Who can speak for the emergently ill? Testing a method to identify communities and their leaders.

Abstract

The Food and Drug Administration (FDA) requires researchers to consult with the community prior to conducting research with exception from informed consent, but little is known about whether people support this and, if they do, who researchers should consult. We sought to determine if people could identify communities and leaders of those communities who researchers should consult with to represent their views about research that requires an exception from informed consent. We conducted a cross-sectional interview study using a convenience sample of patients seeking care in an urban emergency department (ED) to determine if people belonged to specific communities and, if they did, if they could identify communities and leaders appropriate for consultation. Descriptive statistics were used to represent our findings. Most of the 262 participants approached for the study completed the interview (199; 76%). Of those interviewed, 122 (61%) were African American, 54 (27%) were white, 83 (42%) were male, and the mean (+/-standard deviation [SD]) age was 36.2 +/- 14.4 years. Most, (194; 97%), identified that they belonged to a community and most (177; 89%), said that researchers could consult at least one of their communities for consultation about an exception from informed consent study. Participants typically named geographic and religious-affiliated communities and leaders as appropriate for consultation. Most participants identified a community and a leader of that community who researchers could consult about research with exception from informed consent. Geographic and faith-based organizations could play an important role in consultation.