Reportable Events

Definition: Reportable Events generally fall into one of these categories: Noncompliance, Unanticipated Problem Involving Risks to Subjects, Serious Adverse Events, or other miscellaneous items.

Reporting events:

The process begins when IRB receives an email detailing the reportable event is delivered to the IRB@Mckendree.edu mailbox.

The process ends when the IRB Chair has determined that no further action is needed, has referred the submission to the full IRB board, and/or has communicated the event to  University officials.

Steps in handling a reportable event:

Federal regulations require reportable events be addressed in a timely manner. At the University reportable events must be communicated to the IRB no later than five (5) days following the event, using the IRB mailbox IRB@Mckendree.edu. The event should also be communicated directly to the IRB Chair.

For all reported events the IRB determines seriousness.

Examples include:

• • Incidents, experiences, or outcomes that are unexpected, related or the relationship to study participation that suggests 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.

  • Information security incidents involving any unauthorized use, disclosure, transmission, removal, theft, loss or destruction of research-related protected health information.

  • Study personnel noncompliance within authorized study parameters.

  • University faculty, staff, or students conducting unapproved research.

Procedure:

If the Reportable Event represents Noncompliance:

For each allegation of noncompliance, the IRB Chair will undertake the initial steps to make a determination of facts.

For non-serious findings of fact related to risks to subjects or risks to the integrity of the data, the Chair will assess the overall corrective action plan provided by the Principal Investigator. The plan may be approved, approved with contingencies, or needs reply. Depending on the nature of the findings, the study may be temporarily suspended until the action plan is approved.

If the Chair's initial determination is that noncompliance is serious or continuing, then the submission will be referred to the full IRB board for review. Additionally, the findings will be communicated to university officials.  An IRB administrative suspension of the study may be implemented to assure participant safety or data confidentiality.

If the determination is that the noncompliance is neither serious nor continuing, then the IRB Chair will document this conclusion and no further action will be required.