Ethical issues in schizophrenia research: a commentary on some current concerns.

An essential aspect of research on schizophrenia is ensuring that worthwhile scientific studies are done in a way that does not place vulnerable individuals at unreasonable risk. It is important to educate researchers, advocates, potential participants, reviewers, IRBs, and the general public about ethical principles and controversial issues as they impact research on schizophrenia. Federal regulations mandate IRB consideration of "the special problems of research involving... mentally disabled persons..." (45CFR46.111a3). In recent years, there has been a greater focus on subject monitoring to improve safeguards and minimize risks. The process of informed consent is also going through a process of evolution, in order to help ensure that participants are as aware as possible of key aspects of a study, including risks, benefits, alternatives, purpose and design, etc. We focus here on a few of the issues that are current, are relevant to schizophrenia research, and merit additional empirical study. They include medication discontinuation and placebo control designs, compensation for participation, and capacity to consent.