Reporting of Deviations and Incidents
Reports of noncompliance or protocol deviations must be submitted to the IRB within 48 hours of discovery.
To submit a incident report, please follow the instructions below:
- Go to the affected protocol in SPARCS under "My Studies" on the Dashboard
- Click on the protocol
- Navigate to the blue button "+New Submission"
- Select "Incident" from the drop down
- Complete form and submit
- Wait for response from IRB
Detailed instructions on how to add a "New Submission" to a current protocol can be found here
All participant-facing documents must be submitted to the IRB. This includes (but is not limited to):
- Surveys
- Advertisements
- Informed Consents
- Messages/emails to participants
Any changes that are made to these types of documents/materials must be submitted to the IRB before they can be administered to participants. If changes are made to these documents and given to participants without IRB approval, then a incident report must be submitted.
Other examples of noncompliance could include breaches in confidentiality, failure to obtain informed consent before study participation, etc.
