Reporting of Deviations and Incidents

Summary

Reports of noncompliance or protocol deviations must be submitted to the IRB within 48 hours of discovery. Please see this guidance document on how to submit reports.

Full Description

When does an "Incident" need to be submitted?

An "incident" should be submitted when there is: 

• New or increased risk, or a safety issue
• Major or Minor Protocol Deviation: Variation from the IRB approved research plan that happens without prior review and approval of the IRB (e.g., study visit outside protocol window, blood work drawn outside protocol window, etc.).
  • Protocol deviations can be major or minor.
  • Depending on the details, protocol deviations may be determined to be non-compliance (serious, continuing, or otherwise). 
• Noncompliance: failure to adhere to federal, state, or local regulations governing human subject research, organizational policies related to human subject research, or the requirements or determinations of the IRB. Non-compliance may be minor or sporadic, or it may be serious or continuing.  
  • Serious non-compliance is defined as non-compliance that, in the judgment of the convened IRB, creates an increase in risks to subjects, adversely affects the rights, welfare or safety of subjects, or adversely affects the scientific integrity of the study. Willful violation of regulations and/or policies may also constitute serious non-compliance.
  • Continuing non-compliance is defined as a pattern of non-compliance that, in the judgment of the convened IRB, suggests a likelihood that instances of non-compliance will continue unless the IRB or organization intervenes.
• Serious Adverse Events
• Suspension or premature termination by the sponsor, investigator, or institution
• Audit, inspection, or inquiry by a federal agency
• Written reports from a federal agency (e.g., FDA Form 483)

SPARCS Incident Reports

To submit a incident report, please follow the instructions below:

1. Go to the affected protocol in SPARCS under "My Studies" on the Dashboard
2. Click on the protocol
3. Navigate to the blue button "+New Submission"
4. Select "Incident" from the drop down
5. Complete form and submit
   • If reporting a minor OR major protocol deviation, please select the option "Protocol Deviation and/or Noncompliance" under Question 1 of the form
6. Wait for response from IRB

SPARCS Help Page and Instruction Guides 

Changes to Participant-Facing Documents

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.