Community Acceptance of a Pediatric Prehospital Exception From Informed Consent Trial

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Abstract
Background: Federal Exception from Informed Consent (EFIC) regulations allow emergency care research without a priori consent under limited conditions by integrating feedback from community consultation and notification of communities through public disclosure (CC/PD) activities (21 CFR 50.24). Our objectives were to evaluate community acceptance of a pediatric emergency care trial using a commercial survey tool and to determine the characteristics associated with supportive respondents. Methods: The Pediatric Prehospital Airway Resuscitation Trial (Pedi‐PART) is an EFIC trial designed to compare pediatric prehospital airway management strategies. Pedi‐PART conducted community consultation/public disclosure (CC/PD) activities in March–April 2024. The CC/PD process used a commercial marketing research platform (Qualtrics Inc.) to provide study information and solicit feedback via an 18‐question survey. Participants indicated support for the study through three specific questions and provided demographic characteristics. We determined the predictors of trial approval among survey respondents. Results: A total of 6753 individuals completed surveys. The median age was 42 (IQR: 30–59) years, 62% were female, 13% were Black, and 15% were Hispanic. Survey respondents indicated support for conducting Pedi‐PART in their community as follows: 90% of males, 91% of females, 89% of Blacks, 92% of Hispanics, 92% of Whites, 90% of other race/ethnicities, and 93% of parents of a child < 18 years. Among respondents with less than a high school education, 84% approved of the study compared to 93% in those with a post‐graduate degree. Among those with an annual household income < $20,000, 85% approved of the study compared to 94% of those with an > $100,000 annual household income. In multivariable analysis, higher education and being the parent/guardian of a minor child were associated with support of the trial. Conclusions: Survey respondents largely supported the Pedi‐PART trial. Respondents who were parents or who had higher education were more likely to support the trial.
Funding Information
  • National Heart, Lung, and Blood Institute (4UH3HL165019)
  • National Heart, Lung, and Blood Institute (1U24HL165014)
  • Health Resources and Services Administration

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