ABOUT PRACTICE-BASED RESEARCH NETWORKS Practice-based Research Network Studies and Institutional Review Boards: Two New Issues

Background: Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. Objective: To present 2 IRB-related issues that have not appeared in the literature but occurred dur-ing the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. Results: Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amend-ments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human sub-jects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects ’ training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given con-sent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms i