No-consent study raises concern over patient rights

Studies resurrect PolyHeme worries

Health care providers are watching cautiously as the federal government undertakes an ambitious $50 million, five-year research project that will employ a controversial arrangement that avoids the traditional informed consent process. Supporters of the study say the approach is necessary and carefully structured to protect patient rights, but detractors say it goes against hard-fought protections against conducting 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. The studies, organizers say, are the best way to improve treatment of trauma patients — specifically, in resuscitating of patients whose hearts stop, stabilizing patients in shock, and minimizing damage from head injuries.

In the studies, providers would randomly infuse some head trauma patients with hypertonic saline solutions, with or without dextran; emergency medicine providers would randomly try cardiopulmonary resuscitation in some cardiac arrest patients, and use electrical defibrillators in others.

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 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 first must 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.

"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."

Reason for concern

"Studies like the recently suspended PolyHeme [blood substitute] protocol put pressure on the key fault lines in research ethics," commented Kenneth Richman, associate professor of philosophy and health care ethics at Massachusetts College of Pharmacy and Health Sciences. "We desperately want data on how to help trauma patients, but we also believe that patients should not be enrolled in studies without their explicit permission."

Richman says ethicists call this a conflict between beneficence and respect for persons, and says most medical research involves this conflict to some degree.

"Each study has to be examined in the context of available data and applicable guidelines, and people are concerned that scientists and review committees got it wrong in the case of the PolyHeme study," he says.

The study of PolyHeme, manufactured by Northfield Laboratories in Evanston, IL, was criticized for putting trauma patients at risk without consent. 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 PolyHeme 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.

There is good reason for concern with such projects, says Fay Rozovsky, JD, MPH, DFSHRM, president of the Rozovsky Group, a risk management firm in Bloomfield, CT. She says the protections for patient rights built into the proposed trauma treatment studies are ineffective.

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.

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.

"It's taking us down a slippery slope," Rozovsky counters. "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."