What should I do if something unexpected or non-compliance occurs?
During the course of a research study, unintentional mistakes in following the IRB-approved protocol or unexpected issues may occur. Research teams must identify, evaluate, and respond to these deviations and unexpected events to protect the rights, safety, and welfare of participants and others and the integrity of the research data. The Principal Investigator (PI) is responsible for the accurate documentation, timely reporting, investigation, and follow-up of these events.
Reporting Timelines:
- Report the death of a Northwestern or Northwestern affiliate participant or a participant at a site relying on the Northwestern IRB for review that is both Unanticipated and Related or Possibly Related within 24 hours of knowledge or notification.
- Report any other information about an event at Northwestern or Northwestern affiliate or information about an event at a site relying on the Northwestern IRB for review that meets the IRB reporting criteria within five business days of knowledge or notification.
- Report the use of the short form consent process within ten business days.
If the event involved non-compliance or researcher error, you should document the information on who contributed to and why the event happened through a Root Cause Analysis. Visit the Corrective and Preventive Action (CAPA) Plans Page for details on creating and documenting a specific, measurable, actionable, realistic, and time-bound CAPA plan.
You may utilize the Incident Assessment Tool to determine whether to submit a Reportable New Information item to the Northwestern University IRB. See the Reportable New Information (RNI) Page for key things to consider, such as required Additional Notifications (for example, if the event was a data incident or involved the NM Investigational Drug Services pharmacy), what to do If your event does not meet the IRB reporting criteria, steps to take If your event does meet the IRB reporting criteria, and what to do If the Principal Investigator (PI) is unable to make a determination. The RNI page also contains examples of events that require reporting to the IRB and definitions of IRB determinations.
If the PI determines the event meets the IRB reporting criteria, follow the steps on the RNI Page under Preparing an RNI Submission in eIRB+ to submit the event to the IRB within an eIRB+ RNI application. Review the RNI Page, section RNI Categories and Examples, and select all RNI categories in the RNI application that apply to the event you are reporting.
The IRB Office’s process for managing reportable new information is detailed in “SOP: Reportable New Information (HRP-024).”
Northwestern University is obligated to report to institutional officials and all applicable federal oversight agencies information that represents Serious Non-Compliance, Continuing Non-Compliance, Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO), Suspension of IRB Approval, Termination of IRB Approval, or any combination of the above. Refer to SOP: External Reporting Process (HRP-094) for information on submitting external and institutional reports. For US Department of Defense (USDOD) research, the report is sent to the USDOD human research protection officer.
If the IRB makes a reportable determination in reviewing an RNI, the Principal Investigator (PI) of the associated study must review their study’s funding sources in the eIRB+ application for accuracy and email irbcompliance@northwestern.edu within 5 business days from the date of the RNI letter to confirm the accuracy of the funding sources or provide an accurate list of funding sources. See the RNI Page, section Institutional Reporting Obligations, for details.