IRB Report Form Changes

The report form has been reorganized, allowing the following features beginning 2.06.2010:

• All report form types (e.g. adverse events, deviations, breaches, information, etc.) can now be selected on the first page of the report form, instead of on multiple pages.
• The report form now includes a Documents and Attachments page for all types of reports, instead of allowing attachments on multiple pages.

The IRB has not changed any of the information that must be provided in the report form, nor have the IRB reporting requirements changed. For more information about IRB reporting requirements, please visit the IRB website at http://www.research.utah.edu/irb/adverse/index.html

Changing the PI on a Study
When an amendment is submitted to the IRB requesting to change the PI, the original PI is required to submit the amendment; beginning 2/6/2010, the new PI will also be required to sign off on the submission of the amendment. Once the new PI signs off, he/she will gain access to perform the PI role for the amendment application in ERICA and the old PI will no longer be required to respond to IRB requests for the amendment review. Previously, the new PI could not function as the PI in ERICA until the amendment was approved.

To ensure that the PI change is processed correctly, you MUST change the PI in the Update Study Application after completing the amendment application. This will allow the new PI to sign off on the submission after the original PI.

RGE Application – Amendments and Continuing Reviews
Beginning 2/6/2010, the Resource for Genetic Epidemiological Research (RGE) amendment and continuing review applications will be incorporated into the IRB amendment and continuing review applications. This means that all submissions to RGE will be made electronically through the ERICA system. When a PI submits an IRB amendment or continuing review, those studies also requiring review from RGE will be forwarded to the RGE committee. RGE review and approval will occur BEFORE IRB review; the IRB pre-review will not occur until RGE review is complete. PIs must account for this at the time of continuing review to ensure that their studies are submitted with enough time for re-approval prior to study expiration.

For questions regarding RGE submissions, please call 801.581.6351.