The Ethics of Waived Consent Trials

USA Today, bastion of high quality journalism, has an uncharacteristically well written article about the controversy surrounding waived consent clinical trials used for trauma medgadgets. Specifically, they focus on the success of blood substitute PolyHeme (from Northfield Laboratories) and the failure of the AutoPulse (from ZOLL Medical) trial…

With waived-consent studies becoming more prevalent, critics question whether the public understands how they work and whether test subjects get adequate protection…
But another trial, which is reported in today’s Journal of the American Medical Association (JAMA), was halted because a device called the AutoPulse, which was used to revive cardiac-arrest victims, failed to save more lives than when rescuers performed cardiopulmonary resuscitation.
According to the study, as many as 10 people in one city may not have been revived because of their participation. The JAMA study does not identify the city. But doctors have identified the site as Seattle – which has one of the highest resuscitation rates in the nation – in discussions at medical meetings since the AutoPulse trial was halted in March 2005.
Patients in these types of studies – often financed by manufacturers of the tested product – are treated under a broad federal rule that allows researchers to test emergency treatments on patients with specific, life-threatening medical conditions without their explicit consent as long as they remain under close watch of independent reviewers.
Federal officials and medical researchers say there is no substitute for this testing of emergency treatments for the leading causes of death: trauma and cardiac arrest, which claim hundreds of thousands of lives in the USA each year. To the researchers, studies with negative findings are as important as successful trials in their search for the best treatments…
Federal officials say such research is key because emergency treatments are largely untested. “Many of the treatments that are currently used in life-threatening circumstances have not been formally studied,” says Sara Goldkind, a Food and Drug Administration (FDA) bioethicist. “They have not come to be standard-of-care based upon rigorous scientific data.”
Doctors agree. “The only way to make any sort of significant advance in this final frontier is to perform these studies with waiver of informed consent,” says Martin Croce, a Memphis trauma surgeon. “It’s clear that multiple cascades of bad physiologic things happen shortly after injury. Once that snowball begins to roll down the hill, it’s very difficult to stop. To stop it, you need to intervene early. That is at the scene.”
Critics say the trials are conducted on a slippery ethical slope.
“It has to be done carefully,” says Nancy King, a University of North Carolina ethicist who says corporate sponsors of trials don’t always want to make key study information public. “It is so terribly easy to cut corners and say this doesn’t matter as much and we will just put some notices in the newspaper. It makes me concerned.”

The article goes on from there and is worth reading in it’s entirety. The debate hinges on whether the trial denies patients access to existing standards of care. Williams certainly would have died en route to the hospital without PolyHeme. However, once there (in the presence of transfusable blood), was it appropriate to continue the PolyHeme Infusion?
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