New investigational drugs and devices are commonly used in critically ill patients. The development of new drugs and the role of the critical care nurse caring for subjects in clinical trials are crucial to the success of the research process. The purpose of this article is to discuss the Food and Drug Administration's regulatory approval process for significant risk investigational devices.

Critical care nurses may be faced with assisting or conducting clinical research during their career. Also, critical care nurses frequently care for cognitively impaired patients who may become subjects in a clinical study. This article provides insight into the ethical principles in clinical research as they pertain to subjects who may have diminished ability to make their own decisions.