November 20, 1998

The determination of whether psychiatric patients can participate in research should be based on their decision-making capacity. This is the recommendation that APA made to the National Bioethics Advisory Commission (NBAC) at a hearing last month in Arlington, Va.

At press time, the NBAC's draft report, titled "Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity," was expected to be finalized this month.

"The commission's broad focus on mental disorders unnecessarily stigmatizes these individuals and is not based on our current scientific understanding of these illnesses," according to testimony presented by Harold Pincus, M.D., an APA deputy medical director and director of APA's Office of Research. He advised that the commission change the report, recommendations, and title to focus instead on disorders that may impair decision-making capacity.

"Individuals with primary insomnia, mild depression or anxiety, sexual dysfunction, or certain specific phobias are not likely to have a higher incidence of impaired decision making than the general population of potential research participants," said Pincus. "A more accurate term would be 'disorders that may affect decision making.' "

The report and recommendations should also consider medical conditions, such as trauma, stroke, and a variety of other disorders, that reduce decision-making capacity and affect the functioning of the central nervous system, according to Pincus.

Pincus expressed APA's view that requiring Institutional Review Boards (IRBs) to apply additional layers of protections uniquely for all psychiatric patients is unnecessary and may unduly burden future psychiatric research.

If young, talented individuals interested in psychiatric research perceive additional barriers to conducting research, they may decide to enter other lines of research or work, stated Pincus.

"We also believe that NBAC's support for a two-tiered level of risk-minimal risk and greater than minimal risk research-should be changed to a graduated level of risk with the appropriate protections."

Otherwise, minimal risk studies such as questionnaires about a participant's sexual behavior or drug use may be classified as greater than minimal risk, "which would lead to additional onerous procedural requirements that are simply not necessary to protect participants," Pincus testified.

Jay Cutler, J.D., director of APA's Division of Government Relations, commented in a memo to APA research components on the latest NBAC draft released at its meeting last month. He referred to a few changes, which APA supports, that were made since the first draft was released in July. For example, the report no longer recommends that every research participant undergo an independent mental capacity assessment but limits that requirement to participants in studies of greater than minimal risk.

Furthermore, the earlier draft called for IRBs to have two members familiar with the concerns of the mentally ill, with one member being mentally ill or a family member or a representative of an advocacy group for the mentally ill. That has been changed to one IRB member who, at minimum, must be familiar with the concerns of the mentally ill.

Cutler credited the changes in large measure to APA's lobbying efforts, including sending the NBAC a letter drafted by the Mental Health Liaison Group, of which APA is a member, and meeting with the commission's executive staff.

The Mental Health Liaison Group letter was signed by 30 member organizations representing patients, family members, advocates, physicians, and other providers. The letter asked the commission to change the focus of the report from individuals with mental disorders to individuals with impaired decision-making capacity. The letter states that the report "perpetuates the notion that individuals with mental illness are a 'uniquely incompetent class of individuals.'"

APA's views were also reinforced by the National Depressive and Manic-Depressive Association (NDMDA) in a letter to the NBAC last month. The NDMDA noted that many of its members want the opportunity to participate in research trials and expressed its concern that the current focus of the NBAC report and recommendations would limit its members' ability to participate in research.

The National Alliance on Mental Illness (NAMI) issued a statement last month urging the NBAC to reconsider its recommendation that IRBs not approve research with greater than minimal risk if the research does not directly benefit the research participants. NAMI President Jackie Shannon said in the statement, "Because research is so critical to the future of people with mental illness, this threat to future research must be taken seriously."

The text of the NBAC draft report can be read at the NBAC Web site, www.bioethics.gov.