução de pesquisas com seres humanos. Esse desafio pode ser ainda maior em pesquisas clínicas realizadas no Brasil, uma vez que os resultados deste estudo mostraram que o conhecimento médio sobre as informações do TCLE e o porcentual de respondentes que possui conhecimento suficiente sobre esse documento foi inferior ao evidenciado em outras pesquisas clínicas, inclusive em estudos realizados em paí-ses em desenvolvimento 9,11,15,16 .…”