Federal guidelines now allow doctors to bypass longstanding ethics rules that require "informed consent" when a patient is unconscious or too injured to consent.
Suppose you happen to be in a serious car wreck. Or maybe you get shot or suffer cardiac arrest. If you live in King County, it might also mean that in that life-or-death moment, you will become part of an experiment — without your consent.
Researchers at the University of Washington have been studying various treatments for patients in such extreme situations. And because patients can be unconscious or too injured to consent, federal guidelines now allow the doctors to bypass longstanding ethics rules that require so-called “informed consent.”
The researchers say the experimental treatments are safe — maybe even safer than the procedures considered standard protocol at the moment. And they argue that they need the research to improve emergency medical care.
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“If you don’t do these studies, care will never improve,” said Dr. Eileen Bulger, a trauma surgeon at Harborview Medical Center who is leading one study.
But some experts in medical ethics find the situation troubling. They point to previous studies in which waiving consent in test subjects went too far, and they warn that some earlier experiments in emergency medicine may very well have cost people their lives.
“We’re not a nation of research subjects,” said George Annas, a bioethicist at Boston University. “It’s simple: You shouldn’t do research on people without their consent. It’s not rocket science.”
To learn more on the Resuscitation Outcomes Consortium studies or to opt out, go to:
For the cardiac-arrest study: www.uwheartroc.org or 800-607-2926 (local 206-447-5671).
For the trauma/saline study: www.roctrauma.org or 800-607-1879
If you don’t want to be subject to the experimental treatment, you should:
Contact the study administrators (use the links or phone numbers above).
Ask for a free stainless-steel bracelet etched with the words “No Research Study.”
Be wearing the bracelet when the emergency occurs.
The UW studies are part of a $50 million, five-year project called the Resuscitation Outcomes Consortium, now under way in 11 communities in the U.S. and Canada. In all, researchers plan to involve nearly 21,000 people as part of the first large-scale effort to improve pre-hospital trauma and cardiac-arrest care. That’s the care given by emergency responders while patients are in an ambulance or even before they are loaded aboard.
Bulger’s study, which began last summer, is testing a stronger version of the saline solution given to trauma patients to help stabilize their blood pressure.
Another UW study, set to begin next month, will test a procedure in which cardiac-arrest patients — those whose hearts have stopped — are given CPR for a full three minutes before medics turn to electrical defibrillators. It also will test a device that is supposed to help get more blood to the heart during CPR.
A system is set up to choose randomly which patients get experimental treatments instead of the standard procedures. Once patients arrive at a hospital — most likely Harborview Medical Center — the experimental treatments will stop.
Patients, or their survivors, will be told later they were part of the study — but in most cases, not which treatment they got.
To permit such research, the federal Food and Drug Administration has waived the usual consent requirements for some studies. In lieu of getting individual consent, researchers must conduct “community consultation and public disclosure.”
Locally, that meant researchers contacted media outlets, placed information in newsletters and on the online classified-ad site Craigslist, created Web sites and bought bus ads.
Researchers also commissioned telephone polls to ask several hundred people whether they would want to receive experimental treatments without consenting or being told how it compared to standard care. About 75 percent said they would.
That means that now anyone who suffers cardiac arrest, head injuries or goes into shock in King County will be automatically enrolled in the studies — unless they specifically opt out ahead of time.
To opt out, people have to contact the study administrators and ask for a free stainless-steel bracelet etched with the words “No Research Study.” And they would have to be wearing it when it matters.
Ethicists are skeptical that those steps are enough to overcome the hefty ramifications of experimenting on unknowing people in extremely traumatic situations.
“There is very, very little guidance about what it means to do an adequate ‘community consultation,’ ” said David Magnus, who directs the Stanford Center for Biomedical Ethics at Stanford University. “That’s a big problem.”
Underlying ethicists’ concerns are some deaths of emergency patients, elsewhere in the country, who had received experimental synthetic blood substitutes in studies done without consent several years ago. Because of those problems, the FDA is now reviewing the consent-waiver guidelines.
Annas, of Boston University, suggests that if everyone in the community could potentially become research subjects, “you should have a vote.” Or at least do a better job of informing the broader populace by handing out consent forms at toll booths or fairs, he said.
“Consent is a basic rule of health law and medical ethics, and my argument is we should take it seriously,” he said.
For a patient, there is a big difference between “research” and “treatment,” Annas said: In “treatment,” medical providers do what they believe is best in a given situation — not what’s dictated by the research protocol.
Waiving the consent rules, he adds, is just a cover for “lazy investigators” who should work harder to obtain consent — or find other ways to test treatments. “Once you make exceptions here, we’ll make exceptions everywhere,” he said.
The researchers say they need the research because much of what is done now for emergency patients has little evidence to back it up, particularly for cardiac arrest.
“When someone says, ‘I don’t want to be a guinea pig in a study,’ I respect that,” said Dr. Peter Kudenchuk, a UW cardiologist who is the top investigator for the local studies. “But you have to understand you’re getting an experimental therapy when you’re getting standard care.”
The upshot is that people now get different emergency treatment based on where they live and which agencies respond to the emergencies, he said.
“There is no universal standard because no one really knows which approach is better.”
Karen Moe, director of the UW’s Human Subjects Division, the administrative arm of a board that reviews such research, agrees the studies presented “a very serious ethical issue that arouses a lot of very strong feelings in people.”
That’s why such studies are “regulated down to the tiniest detail, to make sure that this waiver of informed consent is granted only in very carefully defined, narrow circumstances,” she said.
The bottom line, the researchers say, is that strict consent rules have held back progress.
“My chance of surviving cardiac arrest in the general community is no different than it was 20 or 30 years ago,” Kudenchuk said.
Bulger, the Harborview doctor, points out that traumatic injuries are the leading cause of death for people under 45, a “huge public-health problem.”
“If we want to make an impact in people who are at very high risk of dying from their injuries, we have to be able to do these studies,” she said.
Carol M. Ostrom: 206-464-2249 or firstname.lastname@example.org