Related Experiment Videos
Informed consent: assessment of comprehension
D A Wirshing1, W C Wirshing, S R Marder
1Department of Psychiatry, West Los Angeles VA Medical Center, CA 90073, USA.
The American Journal of Psychiatry
|November 13, 1998
Summary
Structured informed consent procedures improve understanding for schizophrenia patients in clinical trials. Patients demonstrated retention of critical information, showing comprehension is achievable with tailored approaches.
Area of Science:
- Clinical Psychology
- Psychiatric Research
- Informed Consent
Background:
- Informed consent is crucial in clinical research, especially for vulnerable populations.
- Schizophrenia presents unique challenges in ensuring comprehension of complex research information.
Purpose of the Study:
- To design and evaluate a structured informed consent process for individuals with schizophrenia.
- To assess the understanding and retention of research protocol details by these patients.
Main Methods:
- 49 schizophrenia patients received informed consent forms and questionnaires.
- Information was reiterated until 100% accuracy was achieved.
- Retention was tested 7 days later.
Main Results:
- Initial median score was 80%; 53% needed a second trial, 37% needed three or more.
- Scores improved significantly by day 7.
- 96% felt adequately informed; motivations for participation varied.
Conclusions:
- Rigorous, structured informed consent procedures enable schizophrenia patients to understand and retain key research information.
- Effective communication strategies are vital for ethical research involving this population.