Psychiatrists Put Patient Rights First

June 11, 1998

Washington, DC -- The rights of persons with mental disorders come first in psychiatric research, according to American Psychiatric Association (APA) testimony today before the Subcommittee on Human Resources of the Government Reform and Oversight Committee of the U.S. House of Representatives. The hearing examined "Institutional Review Boards: a System in Jeopardy," a report prepared by the Inspector General of the U.S. Department of Health and Human Services.

"If research cannot be performed without violating the rights of participants, it should not take place," said Paul Appelbaum, M.D*., APA Secretary and Chair of the Association's Ethics Appeals Board. "Coercive techniques to obtain consent are unacceptable, as are inadequate or deceptive disclosures of information to potential subjects. We reject the claim that knowledge must be advanced at any price."

In his testimony, Dr. Appelbaum commended the subcommittee for focusing public attention on the issues involving human participation in medical research raised by the Inspector General's report. He added that the APA--in addressing the complexities of psychiatric research needs and patient protection--endorses two key principles:

Minimizing risk to those persons who volunteer to participate in research studies; and Maximizing participants' knowledge of what their involvement will entail.

These principles will be implemented with the recognition that some populations evoke greater concern and may require greater protection than others; that additional safeguards should be tailored to the needs of particular populations, rather than being applied on a blanket basis; and that appropriate safeguards are required for permitting persons who lack decision making capacities -- either because of age or illness -- to be entered into research projects.

Noting that many medical conditions such as infection, heart attack, stroke, and metabolic imbalances can impair decision-making, Dr. Appelbaum cautioned against focusing only on the decision-making ability of persons with psychiatric or neurological disorders. He said research shows that many persons with mental disorders have no decision-making impairment. "To classify all person with mental disorders as cognitively impaired would revive the stereotypes against which we have been struggling for so long," he said.

Dr. Appelbaum said the APA is commited to bringing the highest standard to research practices. "Effective research is the key to treating these disorders and to the reduction of the suffering they cause," said Dr. Appelbaum. "The development of a newer generation of antipsychotic medications, with greater efficacy and fewer side effects, has not only yielded significant economic savings, but has more importantly restored hundreds of thousands of patients to functional membership in society. None of these advances would have been possible without the assistance of persons suffering from these disorders, who volunteered to participate in trials of the effectiveness of these new medications."

* In addition to his posts in the APA, Dr. Appelbaum is Professor and Chair of the Department of Psychiatry at the University of Massachusetts Medical School. His research over the last 20 years has focused on legal and ethical aspects of medical practice, including informed consent to medical research.

The American Psychiatric Association is a national medical specialty society, founded in 1844, whose 42,000 physician members specialize in the diagnosis and treatment of mental and emotional illnesses and substance use disorders.
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American Psychiatric Association

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