Inclusion of patients with severe mental illness in clinical trials: issues and recommendations surrounding informed consent.

Modern medicine would be unthinkable without the possibility of administering pharmaceuticals and other evidence-based interventions. The development of these interventions requires scientific research, ultimately with human subjects. This venture raises ethical, legal and human rights issues, which are addressed in numerous national and international declarations and regulations.

Patient incompetence and substitute decision-making: an analysis of the role of the health care professional in Dutch law.

In any jurisdiction that takes patient autonomy and patient rights seriously, patient competence is a pivotal concept. Competence, which should be distinguished from criminal responsibility and legal capacity, can be defined as the ability to exercise rights, more in particular the ability to exercise one's right to give or refuse informed consent. It depends upon a patient's competence whether or not this patient has the final say in a health care decision and whether or not the patient can legitimately be subjected to compulsory interventions in that context.