Abstract
Background/Aims Multi-site collaborations offer opportunities to engage diverse research expertise to answer important public health questions. Many of these collaborations have, at their core, large, robust data sources that are critical to achieving research goals. Before scientific work can begin, however, there is a complex maze of administrative and regulatory requirements that must be efficiently navigated in order to avoid project delays. As funders’ interest in comparative effective research (CER), research networks, and ‘big data’ increases, funding periods appear to be shrinking, making administrative and regulatory efficiencies more critical than ever. The current effort documents best practices in these areas.
Methods The study team examined best practices that addressed common challenges for successful project implementation in three large HMO Research Network (HMORN) studies that included 7–16 institutions. We identified three processes that significantly increased administrative and regulatory efficiencies: umbrella institutional review board (IRB) structure (with ceding), reciprocal data use agreement (DUA) and the HMORN subcontract template.
Results An umbrella IRB structure enabled researchers to submit pilot studies and new hypotheses as modifications using the same data source and processes for human subjects’ protections. These study modifications underwent expedited review; often with determinations received in fewer than 10 business days. The HMORN DUA template was modified to make it reciprocal. This allowed limited data sets to be shared among data contributing sites and allowed investigators from any site to lead an analysis, thus, increasing the amount and pace of research that could be achieved. The HMORN subcontract template was “field tested” and results tracked over a 5-year period. Use of the template resulted in a decrease in the average number of days for initial subcontract execution from 215 days to less than 60.
Conclusions We demonstrated that developing new processes and modifying existing ones can accelerate multi-site research. Standardization fosters collaboration, trust, and continued progress while meeting regulatory requirements that maintain human subjects’ and institutional protections.
