Community Acceptance of a Pediatric Prehospital Exception From Informed Consent Trial

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.

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.

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.

Survey respondents largely supported the Pedi-PART trial. Respondents who were parents or who had higher education were more likely to support the trial.