Table 2. Developed country consent studies.
Authors | Country | Sample | Type of clinical research | Method of evaluation |
---|---|---|---|---|
Ellis et al, 201018 | USA | 171 M and F | Malaria vaccine phase I trial | Questionnaire administered after IC document reviewed but before consent |
Ravina et al, 201036 | USA | 149 M and F | Phase II Parkinson's trial | Self-administered questionnaire at final clinical trial visit |
Bergenmar et al, 200837 | Sweden | 282 M and F | Phase II and phase III oncology trials | Mail surveys sent within 3 days–2 weeks of consent |
Knifed et al, 200838 | Canada | 21 M and F | Neuro-oncology trial | Interviews within 1 month of IC |
Agrawal et al, 200639 | USA | 163 M and F | Phase I oncology trials | Interview immediately after consent |
Franck et al, 200740 | UK | 109 Parents | 25 Different paediatric studies | Questionnaire taken immediately after and 3 months after consent |
Marshall et al, 200619 | USA | 348 M and F | Genetic studies of hypertension | Interviews long and variably after consent |
Gammelgaard et al, 200441 | Denmark | 103 M and F | Acute myocardial infarction trials | Mail survey sent to participants in the study 3 weeks after IC |
Kodish et al, 200442 | USA | 137 Parents | Paediatric leukaemia trial | Parent pairs interviewed within 48 h of consent |
Lynöe et al, 200443 | Sweden | 44 M and F | Chronic haemodialysis trials | Mail survey about 1 week after disclosure of information |
Criscione et al, 200344 | USA | 30 M and F | Rheumatoid arthritis trial | Questionnaire 1–4 weeks after consent |
Kupst et al, 200345 | USA | 20 Parents | Paediatric oncology trials | Interviews 1 month after IC |
Pope et al, 200346 | Canada | 190 M and F | Cardiology, ophthalmology and rheumatology trials | Mail survey 2–5 months after consent |
Schats et al, 200347 | The Netherlands | 37 M and F | Subarachnoid haemorrhage emergency management trials | Interviews 7–31 months after IC (median of 20 months) |
Simon et al, 200348 | USA | Majority English speakers: 60 parents | Paediatric oncology trials | Parents interviewed 48 h after consent |
Minority English Speakers: 27 parents | ||||
Minority non-English speakers: 21 parents | ||||
Joffe et al, 200149 | USA | 207 M and F | Oncology trials, phase I, II and III | Mail survey 1–2 weeks after consent |
Daugherty et al, 200050 | USA | 144 M and F | Phase I oncology trials | Interviews within 1 week of first administration of investigational treatment |
Hietanen et al, 200051 | Finland | 261 F | Oncology trial of tamoxifen | Mail survey 5–17 months after consent |
Montgomery et al, 199852 | UK | 158 M and F | 3 In-house and 3 multi-centre anaesthesia trials | Mail survey up to 24 months after consent |
Van Stuijvenberg et al, 199853 | The Netherlands | 181 Parents | Paediatric trial of ibuprofen for febrile convulsions | Mail survey up to 2–3 years after consent |
ACHRE, 199654 | USA | 570 M and F | Oncology and cardiology trials | Brief interviews followed by in-depth interviews |
Harrison et al, 199555 | USA | 71 M and F | HIV vaccine trial | Self-administered questionnaire after disclosure and before consent |
Harth et al, 199556 | Australia | 62 Parents | Paediatric trial of oral asthma drug | Self-administered questionnaire 6–9 months after entered trial |
Estey et al, 199457 | Canada | 29 M and F | Not specified | Interviews 1–6 weeks after consent |
Miller et al, 199458 | USA | 168 M and F | Trial of analgesic drugs | Interviews 30–90 days after entered trial |
Lynöe et al, 199159 | Sweden | 43 F | Gynaecology trial of antiphlogistic drugs for fallopian tube inflammation | Mail survey 18 months after study |
Benson et al, 198560 | USA | Depression study: 24 M and F | Antidepressant trial and antipsychotic trial | Interviews immediately following IC |
Schizophrenia study: 24 M | ||||
Penman et al, 198461 | USA | 144 M and F | Oncology trials, phase II and III | Interviews 1–3 weeks after consent |
Riecken et al, 198262 | USA | 112 M* | 50 Different trials | Interviews within 10 weeks of consent |
Howard et al, 198163 | USA | 64 M and F | Cardiology trial of β-blockers (BHAT) for acute myocardial infarction | Interviews 2 weeks–15 months after consent |
Bergler et al, 198064 | USA | 39 M | Hypertension trial of hydrochlorothiazide versus propranolol | Interviews 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.