Social and demographic predictors of willingness to participate in an exception from informed consent trial

Community consultation and public disclosure are key components of exception from informed consent (EFIC) trials, and mandated by the US Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). However, it is not known how demographic characteristics of community members impact their willingness to participate in such studies. The purpose of this study was to evaluate the demographics of community members regarding their attitudes towards participation in an EFIC trial; participation of relatives in such a trial; the need for emergency medical research; and, the execution of the trial in their community. This analysis is 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.

Multinomial logistic regression analysis of responses to a survey distributed as part of the community consultation campaigns for a large, multicenter EFIC trial in trauma patients. The surveys were distributed to community members in the catchment areas of 77 trauma centers.

A total of 88,711 responses to four separate survey questions were received and analyzed, along with demographics of the survey respondents. 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, female, non-white, had a lower education level, and unknown or lower household income. The pattern was broadly similar for people who responded "I don't know" or "I don't want to answer", albeit with some differences.

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.