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Unanticipated Problems (UPRs), Non-Compliance, and Other Reportable Incidents (Incident Submission)

The Incident Submission electronic form in Cayuse Human Ethics is used to report unanticipated problems involving risks to subjects or others (UPRs) and serious or continuing non-compliance. Details below provide guidance for determining what to report to the IRB and when it should be reported.

Overview

The UCSC Institutional Review Board (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, and any serious or continuing noncompliance with UCSC IRB requirements. 

Investigators can be unsure of what to report to the IRB and may engage in a popular strategy of over-reporting and relying upon the IRB triage mechanisms for deciding what reports go to convened meetings. 

The information provided on this page is intended to guide investigators in determining what to report to the IRB and when it should be reported. Additional information can be found in the UCSC IRB Policy on Unanticipated Problems Involving Risks to Subjects or Others and the UCSC IRB Policy on Noncompliance.

The federal regulations at 45 CFR 46.108(a)(4)(i) require the IRB to ensure that investigators promptly report any unanticipated problems involving risks to subjects or others (UPRs) or any serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB. 

As the phrase “unanticipated problems involving risks to subjects or others” is found, but not defined, in the regulations, UCSC uses the detail provided in the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) guidance document “Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events” regarding what to consider UPRs.

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Terminology

Adverse Event 

Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, associated with the subject’s participation in the research (based on timing), whether or not considered related to 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, although on occasion, they can 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); this includes a loss or destruction of research data not in accordance with IRB approval.

Non-Compliance 

Failure to comply with applicable laws, regulations, or UCSC 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. 

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Reporting Timelines

Adverse Event 

Adverse events that rise to the level of a UPR must be promptly (within one week of discovery) reported via a Cayuse Human Ethics Incident Submission. 

All other adverse events should be tracked, and reported as part of the annual Renewal Submission (Administrative Check-In or Continuing Review).

Non-Compliance 

Non-compliance must be promptly (within one week of discovery) reported via a Cayuse Human Ethics Incident Submission. 

UPRs 

UPRs must be promptly (within one week of discovery) reported via a Cayuse Human Ethics Incident Submission. 

Incidents that do not Qualify as UPRs

Any incidents that do not meet the definition of a UPR  should be tracked, and reported to the IRB in summary form (using a table or spreadsheet) as part of the annual Renewal Submission (Administrative Check-In or Continuing Review).

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Creating 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.”