Use Caution When Leveraging Exception from Informed Consent Rule
May 1, 2023 4 minutes read
During medical emergencies, researchers cannot obtain informed consent from participants as they normally would. Those studies have to be conducted under the exception from informed consent (EFIC) rule. A group of researchers wanted to know more about how researchers are using EFIC.
“There were inconsistencies in prior systematic reports of EFIC trials, suggesting these trials were a bit hard to find,” explains Jon F. Merz, MBA, JD, PhD, associate professor of medical ethics and health policy at Perelman School of Medicine at the University of Pennsylvania.
Merz and a colleague embarked on a multipronged effort to locate completed, ongoing, and planned trials.1 The researchers used Google, ClinicalTrials.gov, and contacted study investigators. Ultimately, the researchers identified 110 clinical trials that were conducted under the EFIC rule since its inception in 1996 until April 2022. Of the 110 trials, 78 were completed (69 were full trials, and nine were “pilot” trials), 13 were currently recruiting, seven were registered on ClinicalTrials.gov (but were not yet recruiting), five had been abandoned before anyone was enrolled, and seven were in the early planning stages.
The authors also determined if those trials were completed or terminated early. Of 69 completed full trials, 30 were terminated early. Poor recruitment was a common reason for early termination. About 18 trials were started in each five-year period since 2001. “The most notable take-away from this study is the frank difficulty in identifying trials,” Merz says.
This, despite the fact the FDA’s EFIC regulation requires public engagement. This means researchers must publicly disseminate the details of the trials before they are finished and publish the results when the study is completed. Despite these requirements, says Merz, there is lack of transparency about EFIC trials.
Another group of researchers analyzed families’ views and willingness to participate in EFIC trials. Catherine Ross, MD, and colleagues are enrolling participants for a EFIC trial on peri-arrest bolus epinephrine for acute hypotension. As part of the process, the researchers were required to obtain community consultation. This entailed interviewing and surveying 60 families whose children were hospitalized in the pediatric ICU. The process elicited some interesting data. Thus, Ross and colleagues decided to publish this information first.2
“While several studies have reported quantitative survey data on public attitudes about EFIC studies, our qualitative data add depth and reasons behind why families may or may not want to participate in this particular trial,” says Ross, the study’s lead author, assistant professor of pediatrics at Harvard Medical School, and a researcher at Boston Children’s Hospital.
Generally, families were supportive; 91% believed using EFIC was “somewhat” or “completely” acceptable. The parties also discussed barriers to participation. Some respondents wanted additional time to decide about EFIC. “This led to an amendment in our public disclosure plan, to allow follow-up for families who requested more time to decide,” Ross reports.
Some parents incorrectly believed their child was not eligible to participate in the study due to medical history. The most common misconception was that a patient who had existing hypertension would not be eligible for the study of acute hypotension. However, in the setting of critical illness, any patient may experience hypotension. “We recommend research staff be able to anticipate the types of misconceptions likely to arise in their particular trial,” Ross reports. “Be prepared to educate the families on these points.”
Many respondents indicated they trusted the clinical team to decide about enrollment during the medical emergency. “As an ICU clinician, I am humbled by how much these families trust our teams, even when it comes to participating in research,” Ross says.
Researchers who perform EFIC trials must balance the critical need for high-quality emergency medical research with the need to protect the inherently vulnerable patient populations they study. “The unique circumstances of the trial dictate the ethical considerations that must be addressed,” Ross adds.
Ross and colleagues gleaned unique insights because research staff interviewed families in the inpatient setting. “Unlike the many outpatient EFIC trials, which have a low likelihood of reaching their actual participants prior to enrollment, we had the opportunity to personally contact families,” Ross explains.
This process preserves trust. It also enhances autonomy by ensuring an opportunity to opt out of participating. “However, this approach may not be feasible or appropriate for all inpatient EFIC studies,” Ross cautions.
A major determinant of the feasibility of personal public disclosure is the ratio of patients at risk for the medical emergency to those who go on to meet enrollment criteria. “If the event of interest is unpredictable and extremely rare among all hospitalized patients, personal public disclosure would not be feasible,” Ross says.
Additionally, it is not feasible to inform all hospitalized patients about a study involving a rare, life-threatening event. “It may cause unnecessary confusion and anxiety for the overwhelming majority of patients who are unlikely to experience the event,” Ross cautions.
REFERENCES
1. Snyder KL, Merz JF. A census of clinical trials conducted under the U.S. exception from informed consent rule. Acad Emerg Med 2023;30:133-138.
2. Ross CE, Lehmann S, Hayes MM, et al. Community consultation in the pediatric intensive care unit for an exception from informed consent trial: A survey of patient caregivers. Resusc Plus 2023;13:100355.
The exception from informed consent (EFIC) regulation requires public engagement. This means researchers must publicly disseminate the details of their trials before they are finished and publish the results when the study is completed. Despite these requirements, there is lack of transparency about EFIC trials.
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