Human Research Protection Office (HRPO)

For secondary research involving Epic data, researchers must provide an explanation in the IRB submission of how they will ensure that only appropriate data are accessed.

Examples of acceptable methods include:

• Engagement with the Research & Evaluation Data Analytics Core (REDAC) to extract data for the study
  • The IRB will accept hybrid extraction, e.g., REDAC is engaged to provide required Epic data with a link to access notes data to allow researchers to extract additional data, such as information from notes
  • The IRB will accept documentation attached in the submission to confirm that REDAC has been consulted and determined that data may be extracted from Epic without REDAC involvement
• Collaboration with an informaticist or other Epic analyst to extract data for the study
• Explanation of expertise in data extraction within the study team – i.e., a study team member has previous experience in using Epic self-service tools (e.g., Slicer-Dicer/Workbench), including knowledge of how to apply the research restriction filter to exclude the records of patients who have opted out, as applicable

If secondary research involves ONLY de-identified data obtained via REDAC or other honest broker, the research is NOT human subject research, i.e., it is not subject to IRB oversight. For this type of secondary research, a not human research determination should be requested via Cayuse HE.