Reporting Problems and Adverse Events
Reporting Problems and Adverse Events
This policy outlines how investigators must report problems, adverse events, and other unanticipated issues in human subjects research. Timely reporting helps ensure participant safety and ensures that researchers are compliant with federal requirements.
General Rule
Any problem, event, or outcome that is unexpected, related or possibly related to the research, and suggests greater risk to participants or others than previously known must be reported promptly (within 7 days) to the IRB using the Incident Submission form in Cayuse. Problems or adverse events that are anticipated, or do not suggest new or increased risk should be reported at the next continuing review, study modification, or closure. If you are unsure, please contact the IRB Administrator for guidance (brian.warby@uni.edu or rsp@uni.edu).
Reporting Incidents: If an incident needs to be reported promptly to IRB, open your study in Cayuse, select the “+ New Submission” button, and follow the prompts to create an "Incident Submission." Answer the questions and certify the submission. Once complete, it will be routed to the IRB Administrator and Chair for review.
If an incident does not meet the criteria that would require prompt reporting (categories A + C from below), PIs must report it and any other incidents in their renewal or closure submissions. A separate incident report is not required.
If researchers decide to modify their study in response to an incident (categories A + C), they should report the incident in their request for a modification. If a modification is in response to an Adverse Event that is also an Unanticipated Problem (Category B from
below), researchers must promptly submit an incident report and then begin the process to request a modification.
Definitions
Adverse Events (AE): Any unfavorable or harmful occurrence in a participant or others during research participation, whether or not it was expected. AEs may be physical or psychological.
Serious Adverse Events: Results in death, hospitalization, significant disability, or poses an immediate threat to life or safety.
Adverse Events are defined as any untoward or unfavorable medical occurrences in one or more human participants, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events include both physical and psychological harm, but not social, economic, or other kinds of harm. Instances of serious harm (death, disability, or hospitalization) that are unexpected are referred to as Serious Adverse Events.
Unexpected Adverse Event: Not described in the protocol, consent form, or other documentation provided to the IRB or to subjects.
Unanticipated Problem (UP): Any incident, experience, or outcome that is unexpected, related or possibly related to participation in the research, and indicates that participants or others face additional risks or greater risk of harm than previously recognized. Adverse Events that meet these criteria are also considered Unanticipated Problems.
Anticipated Problem: A known or foreseeable risk that was previously described to the IRB and participants.
Reporting Categories
| Category | Description | When to Report |
|---|---|---|
A | Adverse Event that was anticipated or unrelated to research | At renewal/closure |
B | Adverse Event that is unexpected and related or possibly related to the research (i.e., also an Unanticipated Problem) | Within 7 days |
C | Unanticipated Problem that is not an Adverse Event (e.g., data breach, procedural error, loss of confidentiality) | Within 7 days if serious; otherwise at renewal/closure |
Reporting Rule: Report B promptly; report A and C at renewal unless severity or patterns suggest new or increased risk.
Examples
Example of Adverse Events that are NOT Unanticipated Problems. Category A
- Emotional discomfort in interviews:
Participants in a trauma study report temporary sadness or anxiety when recalling difficult experiences, as described in consent materials.
AE, but foreseen. - Survey fatigue
Several participants report mild frustration or boredom during a long online survey.
AE, but minor and expected. - Physical injury
A participant experiences a muscle injury while lifting weights in an exercise study.
AE, but expected.
Examples of Adverse Events that ARE Unanticipated Problems. Category B
- Participant panic attack:
A participant in a virtual reality study unexpectedly experiences a severe panic attack requiring emergency care.
AE + UP, because the severity and response were not anticipated. - Threat of harm triggered by study participation:
A participant in an intimate partner violence study is physically assaulted after the partner discovers her participation.
AE + UP — serious and unanticipated risk to participant safety.
Examples of Unanticipated Problems that are NOT an Adverse Event. Category C
- Emotional distress beyond expectations:
Some participants in an interview study about family caregiving become more upset than anticipated, with several becoming visibly agitated and refusing to answer certain questions.
Unexpected level of distress suggests unanticipated psychological risk. - Software failure exposes data:
An online survey platform updates its software, unintentionally removing encryption from stored responses.
No known breaches yet, but new, unanticipated risks are introduced. - Community reaction or stigma:
After a local newspaper reports on a community-based study about substance use, community members identify participants and stigmatize them.
Unexpected reputational and privacy risk emerges.
Examples of events that do not need to be reported.
- Physical injury unrelated to research:
A participant withdraws from a multiple-visit exercise study due to a physical injury sustained 10 days after the previous visit.
Unrelated to the research protocol - Participant complains about research procedures:
A participant complains about the inconvenience of walking to the laboratory to participate in the research
Researchers may consider how to improve participants’ experiences but do not need to report this - Equipment failure:
A piece of equipment breaks during testing but does not cause injury or emotional distress
Researchers may need to submit a modification to their study to substitute a different process or piece of equipment, but do not need to report this as an incident
References
The Office for Human Research Protections (OHRP), Department of Health and Human Services. “Guidance on Reviewing and Reporting Unanticipated Problems involving Risks to Subjects or Others and Adverse Events.” January 15, 2007.