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

ABSTRACTBackground: Community consultation (CC) is required for research in emergency settings using an exception from informed consent (EFIC) in the United States, but uncertainty persists regarding best CC practices. There is ongoing debate about whom to include in CC, specifically, whether to prioritize geographically defined communities or individuals with connections to the condition. Understanding the impact of personal disease experience on views of EFIC research is important for designing CC and interpreting its results. Methods: This study was a secondary analysis of surveys administered to 2612 participants at 12 sites in CC events conducted for ProTECT III: Progesterone for Traumatic Brain Injury, a Phase III, randomized trial conducted using EFIC. Key survey domains included personal traumatic brain injury (TBI) experience, demographic information, and acceptance of both hypothetical personal enrollment under EFIC and the use of EFIC in general in ProTECT III. Descriptive statistics and multiv...