Variability in institutional approaches to ethics review of community-based research conducted in collaboration with unaffiliated organizations

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 institution's) 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).