Addressing ethical issues in the psychiatric research literature.

A llegations of ethical problems in psychiatric research have received intense public attention in the past few years. Two of the most widely publicized examples are research involving withdrawing medication from patients with schizophrenia at the University of California, Los Angeles, investigated by the US Office of Protection From Research Risks, and litigation concerning research conducted by the New York State Office of Mental Health. 1,2 Philip J. Hilts, writing in the science section of The New York Times, described a range of psychiatric research considered to be ethically problematic , including " challenge " experiments in which psychiatric patients were administered drugs to study provoked symptoms. 3 The Boston Globe recently published a 4-part series, entitled " Doing Harm: Research on the Mentally Ill, " detailing alleged abuses of human subjects in psychiatric research. 4-7 The use of placebos in research that tests new drugs to treat psychiatric disorders has also been criticized in the professional medical literature. 8 In December 1998, the National Bioethics Advisory Commission issued a comprehensive report and recommendations on research involving subjects who suffer from psychiatric disorders with the potential to impair decision-making capacity. 9 Some of the criticisms of psychiatric research expose genuine ethical problems, while others distort the scientific and ethical contexts of studies alleged to be abusive. In view of public and professional attention to the ethics of psychiatric research, we recommend that published reports of psychiatric research address ethical issues in a more comprehensive fashion. It is rare for these journal articles to go beyond stating that the research was approved by an institutional review board (IRB) and that investigators obtained informed consent from the research subjects. This minimal attention to ethical issues is sufficient for studies that are not ethically problematic. However, more detailed discussion of ethical issues is warranted in reports of research involving patients with disorders that may impair decision-making capacity, such as Alzheimer disease and schizophrenia, and in reports of research involving interventions that pose ethical concerns—for example, studies in which patients are withdrawn from standard medications, receive a placebo treatment trial, or are administered a challenge agent that can provoke psychiatric symptoms. In published accounts of the results of such research, ethical issues concerning the process of obtaining informed consent and the risks of harm or distress associated with research procedures need to be addressed. We suggest that there is an analogy between devoting attention …