Informed consent for psychiatric research: the case of medication-free research.

Informed consent for research in psychiatry raises a number of ethical and legal issues. To illustrate some of the ethical problems involved, in particular issues of patient competence and proxy consent, as well as the motives of patients to become research participants, as an example the case of so-called medication-free research in schizophrenia is discussed. It is argued that an assessment of the competence of potential research subjects to consent to participation, based on explicit criteria, is necessary. In case of substituted consent it is shown that proxy decision makers may fail to protect the interests of incompetent patients in research. Finally, researchers ought to be aware that research subjects may be motivated to participate in research because they may mistakenly believe that the research project is designed to benefit them directly.