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.
How to Report a Potential Unanticipated Problem
The Investigator must consider each problem, event, or new information and decide whether or not it represents an Unanticipated Problem using the criteria above.
If Unanticipated Problem Criteria Are Met:
Report the problem, event, or information using the Report Form application. The Report Form must be submitted promptly, within 10 working days from the time the investigator learns of the event.
Steps to File a Report:
Complete a Report Form application.
Be sure to review the instructions carefully. Not all sections need to be completed based on the type of information you are submitting.
Submit the completed Report Form via email. Be sure to include any supporting documents with the application to explain the event.
If you will be making changes to the study based on the information you are reporting, an amendment will be needed. In the , be sure to state that you are submitting it based on a report form. In the report form application, be sure to state that you are submitting an amendment as part of your corrective and preventive action plan.
If Unanticipated Problem 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 problems/events need to be reported?
- What are the consequences for submitting a possible Unanticipated Problem late?
- Once my project is determined exempt, do I need to do anything else with the application?
Related Research Topics
- Adverse Device Effects
- Adverse Events
- Breaches of Confidentiality
- Report Forms
- Complaints from Research Participants