Controversy Surrounds Exception from Informed Consent Enrollment
The term “exception from informed consent” for some clinical trials has been around for decades, but most patients know nothing about it. Researchers set out to explore attitudes about enrolling subjects in studies without consent.1
Of 317 patients and surrogates, 90% agreed with or were neutral about a statement indicating they were glad they or their family member was included in a research study on status epilepticus treatment. However, 27% disagreed with someone enrolling them in the study without prospective consent. Black respondents were more likely to disagree with enrollment without consent (36%) than unknown race, other race, or white respondents.
“A basic principle of human research is that potential research subjects should have the ability to prospectively choose to participate or not based upon receiving appropriate information regarding the potential risks and benefits,” says Samuel Tisherman, MD, a professor in the department of surgery and the program in trauma at the University of Maryland.
For patients who experience cardiac arrest, shock, or a severe head injury, resuscitation research is needed to improve outcomes, according to Tisherman. In these situations, the patient is unconscious and cannot provide informed consent. The patient’s legally authorized representative, typically the closest family member, is either unavailable or is under extreme stress after learning their loved one is in this critical situation. “In addition, the interventions that are being studied with resuscitation research usually need to be administered within minutes,” Tisherman notes.
This leaves no time for a truly informed consent discussion. For resuscitation research to proceed, investigators can use an “exception from informed consent” process, developed by resuscitation researchers and federal agencies in the 1990s. The researchers must demonstrate:
- the patient cannot provide consent because of his or her current condition;
- available treatments are unsatisfactory or unproven;
- the intervention may help the patient directly;
- the therapy must start before consent from a legally authorized representative is feasible.
Further, Tisherman says investigators must work with the community in two ways. The first is community consultation. This is meant to be a two-way conversation. “It provides feedback to the investigators and buy-in from the community,” Tisherman notes.
It can take many forms: town halls, meetings with community leaders, or surveys. “Investigators should carefully define the ‘community’ from which research subjects could be drawn,” Tisherman cautions.
It could be based on location or the demographics of people who are most at risk for the condition under investigation. “For instance, the typical person who develops a cardiac arrest is different from the typical person who suffers a head injury,” Tisherman observes.
Second, investigators also must work with the community via public disclosure. This lets everyone know that a particular research project is underway.
Regulatory requirements to govern trials granted an exception from informed consent “are largely aimed at protecting individual autonomy, respecting community values, and promoting public trust,” says William B. Feldman, MD, DPhil, MPH, a research fellow at Harvard.
For example, trial investigators must allow patients or their surrogates a chance to opt out and notify all who are enrolled. “Experience with these trials over the past 25 years has revealed important challenges,” Feldman notes.
One study revealed African American patients, who make up about 13% of the U.S. population, made up 29% of participants in the “exception from informed consent” trials.2 “It is critically important that the burdens and benefits of these trials be distributed fairly across society,” Feldman stresses.
Trial investigators also need to be more transparent. Data are needed on race, the number of refusals, the number of people who withdraw after enrollment once they regain capacity (or surrogate decision-makers who withdraw on behalf of a patient), and the number of patients enrolled with and without consent.
There is no question trials granted an exception from informed consent address important research questions in emergency and critical care medicine. “But we must ensure that these trials promote values of respect and autonomy, and that they avoid propagating existing disparities,” Feldman adds.
- Scicluna VM, Biros M, Harney DK, et al. Patient and surrogate postenrollment perspectives on research using the exception from informed consent: An integrated survey. Ann Emerg Med 2020;76:343-349.
- Feldman WB, Hey SP, Kesselheim AS. A systematic review of the Food And Drug Administration’s ‘exception from informed consent’ pathway. Health Aff (Millwood) 2018;37:1605-1614.
The term “exception from informed consent” for some clinical trials has been around for decades, but most patients know nothing about it. Researchers set out to explore attitudes about enrolling subjects in studies without consent.
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