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An unanticipated problem involving risks to subjects or others is any event or problem that:
- was unexpected (in terms of nature, severity or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB- approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied AND
- suggests that the research places subjects or others (those not directly involved in the research such as research staff or family members) at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized AND
- is 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).
When a research study includes investigational drugs or devices, some unanticipated problems may also meet the definition of an unexpected adverse drug experience (serious or otherwise), or an unanticipated adverse device effect.
Examples of unanticipated problems involving risks to subjects or others include, but are not limited to:
- A breach of confidentiality
- A subject complaint when the complaint indicates unexpected risks or cannot be resolved by the investigators,
- A research team member experiences harm in the conduct of the study
- A new risk of the study drug, device, or study procedure is identified by an outside source (sponsor, federal regulatory agency, outside site, etc.)
Investigators must report any unanticipated problem involving risk to subjects or others using the Reportable Event Form (REF) in the HawkIRB system. This form includes a description of the event, the date of occurrence, whether it is a local or outside report, how the event affected the rights, safety or welfare of the subject or others, current status of subjects, and any planned changes or modifications to the project as a result of the event. Reports from the investigator to the IRB must be submitted via HawkIRB within ten working days of the event or within 10 working days of the PI becoming aware of the event. For IRB-03 studies, reporting must occur within five working days.
The IRB chair compares the content of the REF with the previously approved project materials such as applications, informed consent document(s), protocols, investigator brochures, or other supporting documents to determine whether this event meets the definition of an unanticipated problem involving risk to subjects or others. If the chair agrees the event meets the definition of an unanticipated problem involving risks to subjects or others, the chair determines whether the event represents minimal risk of harm or more than minimal risk of harm to subjects enrolled under the UI study. If the event represents minimal risk of harm, the chair reviews and signs the report through the HawkIRB system. If the event represents more than minimal risk of harm to subjects enrolled under the UI study, the report is referred to the convened IRB for review.
All reports of unanticipated problems involving risks to subjects or others are electronically filed with the appropriate research study. These reports are also reviewed by the IRB at the time of continuing review. Reports of all such problems for all projects reviewed by the Chair or convened IRB are provided by e-mail to all IRB-01, IRB-02, or IRB-03 members as appropriate on a monthly basis.