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In This Section
This page provides information and general guidance about those events that need to be reported promptly to the IRB during the conduct of research activities. The regulatory term used for these events is Unanticipated Problems Involving Risk to Subjects or Others. Serious adverse events (SAE) are just one type of unanticipated problem that require prompt reporting due to their potential to place subjects or others at risk of harm.
IRB SOP 408: Unanticipated Problems Involving Risks to Subjects provides more detailed definitions and describes the required reporting criteria in detail. The IRB's policy conforms to the reporting requirements established in both OHRP's and the FDA's Guidance documents.
Resources to Assist with Reportable Events
One-time Amendments that often apply only to a single participants.
Serious adverse events, unanticipated problems and determining which events require prompt reporting ...
Guidance on alterations or deviations from the IRB-approved research plan.
Guidance on subject status changes which may require reconsent, assent, or reporting to the IRB.
It is important to track all reportable events including SAEs, other unanticipated problems and protocol deviations. The following should be included:
- Subject ID
- Date of the event
- Date the PI became aware of the event
- Description of the event
- Date the event resolved (if applicable)
- Type of harm (if any) experienced by the subject
- Relationship harm to the event (causality)
- Date that report was submitted to the IRB and other regulatory authorities. Many events will not require a report other than at the time of continuing review.
There are other types of unanticipated problems that need to be reported to the IRB. Changes in the status of a subject are particularly important. A change is status means the subject has become pregnant, become a ward of the state or become incarcerated. Each of these events could require the IRB to make a new determination which might require full-board review. Subpart B Protections apply to subjects who are pregnant, additional Subpart D protections 45 CFR 46.409 apply to children who become wards of the state and Subpart C Protections apply to subjects who become prisoners or are incarcerated.