1. IRB reporting updates

2. Main Points Simplified process Electronic submission to IRB
“Robust” guidance from HSO
One reporting mechanism (no separate forms)
New 60 day amendment submission deadline

3. IRB Makes the Determination
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 -If the IRB determines it as NOT promptly reportable, it will be returned to the regulatory team – who will instruct staff to report at the time of continuing review.

4. Primary Prompt Reporting Categories
Conduct of human subjects research without IRB approval
Adverse event:
(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 (PI determination)
Unanticipated adverse device effects
Major protocol deviations/protocol noncompliance:
(1) impact subject safety and/or (2) affect the integrity of the data (PI determination)
Consent and/or authorization issues
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 issue
Incident that may compromise information security, subject privacy, and/or confidentiality (e.g., subject data breach)
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

5. What is NOT Promptly Reportable
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 promptly reportable.
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.

6. 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.

7. Who Makes the Determination at IUSCC?
The Principal Investigator – using the appropriate criteria:
PI discretion but not whether it actually presented a safety issue - instead whether it could have impacted safety
Documentation is essential:
An with the PI rationale is sufficient. As long as it is clear upon review what the basis for the determination was.
Acceptable to pose the question to the PI in an , i.e.:

8. New Single Reporting Form

9. Study Data Requirement

10. Category Selection

11. Level of Detail
Study team should be prepared to provide details about the event, corrective measures to resolve the issue, preventive measures to prevent recurrence, and any plans for notifying sponsors, subjects, etc.

12. New guidance document forthcoming!
Resources
Regulatory Team
HSO Reportable event page:
HSO SOP:
New guidance document forthcoming!