Investigators must report all potential unanticipated problems and events to the IRB. Unanticipated problems (UPs) are defined as any incident, experience or outcome that meets all of the following criteria:
- Unexpected (unforeseen by the researcher or the research participant) in terms of nature, severity,
or frequency, given the research procedures and the subject population being studied;
- Related or probably related to participation in the research, or if the event or problem probably or
definitely affects the safety, rights and welfare of current participants;
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously
known or recognized.
VA RESEARCH: For more information about reporting potential unanticipated problems for VA research,
visit Research Conducted at Veterans Affairs.
How to Report a Potential Unanticipated Problem
The Investigator must consider each problem, event, or new information and decide whether or not it represents a UP, using the criteria above.
If UP Criteria Are Met:
Report the problem, event, or information using the Report Form in ERICA. The Report Form must be submitted promptly, within 10 working days from the time the investigator learns of the event. NOTE: The Report Form must be submitted within 5 working days for VA research.
- Open the study in ERICA
- Click on the Report Forms tab
- Click on the File a Report Form button
- Complete the report form entirely
- Attach any supporting documentation to the report form in the indicated sections
- If you are submitting an amendment in conjunction with the report, link the report form to the amendment in the "Report Forms" section of the amendment application
- Submit the report form to the IRB for review
If UP Criteria Are Not Met:
- Document in the research record how the problem/event/information does not meet the UP Criteria.
- Summarize the problem/event/information in the next Continuing Review application.
Examples of Potential Unanticipated Problems
- Adverse events
- A breach of confidentiality or privacy that involves real or potential risk (e.g. unauthorized use of disclosure of protected health information.)
- Adverse device effects
- Data and safety monitoring reports that indicate that frequency or magnitude of harms or benefits may be different than initially presented to the IRB
- A publication that shows that the risks or potential benefits or the research may be different than initially presented to the IRB
- Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol
- Incarceration of a participant in a protocol not approved to enroll prisoners
- Complaints from participants or others involved in the research that indicate unexpected risks or cannot be resolved by the research team
- Warning or determination letters issued by any funding agency or regulatory body including
Office of Human Research Protections (OHRP), Department of Health and Human Services
(DHHS), Food and Drug Administration (FDA)
Why do these problems/events need to be reported?
The above events/problems may be unanticipated problems involving risks to participants and others. The IRB needs information about these problems and events in order to determine that (a) risks to participants are minimized, and (b) the risks are reasonable in relation to the anticipated benefits.
What are the consequences for late reporting?
Researchers are required to submit the report as soon as possible after the PI learns of the event, but in all cases within 10 working days. If the report is submitted late, a written explanation of its tardiness must accompany the report. Late reports may be reviewed for non-compliance.
Where can I find more information?
- Office for Human Research Protections (OHRP) Policy Guidance on Unanticipated Problems and Adverse Events (January 2007)
- Food and Drug Administration Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Events Reporting to IRBs – Improving Human Subject Protection [PDF] (January 2009)
- Signed UP Letter [PDF] – “University of Utah IRB Standard Operating Procedure (SOP) 901 – Unanticipated Problems Involving Risks to Participants or Others”
- Adverse Events Decision Flowchart [PDF]
- Report Form Frequently-Asked Questions [PDF]
- What Should I Submit – An Amendment or a Report Form? [PDF]