The National Bioethics Advisory Commission has issued a series of recommendations designed to protect psychiatric patients who participate in medical research, a group that currently has no special protections under federal laws and regulations. The recommendations were released over the strong objections of the American Psychiatric Association, which argued that by focusing on the need for additional protections specifically for persons with mental disorders, the commission needlessly stigmatizes these individuals.
The recommendations were issued November 18 in a report entitled Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity and were forwarded to President Clinton, who appointed the commission. If they are adopted, they could be incorporated into existing federal regulations and state laws, bringing more consistency to rules about such research, which now vary widely among the states. However, previous recommendations on research involving institutionalized mentally disabled persons developed in the 1970s were never adopted at the federal level, largely because of objections to the more stringent procedural requirements they advocated.
In separate appearances before the commission in October and November, before the report was released, Harold A. Pincus, M.D., APA deputy medical director, and Ronald Shellow, M.D., chair of APA's commission on government relations, unsuccessfully urged the commission to broaden the recommendations to cover other medical conditions that may reduce decision-making capacity, such as trauma, stroke, and a variety of brain disorders that affect central nervous system functioning. They argued that many individuals with particular diagnoses of mental illness do not as a group have any higher incidence of impaired decision-making capacity than the general population of potential research participants.
APA also objected to the commission's recommendation that research posing a greater than minimal risk without the prospect of direct medical benefit must receive prior approval by a standing Federal Panel on Research on Persons With Impaired Decisionmaking. The commission created the panel after it failed to reach consensus on the controversial question of whether a representative of a mentally ill patient, such as a family member, has the right to enroll the patient in a risky medical study that offers no prospect of benefiting the patient.
APA contended that the panel would not be any more successful in resolving issues surrounding such research than the commission itself had been. The association also argued that the need to gain the panel's approval would restrict the ability of scientists to conduct research that may yield important breakthroughs in the treatment of mental illness.
The 20 recommendations promulgated by the commission cover six areas: review bodies, such as institutional review boards; research design; informed consent and capacity; categories of research; surrogate decision making; and education, research, and support.
Two of the recommendations focus on review bodies. The first calls for institutional review boards that regularly consider research proposals involving persons with mental disorders to include at least two members who are familiar with the nature of the disorders and with the concerns of the population being studied. At least one of the members should be a representative of the study population, a family member or friend of such a person, or a representative of an advocacy organization for the population. Review boards that only irregularly consider such proposals should include two ad hoc consultants who meet the same criteria.
The second recommendation asks the Secretary of Health and Human Services to convene the standing federal panel to review research protocols from institutional review boards that involve greater than minimal risk without the prospect of direct benefits to the subjects. The panel would also develop guidelines for use by the review boards and data on risks of research interventions and on attitudes toward participation in research.
Major recommendations in other areas are as follows.
No research targeting persons with mental disorders may be done when the research can be carried out with other subjects. Investigators should provide institutional review boards with a thorough justification of the research design they will use and a thorough evaluation of the risks and potential benefits to research subjects.
Capacity and informed consent.
No person who is capable of making informed decisions may be enrolled in a study without his or her informed consent. A person's choice not to participate or not to continue in a study must be honored. Research protocols that present a greater than minimal risk should employ an independent, qualified professional to assess the potential subject's capacity to decide whether to participate in the study. A person who has been determined to lack capacity to consent to participate must be notified of that determination before his or her legally authorized representative is contacted for permission to participate.
A review board may approve a protocol that presents minimal risk, regardless of prospective benefit, or greater than minimal risk with the prospect of direct medical benefit if the subject consents or has authorized someone else to enroll him or her in the study. Research involving greater than minimal risk that does not offer the prospect of direct medical benefit may be approved by the review board if the potential subject gives informed consent or has given prospective authorization, or if the protocol falls within the guidelines announced by the federal panel and the potential subject's legally authorized subject gives informed consent.
Surrogate decision making.
A person who has the capacity to make decisions about participation in research may give prospective authorization to a specific type of research if its general risks, direct benefits, indirect benefits, and other pertinent conditions have been explained. A legally authorized representative may give permission to enroll a person who lacks the capacity to decide whether to participate if the representative bases decisions about participation on a best estimate of what the subject would have done if capable of making a decision and if the representative is available to monitor the subject's recruitment, participation, and withdrawal from the study.
Investigators and others involved in research should find ways to recognize involved family and friends of incapacitated patients as part of the health care team and to share appropriate information with them. States that do not already recognize relatives and trusted friends as legally authorized representatives should expand their definitions by statute or judicial decision. States should amend current laws governing durable powers of attorney so that persons creating these kinds of documents would be entitled to grant decision-making authority for research participation.
Education, research, and support.
Professional associations and organizations should develop or review existing educational materials pertaining to research involving persons with mental disorders. The National Institutes of Health should sponsor research that can expand knowledge about the most reliable methods for assessing decision-making capability, the most comprehensive means of evaluating cognitive process among those with impaired decision-making ability, and the best techniques for enhancing informed-consent processes for persons with decisional impairments. When compliance with these recommendations requires additional expenditures, research sponsors, federal or otherwise, should make such additional funds available.
The report can be found on the Internet at http://www.bioethics.gov.
To ensure that mental health managed care programs provide culturally competent services to the growing number of ethnic minorities in the U.S. population, a recent report urges that all public and private mental health agencies be staffed with culturally competent and appropriately qualified bicultural and bilingual personnel. It recommends that cultural-competence training be provided to all direct care staff and those with management responsibilities.
The report was prepared by representatives of four ethnic and racial minority groups—African Americans, Asian Americans and Pacific Islanders, Latinos, and Native Americans. All four groups have been found to be underserved by mental health services and underrepresented in the mental health workforce, including among administrators, service providers, researchers, and educators.
The cultural competence standards were developed through a contract with the mental health program of the Western Interstate Commission for Higher Education and funded by the Center for Mental Health Services (CMHS).
Representatives of the four ethnic groups began meeting in separate panels in 1996 to develop cultural competence standards for their particular group. In June 1997 the co-chairs and selected members of the four panels met together in Washington, D.C., to reach a consensus about core cultural-competence standards applicable to all four groups. Those standards, along with 16 guiding principles, form the basis of the report and are complemented by guidelines for implementation.
As defined in the report, cultural competence includes attaining the knowledge, skills, and attitudes to enable administrators and practitioners within systems of care to provide effective care for diverse populations. The definition further declares that recovery and rehabilitation are more likely to occur where managed care systems, services, and providers have and use knowledge and skills that are culturally competent and are compatible with the backgrounds of consumers from the four racial-ethnic groups, their families, and communities.
U.S. Census data indicate that the four groups will make up an increasing proportion of the U.S. population over the next 50 years. The biggest growth is expected among Hispanics, who represented 10.5 percent of the population in 1996 but are estimated to constitute 24.5 percent in 2050. The percentage of Asian Americans and Pacific Islanders will increase from 3.4 percent in 1996 to 8.2 percent in 2050. Slower growth is expected among African Americans, from 12.1 percent to 13.6 percent, and among American Indians, from .7 percent to .9 percent. The percentage of Americans categorized as white is expected to decrease from 73.3 percent in 1996 to 52.8 percent in 2050.
The standards call for the development of a cultural-competence plan for each managed care mental health plan within both the public and the private sectors; they also call for the incorporation of boards or advisory committees proportionally representative of the consumer populations to be served and the community at large. Equitable access and comparability of benefits across all populations and age groups should be assured. Services should be provided regardless of immigration status, insurance coverage, or language, and each treatment plan should be relevant to the consumer's culture and life experiences.
Another standard requires each health plan to develop and maintain a database to track utilization and outcomes for the four ethnic groups across all levels of care, ensuring comparability of benefits, access to services, and outcomes. The health plan must also develop and manage databases of social and mental health indicators on the covered population from the four groups and the community at large.
The project to develop the standards was part of the CMHS-sponsored Managed Care and Workforce Training Initiative coordinated by the Center for Mental Health Policy and Services Research at the University of Pennsylvania School of Medicine.
The standards are accessible on the Internet at www.mentalhealth.org/ managedcare/cc-stds.
A landmark study in five states indicates that states have the potential to compile and report data on similar performance indicators for their state mental health programs, opening the way for national reporting of comparable data for state programs in the future. However, the report of the study cautions that substantial work still remains to ensure that the measures used are truly comparable across states, and federal funding and technical support are needed to help states fully implement performance measurement systems.
The study, conducted by the National Association of State Mental Health Program Directors Research Institute, was designed to determine whether states with major differences in service and information systems could obtain data on a core set of 28 performance indicators identified by various national organizations as covering critical areas on which a mental health system should be monitored. Indicators selected were those that at least some of the five states could report on within nine months.
The five states—Colorado, Illinois, Massachusetts, South Carolina, and Texas—were selected because of their diversity in geography, organizational structure, funding and service systems, managed care implementation, subgroups served, and the level of development of performance measurement systems.
Ten of the 28 performance indicators covered outcomes, 13 appropriateness and quality, three access, and two structure and plan management. All five states were able to report data on 13 of the 28 indicators (46 percent), and data on three additional indicators were reported by four states (11 percent).
All five states were most able to report data on appropriateness and quality of services, such as supported housing, supported employment, and readmissions within 30 days. They were also able to report on consumer status (outcomes), such as living arrangements and percent homeless; on access measures, such as utilization rates and proportion of consumers receiving community services; and on measures of structure, such as community expenditures and percent of the budget spent on community services.
Measures of outcomes of services, such as improvement in functioning, reduction in psychiatric symptoms, and improvements in school behavior, were the least comparable measures among the states.
Together, the five states reported on services to more than 491,000 individuals in the state fiscal year 1997. Besides assessing states' ability to report comparable measures, the study yielded information about the characteristics of the populations served and the effectiveness of services. It showed that 16 percent of the consumers served in the five state systems had a primary diagnosis of schizophrenia, and 31 percent of affective disorders.
More than 79 percent of consumers surveyed strongly agreed or agreed that they had access to needed services, and 65 percent reported improved outcomes as a result of the services.
A report of the study, entitled Five-State Feasibility Study on State Mental Health Agency Performance Measures, is accessible on the Internet at http://www.mentalhealth.org/mhstats/ feafinal.htm.
Bupropion Pregnancy Registry
Glaxo Wellcome has established the Bupropion Pregnancy Registry in conjunction with the Centers for Disease Control and Prevention and experts in obstetrics and gynecology, teratology, clinical genetics, pediatrics, internal medicine, and epidemiology. The registry is an ongoing national study whose purpose is to monitor women who have intentionally or inadvertently taken bupropion during any portion of their pregnancy for evidence of any major effect on the developing fetus. Physicians and other health care providers with patients who have taken bupropion at any time during pregnancy are encouraged to notify the registry as early in the patient's pregnancy as possible by calling 888-825-5249, ext. 39441, or 919-483-9441.