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Consent to clinical trials in anaesthesia
1Department of Anaesthesia, Derriford Hospital, Plymouth, UK.
Anaesthesia
|June 5, 1998
Summary
Patient satisfaction with clinical trial consent is high, with most recalling information sheets and understanding the voluntary nature of participation. Information complexity did not affect patient contentment.
Area of Science:
- Clinical Research Ethics
- Patient Recruitment and Consent
Background:
- Evaluating patient understanding and satisfaction with the informed consent process is crucial in clinical trials.
- Variations in patient information sheets (PIS) exist between commercial and in-house studies.
Purpose of the Study:
- To assess patient satisfaction and recall of the consent process in clinical trials.
- To compare the readability of PIS from different types of clinical trials.
Main Methods:
- A postal questionnaire was sent to 204 patients participating in six clinical trials (three multicentre commercial, three in-house).
- Readability of patient information sheets was assessed.
- Patient responses regarding satisfaction, recall, understanding, and perceived pressure were analyzed.
Main Results:
- A 77% response rate was achieved, with 82% of patients recalling an information sheet.
- 99% found the information sheets easy to read and understand.
- Most patients understood the voluntary nature of participation (97%) and their right to withdraw (83%).
- No significant differences in patient responses were observed between commercial and in-house trials, despite differences in PIS length and complexity.
Conclusions:
- Patient satisfaction with the clinical trial consent process is high, irrespective of information complexity.
- The approach to obtaining consent for clinical trials is generally well-received by patients.
- Readability and clarity of information are key factors in patient understanding and satisfaction.
Keywords:
Biomedical and Behavioral Research
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