Variability in Institutional Approaches to Ethics Review of Community-Based Research Conducted in Collaboration with Unaffiliated Organizations

Abstract

Academic institutions' requirements for ethics committee (IRB) review of research conducted by investigators from unaffiliated organizations engaged in collaborative, community-based research (CBR) may be highly variable. The present study examined the extent of this variability through a national survey of 196 IRB directors from US academic institutions. Fifty-three percent of respondents reported a formal policy or standardized approach to reviewing this type of CBR, with high volume IRBs more likely than low volume IRBs to do so (aOR 2.11, 95% CI 1.02, 4.35). The most common policy (40%) was to require that unaffiliated community organizations obtain a Federalwide Assurance on which they delegate responsibility for IRB review to their own (i.e., the academic institutions) IRB. Among IRBs without formal policies, 56% reported that human subject risk was their foremost consideration when reviewing CBR. Universities (71%) were more likely than medical schools (33%) to report subject risk as their foremost consideration (aOR 4.68, 95% CI 1.43, 15.28).