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Informed consent: research and the psychotic patient
A D du Plessis1, F J van Heerden, H Oosthuizen
1Eli Lilly (SA) (Pty) Limited, Isando, South Africa.
Medicine and Law
|January 1, 1996
Summary
Obtaining informed consent from psychotic patients in clinical trials requires careful consideration of procedures. This study compared various methods used across different centers, highlighting the need for awareness of legal aspects.
Area of Science:
- Medical Ethics
- Clinical Research
- Psychiatry
Background:
- Western societies increasingly value individual integrity and self-determination.
- Patient consent is a prerequisite for all medical treatments, including diagnostic and therapeutic interventions.
- Clinical trials necessitate specific procedures for obtaining informed consent.
Purpose of the Study:
- To compare procedures for obtaining informed consent from psychotic patients in clinical trials.
- To identify variations in consent processes across different research centers.
Main Methods:
- A comparative study was conducted across multiple centers involved in clinical trials.
- Procedures for obtaining informed consent from psychotic patients were examined.
Main Results:
- The study compared diverse methods used for informed consent in clinical trials involving psychotic patients.
- Variations in consent procedures were observed across different participating centers.
Conclusions:
- Awareness of legal aspects is crucial when conducting clinical trials, particularly concerning patient consent.
- Further investigation into best practices for informed consent in vulnerable populations, such as psychotic patients, is warranted.