The UC Santa Cruz Institutional Review Board (UCSC IRB) must be informed promptly of:
- Any injuries to human subjects.
- Any data security or confidentiality breaches.
- Any unanticipated problems involving risks to subjects or others.
- Any serious or continuing noncompliance with UCSC IRB requirements.
To report unanticipated problems involving risks to subjects or others (UPRs), serious or continuing non-compliance, and other reportable incidents, use the Incident Submission form in Cayuse Human Ethics.
Reporting timelines
- UPRs must be reported within one week of discovery via a Cayuse Human Ethics Incident Submission.
- Incidents of non-compliance must be reported within one week of discovery via a Cayuse Human Ethics Incident Submission.
- All other incidents should be tracked, and reported to the IRB in summary form (using a table or spreadsheet) as part of the annual Renewal Submission.
Create an Incident Submission
- Log in to Cayuse Human Ethics.
- Find the study on the dashboard in “Approved Studies” and select it.
- In the top right corner select the “+ New Submission” button.
- Choose “Incident.”
Event types
Adverse event
Any unfavorable medical occurrence, abnormal sign, or symptom associated with the subject’s participation in the research.
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, and may occasionally occur in the context of social and behavioral research.
Only a small subset of adverse events occurring in human subjects participating in research will meet the criteria for a UPR.
Confidentiality breach
Breach of research data confidentiality (information security incident, loss of subject confidentiality), including a loss or destruction of research data not in accordance with IRB approval.
Non-compliance
Failure to comply with applicable laws, regulations, or UC Santa Cruz institutional policies pertaining to the protection of human subjects, and/or with the requirements or determinations of an IRB (including deviation from the IRB-approved/exempt certified study procedures).
Continuing non-compliance
A pattern of non-compliance that indicates an inability or unwillingness to comply with applicable laws, regulations, or institutional policies pertaining to the protection of human subjects and/or with the requirements or determinations of an IRB.
Serious non-compliance
Non-compliance that has a significant adverse impact either on the rights or welfare of participants or on the integrity of the study data.
Unanticipated problems involving risks to subjects or others (UPRs)
In general, an unanticipated problem is considered to include any incident, experience, or outcome that meets all of the following criteria:
- unexpected (in terms of nature, severity, or frequency) given:
- the research procedures described in the study-related documents (such as the IRB-approved research study and informed consent document); and
- the characteristics of the subject population being studied;
- related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); 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.It may be difficult to determine whether a particular incident, experience, or outcome is unexpected and whether it is related or possibly related to participation in the research.
An incident, experience, or outcome that meets the three criteria above generally will warrant consideration regarding changes to the study or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be considered in response to an unanticipated problem include:
- changes to the study initiated by the investigator prior to obtaining IRB approval to eliminate apparent immediate hazards to subjects;
- modification of inclusion or exclusion criteria to mitigate the newly identified risks;
- implementation of additional procedures for monitoring subjects;
- suspension of enrollment of new subjects;
- suspension of research procedures in currently enrolled subjects;
- modification of informed consent documents to include a description of newly recognized risks; and
- provision of additional information about newly recognized risks to previously enrolled subjects.
Furthermore, there are other types of incidents, experiences, and outcomes that occur during the conduct of human subjects research that represent unanticipated problems (but are not considered adverse events). For example, some unanticipated problems involve social or economic harm instead of the physical or psychological harm associated with adverse events. In other cases, unanticipated problems place subjects or others at increased risk of harm, but no harm occurs.