Research Involving Cognitively Impaired Adults

Abstract

Although the federal government funds research to improve the lives of critically ill adults and of the people who care for them, recent investigations show that it does not provide investigators with guidelines for ensuring that such research is on firm ethical grounds, especially in the case of cognitively impaired subjects.¹⁴ Federal regulations for the protection of research participants, known as “the common rule,” require that research involving “vulnerable” subjects include “additional safeguards” (45 CFR 46.111) and that the investigator obtain informed consent from a “legally authorized representative” (45 CFR 46.116).⁵ But the rule does not describe safeguards in . . .