Reportable Events

OHRP Video on Unanticipated Problems

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 Problemsprovides 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.

Keeping Track of Reportable Events

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.
Summary:

CHOP policy requires prompt reporting of any unanticipated problem involving risks to subjects or others to the IRB within 1 week of identification. Deaths and life-threatening events must be reported within 48 hours of discovery.

Summary:

Protocol deviations or violations (referred to from here on simply as Protocol Deviations) are any alteration or deviation from the IRB-approved research plan as defined in the study protocol. Some institutions distinguish between the terms deviation and violation; at CHOP they are considered to be equivalent. Protocol deviations are not usually anticipated and those that result in harm or have the potential for harm are considered Unanticipated Problems involving risk to subjects and others. To distinguish between those that need prompt reporting as Unanticipated Problems and those that don't, the IRB divides protocol deviations into Minor and Major deviations.

Summary:

Participants who enroll in a study may have a change in their status during the course of their participation. These changes can require re-consent or assent of the subject, reporting to the IRB of an unanticipated problem or additional determinations by the IRB.

Summary:

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.

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