Consent to clinical trials in anaesthesia

• Published in: Anaesthesia 1998-03, Vol.53 (3), p.227-230
• Main Authors: Montgomery, J. E., Sneyd, J. R.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anaesthesia; clinical trials, consent; Anesthesia; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Bioethics; Biological and medical sciences; Child; Child, Preschool; Clinical Trials as Topic; Comprehension; Consent Forms; England; Female; Humans; Information Dissemination; Informed Consent; Male; Medical sciences; Mental Recall; Middle Aged; Miscellaneous; Multicenter Studies as Topic; Patient Education as Topic; Patient Satisfaction; Retrospective Studies; Surveys and Questionnaires
• ISSN: 0003-2409; 1365-2044
• DOI: 10.1046/j.1365-2044.1998.00309.x

In order to evaluate satisfaction with, and recollection of, the consent process, we sent a postal questionnaire to 204 patients who had taken part in one of six clinical trials. Three trials were multicentre commercial studies and three were ‘in house’. The readability of the different patient information sheets was compared. Seventy‐seven per cent of patients responded, of whom 82% remembered having an information sheet. Most (99%) thought this was easy to read and understand. Five patients claimed that they had felt pressurised to take part in the trials. Nearly all patients (97%) realised that participation was voluntary and that other treatment would not be affected; 83% knew they could have changed their minds. There were no differences in the response patterns between the patients taking part in the different trials although the patient information sheets produced by pharmaceutical companies were longer and more complex than the ‘in hospital’ variety. We conclude that increasing the amount and complexity of information does not alter patient satisfaction. Taken overall, patients were content with the way they were approached when asked for consent for clinical trials.