Ethical principles and practices for research involving human participants with mental illness.

This report of the American Psychiatric Association's task force on research ethics addresses ethical issues related to the conduct of research involving human participants with mental illness. The report includes discussion of recruitment and ongoing participation of persons whose decisional capacity may be impaired and the ethical costs of categorically excluding persons with serious mental illness. Investigators should receive education in research ethics that addresses rules and norms governing research; sensitivity to ethical implications of decisions and actions; and skills in ethical problem solving, including ascertainment and disclosure of conflicts of interest. Ethical research design must ensure that a study has scientific merit, methods used should yield knowledge of value, and procedures must minimize risks to participants and optimize benefits. When risks are anticipated, plans should be developed to ensure participants' safety. The task force concludes with 12 recommendations for researchers, ethical review bodies, and advocacy groups to promote research and ensure ethical conduct of research.