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Protection of Human Subjects in Research

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NAMI’s 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 Commission’s (NBAC) consideration of this issue. With NAMI’s 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 NAMI’s policies in this area were adopted by NBAC as formal recommendations to the President, some of which include:

• Recommendation 1: All IRBs that regularly consider proposals involving persons with mental disorders should include at least two members who are familiar with the disorders and concerns of the population, including a consumer, family member, or other advocate;
• Recommendation 3: An IRB should not approve research protocols targeting persons with mental disorders as subjects when such research can be done with other subjects.
• Recommendation 5: Investigators should provide IRBs a thorough evaluation of the risks and potential benefits to the human subjects involved in the proposed protocol.
• Recommendation 6: No person who has the capacity for consent may be enrolled in a study without his or her informed consent;
• Recommendation 7: Any potential or actual subject’s objection to enrollment or to continued participation in a research protocol must always be heeded;
• Recommendation 8: For research protocols that present greater than minimal risk, an IRB should require that an independent professional assess the potential subject’s capacity to consent;
• Recommendation 17: For research protocols involving subjects who have fluctuating or limited decision making capacity or prospective incapacity, IRBs should ensure that investigators establish and maintain ongoing communication with involved caregivers.

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 NBAC’s recommendation of a Institute of Medicine study to examine these issues. Finally, we are working with and support NIMH’s 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.

NAMI’s Advocacy Goals and Strategies

1. NAMI seeks to strengthen the true partnership between consumers and families on the one hand, and researchers, on the other, by:
2. advocating for regulation and/or legislation that will put into practice NAMI’s policies and many of the NBAC recommendations;
3. developing an IRB training program for consumers and families and an informed consent video to be widely disseminated to all researchers and potential subjects in research;
4. working with NIMH and the FDA to enhance scrutiny and protections involved in research involving medication discontinuation/delay and symptom challenge; and
5. researching the views of consumers and family members as they are involved in research and the impact of different policies and practices on consumer experience in research.

For more information about NAMI’s 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 NAMI’s communications staff at 703/516-7963.

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