Ethical principles for clinical trials among forensic psychiatric population

Abstract:

Biomedical and biotechnological research evaluating new treatment methods, new drugs and new devices and technology carries some risk for research subjects. It is very important in research to adhere to ethical principles, and the area of ethical principles in clinical trials needs to be further evaluated and developed. Adherence to ethical principles is especially important in trials including forensic psychiatric patients. Since this population is especially vulnerable, it should be included in trials only in exceptional situations and under conditions that carry minimum risk for the subjects. Before a clinical trial including incarcerated subjects (prisoners, forensic psychiatric patients) can begin, it is ethically imperative to inform the subjects about the fact that their participation in the study shall have no influence on their sentence. An especially important problem from the ethical point of view is determining and evaluating competence of forensic psychiatric patients to provide informed consent. 

Key words:
ethics, research; forensic psychiatry; informed consent