What do patients think about being enrolled in trauma research without informed consent?


Clinical trials for time-sensitive emergency therapies often enroll patients under exception from informed consent (EFIC). U.S. regulations require investigators to conduct a pre-trial “community consultation” with representatives from the communities where the investigation will take place. But what do patients themselves think of EFIC trials? A study publishing next month in Critical Care Medicine explores how injured patients view involuntary enrollment in trauma research.

The study was based on interviews with 85 patients (or their surrogates) enrolled in the Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III) trial. ProTECT III took place at 49 trauma centers in the U.S. between 2009 and 2013.

According to the paper, the interviews showed that EFIC enrollment was generally consistent with the preferences of patients or their surrogates:

  • 84% had a positive attitude toward being included in the trial
  • 72% thought that using EFIC enrollment in the ProTECT III trial was acceptable in general
  • 78% thought their personal inclusion in the trial under EFIC was acceptable
  • 80% thought placebo use was acceptable
  • 92% thought randomization was acceptable

“Only two respondents clearly disagreed with both personal and general exception from informed consent enrollment,” according to the paper. However, the results suggest that black Americans take a relatively dim view of EFIC. “Although there were few black respondents (n = 11), they were less accepting of personal exception from informed consent enrollment than white respondents (55% vs 83%; p = 0.0494).”

Consultations underestimate acceptance?
The paper notes that among ProTECT III participants, patient/surrogate acceptance of EFIC was higher than acceptance of community consultation participants.

For comparison, a 2013 study surveyed participants in a community consultation for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART). According to the survey, 70% of participants said they would agree to take part in the study, and 68% said they would consent to a family member’s participation.

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