A module meant to stimulate discussion among researchers about the ethical issues that arise in conducting research with human subjects who are mentally ill; including topics such as consent, privacy, conflict of interest.
By Stuart J. Youngner, MD and Atwood D. Gaines, Ph.D., MPH
Millions of people in the United States suffer from serious, debilitating mental illness such as schizophrenia, bipolar disorder, and major depression-- at great social, emotional, and economic cost. The number of afflicted individuals constitutes a national problem and makes imperative the research concerning the mechanism(s), treatment(s), and prevention of these forms of mental illness. Research based on biological models will necessarily require the use of somatic interventions or exclusions which use research subjects who are the very people who suffer from the serious forms of mental illness under study.
Patients suffering from mental illnesses are particularly vulnerable as research subjects. At the same time, pressure on those who conduct research have developed and which complicate research issues. Today, private industry increasingly supports psychiatric and neuropsychiatric research. And professional advancement in the medical academy is largely dependent upon extra mural funding, government or private. It is upon research data that publications are based which, in turn, often leads to increased and additional funding and, hence, recognition and status. These developments increase pressures on researchers who conduct biological and pharmacological studies of the mentally ill.
Two research strategies have caused particular concern-- especially when the balance of risks and benefits are taken into account when making decisions regarding research: (a) "Challenge Studies," in which researchers intentionally give patients pharmacological agents in order to induce and study psychiatric symptomology; and, (b) drug "washout" studies, in which patients are removed from all psychiatric medication to study baseline states or pure effects of new drug treatments. An incident at UCLA, in which a former research subject committed suicide after participating in a washout study, was well publicized in the national media and investigated by the Office for Protection from Research Risks (OPRR).
Many approaches have been suggested to aid researchers in facing ethical issues raised by vulnerable patients/subjects such as the mentally ill. For example, ethical issues such as conflict of interest, risk/benefit concerns, consent and surrogate are often suggested. However, it is also well to remember that social identity may increase subjects' vulnerability as when subjects are members of denigrated ethnic, age, religious, or gender groups in addition to being afflicted with mental illness.
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