Event Reporting
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The OSU Event Reporting Form should be used to report untoward events that may affect participants in research approved by an OSU IRB. (For research approved by Western IRB, see WIRB reporting requirements.) Events requiring prompt reporting (see below) include adverse events, protocol deviations, and other unforeseen problems or findings that suggest participants, research staff, or others are placed at greater risk by the research than previously expected. These events, classified broadly as unanticipated problems involving risks to subjects or others, must be reported promptly to the IRB, appropriate institutional officials, and federal agencies. Unanticipated problems can occur in any type of research (medical or non-medical) and may involve physical, psychological, social, legal, or economic harms.
Event Reporting Form version 2.2 - Updated: 9/25/09
Events Requiring Prompt Reporting
Events that may represent unanticipated problems involving risks to subjects or others and therefore require prompt reporting include the following:
- Adverse events or injuries that are serious, unexpected, and related;
- Adverse device effects that are unanticipated;
- Protocol deviations or violations (or other accidental or unintentional changes to the protocol or procedures) involving risks or with the potential to recur;
- Events requiring prompt reporting according to the protocol or sponsor;
- Complaints made by research participants indicating unanticipated risks, or complaints that cannot be resolved by the research staff;
- Unapproved changes made to the research to eliminate an apparent immediate hazard to a research participant;
- Data and Safety Monitoring Board (DSMB) reports, interim analyses, or other oversight committee/monitoring reports altering the risk/benefit profile;
- New information indicating an unexpected change in risks or potential benefits (e.g., literature/scientific reports or other published findings);
- Investigator’s Brochure (IB or IDB) updates or revisions to safety information; and
- Other problem or finding (e.g., breach of confidentiality, loss of study data or forms, etc.) that an Investigator or research staff member believes could influence the safe conduct of the research.
These events should be promptly reported (see below), regardless of whether they occur during the study, after study completion, or to a participant who has withdrawn from or completed study participation. If changes to the research or consent process are proposed as a result of the event, or if additional information will be provided to current and/or past participants, an amendment request must also be submitted for IRB review.
Timeframe for Reporting
All internal events (those occurring in research at OSU or at a site under an OSU IRB’s jurisdiction) and external events (those occurring in research at a site over which another IRB has jurisdiction) as described above should be reported within 10 days of the Investigator’s or research staff member’s learning of the event. Events resulting in temporary or permanent interruption of study activities by the Investigator or sponsor to avoid potential harm to participants should be reported immediately (within 48 hours) whenever possible.
Additional Information
Related adverse events and other problems involving risk that do not meet the reporting requirements and do not represent potential unanticipated problems involving risks to subjects or others should be reported in summary form at the time of continuing IRB review. However, any problem or adverse event that an investigator believes could influence the safe conduct of the research should be reported promptly.
For more information and definitions of terms (e.g., serious adverse event), see the OSU HRPP policy Event Reporting – Unanticipated Problems Involving Risks to Subjects or Others, Adverse Events, and Other Problems.
