Event Reporting
Unanticipated Problems Involving Risks to Subjects or Others, Adverse Events, and Other Problems
Unanticipated problems can occur in any type of research (medical or non-medical) and may include occurrences such as adverse events, subject complaints, protocol deviations, and other untoward events involving risk. Events requiring prompt reporting by investigators and research staff may involve physical, psychological, social, legal, or economic harms.
Event reports and accompanying information will be screened for completeness by ORRP staff members, additional clarifications will be requested from the investigator as necessary. ORRP staff members will make an initial determination about whether the event represents a possible unanticipated problem involving risks to subjects or others and/or potential noncompliance. Reports of events determined during screening to represent possible unanticipated problems involving risks to subjects or others and/or serious/continuing noncompliance will be forwarded to the IRB for convened review. Reports of events that do not meet the requirements for prompt reporting may be returned. All other event reports will be reviewed by the expedited procedure.
For more information, see HRPP policy Event Reporting – Unanticipated Problems Involving Risks to Subjects or Others, Adverse Events, and Other Problems
Event Examples and Reporting RequirementsContact ORRP with questions: 614-688-2208 NOTE: This table represents a non-exhaustive list of examples that can vary depending on specific scenarios and circumstances |
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|---|---|---|---|
| Event | Examples (not all-inclusive) | Reporting Criteria | How to Report |
| Adverse Event (AE) |
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An adverse event that is:
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Buck IRB Event Report within 10 Days |
| AE Reports
(PI request to change research due to new or increased risk)
|
Participant experienced event at a site not under Ohio State IRB jurisdiction and enrolled in research that is not conducted at Ohio State
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In the opinion of the PI an unanticipated problem that adversely affects the:
|
Buck IRB Amendment to Research Request
If implementing changes to eliminate an apparent immediate hazard to participants prior to approval of the amendment, please also submit a Buck IRB Event Report within 10 Days. |
| Event | Examples (not all-inclusive) | Reporting Criteria | How to Report |
| AE Reports
(no change to research planned) |
Participant experienced event at a site not under Ohio State IRB jurisdiction and enrolled in research that is not conducted at Ohio State
|
In the opinion of the PI the event does not warrant a change in the research or adversely affect Ohio State research:
|
Buck IRB Continuing Review Application
A DSMC report or investigator summary reflecting changes to the risk benefit ratio should be provided at continuing review. Individual reports should be maintained by the Investigator and not submitted with the continuing review application. |
| Breach of Confidentiality |
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Any failure to maintain confidentiality of research data as approved by the IRB that adversely affects the:
|
Buck IRB Event Report within 10 Days
Any breach of PHI requires immediate reporting to the appropriate HIPAA privacy and/or data security officer. |
| Major Protocol Deviation/ Violation |
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Any change from IRB approved protocol that adversely affects the:
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Buck IRB Event Report within 10 Days |
| Minor Protocol Deviation |
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Protocol deviations that are minor do not require reporting to the IRB unless they meet ANY of the following criteria:
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Buck IRB Event Report within 10 Days ONLY if the minor protocol deviation meets the defined reporting criteria |
| Event | Examples (not all-inclusive) | Reporting Criteria | How to Report |
| Participant Protocol Deviation |
|
Protocol deviations that are the result of participants’ behavior do not require reporting to the IRB unless they meet ANY of the following criteria:
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Buck IRB Event Report within 10 Days ONLY if the participant protocol deviation meets the defined reporting criteria |
| Research Complaint
(unable to be resolved by the research team) |
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A complaint associated with the study unable to be resolved by the research team that adversely affects the:
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Buck IRB Event Report within 10 Days |
| Report or Action by a Federal Agency, Sponsor, or Other Oversight Committee |
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Any finding issued that adversely affects the:
|
Buck IRB Event Report within 10 Days
Events resulting in temporary or permanent suspension of study activities by the investigator or sponsor to avoid potential harm to participants should be reported immediately (within 48 hours). |
| Other Event Resulting in an Unanticipated Problem |
|
Unanticipated problem that adversely affects the:
|
Buck IRB Event Report within 10 Days |
| Event | Examples (not all-inclusive) | Reporting Criteria | How to Report |
| Reports, Publications, Updated Investigator’s Brochures, or Interim Results or Findings
(PI request to change research due to new or increased risk) |
|
In the opinion of the PI an unanticipated problem that adversely affects the:
|
Buck IRB Amendment to Research Request
If implementing changes to eliminate an apparent immediate hazard to participants prior to approval of the amendment, please also submit a Buck IRB Event Report within 10 Days. |
| Reports, Publications, Updated Investigator’s Brochures, or Interim Results or Findings
(No Change to Research Planned) |
|
In the opinion of the PI the event does not warrant a change in the research or adversely affect the:
|
No reporting required.
Individual reports should be maintained by the investigator and not submitted with the continuing review application. |
