Controlling Research Trials

Abstract

Clinical research, especially in the form of large multicenter trials, promotes changes in practice; without the accrual of new knowledge, clinical care will not advance. A deadlock between the National Heart, Lung, and Blood Institute (NHLBI) and the Office of Human Research Protections (OHRP) of the Department of Health and Human Services about the ethics of a clinical trial has the potential to bring much clinical research to a halt. The trial in question is designed to examine the ability of intravenous-fluid management directed by physiological data obtained from a pulmonary-artery catheter to influence outcomes in medical intensive care units. . . .