Abstract
There has been substantial recent activity addressed at the challenge of protecting the rights and welfare of vulnerable human participants in various kinds of research protocols, on one hand, without unduly impeding the conduct of research that promises findings that may substantially improve health and quality of life for many beneficiaries of research, on the other. Many of the emerging recommendations for improved participant protection are relevant to, and in some cases explicitly targeted at, vulnerable older persons, including long-term, chronically dependent nursing home and home health patients, who may be approached by investigators. Thus far, virtually all of the discussion and recommendations regarding research participant protection pertain to possible legal and policy changes at the federal level. Yet, both current federal law and emerging policy recommendations defer, either expressly or by default through their silence, on some very important matters about research participation, especially regarding informed consent, determinations of decisional capacity, and surrogate decision-making authority, to the laws of individual states. This article analyzes and interweaves recommendations regarding the role of state law and public policy in protecting older persons who are or may become participants in long-term care research projects.