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 patients’ permission.
The $50 million, five-year project, which will involve more than 20,000 patients in 11 sites in the U.S. 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, 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.
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, a network that includes medical centers in Seattle, Portland, San Diego, Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto and Ottawa and around Iowa and British Columbia.
The first experiments, involving nearly 6,000 patients, involve patients who are in shock or have suffered head injuries.
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. That study is expected to start next month.
“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. “Even if there are family members present, they know their loved one is dying. The ambulance is there. The sirens are going off. You can’t possibly imagine gaining a meaningful informed consent from someone under those circumstances.”
Before starting the research at each site, researchers complete a “community consultation” process. Local organizers try to notify the public about the study and gauge the reaction through public meetings, telephone surveys, Internet postings and advertisements and through stories in local media. Anyone who objects can get a special bracelet to alert medical workers that they refuse to participate.
Some bioethicists say the new research is more ethical than some of the earlier studies in several ways, including that patients are not being denied highly effective therapies. Most patients who receive the current treatments do not survive.
But others say that the studies could be done by finding patients or family members who are in a position to provide consent, even though that might make such studies more difficult.
“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 Annas, a Boston University bioethicist. Annas was particularly disturbed that children as young as 15 might be included in the research.
“Suppose a 15-year-old child is in the back of a car that is in a terrible accident,” Annas said. “The EMTs arrive and say: ’We are doing an experiment with two techniques. We think they are about equal. Is it okay if we flip a coin to see how we treat your son? Or would you rather we just give him the treatment we think is best?’ Unless you think all parents would have the EMTs flip a coin, consent here is necessary.”
But Weisfeldt at Johns Hopkins said the critics would be unhappy under any circumstances.
“Some people object to the whole concept of doing any study whatsoever without permission,” Weisfeldt said. “We try to explain all the layers of approval we’ve gone through and that this is the only way we can do the kind of research that could save many more lives in the future.”