All, Following up from yesterday's dev call...I contacted PCORnet with questions about the need for and logistics of IRB submissions for the Overlap/Table 1 query. My questions to and responses from PCORnet are below:
1. The slides state that sites should submit the protocol document to their local IRB. Is there a lead IRB to which local IRBs should be relying on? I got the impression this was not the case but wanted to confirm. RESPONSE: No. Sites should submit for local review. The guidance that we have received is that it's generally not practical to use a central IRB for exempt research. 1. Is the document found here https://pcornet.imeetcentral.com/p/aQAAAAAECNB6cwAAAAAACkq6<https://urldefense.com/v3/__https:/pcornet.imeetcentral.com/p/aQAAAAAECNB6cwAAAAAACkq6__;!!OToaGQ!8ri3r9naSElD_xylGNzhWoDtbfc0n841pNN8NeV8nRDWPU9ft-g533cWKAJmeROJgnXa$> the current version that sites should use to submit to their IRB? RESPONSE: Yes, that is correct. 1. Some sites, including UIOWA, have blanket approval for PCORnet queries requesting aggregate, de-id, or limited data. My understanding is that the Table 1 query will be consistent with these data types. If so, and insofar as this may be true for a particular site, is the request for sites to submit the Table 1 query protocol for approval due to the 'sensitive' nature of the query (namely, that it is leveraging PHI to generate tokens)? Since we already have IRB to use the Datavant solution, on the surface it seems redundant to submit this specific query for approval - hence, our need to clarify with you in case we are missing something. RESPONSE: If sites feel their existing IRB protocols cover this work, there is no need to submit a separate protocol. We put together a protocol mainly to document the work that we were proposing. We've had major delays in previous linkage projects even if they're found to be non-human subjects research because there wasn't a clear understanding of the proposed analyses. So sites can keep the document for reference in case there are questions, but there is no need to resubmit. They can just provide that info to the PMO when asked. Brian M. Gryzlak, MSW, MA Project Coordinator S414 CPHB 319.335.8218 The University of Iowa Iowa City, IA 52242 brian-gryz...@uiowa.edu<mailto:brian-gryz...@uiowa.edu> Health Effectiveness Research Center (HERCe)<http://www.public-health.uiowa.edu/herce/>
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