Issues Concerning Informed Consent and Protections of Human Subjects in Research

Policies on strengthened standards for protection of individuals with severe
mental illnesses who participate as human subjects in research.
(Adopted by the NAMI Board of Directors, 2/4/95)
1. 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.
2. National standards to govern voluntary consent, comprehensive
exchange of information, and related protections of persons with
cognitive impairments who become research subjects must be
developed, in which the interests of persons who become human
subjects, families and other caregivers are included.
3(A). Participants in research and their involved family members must be
fully and continuously informed, orally and in writing, about all
aspects of the research throughout the process. Research
investigators must provide information in a clear, accessible manner
to ensure that participants and their involved families fully understand
the nature, risks and benefits of the research.
3(B). The consent protocol must provide information which is clear and
understandable on an individual basis for each participant and their
family members. The consent protocol must provide information on the
purposes and scale of the research, what is hoped to be learned and
prospects for success, potential benefits and potential risks to the
individual (including options for treatment other than participation in
research, since research is not the same as treatment). The consent
protocol should also contain information concerning the function of the
Institutional Review Board (IRB), the identity of the IRB Administrator,
the address and telephone number of the IRB administrator and other
information, as appropriate.