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Human Subjects

Reportable Events

Per the IU SOP on Reportable Events, investigators must report to the IRB noncompliance and unanticipated problems that occur during the conduct of their research. Events that may impact subject safety, confidentiality, information security, or privacy, or conduct of human subjects research without IRB approval require prompt reporting, while other less serious issues do not require reporting to the IRB until the next Renewal.

If investigators need guidance determining what category an event should be reported under, whether the event is reportable promptly, or if other IU institutional policies may apply, please contact the Human Subjects Office (HSO).

When the HSO receives a reportable event submission, staff will verify whether the event information meets prompt reporting criteria. If it does not require prompt reporting, HSO staff will communicate this to the study team, confirm the event should be reported at the next Renewal, and withdraw the item from further separate review. If the item does require prompt reporting, HSO staff will prepare the information for review by the convened IRB (unless expedited review is permitted by the VA regulations as described below).

Promptly 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 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 KC IRB Questionnaires, formal protocol document, consents, etc.
    • Inclusion of vulnerable subject populations without specific IRB approval.
    • Conduct of research when IRB approval has expired or been suspended or terminated.

      NOTE
      : expiration of IRB approval in itself is not promptly reportable, but conduct of research activities after expiration is.
    • 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, (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/protocol noncompliance that occurred and may, in the opinion of the PI, (1) impact subject safety and/or (2) affect the integrity of the data, such as:
    • Dosing errors.
    • Enrolling a subject who does not meet eligibility criteria.
    • Study visits outside of the protocol-specified timeframe or missed study visits.

      NOTE: Study visit deviations that do not meet either criteria 1 or 2 above should be reported with the next Renewal submission.
  • Consent and/or authorization issues, including:
    • Failure to obtain consent and/or authorization from subjects, including obtaining consent from someone who cannot legally consent for the subject.
    • Failure to obtain the subject’s signature on the informed consent and/or authorization (unless a waiver of documentation of consent has been granted) prior to subjects' starting study procedures.
    • Enrolling subjects using a consent which does not include all known risks, or continuation of subject participation without notification of newly identified risks.
    • Other major deficiencies in informed consent or HIPAA authorization process or documentation (e.g., substantive outdated informed consent or HIPAA content, such as missing study procedures information, that may affect subjects’ willingness to participate).
    • Minor deficiencies in informed consent or HIPAA authorization process or documentation affecting ten (10) or more subjects (e.g., outdated informed consent or HIPAA content that is not substantive, such as change in number of subjects to be enrolled, or lack of signature of individual obtaining consent).

      NOTE: Generally, the IRB would not expect subjects to be re-consented for this type of event.
  • Subject complaints that indicate an unexpected risk and/or that affect the rights and welfare of human subjects.
  • Study suspensions or holds related to risk, safety or compliance issues.
  • Incident that may compromise information security, subject privacy, and/or confidentiality (e.g., subject data breach) [see References section for a link to additional IU institutional requirements for reporting this type of event].
  • Local audit reports (i.e., Human Subjects/QIO audits, VA audits).
  • Follow-up information for a previous reportable event.
  • Failure to submit amendments which update risks, benefits, or procedures within 60 days of receipt or promptly report events when required per IU IRB SOPs.

    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 events require reporting to the IRB and, if so, whether the event(s) meet prompt reporting criteria.

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

  • Local research deaths which are unanticipated and related to the research.

    NOTE: the IRB must be immediately verbally notified, with written report submitted within 5 business days.
  • Local serious adverse events (SAEs) or serious problems which are unanticipated and related to the research.
  • Any event constituting apparent serious or continuing noncompliance (see ORO Guidance document “Examples and a Brief guide for Reporting Apparently Serious or Apparently Continuing Noncompliance in Human Research That May Be Reportable to ORO under VHA Handbook 1058.01” for a comprehensive list of reportable events).

Discovery of reportable event(s) after study closure

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. Investigators can use the Notify IRB action to submit such reports.

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


Reports that may be reviewed via expedited procedures

For VA studies, events requiring prompt reporting are reviewed within five (5) business days of receipt by the IRB Chair or qualified IRB member-reviewer. If such reviewer determines the event is NOT serious and unanticipated and related to the research, further review by the convened IRB is not required. However, the reviewer may determine that a report should be reviewed by the convened IRB at their discretion.


Events that do not meet promptly reportable events criteria

Events that do not meet the criteria for prompt reporting should be reported at the time of next study renewal to ensure the IRB has a full understanding of the conduct of the research. Events that must be reported with the next study renewal submission include:

  • Local adverse events related or possibly related to study participation not previously reported to the IRB.
  • Protocol deviations/protocol noncompliance not previously reported to the IRB.
  • Minor noncompliance (i.e., likely not serious or continuing), such as:
    • Use of a consent form that is not the most recently-approved version when the content is not substantively different from the current IRB approved consent.
    • Use of an unstamped consent form when the content is the same as the current IRB approved version.
    • Enrolling more subjects than approved by the IU IRB.
    • Conduct of research by individuals not listed on the study protocol but who have completed appropriate investigator requirements.
    • Implementing minor wording changes to IRB study documents without prior IRB approval.
    • Failure to appropriately document consent and/or authorization, if the missing information can be clearly corroborated by other documentation (e.g., research notes).
    • missing demographic information on Authorization form

      missing or incorrect dates

      missing signature of person obtaining consent/authorization

      NOTE: Informed consent and/or authorization documents that are missing the subject’s signature should NOT be considered minor noncompliance and should be reported promptly.

NOTE: Generally the IRB would not expect subjects to be re-consented for events that do not meet reportable events criteria.

References:

  • IU SOP on Reportable Events, available on the Policies & Guidance page.
  • VHA Handbook 1058.01
  • ORO Guidance: Examples and a Brief guide for Reporting Apparently Serious or Apparently Continuing Noncompliance in Human Research That May Be Reportable to ORO under VHA Handbook 1058.01
  • ORO Decision Chart: Reporting Local Deaths, Local Serious Adverse Events (SAEs), and Serious Problems in VA Research
  • Protect IU: Report an Incident

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