Paul Fortun|Joe West|Lyman Chalkley|Anthony Shonde|C. J. Hawkey
Recall of informed consent information by healthy volunteers in clinical trials
University of Nottingham|University of Nottingham|University of Nottingham|University of Nottingham|University of Nottingham
information sheets clinical research becoming increasingly complex extent understood uncertainto assess primary outcome recall healthy volunteers key facts patient information sheet phase 3 clinical trial secondary outcomes examined whether difference medical student nonmedically trained volunteersquestionnaire determine recall healthy volunteers informed consent informationeightytwo healthy volunteers participating capsule endoscopy study given 13 page written information sheet allowed asked questions indicating ready give consent asked complete 6item questionnaire covering identity adverse effects trial treatments procedure duration trial value inconvenience allowanceall 82 healthy volunteers questioned volunteers 74 90 university level education 49 60 clinical medical students however 10 subjects 12 could name three trial drugs maximum number risks remembered 6 n 2 23 14 17 could name three potential risks medication might exposed whilst 17 20 could identify none subjects 7782 90 identified capsule endoscopy trial procedure impactionobstruction main risk 5282 64 one subject 988 could recall exact value inconvenience paymenta comprehensive information sheet resulted limited recall trial risks shorter information sheets test feedback session trialled informed consent becomes valid informed consent