Table 2

Developed country consent studies

AuthorsCountrySampleType of clinical researchMethod of evaluation
Ellis et al, 201018USA171 M and FMalaria vaccine phase I trialQuestionnaire administered after IC document reviewed but before consent
Ravina et al, 201036USA149 M and FPhase II Parkinson's trialSelf-administered questionnaire at final clinical trial visit
Bergenmar et al, 200837Sweden282 M and FPhase II and phase III oncology trialsMail surveys sent within 3 days–2 weeks of consent
Knifed et al, 200838Canada21 M and FNeuro-oncology trialInterviews within 1 month of IC
Agrawal et al, 200639USA163 M and FPhase I oncology trialsInterview immediately after consent
Franck et al, 200740UK109 Parents25 Different paediatric studiesQuestionnaire taken immediately after and 3 months after consent
Marshall et al, 200619USA348 M and FGenetic studies of hypertensionInterviews long and variably after consent
Gammelgaard et al, 200441Denmark103 M and FAcute myocardial infarction trialsMail survey sent to participants in the study 3 weeks after IC
Kodish et al, 200442USA137 ParentsPaediatric leukaemia trialParent pairs interviewed within 48 h of consent
Lynöe et al, 200443Sweden44 M and FChronic haemodialysis trialsMail survey about 1 week after disclosure of information
Criscione et al, 200344USA30 M and FRheumatoid arthritis trialQuestionnaire 1–4 weeks after consent
Kupst et al, 200345USA20 ParentsPaediatric oncology trialsInterviews 1 month after IC
Pope et al, 200346Canada190 M and FCardiology, ophthalmology and rheumatology trialsMail survey 2–5 months after consent
Schats et al, 200347The Netherlands37 M and FSubarachnoid haemorrhage emergency management trialsInterviews 7–31 months after IC (median of 20 months)
Simon et al, 200348USAMajority English speakers: 60 parentsPaediatric oncology trialsParents interviewed 48 h after consent
Minority English Speakers: 27 parents
Minority non-English speakers: 21 parents
Joffe et al, 200149USA207 M and FOncology trials, phase I, II and IIIMail survey 1–2 weeks after consent
Daugherty et al, 200050USA144 M and FPhase I oncology trialsInterviews within 1 week of first administration of investigational treatment
Hietanen et al, 200051Finland261 FOncology trial of tamoxifenMail survey 5–17 months after consent
Montgomery et al, 199852UK158 M and F3 In-house and 3 multi-centre anaesthesia trialsMail survey up to 24 months after consent
Van Stuijvenberg et al, 199853The Netherlands181 ParentsPaediatric trial of ibuprofen for febrile convulsionsMail survey up to 2–3 years after consent
ACHRE, 199654USA570 M and FOncology and cardiology trialsBrief interviews followed by in-depth interviews
Harrison et al, 199555USA71 M and FHIV vaccine trialSelf-administered questionnaire after disclosure and before consent
Harth et al, 199556Australia62 ParentsPaediatric trial of oral asthma drugSelf-administered questionnaire 6–9 months after entered trial
Estey et al, 199457Canada29 M and FNot specifiedInterviews 1–6 weeks after consent
Miller et al, 199458USA168 M and FTrial of analgesic drugsInterviews 30–90 days after entered trial
Lynöe et al, 199159Sweden43 FGynaecology trial of antiphlogistic drugs for fallopian tube inflammationMail survey 18 months after study
Benson et al, 198560USADepression study: 24 M and FAntidepressant trial and antipsychotic trialInterviews immediately following IC
Schizophrenia study: 24 M
Penman et al, 198461USA144 M and FOncology trials, phase II and IIIInterviews 1–3 weeks after consent
Riecken et al, 198262USA112 M*50 Different trialsInterviews within 10 weeks of consent
Howard et al, 198163USA64 M and FCardiology trial of β-blockers (BHAT) for acute myocardial infarctionInterviews 2 weeks–15 months after consent
Bergler et al, 198064USA39 MHypertension trial of hydrochloro-thiazide versus propranololInterviews and quizzes just after consent; repeated 3 months later
  • * The trial involved 156 participants, but only 112 indicated that they were aware that they were participating in a trial, and therefore only 112 were asked questions about voluntariness.

  • ACHRE, Advisory Committee on Human Radiation Experiments; F, female; IC, informed consent; M, male.