HOW TO REPORT PROTOCOL DEVIATIONS AND UNANTICIPATED PROBLEMS TO THE OUHSC IRB FOR REVIEW

Effective August 7, 2018, the HSC IRB no longer accepts or review the Protocol Deviation or Unanticipated Problem Report Forms. “NC” has been added to the form names to indicate they are for the Norman Campus only.  A new form has been created to report such events to the HSC IRB called “HSC Incident Report Form”.  Instructions for accessing and submitting the form are noted below.
 

  1. Log into iRIS (https://iris.ouhsc.edu)
  2. Click My Studies under the Study Assistant tab on the left.
  3. Locate the study which the event occurred and requires reporting. Click the Open icon on the far left side next to the appropriate study.
  4. Once in the Submissions screen, scroll down to the second section/table on the left side of your screen.
  5. Locate and click on the HSC Incident Report Form option.
  6. On the next screen, locate and click the Add New Form button on the right side to create a new submission form.
  7. Respond to all questions in every section, typing ‘N/A’ or selecting the ‘N/A’ option where appropriate. Click the Save and Continue to Next Section button to proceed throughout the form.
  8. Once you reach Section 700 – Document Upload, you may upload and attach any supporting documents regarding the event (e.g. training documentation, memos, reports, etc.).
  9. Once finished – or if you do not have documents to attach – click the Save and Continue to Next Section button to proceed. 
  10. At the end of the form, you may either the Exit Form button to close the submission without submitting the form, or click one of the following:
    1. Notify PI to Signoff – this presents for KSP who are not PI and routes the form to the PI for submission.
    2. Signoff and Submit – this presents for PIs and allows them to complete the signoff screen for submission.
  11. You may exit the form once you notify the PI to signoff. iRIS will send an email correspondence to the PI to notify them of a signoff task; but you may also contact your PI directly to notify them that the form is ready for their signoff in iRIS.   
     

Once the PI completes the signoff to submit to the IRB, the submission will be routed to our office for processing. You will be notified of the IRB’s determination via email correspondence from iRIS with an attached outcome letter.