Research@UIC > Protocol Review > IRB > UPIRSOs

Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs)

Unanticipated problems involving risks to subjects or others (UPIRSOs) are research related incidents that may impact the rights, safety, or welfare of subjects or others. An UPIRSO may occur in both biomedical and social/behavioral research, and may impact the risks or harms to physical, financial, legal, social, emotional or psychological well being, privacy, or confidentiality. Although the reporting of adverse events is commonplace in biomedical research, an unanticipated problem meeting the level of an UPIRSO and prompt reporting to the IRB can occur in any type of research.

Policy

• Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) and Other Adverse Events: Investigator Reporting Responsibilities and OPRS/IRB Processing and Reporting

Form

• Event Requiring Prompt Reporting to the IRB - Form and Instructions

Decision Trees and Examples

• How to Determine Whether Your Adverse Event is an UPIRSO and Requires Prompt Reporting to the IRB
• How to Determine Whether Your Adverse Event for Research Conducted at the Jesse Brown VAMC Requires Prompt Reporting to the IRB
• Examples of events that should be promptly reported to the IRB
• Examples of events not requiring prompt reporting to the IRB
• Reporting the Death of a Research Subject

Education Overview

• UIC OPRS Event Requiring Prompt Reporting to the IRB - PPT

Sponsor Letter

• UIC OPRS Sponsor Letter

Prompt Reporting Timelines

• Prompt reporting timelines for research being conducted at UIC
• Prompt reporting timelines for research being conducted at JBVAMC

Last updated: Thursday, February 09, 2012.