Unanticipated Problems
Unanticipated problems involving risks to participants or others
It is the policies of the University of Utah IRB to require researchers to submit reports on events that may represent unanticipated problems involving risks to participants and others (UPs) including unexpected, related adverse events. 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.
PDF Version of Guidance (version date: July 2008).
What should I Submit-Amendment or Report?
What is an unanticipated problem involving risks to participants or others (UPs)?
- UPs are defined as any incident, experience or outcome that meets all of the following criteria:
- Unforeseen (not expected by the researcher or the research participant) 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; and
- 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.
What needs to be promptly reported?
- Unanticipated problems involving risks to participants or others (see above definition) including but not limited to:
- Unexpected, related adverse events
- A breach of confidentiality or privacy that involves real or potential risk such as unauthorized use of disclosure of protected health information (PHI)
- Unanticipated adverse device effects
*New information about the effect on health or safety or any life-threatening problem or death caused by, or associated with, a deceive, if that effect, problem or death was not previously identified in a nature of severity, or degree of incidence or any other unanticipated, serious problem associated with a device that relates to the rights, safety or welfare of subjects)
- New information indicating a change to the risks or benefits of the research including but not limited to:
- DSMB summary reports that indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB
- 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).
- Protocol Deviations if:
- Intended to eliminate apparent immediate hazard to a research participant or
- Harmful (caused harm to participants or others, or placed them at increased risk of harm - including physical, psychological, economic, or social harm), or
- Possible serious or continued noncompliance
Why do these events/problems need to be reported?
The above events/problems may be unanticipated problems involving risks to participants and others. The IRB will review the events to identify and report any unanticipated problems involving risks to participants and others as required by federal regulations.
What does "prompt" reporting mean?
Prompt reporting means that the report should be submitted as soon as possible after the PI learns of the event, but in all cases within 10 working days. The deadline for reporting begins at the time the investigator learns of the event. If the report is submitted late, a written explanation of it's tardiness must accompany the report.
How is a report made?
To report and adverse event, log on to ERICA, select the study in questions, click on the "AE" tab, and follow the instructions on that form. All events/problems may be reported through the AE form, the form will be re-named in the future to clearly indicate reporting of all events regardless of whether they are "adverse events."
Where can I find more information?
Office for Human Research Protections (OHRP)
Policy Guidance on Unanticipated Problems and Adverse Events (January 2007)
