NAMI Applauds Research Protections, Opposes Threats to Research In Draft Report Issued By National Bioethics Advisory Commission
Statement by Jackie Shannon, President National Alliance for the Mentally Ill (NAMI)
Oct 20 1998
The National Alliance for the Mentally Ill (NAMI) today commends the National Bioethics Advisory Commission (NBAC) for its draft report that will significantly enhance protections for individuals with mental illnesses who participate as human subjects in research. However, we are deeply concerned that the report, Research Involving Persons with Disorders that May Affect Decision-making Capacity, includes a specific recommendation that has the real potential of bringing such research to a grinding halt.
NAMI’s Primary Concern About the NBAC Report
A recommendation in the report will greatly limit the ability to conduct research that presents "greater than minimal risk" (as defined in the NBAC report) and that does not have direct medical benefits. Short of using elaborate legal mechanisms, it will be virtually impossible for researchers to conduct studies that involve routine procedures such as brain imaging, genetics studies, and brain waves analysis – all of which pose very modest risks to those involved. These are the kinds of studies that will likely lead to breakthroughs in understanding serious brain disorders such as schizophrenia and bipolar disorder.
Because research is so critical to the future of people with mental illnesses, this threat to future research must be taken seriously. This recommendation also fails to recognize the heroic contribution that consumers willingly make to advancing the scientific understanding of the true nature of serious brain disorders. These individuals are intensely committed to making a contribution that may one day lead to a medical breakthrough.
NAMI Supports NBAC’s Research Protections
Research advances, however, must never come at the price of a patient’s health and well-being. For that reason, we applaud the many recommendations in the NBAC report that embrace specific measures for which NAMI has been advocating for several years. These measures, which were adopted as official NAMI policy in 1995, include the following:
- that institutional review boards include the active participation of consumers and family members who have direct and personal experience with the illness being studied
- that all participants in research protocols that involve the assessment of new medications are provided with opportunities for a trial on the medication being studied
- that the research investigator should not be an individual’s primary clinician to ensure that the goals of the research do not supersede the health and well-being of the individual
- that the informed consent process be strengthened through the application of a number of measures (e.g., the use of independent auditors to witness the informed consent process; giving family members a role in the process; and allowing for clear and continual informed consent by research participants)
NAMI’s Role in Research Advocacy
The National Alliance for the Mentally Ill (NAMI) is this country’s leading grassroots advocacy organization representing more than 185,000 consumers and family members throughout the United States. Since NAMI’s inception nearly 20 years ago, research has been at the center of our advocacy and vision for improving the quality of life for millions of individuals affected by severe mental illnesses.
Our members, who face the daily hardships and challenges of severe mental illnesses, passionately support the need for continued and vigorous research into the causes, symptoms and treatments of debilitating brain disorders. In fact, hundreds of our members have participated in research, as subjects, supportive family members, and members of Institutional Review Boards. NAMI has taken a lead in research by helping to found the National Alliance of Research on Schizophrenia and Affective Disorders. In addition, NAMI also directs its own Research Institute that has become one of the largest supporters of schizophrenia and bipolar disorder research in this country.
In the last decade, significant scientific advances have provided the first real hope for people with severe mental illnesses. Pioneering research has found a biological basis for serious brain disorders and effective treatments are restoring people’s lives. But, we’re far from discovering a cure to these debilitating disorders and many individuals will continue to suffer until research unlocks the key to understanding.
NAMI accepts the critical necessity for research using human subjects, acknowledges the important contribution of persons who become human subjects, and affirms that all such research should be conducted in accordance with the highest medical, ethical, and scientific standards. Indeed, NAMI consumers and family members have led this nation’s advocacy efforts to improve protections for subjects with mental disorders so that no one suffers unnecessarily while participating in research.
In closing, I want to take this opportunity to convey my deepest appreciation to Laurie Flynn, NAMI’s executive director and member of the National Bioethics Advisory Commission, for her continued leadership in representing before the Commission the concerns of tens of thousands of consumers and family members directly affected by mental illness in this country.
NAMI will continue to advocate for vibrant research into the causes, symptoms, and treatments of severe and persistent mental illnesses that fully honors, protects and partners with consumers and their families.
With more than 185,000 members, NAMI is the nation’s leading grassroots advocacy organization solely dedicated to improving the lives of persons with severe mental illnesses including schizophrenia, bipolar disorder (manic-depressive illness), major depression, obsessive-compulsive disorder, and severe anxiety disorders. NAMI’s efforts focus on support to persons with serious brain disorders and to their families; advocacy for nondiscriminatory and equitable federal, state, and private-sector policies; research into the causes, symptoms and treatments for brain disorders; and education to eliminate the pervasive stigma surrounding severe mental illness. NAMI has more than 1,200 state and local affiliates in all 50 states, the District of Columbia, Puerto Rico, American Samoa, and Canada.