Create an Incident Report

Unanticipated Problems (UPRs), Non-Compliance, and Other Reportable Incidents (Incident Submission)

The Incident Submission electronic form in Cayuse Human Ethics is used to report unanticipated problems involving risks to subjects or others (UPRs) and serious or continuing non-compliance. Details below provide guidance for determining what to report to the IRB and when it should be reported.

Overview

The TCU Institutional Review Board (IRB) must be informed promptly of any injuries to human subjects, any data security or confidentiality breaches, any unanticipated problems involving risks to subjects or others, and any serious or continuing noncompliance with TCU IRB requirements.

Investigators can be unsure of what to report to the IRB and may engage in a popular strategy of over-reporting and relying upon the IRB triage mechanisms for deciding what reports go to convened meetings.

The information provided on this page is intended to guide investigators in determining what to report to the IRB and when it should be reported. Additional information can be found in the TCU IRB Policy on Event reporting.

The federal regulations at 45 CFR 46.108(a)(4)(i) require the IRB to ensure that investigators promptly report any unanticipated problems involving risks to subjects or others (UPRs) or any serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB.

As the phrase “unanticipated problems involving risks to subjects or others” is found, but not defined, in the regulations, TCU uses the detail provided in the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) guidance document “Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events” regarding what to consider UPRs.

Creating an Incident Submission

• Log in to Cayuse Human Ethics.
• From the Product drop-down menu, select Human Ethics
• Find the study on the dashboard in “Approved Studies” and select it.
• In the top right corner select the “+ New Submission” button.
• Choose “Incident.”