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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 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.