A controversial drug test on non-consenting patients has been proposed by doctors in Massachusetts. The trial, which will test the effectiveness of the drug progesterone, would involve patients who have sustained a brain injury a few hours before treatment. Many patients arrive at hospital unconscious and doctors argue that they need to perform the test without their consent.
The study, recently submitted to the Food and Drug Administration for approval, will examine the efficacy of the drug in preventing a "secondary cascade" of brain injury resulting from swelling, fluid build-up and metabolic changes.
"We have a devastating disease that causes tremendous lifelong disability for people around the country and around the world, with no proven treatment," said Dr Joshua Goldstein, an investigator and director of the Center for Neurologic Emergencies at Massachusetts General. "We're hoping that the time has come to find a treatment."
But some bioethicists believe that informed consent is almost always more important than research. George Annas, a Boston University bioethicist who is not involved in the brain trauma proposal, argued that "you need something that's as powerful as consent". "People don't expect to be researched on when they go to an emergency department, and they don't consent to research just by being in an accident", he said.
In lieu of individual consent, researchers are trying to foster community support for the study. The Boston researchers have issued surveys, hosted a table at Boston University's wellness fair, convened focus groups, and made presentations to various community groups. Other study trial sites have tried billboards.
Federal law and the generally accepted ethics of medical research require that patients or their surrogates be told about any risks of participating in a study and have the chance to refuse enrolment. But in 1996 the FDA created rules allowing exemption in some cases involving emergency care. With 40 hospitals already participating, the trial has enrolled more than 760 people.