Ethical and legal issues in conducting research involving elderly subjects.

Older people are increasingly the focus of biomedical and behavioral research not only because the elderly constitute the fastest growing segment of our population but because there is a societal concern to improve the elderly's quality of life. The profound need to advance that research carries with it an equally profound obligation to protect the rights and welfare of elderly research subjects, and thus raises difficult ethical and legal issues. Against a background of foundational principles for the protection of human subjects, we discuss whether older subjects should be treated as a special class, the ethical and legal issues over informed consent, capacities for consent, and special problems related to cognitive impairment. We discuss surrogate/proxy consent procedures in research, recruitment of elderly subjects, conflicts of interest, special problems regarding institutional research, and risk/benefit analyses. We offer recommendations and practical guidelines for conducting current and future research involving elderly participants.