Hi Nichelle (and Brittany for tracking), We've had a question arise on the gpc-dev call that is at the intersection of how we manage data for the PCORnet central office distributed research queries.
We've been operating on the understanding that for prep to research queries from PCORI, we will be hosting fully de-identified i2b2 and PCORnet CDM databases at each site. The current model based on the data sharing is that prep to research queries of these resources will have Data Request Oversight but not IRB. There's a discussion now of an added requirement that we also generate limited datasets with the precise dates. - This could either be a persistent database copy (what they'd prefer) - Or, could theoretically be a dataset for each project The question is, when they want to distribute code that runs against these data files, is there a consistent interpretation of what IRB oversight is required? What's the GPC IRB verdict? - Each research project has its own approved IRB protocol? - Or - There are exceptions approved by GPC IRB where if data doesn't flow back with cell sizes less then 11, they don't need IRB Is this a topic you've already addressed or should we bring this up at a meeting? Russ Waitman, PhD Director of Medical Informatics Assistant Vice Chancellor for Enterprise Analytics Associate Professor, Department of Internal Medicine University of Kansas Medical Center, Kansas City, Kansas 913-945-7087 (office) [email protected]<mailto:[email protected]> http://www.kumc.edu/ea-mi/ http://informatics.kumc.edu<http://informatics.kumc.edu/> http://informatics.gpcnetwork.org<http://informatics.gpcnetwork.org/> - a PCORnet collaborative
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