Research involving subjects with dementia and other cognitive impairments

Abstract

Illnesses that involve some degree of cognitive impairment and are of interest to neurologic researchers include Alzheimer's disease, Huntington's chorea, cerebrovascular disease, some psychiatric disorders, chronic alcoholism, and AIDS dementia complex. Dementing and some psychiatric illnesses compromise or eliminate a research subject's ability to provide valid informed consent, and thus research on these disorders presents ethical challenges. This paper provides an overview of the Warren G. Magnuson Clinical Center's (CC's) approach to some of these challenges. We hope it will encourage neurologists to participate in and inform the ongoing national debate about the ethical and legal aspects of research involving cognitively impaired human subjects. The Belmont Report [1] articulates the ethical principles relevant to the conduct of all research with human subjects. The principle of \``Respect for Persons'' incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principles of the Belmont Report are incorporated into Department of Health and Human Services (DHHS) regulations (45 Code of Federal Regulations [CFR] 46--Protection of Human Subjects). These regulations charge institutional review boards (IRBs) with protecting the rights and welfare of human subjects, including those who are cognitively impaired. IRBs are given broad authority by 45 CFR 46.111(b) to ensure that, \``where some or all …