Reportable New Information

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Events that occur during the course of the research, such as: unplanned changes, unexpected outcomes of a study, failure to follow an approved protocol, breaches of confidentiality, and subject complaints that cannot be resolved by the research team must be submitted to the IRB as Reportable New Information (RNI). This list is not comprehensive. See HRP-103 for more detailed information on what constitutes reportable information. An RNI must be submitted within 5 business days.

Breach of Confidentiality Example: You lost your laptop with participant data.

Unexpected Outcome and Failure to Follow an Approved Protocol Example: Your research participant is unexpectedly triggered by an interview question and becomes very emotional so you change the interview questions.

 

“Report New Information” in CATS IRB following the steps below. 

 

Select “IRB” to access the “Active” tab to find all active studies.  Select the desired study by clicking on the study name if associating the report with a specific study. Click the “Report New Information” button on the left side of the screen.

Picture of the Active submissions tab in CATS IRB

 

 

 

 

If not associated with a specific study, the “Report New Information” button is available on the home page in CATS IRB.

Picture of button to create reportable new information

 

 

 

 

Complete all questions in the form. An example is given below. Click “Continue” at the end of the form to be taken back to the RNI workspace.

Report New Information page

 

Submit the RNI, by selecting “Submit.” Confirm the submission by verifying the submission state has changed to “Pre-Review.”


Pre-review flowchart