Ethical use of emergency exceptions to consent
New guidance pending to help IRBs, researchers
Is reluctance to permit exceptions from informed consent in emergency research (EICER) preventing important studies from moving forward?
A team of emergency research specialists is concerned that it might be, and is putting the finishing touches on new guidance designed to explain the ethical use of such exceptions. The guidance, developed by the National EMS Research Agenda Writing Group, is based on a 2007 EICER guideline consensus conference in Washington, D.C. that included investigators, sponsors and representatives from IRBs.
In recent years, use of the emergency exception has gotten widespread and sometimes critical public attention.
Michael Sayre, MD, associate professor of emergency medicine at Ohio State University in Columbus, and a co-investigator for the project, says that while EICER can be controversial, it provides an ethical way for researchers to conduct studies in situations where traditional informed consent may be impossible to obtain from unconscious or confused subjects.
He says that the initial goal of the guidance, which is expected to be published in its final form in late spring, was to provide a nuts-and-bolts guide to IRBs and researchers about how to conduct and review studies involving EICER. That goal was complicated by the varied opinions regarding the use of the exception.
"By the end of the meeting it was clear that we couldn't gain consensus around what exactly people should do," Sayre says. "But I don't think it's necessary that everybody does it exactly the same way. I think there ought to be variation depending on the relative risk of the study in question. And given the wide variety of different sorts of projects that might be undertaken, I think every IRB has to make a judgment about how they would approach the community consultation and public disclosure (requirements) for that particular study."
Important research
Sayre says the report does underline the importance of doing such research. The report notes that some IRBs have essentially refused to approve any research carried out using EICER.
"In my observation, for many IRBs, the temptation is to say, 'This is just too hard, so let's not do that,'" Sayre says. "There are too many people dying in our country from major injury or cardiac arrest who potentially could be saved if we just learned how to take care of them better."
Graham Nichol, MD, MPH, medical director of the University of Washington Clinical Trials Center in Seattle, says research into treatments for sudden cardiac arrest is a case in point.
He notes that while there are established treatments for sudden cardiac arrest such as CPR and defibrillation, they have low rates of success, pointing to the need for emergency research to find more promising approaches.
"We know that the average survival after out-of-hospital cardiac arrest in the United States is 8%," he says. "Some places are able to achieve much better outcomes, but overall, the existing treatments for out-of-hospital cardiac arrest are unsatisfactory, because 90% of people die."
Under EICER, a researcher may conduct a study in an emergency setting without obtaining individual prior informed consent from subjects.
IRBs may only permit studies to go forward under EICER rules if they involve life-threatening conditions, if existing treatments are unproven or unsatisfactory and in situations where subjects cannot give consent and a legally authorized representative cannot be contacted quickly enough.
The EICER rules in essence substitute a community consultation and public notification process for the traditional individual informed consent, Nichol says.
"It's not that there's no consent, it's that the community consents on behalf of the patients," he says.
Once a study is under way and subjects are enrolled while unable to give individual consent, the researcher must inform them as soon as possible about their participation and give them the opportunity to withdraw.
One ethical issue raised by research conducted under EICER rules is that researchers must be able to access patient files to see if the study intervention harms the subjects. Sayre and Nichol say this holds true even if a subject withdraws from the study.
"People who discontinue from the study need to be followed to see what kind of outcome they have," Sayre says. "The FDA's position is you have to follow them, even if they say they don't want to participate any more.
"Clearly you can opt out of the continued risk of being in the study but the FDA feels strongly that if you allowed people to just opt out totally from any kind of further data collection, you could potentially introduce a pretty significant bias in measuring the outcome, and then maybe draw the wrong conclusion about whether the intervention worked or didn't work."
Nichol says this point is raised in the community consultation process.
"There's a description that in addition to giving you the intervention in the field, we're going to look at your records and check whether or not you were harmed by the intervention," he says.
Sayre says one question for IRBs is how much information should be given to researchers in those cases.
"You can follow somebody and tell if they're alive or dead without actually talking to them," he says. "Collecting that kind of information certainly wouldn't be intrusive. But if you wanted to sample their blood to see if they had some uncommon adverse effect, that must be viewed by most as unduly intrusive and not acceptable without consent."
In the end, Nichol says, the issues involved in EICER studies are similar to any other interventional study. What is the rationale for using this treatment? Do the risks outweigh the benefits? Have all reasonable steps been taken to ensure patient safety?
"Some members of the public are uncomfortable when they hear that someone is doing research without consent, but we all need to understand that when we do this special form of research in the emergency setting, the patient is not able to consent," Nichol says.
"I think the approach of getting the community to consent and having multiple committees check that we're doing the right thing before we start and check that we're continuing to do the right thing — and then notifying the patient and giving them an opportunity to opt out is actually the safest approach possible in this particular, narrow area of research."
[Editor's note: The final version of the EMS Research Agenda Writing Group's guidance on Exception from Consent in Emergency Research is due to be completed in late spring. To find the most recent version of this guidance, please visit www.researchagenda.org]
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