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What about consent under emergency conditions?
Most IRBs can’t answer that question
Except on the television drama "ER," it rarely occurs, even at medical universities and affiliated hospitals, but occasionally an IRB may encounter a case where an investigator desires to have informed consent waived in order to conduct emergency medical research.
When such a case arises, is your IRB prepared to handle it?
"Our policy is we take the waiver of informed consent on a case-by-case basis," says John C. Smith, MSW, CIM, IRB administrator at the Morehouse School of Medicine in Atlanta.
"For emergency medicine, it’s our policy to allow the principal investigator to make that decision," he says.
For instance, if the investigator encounters a case where a particular patient’s life is in jeopardy unless an investigational intervention is made, the clinical investigator will take care of the patient and then, within 48 hours, inform the IRB of what has happened, Smith explains.
IRBs may not be ready to handle such cases because emergency medical research is so rare.
"It’s been recognized that research in ER [emergency room] settings, and therefore advances in clinical care in those settings have fallen behind other areas of medicine because of the difficulty of getting consent, because people are often incapacitated," says Daniel K. Nelson, MS, CIP, director of human research ethics and an associate professor of social medicine and pediatrics at the University of North Carolina-Chapel Hill.
At UNC, there has not been any use of the waiver of consent for emergency medicine research, but the university’s IRB is open to considering such a proposal if presented with one, he adds.
The Concord (NH) Hospital has had a few situations of emergency medical research, but it’s very rare that the IRB ever waives informed consent, says Lisa Rocheford, MBA, CIM, education and research coordinator for the medical staff services and IRB manager.
"If there was a protocol that a physician wanted to use in the emergency department, we’d follow guidelines very closely," she says.
First, the clinician should know to inform the IRB even during an emergency situation of what is happening. Then the IRB would ask that family members be included and asked to give informed consent whenever possible. Finally, as soon as possible, the clinician should inform the patient of what took place.
IRBs can avoid after-the-fact emergency medical research conflicts by establishing criteria for how such a situation should be handled by clinical researchers, Smith suggests.
"There are situations where an expedited review could take place by an IRB administrator or an IRB chair or vice chair," he says. "But if in an emergency room situation, it’s something that needs to be approved by the IRB prior to the procedure taking place."
For example, suppose an IRB administrator is called by a principal investigator (PI) and told that one of the PI’s study subjects is in the emergency room, Smith says.
"And the PI wants the IRB’s approval to administer something without getting the proper consent," he adds. "I don’t believe we could act on that in that same day, because we’d just be reacting to a situation, and we wouldn’t have time to process it and look at it."
Instead, the IRB could inform investigators that it is the IRB’s policy to have investigators contact the IRB in advance when there are new and experimental procedures that might be used in an emergency medical research situation, Smith explains.
"This way, we can look at the risk-benefit ratio to see whether this procedure is worth doing and to see whether there might be some sort of subject coercion involved," he says. "When people are in shock, they especially need to be informed about what is going to be done to them."
Involve the patient advocate
In Georgia, a legal representative can make an informed consent decision for an incapacitated patient, so the IRB would ask researchers to also involve a patient advocate, because this impartial advocate can decide whether the person who is giving consent on the behalf of a loved one is indeed a legal representative who is entitled to sign an informed consent document, Smith adds.
There also is the question of whether emergency medical patients should be included in data collection studies without their informed consent.
The IRB at Concord Hospital had to take a look at this issue last year when the committee was presented with a proposal for research involvement in the Acute Decompensated Heart Failure National Registry (ADHERE), Rocheford reports.
The hospital will participate in the ADHERE registry as part of a quality initiative under its accreditation with the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL. The hospital’s heart failure program nurses will do chart analysis and supply the data to the ADHERE registry, she says.
"ADHERE told our heart failure coordinators that if informed consent was required, the site couldn’t participate in the study," Rocheford says.
"We took a look at this and the guides the IRB uses for the Food and Drug Administration, and we looked at protocols that were exempt from informed review or consent," she explains. "The study did seem to fit into the category of exemption because there was no deviation from the standard of care, no investigational products, and it was simply collecting data from patients who received care."
Since the people who participated in reviewing data for the study were the same people who were providing the patient care, there was no breach of confidentiality, Rocheford adds. "Everything seemed to fit very nicely into the exempt category, and that’s why it was allowed to go through as a quality improvement initiative and not as a clinical research trial."