New Protections Urged for Mentally Ill

WASHINGTON — A presidential advisory commission that studies bioethical issues is expected today to call for increased protections for research subjects who have mental disorders and whose decision-making capacity may be impaired.

Acknowledging the critical importance of research into mental disorders, the National Bioethics Advisory Commission nevertheless described current safeguards as inadequate and said that more needs to be done to ensure that those who participate in such studies receive ethical treatment.

“We anticipate that many new, potentially useful therapies for treating [mental] disorders will be developed over the next few years,” committee members said in the draft of their report, scheduled to be formally voted upon today.

“The prospect of increasing numbers of research protocols, with the attendant potential increase in the number of persons with impaired decision-making capacity in these kinds of studies, makes it all the more important to clarify the ethical framework required for such research,” the report said.

In any given year, more than 5 million Americans suffer an acute episode of a major mental illness and one in five families in the nation will have to deal at some point during their lives with someone who experiences a mental disorder, according to the National Alliance for the Mentally Ill.

In the draft, commission members repeatedly cited a tragedy that was revealed in 1994 involving two subjects in a UCLA study of an anti-schizophrenia drug who were taken off the medication without their knowledge. One threatened to kill his parents and attempted to travel to Washington to assassinate the president. The other later committed suicide. The researchers were reprimanded by the National Institutes of Health for failing to provide “informed consent.”

The concept of informed consent--in which subjects are required to be fully informed of the potential risks and benefits of medical experiments in which they participate--and the work of institutional review boards that approve research proposals have been the ethical cornerstones of research in this country for more than two decades.

But there are obvious inherent tensions in studying patients with mental disorders. On one hand, patients and their families “desperately want medical science to find ways to improve their conditions,” the report said. On the other hand, there is much disagreement about how this can be done “without exploiting those . . . who participate.”

Currently, there are no specific federal regulations targeted for research participants who experience mental disorders, although existing rules cover them--and other populations--generally. There are specific regulations that apply to children, women and prisoners.

The commission, which was appointed in 1995 by President Clinton to advise the White House on bioethical issues arising from research, said that it found no instances of widespread abuse in this area.

But members said they worried that the lack of specific protections could raise the risk of future harm.

The recommendations will be forwarded to the White House, which will decide whether to implement them through federal regulation.

In the meantime, the commission is expected to urge the research community to follow them voluntarily.

The report, which followed a year of study, recommended among other things that institutional review boards that examine research proposed for a specific mental condition have at least two experts familiar with the disorder participate in the review process.

One of them, preferably, should be diagnosed with the disorder, be a family member of such a person or come from an advocacy organization for the disorder, the group said.

Such representation would ensure that the board’s decisions “will be responsive” to the interests of the affected groups, the report said.

The commission also urged that people with mental disorders not be involved in research if other subjects would suffice--that is, mentally ill individuals should not be recruited simply because they may be more available than other possible participants.