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. Author manuscript; available in PMC: 2016 Apr 8.
Published in final edited form as: J Med Ethics. 2012 Feb 7;38(6):356–365. doi: 10.1136/medethics-2011-100178

Table 1. Developing country consent studies.

Authors Country Sample Type of clinical research Method of evaluation
Ellis et al, 201018 Mali 89 M and F Malaria vaccine phase 1 trial Questionnaire administered after IC document reviewed but before consent
Vallely et al, 201020 Tanzania 99 F Placebo controlled trial of HIV vaginal microbicide Interviews at 4, 24 and 52 weeks
Sarkar et al, 200921 India 368 Parents Birth cohort study of diarrhoeal disease Structured interviews 3–7 months post-trial
Oduro et al, 200822 Ghana 270 Mothers Paediatric trials evaluating immune correlates of protection against malaria Questionnaire administered at end of study
Hill et al, 200823 Ghana 60 F Vitamin A supplementation trial Semi-structured interviews after consent
Minnies et al, 200824 South Africa 192 Mothers Paediatric case–control trial of immune correlates against severe childhood TB Self-administered questionnaire with staff help if necessary, within 1 h of consent
Kaewpoonsri et al, 200625 Thailand 84 M and F Malaria drug trials Interview at third follow-up visit
Marshall et al, 200619 Nigeria 307 M and F Genetic studies of hypertension Interviews administered at variable times usually long after consent
Krosin et al, 200626 Mali 163 Parents Paediatric malaria vaccine prevention trial Questionnaire within 48 h after consent
Moodley et al, 200527 South Africa 334 M and F Influenza vaccine trial Interviews 4–12 months post-trial
Pace et al, 200528 Thailand 141 M and F HIV study of IL-2 effectiveness Interviewers administered survey immediately after consent
Pace et al, 200529 Uganda 347 Parents Paediatric malaria treatment study Interviews immediately after consent
Ekouevi et al, 200430 Côte d'Ivoire 55 F HIV mother-to-child transmission prevention trial Interviews a median of 136 days after consent
Joubert et al, 200331 South Africa 92 F Trial of vitamin A for prevention of mother-to-child HIV transmission Interviews a median of 14 months after consent
Lynöe et al, 200132 Bangladesh 105 F Nutritional trial of iron supplements for pregnant women Interviews after consent
Leach et al, 199933 The Gambia 137 Mothers Paediatric trial of Haemophilus influenzae type B conjugate vaccine Interviews within a week of consent
Karim et al, 199834 South Africa Evaluation study group: 56 F Perinatal HIV transmission trial Questionnaires administered before and after counselling and consent
Sensitisation control group: 56 F*
Pitisuttithum et al, 199735 Thailand 33 M and F HIV vaccine trial with drug users Questionnaire before signing consent
*

To evaluate the informed consent obtained for the HIV testing that preceded induction into the perinatal transmission trial, researchers administered both pre- and post-counselling questionnaires to an evaluation study group (n=56). A sensitisation control group (n=56) received only post-counselling questionnaires, so as to measure the sensitising effect of the pre-counselling questionnaire given to the evaluation study group.

F, female; IC, informed consent; M, male.