Does experience matter? Implications for community consultation for research in emergency settings

Area of Science:

• Emergency Medicine Research
• Clinical Trial Ethics
• Informed Consent

Background:

• Community consultation (CC) is essential for research in emergency settings utilizing exception from informed consent (EFIC) in the U.S.
• Best practices for CC remain unclear, particularly regarding participant selection (geographic vs. condition-connected).
• Understanding the influence of personal disease experience on views of EFIC research is crucial for effective CC design and interpretation.

Purpose of the Study:

• To analyze the impact of personal traumatic brain injury (TBI) experience on participant acceptance of EFIC research.
• To explore demographic variations, including race, in the acceptance of EFIC.
• To inform best practices for community engagement in EFIC research.

Main Methods:

• Secondary analysis of 2612 surveys from CC events for the ProTECT III TBI trial using EFIC.
• Survey domains included personal TBI experience, demographics, and acceptance of personal and general EFIC enrollment.
• Descriptive statistics and multivariable regression models were employed to assess relationships.

Main Results:

• Individuals with TBI experience (personal, family, or acquaintance) showed slightly higher acceptance of hypothetical personal enrollment and general EFIC use.
• White participants with TBI experience reported higher acceptance of EFIC.
• Black participants with closer TBI connections exhibited numerically lower acceptance of EFIC.

Conclusions:

• Personal TBI experience generally correlates with increased acceptance of EFIC research for TBI.
• The effect of personal experience on EFIC acceptance is heterogeneous, particularly among Black participants.
• Inclusion of individuals with relevant disease experience in CC is supported, emphasizing the need for minority engagement.