Guidelines may hinder progress, advocates say

The pending release of national guidelines for using test subjects who have mental illness is getting mixed reactions from advocates for the mentally ill. Some advocates say recommendations from the National Bioethics Advisory Commission will halt many studies designed to find new treatments for mental illness.

The Arlington, VA-based National Alliance for the Mentally Ill (NAMI), a 185,000-member advocacy organization, released a statement last October commending the commission’s work but expressing "deep concern" that one of the proposed recommendations would bring research involving the mentally ill to a "grinding halt."

"A recommendation in the report will greatly limit the ability to conduct research that presents greater than minimal risk’ and does not have direct medical benefits," said NAMI president Jack Shannon. "Short of using elaborate legal mechanisms, it will be virtually impossible for researchers to conduct studies that involve routine procedures such as brain imaging, genetic studies, and brain wave analysis — all of which pose very modest risks to those involved."

These kinds of studies have led to breakthroughs in the treatment of brain disorders such as schizophrenia and bipolar disorder, Shannon noted.

There is no way to eliminate the risk to human study subjects completely, and there is almost always a conflict between attempts to institute protections for individual subjects and the need to design a meaningful study, says Patricia Backlar, research professor of bioethics at Portland State University and assistant director of the Center for Ethics in Health Care at Oregon Health Sciences University, both located in Portland, OR. Backlar is a member of the 17-person multidisciplinary National Bioethics Advisory Commission panel.

Backlar emphasizes that the commission is still at work on a final draft of its recommendations, and she hopes the finished guidelines will balance the needs of the subjects with the demands of the research effectively. The report, titled Research Involving Persons with Mental Disorders that May Affect Decision-Making Capacity, is expected to be released in early 1999.

"What I am really interested in is doing the best we can — making sure these patients have adequate protection," she says.