WASHINGTON -- 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 the patient's permission.
The $50 million, five-year project will involve more than 20,000 patients in 11 sites in the United States and Canada and is designed to improve treatment after 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.
Many trauma specialists and some bioethicists have endorsed the project, but others question it. The harshest critics say the research violates fundamental ethical principles.
The organizers said the studies are going forward only after an exhaustive scientific and ethical review by the National Institutes of Health, which authorized the funding in 2004, and the Food and Drug Administration, which approved the first phase about a year ago and the second phase six months ago.
The studies are being conducted by the Resuscitation Outcomes Consortium, with medical centers in Seattle, Portland, San Diego, Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto, Ottawa, and in Iowa and British Columbia.
The first experiments, involving nearly 6,000 patients, involve patients who are in shock or have suffered head injuries from a crash, fall, or some other trauma.
About 40,000 such patients show up at hospitals each year, and the standard practice is to give them saline infusions to stabilize their blood pressure.
For the study, emergency medical workers are randomly infusing some patients with solutions containing much higher levels of sodium, with or without a drug called dextran. Animal research and small studies involving people have indicated that hypertonic solutions could save more lives and minimize brain damage.
The next experiment, which will involve about 15,000 patients, is designed to determine how best to revive patients whose hearts suddenly stop beating. About 180,000 Americans suffer these sudden cardiac arrests each year.
"We will never know the best way to treat people unless we do this research. And the only way we can do this research, since the person is unconscious, is without consent," said Myron Weisfeldt of the Johns Hopkins University School of Medicine, who is overseeing the project.
Before starting the research at each site, researchers complete a "community consultation" process. Anyone who objects can get a bracelet to alert medical workers that they refuse to participate.
"This just seems like lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible," said George J. Annas, a bioethicist at Boston University. "I don't think we should use people like this."
Others are concerned patients might be getting experimental therapies that could turn out to be inferior to standard treatments.