This note is a reminder and clarification on the role of REB (Research Ethics Board) approval for any research using Health Data Nexus data.
Studies involving human participant information using data from Health Data Nexus that meet definition of Research in TCPS 2 (i.e., an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation) require REB review. For studies that meet the definition of research led by someone at U of T, the lead of the study should submit a protocol through U of T’s Research Ethics Board. For studies that are led by TAHSN hospital partners or externals sites, the leads of these studies should submit their project for REB administrative review.
This holds regardless of which Zone the dataset is placed within. As a reminder, Zone 1 requires a credentialing application, all required trainings to be completed, and the corresponding Data Use Agreement to be signed. Zone 2 additionally requires the submission of a project plan which must be approved by the Data Holder. Zone 3 additionally requires the project plan submission to be accompanied by REB approval which is reviewed by the Data Holder. (This can be the same REB approval as that which is required for access to the data for research purposes.)
Use of human participant information using data from Health Data Nexus that do not meet the definition of Research in TCPS 2 do not require REB review. This includes preliminary review and data exploration, educational uses (such as courses and datathons/hackathons), and general purpose investigations into the data.