To ensure the protection of research participants, federal regulations and IRB policy require study teams to submit reportable events to the IRB for review. 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 unexpected events involving risk. Events requiring prompt reporting by investigators and research staff may involve physical, psychological, social, legal, or economic harms.
Reporting Requirements
The following information represents a non-exhaustive list of examples that can vary depending on specific scenarios and circumstances.
Adverse Event (AE)
Examples (not all-inclusive)
- Participant with acute renal failure at a site under Ohio State IRB jurisdiction, probably related to study drug administration, resulting in hospitalization, renal failure not listed as a known risk in the informed consent document or investigator’s brochure.
- Participant with suicidal ideation at a site not under Ohio State IRB jurisdiction but engaged in Ohio State research, resulting in hospitalization, unexpected, related to protocol behavioral intervention, not listed as a known risk in the informed consent.
Reporting Criteria
An adverse event that is:
- serious,
- unanticipated and
- related.
How to Report
- Buck-IRB Event Report within 10 Days
AE Reports (PI request to change research due to new or increased risk)
Examples (not all-inclusive)
Participant experienced event at a site not under Ohio State IRB jurisdiction and enrolled in research that is not conducted at Ohio State
- IND Safety Reports
- MedWatch Reports
- CIOMS Reports
Reporting Criteria
In the opinion of the PI an unanticipated problem that adversely affects the:
- risk/benefit ratio of the study or
- rights, safety, or welfare of the participants or others or
- integrity of the study.
How to Report
- 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.
AE Reports (no change to research planned)
Examples (not all-inclusive)
Participant experienced event at a site not under Ohio State IRB jurisdiction and enrolled in research that is not conducted at Ohio State
- IND Safety Reports
- MedWatch Reports
- CIOMS Reports
Reporting Criteria
In the opinion of the PI the event does not warrant a change in the research or adversely affect Ohio State research:
- risk/benefit ratio of the study or
- rights, safety, or welfare of the participants or others or
- integrity of the study.
How to Report
- 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
Examples (not all-inclusive)
- stolen unencrypted laptop with protected personal information (PPI) or protected health information (PHI)
- disclosure of PPI or PHI without appropriate approvals
Reporting Criteria
Any failure to maintain confidentiality of research data as approved by the IRB that adversely affects the:
- risk/benefit ratio of the study or
- rights, safety, or welfare of the participants or others or
- integrity of the study.
How to Report
- Buck-IRB Event Report within 10 Days
- any breach of PHI requires immediate reporting to the appropriate HIPAA privacy and/or data security officer security@osu.edu
Major Protocol Deviation/Violation
Examples (not all-inclusive)
- failure to follow the currently approved protocol procedures
- failure to obtain informed consent prior to research activities
- drug dispensing/dosing error
- enrollment of a participant who did not meet all inclusion/exclusion criteria
Reporting Criteria
Any change from IRB-approved protocol that adversely affects the:
- risk/benefit ratio of the study or
- rights, safety, or welfare of the participants or others or
- integrity of the study.
How to Report
- Buck-IRB Event Report within 10 Days
Minor Protocol Deviation
Examples (not all-inclusive)
- blood samples obtained at times close to, but not precisely at the protocol-specified time points, and did not pose risk to the participant
- investigators miss giving a participant a protocol required quality of life questionnaire
Reporting Criteria
Protocol deviations that are minor do not require reporting to the IRB unless they meet ANY of the following criteria:
- the incident(s) suggest that a participant’s safety is being affected or
- the incident(s) adversely affects the integrity, accuracy, and/or reliability of the research data from the participant or
- a pattern of protocol deviations occurs that indicates a need for changes in the protocol or informed consent document(s).
How to Report
- Buck-IRB Event Report within 10 Days ONLY if the minor protocol deviation meets the defined reporting criteria protocol or informed consent document(s)
Participant Protocol Deviation
Examples (not all-inclusive)
- participant misses study visit due to inclement weather or a personal issue
- participant forgets to take an at-home blood pressure reading
- participant fails to return a study diary
Reporting Criteria
Protocol deviations that are the result of participants’ behavior do not require reporting to the IRB unless they meet ANY of the following criteria:
- the incident(s) suggest that a participant’s safety is being affected or
- the incident(s) adversely affects the integrity, accuracy, and/or reliability of the research data from the participant or
- a pattern of protocol deviations occurs that indicates a need for changes in the protocol or informed consent document(s).
How to Report
- 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)
Examples (not all-inclusive)
- complaint from a participant regarding research activities
- complaint from study personnel regarding conduct of the research
Reporting Criteria
A complaint associated with the study unable to be resolved by the research team that adversely affects the:
- rights, safety, or welfare of the participants/others or
- integrity of the research.
How to Report
- Buck-IRB Event Report within 10 Days
Report or Action by a Federal Agency, Sponsor, or Other Oversight Committee
Examples (not all-inclusive)
- FDA Form 483 or Warning Letter
- adverse sponsor audit results
- FDA clinical hold
- suspension or premature termination of research by sponsor, investigator, or other entity (e.g., Data Safety Monitoring Committee (DSMC), Institutional Official)
Reporting Criteria
Any finding issued that adversely affects the:
- risk/benefit ratio of the study or
- rights, safety, or welfare of the participants or others or
- integrity of the study.
How to Report
- 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
Examples (not all-inclusive)
- an event in the opinion of the PI that may represent an unanticipated problem
- participant becomes incarcerated
- sponsor required reporting
Reporting Criteria
Unanticipated problem that adversely affects the:
- risk/benefit ratio of the study or
- rights, safety, or welfare of the participants or others or
- integrity of the study.
How to Report
- Buck-IRB Event Report within 10 Days
Reports, Publications, Updated Investigator’s Brochures, or Interim Results or Findings (PI request to change research due to new or increased risk)
Examples (not all-inclusive)
- DSMB reports and recommendations
- regulatory agency public health advisory
- “Dear Healthcare Professional” letter
- revised investigator’s brochure
- revised label/package insert
- updated device manual
Reporting Criteria
In the opinion of the PI an unanticipated problem that adversely affects the:
- risk/benefit ratio of the study or
- rights, safety, or welfare of the participants or others or
- integrity of the study.
How to Report
- Buck-IRB Amendment to Research Request
- If implementing changes to eliminate an apparent immediate hazard to participants prior to the 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)
Examples (not all-inclusive)
- DSMB reports and recommendations
- regulatory agency public health advisory
- “Dear Healthcare Professional” letter
- revised investigator’s brochure
- revised label/package insert
- updated device manual
Reporting Criteria
In the opinion of the PI the event does not warrant a change in the research or adversely affect the:
- risk/benefit ratio of the study or
- rights, safety, or welfare of the participants or others or
- integrity of the study.
How to Report
- No reporting required.
- DSMB reports should be submitted at the time of continuing review. All other reports should be maintained by the investigator and not submitted with the continuing review application.