Abstract 20402: Does Experience Matter? Implications for Community Consultation for Research in Emergency Settings
Introduction: Community consultation (CC) is required for clinical studies in emergency settings using an exception from informed consent (EFIC) in the US, but uncertainty persists regarding how to conduct CC efficiently and effectively. There is ongoing debate about whom to include in CC efforts; specifically whether to prioritize geographically-defined communities or individuals with connections to the condition under study. Understanding the impact of personal disease experience on views of EFIC research is important for designing CC efforts and interpreting their results.
Methods: This study was a secondary analysis of surveys administered to 2612 participants at 12 sites in CC events conducted for the ProTECT III: Progesterone for Traumatic Brain Injury trial, a phase III, randomized, placebo-controlled trial conducted using EFIC. Key survey domains included personal experience with traumatic brain injury (TBI), demographic information, acceptance of hypothetical personal enrollment in ProTECT III under EFIC, and acceptance of the use of EFIC in ProTECT III in general. Descriptive statistics and multivariable regression models were used to explore relationships between attitudes towards EFIC and personal disease experience.
Results: 1256 (49%) CC participants were either TBI patients, had a family member/loved one with TBI or knew someone else with TBI. Participants with personal TBI experience were slightly more accepting of hypothetical personal enrollment under EFIC (Adjusted OR 1.14-1.54) and use of EFIC in general (AOR 1.06-1.39) for the ProTECT study than those without personal TBI experience. In a sub-group analysis based on race, this relationship did not exist among black participants, for whom a trend in the opposite direction was observed.
Conclusions: Personal TBI experience was associated with increased acceptance of EFIC research for that condition, except among black participants. Heterogeneity of the effect of personal disease experience on EFIC views further supports the inclusion of individuals with relevant disease experience in CC efforts and highlights the importance of engaging minority participants. The need for continued involvement of geographically-defined communities is unclear.
Author Disclosures: V.M. Scicluna: None. M.K. Ali: None. R.D. Pentz: None. D.W. Wright: Research Grant; Significant; NIH-NINDS, DOD. Expert Witness; Significant; Various law firms. Other; Significant; Royalties (Emory University—LC to BHR Pharma), Patent (Progesterone for traumatic brain injury, Emory University. N.W. Dickert: None.
- © 2016 by American Heart Association, Inc.