National Alliance on Mental Illness
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Protection of Human Subjects in Research
NAMIís Position (Summarized from the NAMI Policy Platform)
NAMI members strongly support severe mental illness research, including research involving human subjects, as this is the basis for all future advances in treatment. However, research involving human subjects must be in accord with the highest scientific, medical, and ethical standards and must protect and honor the individuals and their families who make this contribution to scientific progress. Specifically, NAMI demands that 1) research subjects give truly informed consent and that they and their families fully understand the protocols and risks and benefits of the research; 2) independent and ongoing evaluation of research subject capacity to consent; 3) IRBs include consumers and family members as members; 4) consumers may withdraw from a study at any time, without penalty; 5) at the end of a study, or if a consumer terminates participation prematurely, ongoing effective treatment and aftercare are assured as is feedback on the study results.
Understanding the Issue
As the adequacy of protections for individuals impaired by severe mental illnesses involved in research has come under increased scrutiny, NAMI has sought to implement its ground-breaking policy formulated in 1995. Specifically, while continuing to advocate in the strongest terms for increased severe mental illness research, NAMI most recently and prominently, helped to shape the National Bioethics Advisory Commissionís (NBAC) consideration of this issue. With NAMIís executive director, Laurie Flynn, as a presidentially-appointed member of the commission and written and oral testimony provided by NAMI leadership and staff, many of NAMIís policies in this area were adopted by NBAC as formal recommendations to the President, some of which include:
Amid significant controversy, NBAC recommended enhanced regulation and limits on research involving subjects with impaired judgment in which there is more than minimal risk and no likely benefit to the subject. NAMI and other research advocates were concerned that such regulations would needlessly hamper crucial research, such as PET scans, MRIs, and EEGs, which typically involve very limited risk but offer great opportunity for increased knowledge of these brain disorders. NAMI hopes that the creation of a Special Standing Panel by the Secretary of the Department of Health and Human Services will expeditiously consider these issues and offer guidance that will permit important brain research to move forward without unnecessary regulatory burden.
NAMI continues to take initiatives in research ethics, beginning its own program to recruit, train, and place consumers and family members on IRBs and to create a video on informed consent that all potential research subjects can view and learn about their rights in research. NAMI has also been taking the pulse of consumers to ascertain their own views of research, showing, for the first time, that consumers overwhelmingly support research; that they often do so for altruistic reasons; but, that they want to be full partners in the research enterprise, with all the dignity and decision-making power that affords. NAMI continues to examine troubling issues in research, including studies involving the delay and discontinuation of treatment and/or symptom provocation, so as to promote the highest quality, safe research possible. We are pleased with NBACís recommendation of a Institute of Medicine study to examine these issues. Finally, we are working with and support NIMHís examination of ethical issues in psychiatric research, and their move to enhance both intramural and extramural research practices involving human subjects with severe mental illness.
NAMIís Advocacy Goals and Strategies
For more information about NAMIís activities on this issue, please call Rex Cowdry, M.D. at 703/312-7887, or Laurie Flynn at 703-312-7888. All media representatives, please call NAMIís communications staff at 703/516-7963.