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No-consent study raises concern over patient rights
Supporters say acceptable for consent to come from IRB
The federal government is undertaking an ambitious $50 million, five-year research project that will employ a controversial arrangement that avoids the traditional informed consent process, and the whole idea is making some health care providers nervous. Supporters of the study say the approach is necessary and carefully structured to protect patient rights, but detractors say it is just wrong to test medical treatment on people without their knowledge.
The project will involve more than 20,000 patients in the United States and Canada. It is designed to improve treatment after car accidents, shootings, cardiac arrest, and other emergencies.
Myron Weisfeldt, MD, chair of the Department of Medicine at the Johns Hopkins University School of Medicine in Baltimore, who is overseeing the project, says he believes in informed consent as strongly as any other health professional, but he explains that this research could not be done if the researchers first had to obtain consent. And, he explains, the research is not being done without consent of any kind. It is important, he says, to understand that the researchers must first obtain approval from the community and from the local health care provider's institutional review board (IRB).
Weisfeldt says researchers complete a "community consultation" process before beginning. Local organizers try to notify the public about the study and gauge the reaction through public meetings, telephone surveys, Internet postings and advertisements, and stories in local media. Anyone who objects can get a special bracelet to alert medical workers that they refuse to participate. (See box below for more on how the studies work.) "Federal regulations allow this to happen only in very specific circumstances, so there is no need to worry that this is going to be the way researchers conduct all medical research," Weisfeldt says. "I don't believe this research poses any threat."
Studies will assess methods in emergencies
Current studies that will be conducted without the traditional consent process underwent 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 first experiments, involving nearly 6,000 patients, focus on people who are in shock or have suffered head injuries from a car crash, a fall, or some other trauma, explains Myron Weisfeldt, MD, chair of the Department of Medicine at the Johns Hopkins University School of Medicine in Baltimore.
The standard practice for those patients is to give them saline infusions to stabilize their blood pressure. For the study, emergency medical workers will be randomly infusing some patients with hypertonic solutions containing much higher levels of sodium, with or without the drug dextran. Animal research and small studies involving people have indicated that hypertonic solutions could save more lives and minimize brain damage, Weisfeldt says.
The other part of the study will involve about 15,000 patients and is designed to determine how best to revive those whose hearts suddenly stop beating — whether cardiopulmonary resuscitation should be used before shocking the heart.
Reason for risk managers to worry
There is good reason for risk managers to be concerned if such a project is proposed at their facilities, says Fay Rozovsky, JD, MPH, DFSHRM, president of the Rozovsky Group, a risk management firm in Bloomfield, CT, and former president of the American Society for Healthcare Risk Management in Chicago. She says the protections for patient rights built into the study are ineffective.
"There is a lot of opportunity here for risk," she says. "Everybody makes a good argument for how necessary this is and it's easy for people to jump on the bandwagon and say they're helping to advance medicine; but it's the risk manager who will be left to clean up if things go wrong and those same people who were so enthusiastic are nowhere to be found."
For starters, she expresses great concern over the idea that patients are protected by having the researchers inform the community as a whole. "That's a fallacy. We are a very mobile society, and when you're talking about testing treatments in an emergent situation, there is no way to know if that individual received the information," she says. "That person may not even be from the community that was notified. So it is of little benefit that the community has been notified."
Rozovsky also raises the issue of insurance coverage for a lawsuit stemming from treatment in which the patient did consent in the traditional manner. "Is your insurance going to cover any injury that might arise from the use of this test treatment? It might, but it's an interesting question and, as the risk manager, I'd want to know for sure before this thing gets under way," she says.
Health insurance plans are another concern for the risk manager, Rozovsky says. "Health insurance plans and managed care tend to say they will not cover any type of care that is investigational, so if they say that, who picks up the tab? The deep pocket might be the hospital," she says.
Consent difficult to obtain
The researchers say the work will help them find better treatment methods, but that informed consent cannot be obtained because these patients often are unconscious and families, if they are available, are too upset to give true informed consent.
"Can you imagine trying to get informed consent from a spouse who was also in the car accident and may or may not be injured herself? We could give her some papers and explain what we're doing, but would that really be informed consent?" Weisfeldt says. "Don't forget that the members of the IRB who approve this, if they are injured in a car accident in their community, they will be a participant in this study."
Rozovsky doesn't buy that argument. She has opposed the idea since the Food and Drug Administration (FDA) first established a protocol for such research in 1996. "It's taking us down a slippery slope," she says. "It is trodding on the very autonomy of the individual. Some people may not want to be the recipient of a test article when they are in extremis, and we are taking away a liberty. We are in danger of eroding the concept of informed consent that risk managers have supported for so long."
Not first time for no-consent idea
The current research is not the first to use this controversial approach to consent. In 2006, a study testing a blood substitute called PolyHeme, manufactured by Northfield Laboratories in Evanston, IL, was criticized for putting patients at risk without consent. The testing was completed at more than 25 Level I trauma centers in the United States. PolyHeme was the 15th such experiment allowed by the FDA.
As in the current research, controversy arose from the fact that the participants in the PolyHeme study were incapable of giving their consent due to the nature of their injuries.
The only way to opt out from the study was by wearing a special bracelet prior to needing emergency care. After criticism from patients' rights advocates, the FDA launched a review of the entire program that permits experiments to be done without consent in emergency situations but sanctioned the current project under similar terms.
Risk managers should get involved
There may not be a solution that would make everyone happy, Rozovsky says. In the meantime, Rozovsky says risk managers should act to protect the informed consent process any time researchers propose a project that involves anything less than the traditional informed consent process.
Even with a large project that is promoted as vitally important to the advancement of health care, such as the current study, Rozovsky says it is up to risk managers to make the researchers justify the deviation from the informed consent process. Also, she says risk managers should help educate the IRB about risk and ethics concerns. In particular, she says, the risk manager should make sure the IRB is not accepting this concept that "we can't do it any other way" too readily. Make sure this type of project remains the exception, not the rule.
"With this current project or any other that comes later, you should make them spell out every contingency, every detail of how this will work, and what they are doing to protect patient rights," Rozovsky says. Don't leave this up to the IRB alone, she says. "Ask the hard questions about what will happen to patients from outside the community, those who don't speak English, or patients who expressly do not want to participate," she says. "Make sure all the I's are dotted and the T's are crossed."
For more information on the research project and informed consent, contact:
Universal consent could be option, but still imperfect
So is there a solution that would make the critics happy and still allow research without specific consent?
Fay Rozovsky, JD, MPH, DFSHRM, president of the Rozovsky Group, a risk management firm in Bloomfield, CT, and former president of the American Society for Healthcare Risk Management in Chicago, says the only real solution she sees would entail completely changing the concept of informed consent so that everyone in our society is presumed to consent to medical research unless they specifically opt out. The same idea has been proposed for organ donation also, with everyone presumed to be an organ donor unless they declare otherwise.
That approach is similar to what is done on a local basis with these research projects, with the researchers informing the community through the local media and any other available outlet. But Rozovsky says the difference would be that the entire society is informed of the situation rather than just a local community. There would be less chance that a person was just not aware that they would be subject to the experimental protocol.
"I'm not sure I'd advocate that either, but it's the only way I could feel comfortable that people really know what awaits them if they are emergent," she says.