February 13th, 2017

Effective today, the following updates are active in the ERICA system:

• The Study Location and Sponsors page of the IRB Application has been updated for improved collection of study location(s), including external locations.  The IRB has made these updates to clarify that sites, both internal and external, only need to be listed if the University of Utah Human Research Protection Program and/or IRB is involved in the oversight and/or approval of that site. If a location is supporting the research, but does not need IRB approval to cover their activities (i.e., the location is not ‘engaged in research’), the location should not be added as a site, but described on the Resources and Responsibilities page.

• The UUHSC EDW Data Request Form is no longer required in order to request data from the EDW for use in research.  As such, the IRB application question regarding use of EDW data has been removed. Investigators must continue to ensure that their IRB application describes the data use in appropriate sections of the application, such as the Study Information and the Waiver of Consent/Authorization pages. The UUHSC EDW uses the approved IRB application to assess the appropriateness of research data requests and amendments to an IRB application may be needed if data is not appropriately or clearly described.

• ERICA is now able to stamp PDF versions of consent documents, but will continue to stamp DOC and DOCX versions as well.  The IRB still expects the standard revision tracking on any version of the consent document during the review process.

If you have any questions, please contact the IRB at 801-581-3655 or irb@hsc.utah.edu.