Schizophrenia patients' and psychiatrists' perspectives on ethical aspects of symptom re-emergence during psychopharmacological research participation.

RATIONALE: Study designs involving medication-free intervals have become the subject of controversy in the current dialogue on the ethics of serious mental-illness research.
METHODS: Schizophrenia patients ( n=59; response rate 75%; 48% inpatients) and psychiatrists ( n=70; response rate 83%) responded to ten questions about a hypothetical scenario in which a schizophrenia study participant experienced the re-emergence of serious symptoms during the "wash-out" phase of a psychopharmacological trial. Patients provided their personal views, and psychiatrists gave their personal views and made predictions as to how schizophrenia patients in general would respond.
RESULTS: Schizophrenia patients and psychiatrists judged the hypothetical protocol as moderately harmful. Both expressed relatively low likelihood of willingness to participate in the study, given this potential outcome. Schizophrenia patients and psychiatrists found the decision fairly easy. Psychiatrists underestimated the level of harm and overestimated the difficulty of the decision as perceived by schizophrenia patients. Schizophrenia patients acknowledged that the offer of money and request by their doctor or family would increase the likelihood of their participation, and psychiatrists accurately predicted these responses. In hypothetical decisions about the symptomatic study participant, 38% of patients and 39% of psychiatrists said they would allow him to leave the hospital. A majority of both groups (63% and 52%, respectively) indicated that medication should be given despite the study participant's objection. Psychiatrists incorrectly predicted this response, expecting instead that most schizophrenia patients would support the discharge request and few would support involuntary administration of medication. Patients and psychiatrists offered similar reasons for participation decisions but differed in their strategies for handling the situation.
CONCLUSION: These findings suggest potential strengths of decisionally capable schizophrenia patients in assessing ethically important design elements of psychopharmacological trials. Implications for informed consent for research, expectations of the therapeutic obligations of clinical investigators, and the role of psychiatric advance directives in psychopharmacological research are outlined.