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Survey offers insight into informed consent
Very few were aware of PolyHeme study
Arecent study suggests that emergency medicine patients may not have a high level of acceptance of the practice of providing an exemption to informed consent for research involving emergency medical settings.1
"We looked at nearly 500 patients who presented to the emergency room and who were not critically injured, and we queried them on their attitudes and beliefs about having an exception to informed consent," says Wayne Triner, DO, MPH, FACEP, an associate professor in the department of emergency medicine at Albany Medical College, and a senior fellow at the Alden March Bioethics Institute in Albany, NY.
"We found that, by and large, patients agreed with the notion that research of this nature, with a waiver for informed consent, was important to do, but they had issues with such research transpiring among themselves or family members," Triner says.
About one-third of those surveyed said they would be willing to have themselves or family members participate in such a study, and one third strongly disagreed, while about 80 percent of participants agreed that such studies need to be done, Triner says.
Investigators pointedly did not survey people who were involved in a research project.
The study took place after there were some general media reports about concerns over the enrollment and disclosure practices of the PolyHeme clinical trial, which was sponsored by Northfield Laboratories Inc. of Evanston, IL.1
PolyHeme is an oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood isn't immediately available. During clinical trials, some patients receiving the product died of heart attacks, which raised questions about the waiver of informed consent.
The trial was conducted with informed consent waivers because of its use in emergency, life-threatening situations. Community education was conducted prior to the trial's initiation, and the public was offered a way to opt-out of inclusion.
"We specifically did this after the PolyHeme study," Triner says. "We thought the emergency department patients were the best surrogate for actual patients to be enrolled from this population."
Researchers asked participants about the PolyHeme study, and found that awareness of the study was very low prior to the media scrutiny, Triner notes.
About half of the participants were surveyed after widespread media reports involving PolyHeme, and participant awareness remained low, he adds.
"The number of people reporting awareness was approximately 8 percent," Triner says.
About half of this number knew any specifics about the trial, he adds.
"Many previous studies that investigate community acceptance of waivers of informed consent in studies have all been done at community meetings, and there's a selection bias of who goes to these meetings," Triner says. "There are several articles showing nearly unanimous acceptance of waivers of informed consent among people who attend these meetings."
The acceptance was considerably lower among the emergency room patients, Triner says.
"We think that more closely matches the actual population," he adds.
The survey's results raise questions about the use of opting out in such waiver cases.
"Intrinsic to the regulations surrounding those studies, people had to sign up if they didn't want to be enrolled in the emergency research," Triner says. "If only 4 percent of the population affected by the study is even aware the study exists, then how do the majority of people know to opt out?"
Alternately, opt-in registries would be impractical for researchers, he says.
"What happens is you're not going to reach a significant proportion of the population eligible for enrollment, and if you did reach them, they'd have to exercise the intent and actively enroll themselves on that registry for that particular study," Triner explains. "So from an investigator's standpoint, you would not enroll anybody, and you'd have very limited opportunity to enroll patients."
This creates an interesting dilemma for IRBs, who have to weigh the potential benefits against potential risks and individual rights, Triner notes.
"I think we need to clarify social benefits versus individual rights and risks, and there may be situations or conditions where it's more important to do the study," he adds.
"We're in an era of finding strong evidence to justify or reject the things we do in medicine," Triner says. "We have a long history of embracing innovations in medicine based on case history, but the strongest evidence is randomized trials."
In the big picture, it's important that resuscitation research continue so medical providers will have evidence on which to base emergency medical decisions, Triner says.
"I hope IRBs don't reach the point of not approving waivers for informed consent," Triner says. "What our study highlights is that for the short term they need to consider how these studies are being initiated and how the notification of affected populations is being brought into the process."
This would require genuine community representatives being engaged in the process and identifying formal and active community leaders, Triner says.
"As an emergency room practitioner I firmly believe that these studies are essential," Triner adds.