title: 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 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).
authors.affiliation: Boston University, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Silverstein
authors.forename: Mary
authors.initials: M
authors.lastname: Banks
authors.forename: Susan
authors.initials: S
authors.lastname: Fish
authors.forename: Howard
authors.initials: H
authors.lastname: Bauchner