Ethics in psychiatric research: study design issues.

OBJECTIVE To identify and discuss ethical aspects of study design issues in psychiatric research. METHOD We conducted a literature review and conceptual analysis of study design in psychiatric research focusing on placebo, medication tapering and withdrawal (washout), and symptom provocation (challenge) designs. RESULTS While advances in the care and treatment of persons with psychiatric disorders are crucial to the improved well-being of this stigmatized and often forgotten population, past abuses demonstrate the importance of the thoughtful application of ethical principles in the conduct of research. Some ethical issues have particular relevance to psychiatric research arising primarily from the specific vulnerabilities of those with mental illness and the risks posed by some research methodologies. Accordingly, sensitivity is required in the design of psychiatric research. CONCLUSION Placebo, challenge, and washout study designs can present particular risks in the population of persons with mental illness. These issues are described and suggestions offered to promote the ethical design of psychiatric research.