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:
- Complete the Incident Report Form
- Send email to researchcompliance@wm.edu to confirm submission of form.
- Wait for response from IRB
All participant-facing documents must be submitted to the IRB. This includes (but is not limited to):
- Surveys
- Advertisements
- Informed Consents
- Messages 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.
Once the IRB switches to SPARCS, there will be a form within the system to submit an incident. This page will be updated once SPARCS is launched for IRB protocols.
