53 - Social and Demographic Predictors of Willingness to Participate in an Exception from Informed Consent Trial

Background:  Community consultation and public disclosure are requirements of exception from informed consent (EFIC) trials, and mandated by the US Department of Health and Human Services and the Food and Drug Administration. However, it is not known how demographic characteristics of community members impact their willingness to participate in such studies.

Methods:  A 14-question survey designed to evaluate respondents’ willingness to be enrolled in a trauma trial and to collect the demographics of the respondents was developed as part of a community consultation campaign for a large, multicenter EFIC trial. The surveys were administered using Qualtrics survey software platform. We aimed to have at least 300 completed surveys from each participating trial site. The surveys were targeted to individuals who reside in counties in the catchment areas of 77 participating trauma centers in the US. The surveys were also accessible from the study websites, from a QR code on a study handout that sites placed in areas where they felt they could reach at-risk or underserved community members, or directly using a web browser. 22,441 individuals completed the surveys, yielding 88,711 responses to the survey questions. These responses were analyzed, along with the demographics of the survey respondents. This analysis focused on the minority of individuals who have unfavorable views towards participation and emergency care research so that we can better understand their needs and concerns.

Results:  13,201 of 22,441 respondents (58.8%) indicated they would want to be entered in the trial. 3,625 (16.2%) responded they would not want to be enrolled and 5,615 (25.1%) responded “I don’t know” or “I don’t want to answer”. 19,430 of 22,329 (87.0%) responded they believe that emergency medical research was necessary and 19,555 of 22,324 (87.6%) believed that this study should be done in their community. Individuals who responded “No or “I don’t know”’ to the questions were younger, non-male, non-white, had a lower education level, and unknown or lower household income. The relationship between individuals’ age, income, education level, and their willingness to participate was broadly similar for people who responded “I don’t know” or “I don’t want to answer”, albeit with some small differences.

Limitations: Not all EFIC studies are the same, and respondents’ opinions may vary depending on the type of treatment under investigation. Our study did not analyze geographic locations within this analysis as a possible factor. It is unclear if respondents who complete on-line surveys are representative of the local community. Lastly, more work is needed to better understand how digital inequities could possibly contribute to underrepresented community groups and how better to address these structural biases.

Discussion:  Community consultation is a key component of establishing trust with the community in which a given study will be conducted. Understanding which individuals, or groups of individuals, are reluctant to engage is important, and disadvantaged communities often experience a greater burden of injustice. It is imperative that a wide net be cast to understand the social and demographic differences within each community. We are reassured that the majority of individuals who responded to the community consultation materials would participate in EFIC clinical trials and thought that such research is important.