ETHICAL AND LEGAL ISSUES IN CONDUCTING RESEARCH INVOLVING ELDERLY SUBJECTS

Older people are increasingly the focus of biomedical and behavioral r esearch not only because the elderly constitute the fastest growing se gment of our population but because there is a societal concern to imp rove the elderly's quality of life. The profound need to advance that research carries with it an equally profound obligation to protect the Fights and welfare of elderly research subjects, and thus raises diff icult ethical and legal issues. Against a background of foundational p rinciples for the protection of human subjects, we discuss whether old er subjects should be treated as a special class, the ethical and lega l issues over informed consent, capacities for consent, and special pr oblems related to cognitive impairment. We discuss surrogate/proxy con sent procedures in research, recruitment of elderly subjects, conflict s of interest, special problems regarding institutional research, and risk/benefit analyses. We offer recommendations and practical guidelin es for conducting current and future research involving elderly partic ipants.