MIAMI FL -- A presidential advisory commission studying bioethical issues today recommended that the federal government adopt new regulations to protect people with mental disorders who are involved as subjects in research. In a report approved at its meeting here today, the National Bioethics Advisory Commission (NBAC) proposes a number of additional safeguards to ensure that when people suffering from such conditions as schizophrenia, manic depression, dementia, or mental retardation and cannot give their fully informed consent, there are appropriate protections in place to enroll them in clinical trials.

        The recommendations are directed at institutional review boards (IRBs), which are responsible for reviewing and approving research; the National Institutes of Health, professional organizations, and state legislatures. If adopted by the federal government, these would be the first regulations ever promulgated in the U.S. specifically designed to ensure that the rights and welfare of research subjects with mental disorders are protected. They also would help researchers better understand the ethical constraints under which research can proceed.

        The report follows more than a year of study by NBAC. NBAC was appointed in 1995 by President Clinton to advise the White House's National Science and Technology Council and other government entities on bioethical issues arising from research on human biology and behavior. Chaired by Princeton University President Harold T. Shapiro, Ph.D., the 17-member commission is comprised of physicians, theologians, ethicists, scientists, psychologists, legal experts, and mental health advocates.

        Currently, research involving adults suffering from mental disorders is not governed by a specific set of regulations, although existing federal regulations do apply generally to these and other populations. Other populations who participate in clinical investigations such as children, pregnant women, and prisoners are protected through additional regulations. But the same protections are not extended to people who suffer from mental disorders.

        "We want to ensure that all research goes ahead under appropriate ethical guidance and provide the public with confidence in medical research so that the twin goals of subject protection and research progress can be met,"says Shapiro. "By extending the same safeguards to people with mental disorders that already exist for other vulnerable groups, a gap in current federal research standards can be closed."

        People with mental disorders are needed to participate in research trials to test the benefits of therapies linked to their conditions. A diagnosis of a mental disorder does not necessarily render someone incapable of deciding whether to participate in research. But some conditions make it difficult, if not impossible, to give fully informed consent.

        The Commission has found no indication that there are widespread abuses occurring in research involving mentally ill people. But there is a perception that a lack of specific guidelines puts these people at risk of exploitation and harm. The longer this gap persists, commissioners say, the greater the likelihood that inappropriate research will go forward. This could inadvertently halt valuable research that has led to the development of such life-saving drugs as clozapine for schizophrenia and lithium for bipolar disorders.

        The report specifies conditions and steps IRBs and researchers need to take to address those concerns, including the importance of assessing the capacity of potential subjects, how to handle research that presents greater than minimal risk and does not offer the prospect of direct benefit to the subject, and how to involve others in decisionmaking about research participation.

        The Commission does not believe that the added regulations will inappropriately impede research or excessively burden researchers. By articulating the conditions under which research should take place, NBAC hopes to give investigators the tools they need to appropriately protect the public from harm. These safeguards can be embraced while still encouraging important research to flourish, says the commission.

        The report includes recommendations for regulatory reform and a number of other important areas of guidance. Many of the recommendations are directed at institutional review boards. Here is a summary of them:

o All IRBs that consider proposals involving people with mental disorders should have at least two members who are familiar with the nature of this condition and the concerns of this population. This would help ensure that the special concerns of the population are likely to be represented.

• The Secretary of the Department of Health and Human Services should convene a federal panel on Research Involving Persons with Impaired Decisionmaking to review and approve protocols from IRBs that involve greater than minimal risk without the prospect of direct benefit. The panel would provide another avenue in which important research can be reviewed and discussed to ensure the public that ethical views are being considered at a national level.

• IRBs should not approve research targeting people with mental disorders as subjects when other subjects would suffice. The commission doesn't think mentally ill people should be "unfairly burdened" with involvement in research simply because they may be more available.

• An IRB should not approve research that involves greater than minimal risk unless a qualified professional who is independent of the research team assesses the subject's capacity using an appropriate method.

• A person who has been deemed unable to make decisions must be notified of that determination before permission can be sought from a legally authorized representative to enroll that person in an investigation.

• A subject's refusal to participate in research must be honored whether the subject previously agreed to participate in research when competent to do so. Although dissent must always be respected, there are cases when investigators can reproach to ascertain whether the individual would like to participate.

• Investigators should provide a detailed explanation of their assessment of risks and benefits of research.

• Investigators should provide a detailed justification of the research design they will use, including any efforts they will use to reduce the risk in studies.

• An IRB may approve protocols for research that presents greater than minimal risk and offers the prospect of direct benefit if the potential subject is capable of making a decision about participation. In the case of subjects who are incapable of making a decision, protocols would be allowed if certain conditions are met to ensure that the subject has expressed a wish to participate or the subject's legal representative has given permission.

        The Commission also is recommending that additional research be done to provide information about assessment of capacity, informed consent and other relevant topics.

        Within the next few weeks, the final report will be forwarded to the White House. Meanwhile, NBAC is urging researchers to adopt them voluntarily.

        NBAC was established in October 1995 to advise the National Science and Technology Council and other appropriate government entities regarding bioethical issues arising from research on human biology and behavior. NBAC's first priority, as directed in its Executive Order, was to "consider the protection of the rights and welfare of human research subjects; and issues in the management and use of genetic information." The Order encourages NBAC to identify other bioethical issues for the purpose of providing advice and recommendations.

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