Protecting patients during clinical research.

Jacqueline Byers is an associate professor at the University of Central Florida in Orlando, Fla. She has served on bioethics committees and institutional review boards for more than a decade. ment and you realize that the patient or family is not aware that the patient could have been randomized to placebo (no treatment). In this article, I discuss ethical and statutory obligations for protecting patients during the research process and explain how to meet those obligations in critical care research situations.