Information items that fall into one or more of the categories listed below must be reported to the IRB. These information items will be reviewed by the IRB to determine if they represent noncompliance, unanticipated problems involving risks to subjects or others, and/or result in suspension or termination of IRB approval. For more information, see the How to Submit a Reportable Event page. Do not include any identifiable information related to subjects in the submission or supporting materials. Maintain electronic copies of all information submitted to the IRB. See the Reportable Events example table for examples of common reportable events and their categories.

• What to Report in 1 business day (Report the information items that fall into one or more of the following categories to the via phone call to the IRB Chair and Director within 1 business day):
  • Events that occur in studies and are:
    • Probably caused by or associated with study participation; and
    • Unexpected (not previously identified in nature, severity, or frequency in IRB documentation); and
    • Immediately life-threatening or severely debilitating to current subjects or others not participating in the study (including events where a death occurred)
• What to Report in 10 Business Days (Only for Studies Involving Testing of Investigational Device):
  • An event must be reported within 10 business days if the event was caused by/associated with the device and not previously identified in nature, severity or frequency in any IRB documents (or relates to the rights, safety and welfare of subjects).
• What to Report Within 14 Business Days (Report the information items that fall into one or more of the following categories to the IRB within 14 business days):
  • Information that indicates a new or increased risk, or a new safety issue. For example:
    • New information (e.g., an interim analysis, safety monitoring report, publication in the literature, sponsor report, or investigator finding) indicates an increase in the frequency or magnitude of a previously known risk or uncovers a new risk.
    • An investigator brochure, package insert, or device labeling is revised to indicate an increase in the frequency or magnitude of a previously known risk or describe a new risk.
      • Note, if revised study documents will be received by the study team within 14 business days of learning of the new information, ONLY a change of protocol would need to be submitted. If revised study documents are not expected to be received in time to submit a change of protocol within 14 days, a new information report should be submitted as a placeholder. Study teams should consider whether subjects should be informed of this change prior to the approval of the change of protocol.
    • Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol
    • Protocol violation that harmed subjects or others or that indicates subjects or others might be at increased risk of harm
    • Complaint of a subject that indicates subjects or others might be at increased risk of harm or at risk of a new harm
    • Any changes significantly affecting the conduct of the research
  • Harm experienced by a subject or other individual, which in the opinion of the investigator are unexpected and probably related to the research procedures. See decision tool for guidance.
    • A harm is “unexpected” when its specificity or severity are inconsistent with risk information previously reviewed and approved by the IRB in terms of nature, severity, frequency, and characteristics of the study population.
    • A harm is “probably related” to the research procedures if in the opinion of the investigator, there is a reasonable possibility that the incident, experience or outcome may have been caused by the procedures involved in the research.
  • Noncompliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such noncompliance.
  • Audit, inspection, or inquiry by a federal agency that result in reportable findings (e.g., FDA Form 483.)
  • Written reports of study monitors that result in reportable findings (e.g., noncompliance with the IRB approved protocol)
  • Failure to follow the protocol due to the action or inaction of the investigator or research staff. (see Guidance for What Does Not Require Reporting to the IRB)
  • Breach of confidentiality. Note that breaches that involve PHI must be reported to the HIPAA privacy officer.
  • Incarceration of a subject in a study not approved by the IRB to involve prisoners.
  • Complaint of a subject that cannot be resolved by the research team.
  • Unexpected change in study status by the sponsor, investigator, or institution that appears to impact subject safety and/or the ability of the study to meet its original aims (e.g., halt to enrollment due to equipment malfunction or drug supply issues). NOTE: This does not include meeting enrollment goals earlier than planned or a temporary suspension due to a planned interim analysis.