In early 2007 the National Institutes of Health (NIH) established NETT – the Neurological Emergencies Treatment Trials. NETT is a permanent research framework that currently involves 22 university medical centers throughout the United States. The Neurotrauma Center at the University of Cincinnati Gardner Neuroscience Institute is part of this large and ongoing program. NETT enables physicians from many disciplines to work together as they search for better ways to treat brain emergencies. With the enduring framework for NETT in place, researchers can begin new neurological emergency studies whenever new therapies become available for testing.
Exception from Informed Consent for Emergency Research
Under normal circumstances, people participate in clinical trials after careful consideration and after providing their consent. People who suffer a brain emergency, however, are unlikely to be conscious or able to provide informed consent for themselves. In such emergency cases, a relative or guardian can provide consent for the patient.
In the event that a relative or guardian cannot be reached, federal law has established a system that allows physicians – when no proven or effective treatment is available — to begin emergency investigational treatment. This is called “exception from informed consent.” This exception from informed consent will be necessary for some clinical trials that are part of NETT. If exception from consent is part of a NETT study, public comment is required before the study begins.
Why Neurological Emergency Research is Necessary
Every year 1.1 million Americans suffer a devastating brain or spine emergency – about one every 28 seconds. These emergencies can be caused by strokes, seizures, vehicle crashes, falls, or severe blows to the head. Every year 250,000 Americans die from brain and spinal emergencies, and thousands more suffer a loss of independence.
NETT was developed because modern medicine cannot cure all sudden brain emergencies. NETT will further researchers’ efforts to develop new therapies that can minimize the damage after an accident, stroke, or seizure has occurred. Testing new therapies is part of the process of finding out which therapies works best.
If you wish to opt out
If you are opposed to being enrolled in a NETT study in the event that you were to suffer a neurological emergency, you can request an “opt out” bracelet by calling 513-558-NETT (0095). Leave your name and address, and a bracelet will be mailed to you.
For more information about NETT, please visit http://nett.umich.edu/nett/welcome
Or contact: 513-558-NETT (0095) or email@example.com