Say you get hit by a car, trip on stairs or slip off a ladder and hit your head.
While you’re unconscious, you may be enrolled in a study and injected with a drug researchers at Harborview Medical Center hope will prevent bleeding in your brain.
Reasonably, you might now ask: How can you do an experiment on me without my consent? Isn’t the right to informed consent what separates people from lab rats? Do I get a choice?
The last time Harborview Medical Center tried this type of no-consent study, it riled quite a number of King County residents. Nationally, the controversy over the ethics of such studies got even hotter when no-consent trials elsewhere in the country found that patients who received an experimental blood substitute died at a much higher-than-expected rate.
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Dr. Eileen Bulger, Harborview’s chief trauma doctor and that site’s principal investigator for the new study, says there’s no other way to test some emergency treatments. This one is aimed at preventing a major cause of death and disability after a traumatic brain injury.
Bypassing informed consent, long a staple of human studies, is allowed under federal regulations — but only if researchers adequately inform their communities ahead of time and give people a chance to opt out. Ethics experts say there’s little guidance on what constitutes adequate community consultation.
Some argue that researchers, in their enthusiasm for experimental treatments, haven’t given enough weight to people’s rights.
“I think the whole concept of doing research on people without consent is bad,” said George Annas, chairman of the Department of Health Law, Bioethics & Human Rights at Boston University. “I want researchers to take informed consent as seriously as they take their study.”
The drug to be studied, tranexamic acid (TXA), is already FDA-approved for other uses and widely used at trauma centers, including Harborview, to help stop internal bleeding with minimal side effects, Bulger said.
“We think it’s very safe, and we just want to know if it’s going to make a difference in the outcome” for brain-injured patients, she said.
The trial at Harborview and nine other centers in the U.S. and Canada is the first to systematically test the drug given as early as possible to patients with significant traumatic brain injury (TBI), Bulger said, and will measure not only survival, but neurological outcomes at six months.
Because brain-injury patients are often unconscious, and because Bulger and other researchers believe it’s crucial to give the drug right away, local brain-trauma victims age 15 and older, unless a parent objects, will instantly, automatically be enrolled in the study by emergency medical responders, who will inject them with the standard saline treatment or the experimental dose.
“If we give it too late, it won’t be effective,” Bulger said.
Researchers will try to contact patients’ families as soon as possible, she said, and will stop the experimental treatment if requested.
Traumatic brain injuries are the leading cause of death among trauma patients and among people 40 and younger, and earlier findings suggest this drug’s success in brain bleeds, Bulger said. According to the study proposal, more than 1.6 million people each year suffer brain injuries, with 52,000 deaths and 80,000 permanent severe neurological disabilities.
“When you hit your head, you have bleeding around the inside of the skull, which is kind of a fixed space,” Bulger explained. “It increases the pressure and that worsens the brain injury.”
No new drug treatments for severe brain injuries and their aftereffects have been put into use for three decades, the researchers say, because all treatments studied so far have failed.
The study, funded by the U.S. Department of Defense and the National Institutes of Health, is planning to enroll about 1,000 patients; about 100 of those would be enrolled at Harborview. Like the earlier studies, this trial is being conducted by the Resuscitation Outcomes Consortium, a network of research centers in the U.S. and Canada.
In 2007, Bulger was at the center of an ethical debate after Harborview bypassed traditional “informed consent” requirements for a different study on unconscious patients.
That study at Harborview and elsewhere, on concentrated saline injection for trauma victims, was stopped when it didn’t lessen death rates compared to standard treatment. The trial failed, but it stopped useless further investments and study, Bulger said.
“So I don’t consider it a failure at all — it was very valuable information.”
Research in 2009 found that although 88 percent of people surveyed supported research into emergency care, only 35 percent agreed with enrolling patients into studies without consent. But 51 percent said they would want to be enrolled if they were too sick to consent.
For this study, Harborview plans to reach out to non-English-speaking communities and sports leagues, including the Cascade Bicycle Club, Bulger said, and use social media such as Twitter and Facebook and local media outlets.
They will also distribute study brochures at food banks, soup kitchens and homeless shelters. As they did last time, researchers also plan a random telephone survey to ask community residents for their opinions on the study. In all, the Harborview study site has budgeted $34,000 for community notification and consultation.
“We’re really trying to canvass the whole community widely,” said Bulger, who hopes to start the one-year study this fall or winter.
People can opt out by requesting a “NO-STUDY” bracelet (call 206-744-7724 or email email@example.com).
The research oversight board for the study has approved the protocol, but researchers must present results of the community notification and reaction before getting final approval.
Annas said he’s not against such studies when researchers have reason to believe the experimental treatment might be better than current practice.
But, he added: “They’re always sure it’s going to work. The fact that you believe in it, that’s good — it’s good for religion, but it doesn’t really help us for science.”
Everyone wants evidence-based treatments, he said. “But if you had the evidence, you wouldn’t be doing the study.”
He gives Harborview some credit for its community-engagement plan. “Using your newspaper is not stupid,” Annas said. And he likes Bulger’s plan to involve a local bicycle club, because that’s targeting a population vulnerable to TBIs.
But “community consultation means more than an ad in the paper and a meeting that nobody comes to,” he said. “I think it has to be something that gets more than half the people in town aware of it.”
Researchers also must make it much easier for people to opt out than having to request — and wear — a bracelet, Annas said. For example, they might specify a particular sign that people could mark on an inconspicuous area of their bodies.
“I want to get (researchers) to think. … They should get all these smart people together to use their imagination and put their heads together and figure out how they would make it well-known in the community and easy to opt out.”
Carol M. Ostrom: 206-464-2249 or firstname.lastname@example.org.
On Twitter @costrom