Table 1

Developing country consent studies

AuthorsCountrySampleType of clinical researchMethod of evaluation
Ellis et al, 201018Mali89 M and FMalaria vaccine phase 1 trialQuestionnaire administered after IC document reviewed but before consent
700 Parents
Vallely et al, 201020Tanzania99 FPlacebo controlled trial of HIV vaginal microbicideInterviews at 4, 24 and 52 weeks
Sarkar et al, 200921India368 ParentsBirth cohort study of diarrhoeal diseaseStructured interviews 3–7 months post-trial
Oduro et al, 200822Ghana270 MothersPaediatric trials evaluating immune correlates of protection against malariaQuestionnaire administered at end of study
Hill et al, 200823Ghana60 FVitamin A supplementation trialSemi-structured interviews after consent
Minnies et al, 200824South Africa192 MothersPaediatric case–control trial of immune correlates against severe childhood TBSelf-administered questionnaire with staff help if necessary, within 1 h of consent
Kaewpoonsri et al, 200625Thailand84 M and FMalaria drug trialsInterview at third follow-up visit
Marshall et al, 200619Nigeria307 M and FGenetic studies of hypertensionInterviews administered at variable times usually long after consent
Krosin et al, 200626Mali163 ParentsPaediatric malaria vaccine prevention trialQuestionnaire within 48 h after consent
Moodley et al, 200527South Africa334 M and FInfluenza vaccine trialInterviews 4–12 months post-trial
Pace et al, 200528Thailand141 M and FHIV study of IL-2 effectivenessInterviewers administered survey immediately after consent
Pace et al, 200529Uganda347 ParentsPaediatric malaria treatment studyInterviews immediately after consent
Ekouevi et al, 200430Côte d'Ivoire55 FHIV mother-to-child transmission prevention trialInterviews a median of 136 days after consent
Joubert et al, 200331South Africa92 FTrial of vitamin A for prevention of mother-to-child HIV transmissionInterviews a median of 14 months after consent
Lynöe et al, 200132Bangladesh105 FNutritional trial of iron supplements for pregnant womenInterviews after consent
Leach et al, 199933The Gambia137 MothersPaediatric trial of Haemophilus influenzae type B conjugate vaccineInterviews within a week of consent
Karim et al, 199834South AfricaEvaluation study group: 56 FPerinatal HIV transmission trialQuestionnaires administered before and after counselling and consent
Sensitisation control group: 56 F*
Pitisuttithum et al, 199735Thailand33 M and FHIV vaccine trial with drug usersQuestionnaire 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.