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Community consultation is key
When looking at a study that would involve the use of the exception from informed consent for emergency research (EICER), IRBs first should consider whether the exception is necessary and appropriate, says Graham Nichol, MD, MPH, medical director of the University of Washington Clinical Trials Center in Seattle.
Nichol works with the Resuscitation Outcomes Consortium (ROC), a group of 10 clinical centers in the United States and Canada conducting collaborative clinical trials aimed at improving resuscitation outcomes.
He says an IRB reviewing the proposed use of EICER in a study must ask the following questions:
—Are the patients involved in a life-threatening situation?
—Are available treatments unproven or unsatisfactory?
—Is getting informed consent not feasible, because the patient is unconscious or confused?
—Is the research likely to directly benefit the patients?
—Can the research be done without the exception from consent?
If an IRB determines that an EICER is necessary, it then must consider the proposed community consultation and public notification process. This can take different forms, from community meetings to public notices in local news media to the telephone survey method employed by the ROC.
"The regulations encourage town hall meetings," Nichol says. "The sites participating in ROC tried to do that. The problem is you don't get a lot of people at town hall meetings. The sample you get isn't representative.
"Whereas if you do a random-digit dialing survey, you can ensure that you are getting a representative sample of young and old people, college graduates and high school graduates and people from different ethnic communities," he says. "To me, that is a much more balanced or representative approach to asking the community to consent to the research, which in essence is what we do when we do exception from consent research."
Michael Sayre, MD, associate professor of emergency medicine at Ohio State University in Columbus, says that when a conference was convened in 2007 to put together guidance on the use of EICER, it was difficult to gain consensus on a number of issues, including exactly what role the community consultation should play in an IRB's ultimate decision about a study.
"Was the purpose of it to let the community know, or to seek input about the study from the community?" he says. "We heard from different IRB people about their own interpretations of what this meant.
"Do you hold a vote – if there's 50.1% support, you go ahead? Or is it more consultative? Ultimately, it's the IRB's decision whether the study is ethical."
According to the proposed guidance, an EMS agency enrolling patients in a study is engaged in research and may be required to complete a Federalwide Assurance (FWA) for protection of human subjects. As part of that process, the agency must designate IRBs to review protocols and must train staff in research procedures.
Nichol says he doesn't believe EMS agencies would require any more or less training than would the nursing staff in an emergency department or intensive care unit. While he says EMTs sometimes don't have research experience, "they're used to rapidly identifying who's sick or who's not sick and initiating treatment as soon as possible. They understand that (research) is being done to improve the care that they provide to their patients, so they embrace that."
Regulations do not require that researchers give people in the community a chance to opt out of a study in advance, but FDA guidance recommends some mechanism for people to be able to register their opposition to potentially being included in a trial. That mechanism may take the form of an "opt-out bracelet" that can be worn or a wallet-sized card they can carry.
Once patients have been enrolled in a study while unable to give consent, the researcher must inform them as soon as possible about the study and give them a chance to withdraw if they wish, although researchers still can review their records to determine whether the study intervention caused harm.
When an IRB is encountering an EICER study for the first time, Sayre recommends checking with IRBs that have more experience in this type of research, to get ideas about how to handle particular issues or pitfalls to avoid.
Nichol says emergency research can raise new and challenging questions for IRBs, but it's worth the time and effort to answer them.
"Research in this arena can be difficult, but there are multiple layers of oversight," he says. "My experience has been that if investigators and IRBs and regulatory agencies focus on trying to improve care for patients, they'll find the appropriate balance between the need for consent, the recognition that consent is difficult if not impossible in this setting and the need to ensure both improvement in care over time and patient safety."