Critical Care Without Consent: Ethicists Disagree on Experimenting During Crises

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. 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 of medical centers that do research in Seattle, Portland, San Diego, Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto and 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 car crash, a fall or some other trauma. About...