Office of Responsible Research Practices
The Ohio State University

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 Requirements

Contact ORRP with questions: 614-688-8457

Event Examples (not all-inclusive) Reporting Criteria How to Report
Adverse Event (AE)
  • 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.
An adverse event that is:

  • Serious,
  • Unanticipated,
  • and Related
Buck IRB Event Report within 10 Days
Event Examples (not all-inclusive) Reporting Criteria How to Report
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

  • IND Safety Reports
  • MedWatch Reports
  • CIOMS Reports
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
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

  • IND Safety Reports
  • MedWatch Reports
  • CIOMS Reports
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
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.

Event Examples (not all-inclusive) Reporting Criteria How to Report
Breach of Confidentiality
  • Stolen unencrypted laptop with protected personal information (PPI) or protected health information (PHI)
  • Disclosure of PPI or PHI without appropriate approvals
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
Buck IRB Event Report within 10 Days

Additional reporting to the HIPAA privacy and data security officers may also be required.

Event Examples (not all-inclusive) Reporting Criteria How to Report
Major Protocol Deviation/ Violation
  • Failure to follow the currently approved protocol procedures
  • Failure to obtain informed consent prior to research activities
  • Drug dispensing/dosing error
  • Deviation necessary to eliminate an apparent immediate hazard to a participant
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
Buck IRB Event Report within 10 Days
Event Examples (not all-inclusive) Reporting Criteria How to Report
Research Complaint

(unable to be resolved by the research team)

  • Complaint from a participant regarding research activities
  • Complaint from study personnel regarding conduct of the research
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 or others, or
  • integrity of the research
Buck IRB Event Report within 10 Days
Event Examples (not all-inclusive) Reporting Criteria How to Report
Report or Action by a Federal Agency, Sponsor, or Other Oversight Committee
  • FDA Form 483 or Warning Letter
  • Adverse sponsor audit results
  • FDA clinical hold
  • Suspension or premature termination of research by sponsor, investigator, or other institutional entity (i.e. Data Safety Monitoring Committee (DSMC)
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
Buck IRB Event Report within 10 Days
Event Examples (not all-inclusive) Reporting Criteria How to Report
Other Event Resulting in an Unanticipated Problem
  • An event in the opinion of the PI that may represent an unanticipated problem.
  • Participant becomes incarcerated
  • Sponsor required reporting
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
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)

  • DSMB reports and recommendations
  • Regulatory agency public health advisory
  • “Dear Healthcare Professional” letter
  • Revised investigator’s brochure
  • Revised label/package insert
  • Updated device manual
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
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
Reports, Publications, Updated Investigator’s Brochures, or Interim Results or Findings

(No Change to Research Planned)

  • DSMB reports and recommendations
  • Regulatory agency public health advisory
  • “Dear Healthcare Professional” letter
  • Revised investigator’s brochure
  • Revised label/package insert
  • Updated device manual
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
No reporting required.

Individual reports should be maintained by the investigator and not submitted with the continuing review application.