Suspension of the NIH ARDS Network fluids and catheters treatment trial

Excerpt

Recently, the National Heart, Lung, and Blood Institute (NHLBI) of the United States National Institutes of Health (NIH) suspended the "Fluids and Catheters Treatment Trial" (FACTT) conducted by the Acute Respiratory Distress Syndrome (ARDS) Network because concerns were raised regarding the safety of patients. This spectacular decision was taken after a federal office in charge of overseeing research involving human subjects, the Office for Humane Research Protection (OHRP) questioned the study design and patients' safety in another study previously conducted by the ARDS Network, a trial of mechanical ventilation with lower tidal volumes, completed and published with much publicity in 2001 [1]. A recent issue of the New England Journal of Medicine (3 April 2003) included several articles on the problems raised by this important crisis in the clinical research realm, for example, research with or without direct benefit to enrolled patients, safety of patients during clinical trials, consent to critical care research, surrogacy, control group in trials dealing with deadly diseases, and definition of "routine care." …