A Survey of Researchers Using a Consent Policy for Cognitively Impaired Human Research Subjects

Abstract

Illnesses leading to some degree of cognitive impairment are a considerable health problem in the United States. These include Huntington’s disease, cerebrovascular disease, psychiatric disorders, chronic alcoholism, and AIDS dementia complex. For many years, investigators at the Warren G. Magnuson Clinical Center (CC) of the National Institutes of Health have conducted research involving cognitively impaired subjects in order to investigate the etiology and treatment of these disorders. However, dementing and mental disorders may limit or destroy research subjects’ abilities to give informed consent. Therefore, a challenge to all institutions and investigators conducting such research is balancing the scientific mandate to advance knowledge with the ethical requirement to protect the rights and safeguard the welfare of human subjects. The Belmont Report interprets the relevant principle of respect for persons as incorporating two ethical convictions: that individuals should be treated as autonomous agents, and that persons with diminished autonomy are entitled to protection. Also, protecting human subjects with diminished autonomy is addressed broadly in Department of Health and Human Services regulations: “where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, . . . appropriate additional safeguards have been included to protect the rights and welfare of these subjects . . . .” In 1987, the CC adopted an informed consent policy that provides additional safeguards for research subjects who, because of their underlying diseases, are or are likely to become cognitively impaired during the course of the research. We report the results of a survey conducted in 1990 to address practices and attitudes concerning this policy. It is our intent that by presenting the experience with the CC policy, other IRBs and researchers will be encouraged to evaluate and formulate practical safeguards for cognitively impaired research subjects.