C-A2-01: IRB Review in the Era of ARRA: Streamlining Without Sacrifice

Abstract

Background and Aims: In the era of ARRA, we are routinely confronted with compressed timelines and an accelerated pace of research. Concurrently, discussions have intensified over recent months about the HMORN’s capacity to conduct comparative effectiveness research on topics of national interest. Building on these unique challenges and opportunities, this interactive session will serve as a forum for conference attendees to discuss recent HMORN efforts to make multi-site IRB review as agile as possible. In particular, we will showcase the HMORN facilitated review process and discuss how it might be further improved or expanded. Methods: In early 2008, the HMORN ratified its first Standard Operating Procedure (SOP), which outlines procedures for inter-institutional IRB review of data-only studies. This SOP helped clarify what steps to take and who to contact, both in order to pursue ceding, and when multiple IRBs need to review the same study. This process has now been used in a majority of HMORN member institutions. As its use has increased, researchers and IRB administrators have become more familiar with the process. In September 2009, the HMORN Governing Board identified continuing such work to ensure IRB agility as a key 2010 priority for the HMORN. Results: In this session, we will review how to use the facilitated IRB review process outlined in the SOP and learn from attendees how we can further facilitate multi-site IRB review, along with attendant concerns such as HIPAA. In addition, we will give a snapshot of recent and upcoming developments across the Network sites, including human research protection program accreditation efforts and migration to electronic IRB systems. Conclusions: This session will enable research investigators, IRB administrators and HMORN leadership to engage in a constructive dialogue about the residual barriers to using the facilitated IRB process for data-only studies, and identify pathways to institutionalize this process in our Network’s routine research processes. This session will also introduce how the demands of IRB accreditation and the implementation of new electronic IRB systems may facilitate or impede our progress in this area.