QJM Advance Access originally published online on May 16, 2008
QJM 2008 101(8):625-629; doi:10.1093/qjmed/hcn067
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Recall of informed consent information by healthy volunteers in clinical trials
From the Department of Gastroenterology, University Hospital Nottingham, Nottingham, UK
Address correspondence to P. Fortun, Department of Gastroenterology, University Hospital Nottingham, UK. email: paul.fortun{at}nottingham.ac.uk
Received 5 March 2008 and in revised form 24 April 2008
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Abstract |
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Background: Information sheets for clinical research are becoming increasingly complex but the extent to which they are understood is uncertain.
Aims: To assess, as our primary outcome, recall by healthy volunteers of key facts in a patient information sheet in a phase 3 clinical trial. As secondary outcomes, we examined whether there was a difference between medical student and non-medically trained volunteers.
Design: Questionnaire to determine recall by healthy volunteers of informed consent information.
Methods: Eighty-two healthy volunteers participating in a capsule endoscopy study were given a 13 page written information sheet and allowed to asked questions. After indicating they were ready to give consent they were asked to complete a 6-item questionnaire covering the identity and adverse effects of trial treatments and of the procedure, the duration of the trial and value of the inconvenience allowance.
Results: All 82 healthy volunteers were questioned. Of the volunteers, 74 (90%) had university level education and 49 (60%) were clinical medical students. However, only 10 subjects (12%) could name the three trial drugs. The maximum number of risks remembered was 6 (n = 2) of 23. Only 14 (17%) could name three or more potential risks of the medication they might be exposed to, whilst 17 (20%) could identify none. Most subjects (77/82, 90%) identified capsule endoscopy as the trial procedure and impaction/obstruction as its main risk (52/82, 64%). All but one subject (98.8%) could recall the exact value of the inconvenience payment.
Conclusion: A comprehensive information sheet resulted in limited recall of trial risks. Shorter information sheets with a test and feedback session should be trialled so that informed consent becomes valid informed consent.