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.