Does proximity to violence negatively influence attitudes toward exception from informed consent in emergency research?

Abstract

Trauma research has been limited by perceived patient reluctance to participate in exception from informed consent (EFIC) studies. We hypothesized that race, socioeconomic status, and proximity to violence influence willingness to participate in and perception of EFIC research among at-risk populations. Trauma patients, families, and community members ranked statements regarding attitude toward EFIC in the context of an upcoming trial and willingness to participate in emergency research using a 5-point Likert scale during a community consultation. Higher total scores reflected a more positive attitude regarding EFIC (range, 6-30; neutral, 18) and willingness (range, 23-115; neutral, 69). Subject zip code was used to calculate median income, as an estimate for socioeconomic status, and proximity to the five most violent city zip codes. Linear regression, Spearman's correlation, and Kruskal-Wallis tests (p < 0.05) were used to evaluate relationships between estimated socioeconomic status, race, mechanism of injury, proximity to violence, and attitudes toward EFIC. A total of 179 subjects participated including trauma patients (n = 99), families (n = 33), and community members (n = 47). Overall, participants were supportive of EFIC and reported high scores in willingness to participate (median, 24; interquartile range, 21-25; median 89, interquartile range, 82-95, respectively). Proximity to violence did correlate with race (p = 0.03) but was not associated with violent mechanism of injury, perception of EFIC, or willingness to participate in emergency research. Estimated socioeconomic status and race did not correlate with perception of or willingness to participate in EFIC. Based on our data, there is no correlation between either proximity to violence or estimated socioeconomic status and willingness to participate in EFIC research. Given this lack of correlation, researchers should partner with at-risk communities to conduct EFIC studies without concern for limited participation. Epidemiologic/prognostic study, level III.