National stakeholders involved in multi-site research have called for new methods for eliminating duplication of effort in the review of investigations conducted in multiple centers under separate Institutional Review Board (IRB) jurisdiction. The current multisite review model is time and resource intensive as studies undergo multiple changes during review, which may not be congruent at each site. This consequently tends to delay, and sometimes even prevents studies that are of high quality from being initiated at one or more sites in a given network. We propose addressing this national problem and unmet need by implementing a Planning Conference Series that focuses on developing and establishing efficient model(s) for IRB evaluation and review of multi-site investigations. This Planning Conference Series titled: Novel IRB Model(s) for Efficient Multi-Site Review, serves as a natural progression to previous workshops and conferences that have exposed the challenges of multi-site IRB review (e.g. 2005 NIH Alternative Models of IRB Review Workshop, 2006 OHRP National Conference on Alternative IRB Models). This proposal consists of 3 key meetings and interim teleconferences over a three-year period focused on operationalizing a model that addresses these review issues. Each meeting will engage a Steering Committee of carefully selected, dedicated participants that will evolve discussions into practical deliverables that will be implemented at participating sites to begin to mitigate this national problem. We have strategically sought out core Steering Committee members who have a keen interest to address this topic, have relevant expertise in this field and have developed this expertise through a variety of backgrounds. Each individual's unique perspective on the negative effects and inefficiencies of the current multi-site review process will assure a creative and innovative solution is developed through this Conference Series. We will leverage technical and informatics expertise at Vanderbilt University and the Clinical and Translational Science Awards (CTSA) Consortium, which is charged with developing infrastructure to expedite the pace of clinical and translational research nationwide, to develop a business plan and electronic sharing resource model that can benefit the IRB multi-site review process for all IRBs nationwide. Use of improved information technology to share key review documentation could help promote consistency and compliance, as well as provide shared access to data - all of which has great potential to improve quality, participant safety, and timeliness of results. This is the first-known dedicated Conference Series that will allow for key experts to congregate and explore these issues while being charged with developing a business, implementation and dissemination plan supported by an informatics resource to address these challenges across the country.
(provided by applicant): National stakeholders involved in multi-site research have called for new methods for eliminating duplication of effort in the review of investigations conducted in multiple centers under separate Institutional Review Board (IRB) jurisdiction. We propose responding to this call to action by hosting a series of working meetings to convene experts and stakeholders of the multi-site review process that will collectively identify, develop and operationalize a novel review model that will help improve the efficiency of multi-site investigations.
|O'Rourke, P Pearl; Carrithers, Judith; Patrick-Lake, Bray et al. (2015) Harmonization and streamlining of research oversight for pragmatic clinical trials. Clin Trials 12:449-56|