On October 3,1995, President Clinton issued Executive Order 12975 instructing the Office for the Protection from Research Risks (OPRR) to review its policies regarding the protection of the rights and welfare of persons participating in research. The Order also created the National Bioethics Advisory Commission. In a March 27, 1997 memorandum to his Cabinet, the President also strengthened protections for human participants of classified research. These actions were taken in the context of rapid advances in genetic research and amid concerns that cloning would soon be possible. These developments renewed the discussion of ethics and biomedical research. At the same time, news stories focused on past lapses in research ethics (the Tuskegee syphilis study, the cold war radiation experiments) while raising questions regarding current research (for example, whether consent procedures had been properly followed for research into new treatments for breast cancer).

The Department of Mental Health Law and Policy has developed training to address the issues of ethical standards in Behavioral Health Services Research. Historically, much of the discussion of research ethics has focused on the use of clinical trials in biomedical research. In the behavioral health area, trials for psychopharmaceutical research have received the most attention. In contrast, these workshops will focus on ethical and legal issues that arise in the conduct of less invasive behavioral health services research in which people with serious mental illness are involved. We have chosen this focus for three reasons.

First, services research has become increasingly important given the dramatic changes in the financing and organization of health and behavioral health services that have occurred over the last decade. It is estimated that expenditures for mental health and substance abuse services comprise approximately 15 percent of all health care spending in the United States, and many cost containment strategies have been adopted in recent years in an effort to contain the rate of inflation in those expenditures.

Second, the ethical and legal issues that lie at the heart of almost all biomedical research (questions of individual capacity; whether participation is voluntary; concerns regarding confidentiality) may be exacerbated when people with serious mental illnesses are participants. For example, severe mental illness may compromise decision-making capacity to a greater degree than is the case with other populations. Confidentiality concerns may be more pressing because of the continuing stigma associated with mental illness. Perceptions as to what is coercive may be quite different from the viewpoint of the person with mental illness and the perspective of the researcher or practitioner. It is important for researchers and IRB members to understand that the issues they commonly address may be different in the context of research involving individuals with serious mental illness.

Finally, the technology used in services research, while seemingly innocuous on its face, may be problematic when employed with people with serious mental illness or when raising questions regarding the mental health of respondents. For example, a common technique in services research is the use of surveys. Yet as one study reported, approximately 10% of the individuals surveyed indicated becoming emotionally distressed by questions concerning psychological symptoms. In a subsequent study, 7% of the respondents to a community survey of elderly persons on dementia reported that the survey made them distressed, depressed, or constituted an invasion of their privacy.

Other information-gathering techniques (e.g., follow-up telephone calls or home visits) may raise similar concerns. For example, if the distress caused is significant in a particular case, it raises a collateral issue of importance: what is the researcher's ethical and legal obligation to address the participant's distress caused by the researcher's methodology?

In addition, as services research proceeds, the collection of information may raise new ethical questions. For example, if a researcher obtains access to a variety of data bases on service utilization, and then links previously unrelated systems, he or she may create a much more comprehensive profile of the individual than would be available simply through using discrete data sources. Does this ability to link data sets require the consent of the individual before it is utilized? Do confidentiality and privacy become distinct issues in such a setting?

By focusing on services research in which people with serious mental illness are we able to address issues that are related to but different in application than the ethical and legal issues ordinarily associated with biomedical research employing clinical trials.