The federal government is undertaking the most ambitious set of studies ever mounted under a controversial arrangement that allows researchers to conduct some kinds of medical experiments without first getting patients' permission.
The $50 million, five-year project, which will involve more than 20,000 patients in 11 sites in the United States and Canada, is designed to improve treatment after car accidents, shootings, cardiac arrest and other emergencies.
The three studies, organizers say, offer an unprecedented opportunity to find better ways to resuscitate people whose hearts suddenly stop, to stabilize patients who go into shock and to minimize damage from head injuries. Because such patients are usually unconscious at a time when every minute counts, it is often impossible to get consent from them or their families, the organizers say.
The project has been endorsed by many trauma experts and some bioethicists, but others question it. The harshest critics say the research violates fundamental ethical principles.
My colleague at UW, Dr. Norman Fost, was a leading proponent of the regulatory changes that permit such research. I have been of mixed mind on this topic.