Reportable Events

The following events must be reported to the IRB within five (5) business days of the study team becoming aware of the event, regardless of the level of review of the study (i.e., Full Board, Expedited, Exempt):

• Conduct of human subjects research without IRB approval, including:
  • Conduct of research without submitting study for IRB review.
  • Conduct of research prior to receiving IRB notification of final approval.
  • Initiation of substantive changes (i.e., changes that would affect the subjects' willingness to participate, such as changes to study procedures, risks and/or benefits) to the research protocol without prior IRB approval, including changes necessary to eliminate apparent immediate hazards to the subject.

    NOTE: “IRB-approved protocol” refers to all study information, including that contained in the IRB application forms, formal protocol document, consents, etc.

  • Inclusion of vulnerable subject populations without specific IRB approval.
  • Conduct of research when IRB approval has expired or been closed, suspended, or terminated.

    NOTE: Expiration of IRB approval in itself is not promptly reportable, but conduct of research activities after expiration is reportable.

  • Subject interactions or review of identifiable research data by individuals who have not completed appropriate investigator requirements (e.g., COI disclosure and CITI training).
• Adverse event (either locally or at an external site) assessed by the principal investigator (PI) as (1) unexpected  (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the study-related documents, and (b) the characteristics of the subject population being studied, (2) related or possibly related to study participation, AND (3) suggests that the research places subject(s) or others at greater risk of harm than was previously known.
• Unanticipated adverse device effects.
• Major protocol deviations that placed subjects at greater risk of harm (including physical, psychological, economic, or social harm), caused actual harm to subjects or others, OR for greater than minimal risk research, compromised the integrity of the study data such that the subject’s data can no longer be used in analysis of study outcomes. This may include:
  • Dosing errors.
  • Enrolling a subject who does not meet eligibility criteria.
  • For greater than minimal risk research, enrollment of more subjects study-wide than approved by the IRB
  • Study visits outside of the protocol-specified timeframe or missed study visits.

    NOTE: Study visit deviations that do not meet any criteria above should be reported with the next renewal submission, if applicable, or study closure.

• Consent, assent, and/or authorization issues, including:
  • Failure to obtain consent, assent, and/or authorization from subjects, including obtaining consent or authorization from someone who cannot legally act on behalf of the subject.
  • Conduct of research after subject decides not to participate, dissents, or withdraws from the research
  • For subjects originally enrolled as minors with parental permission, failure to obtain consent prior to direct interaction after a subject turns eighteen years of age
  • For subjects originally enrolled via consent of a legally authorized representative, failure to obtain consent prior to direct interaction after a subject gains consent capacity
  • Following use of a short form consent, failure to re-consent the subject on a translated consent form unless an exception applies
  • For greater than minimal risk research, failure to obtain the subject's signature on the informed consent.
  • When use of a witness is required, failure to document the involvement of a witness in the consent process
  • Enrolling subjects or continuation of subject participation using an inaccurate consent that could affect the subject’s willingness to participate (such as omission of study procedures, risks, and/or benefits).
• Research billing compliance error which results in a subject being incorrectly billed for research procedures
• Complaints about the conduct of the research
• Study suspensions or holds related to risk, safety or compliance issues
• Disclosure or release of identifiable subject data outside the research team, which:
  • May place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, educational advancement, or reputation, and/or
  • Is determined by the appropriate covered entity’s HIPAA Privacy Officer, after review, to be a reportable breach as such term is defined in the HIPAA Privacy Rule.
    • IU researchers must report unauthorized disclosures or releases of PHI at https://protect.iu.edu/online-safety/report-incident/index.html.
    • Events that are reportable due to being determined to be a HIPAA breach must be reported to the IRB within five (5) business days of the Privacy Officer notifying the study team that the event has been determined to be a breach.
• Local audit reports with any findings which meet prompt reporting criteria described in this guidance (e.g., Quality Improvement Office audits, VA audits).
• Failure to submit amendments which update risks, benefits, or procedures within 60 days of receipt.
• Failure to promptly report events when required per IU HRPP Policies
• Failure to report required information to the IRB at the time of renewal. Specifically,
  • Systemic failure to report minor protocol deviations and/or minor noncompliance at time of renewal
  • For multi-site research where IU is serving as the IRB of record for external sites, failure to report information related to external sites at time of renewal
• IRB or HRPP noncompliance, including:
  • Failure to provide the required level of IRB review
  • Failure to assign an appropriate expiration date to research which results in IRB review being conducted less frequently than required
  • Failure to communicate to the study team in a timely manner a study suspension or termination
  • Any other error that may significantly compromise the rights or welfare of subjects

NOTE: Receipt of an external auditing/monitoring report, such as an FDA Form 483, in itself does not require prompt reporting. However, the study team must evaluate each finding in any such report and assess whether the event(s) meet prompt reporting criteria.

For studies relying on an external IRB, please refer to the IU HRPP Policy on Reportable Events, section 2.2 to determine whether an event meets prompt reporting criteria.

For VA studies, additional reporting requirements apply. Investigators conducting VA research must also promptly report the following to the IRB:

• Local research deaths which are unexpected and related or possibly related to the research.
• Apparent unanticipated problems involving risks to subjects or others.
• Any event constituting apparent serious or continuing noncompliance (see VHA Directive 1058.01 Research Compliance Reporting Requirements for a comprehensive list of reportable events)
• Information security and privacy incidents
• Other events involving VA Human Research Protection Programs reportable to ORO

If the event meets the reporting criteria and would have been required to be reported promptly while the study was open, it should be reported even after the study is closed, regardless of the length of time since study closure. Please contact the HRPP about appropriate steps to take to report the event.

If the event does not meet the prompt reporting criteria, investigators do not need to submit a report.

For VA studies, certain events requiring prompt reporting must be reviewed within five (5) business days of receipt (one (1) day for local subject deaths) by the IRB Chair or qualified IRB member-reviewer to assess and document whether any actions are warranted to eliminate apparent immediate hazards to subjects.  The IRB must then review the event and the immediate hazard assessment in accordance with VHA policies.

Events that do not meet the criteria for prompt reporting must be reported at the time of study renewal or closure, whichever occurs next, to ensure the IRB has a full understanding of the conduct of the research.  Events that must be reported at time of next renewal or closure include:

• Minor protocol deviations
• Minor noncompliance