261 - Characteristics of Respondents to Exception from Informed Consent Community Consultation Surveys in a Pediatric Emergency Care Trial
Saturday, April 26, 2025
2:30pm – 4:45pm HST
Publication Number: 261.4229
Matthew l. Hansen, Oregon Health & Science University School of Medicine, Portland, OR, United States; Shannon Stephens, University of Alabama at Birmingham, Birmingham, AL, United States; Manish I.. Shah, Stanford University School of Medicine, Palo Alto, CA, United States; Nichole Bosson, LA County EMS Agency, Santa Fe Springs, CA, United States; Marianne Gausche-Hill, University of California, Los Angeles David Geffen School of Medicine, Torrance, CA, United States; John VanBuren, University of Utah School of Medicine, Salt Lake City, UT, United States; Sara F. Goldkind, Goldkind Consulting, L.L.C., Chevy Chase, MD, United States; Miriam R.. Elman, Oregon Health & Science University School of Medicine, Portland, OR, United States; Henry W. Wang, The Ohio State University, Columbus, OH, United States
Professor Oregon Health & Science University School of Medicine Portland, Oregon, United States
Background: Emergency care research is essential to improve outcomes for children with critical illness and injury. Federal Exception from Informed Consent (EFIC) regulations allow emergency care research to proceed without a priori consent by integrating feedback from community consultation and public disclosure (CC/PD) activities. Objective: Our objectives were to evaluate community acceptance of a pediatric emergency care trial using a commercial survey tool and to determine the characteristics of respondents supportive of the trial. Design/Methods: Pedi-PART is a trial designed to evaluate three pediatric prehospital airway management strategies utilizing EFIC. Pedi-PART conducted CC/PD activities in March and April of 2024. The CC/PD process used a commercial marketing research service to reach the communities of interest and solicit feedback via an 18-question survey. Participants were provided information about the study and asked to indicate their support for the study. The survey also solicited demographics including sex, age, race/ethnicity, education, income, if the individual was a parent of a child < 18 years, and if they were a healthcare provider. We evaluated the study’s acceptability by asking, “Do you believe that this study should be done in your community (yes/no).” We used descriptive statistics and logistic regression to evaluate study approval. Results: A total of 6,753 individuals completed surveys (Table 1). The median age was 42 years (IQR: 30-59), 62% were female, 13% were Black and 15% were Hispanic. Sixty percent of respondents had less than a bachelor’s degree, and 39% had an annual income of < $50,000. Survey respondents indicated support for conducting Pedi-PART in their community as follows: 90% male, 91% female, 89% Black, 92% Hispanic, 92% White, 90% other race/ethnicities, and 93% of parents of a child < 18 years. Among respondents with less than a high school education, 83.7% approved of the study compared to 92.9% in those with a post-graduate degree. Among those with an annual household income <$20,000, 85% approved of the study compared to 93.5% of those with a >$100,000 annual household income (Figure 1). In multivariable analysis, older age, Hispanic ethnicity, higher income, and being a parent were all significantly associated with increased adjusted odds of supporting the trial (Table 2).
Conclusion(s): This study demonstrated that most survey respondents supported the trial. Individuals who were parents of a child or had a higher income were significantly more likely to support the trial.
