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  • Investigators must provide the following information about research related events to the IRB in high-level summary format at the time of continuing review:
    • Noncompliance including major and minor protocol deviations
    • Anticipated Adverse Events and Serious Adverse Events that have taken place at a  greater frequency or severity than expected 
    • All UPs
    • Unresolved subject complaints
    • Information about new risks

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  • If OHSRP Compliance and Training analysts have additional questions about the event RNI report, these will be provided as stipulations a request for clarification to the PI prior to further review.
  • After review by OHSRP leadership, the event may be referred for further review by the NIH IRB or the NIH Research Compliance Review Committee (RCRC).
  • Review by the NIH IRB: If the reported event is thought by OHSRP leadership to be a possible UP or new information that may affect a subject's willingness to enroll or continue study participation, it is referred for review by the IRB (full board review). If there will be an amendment a modification to update the protocol and/or consent as a result of the event, this amendment modification is often reviewed at the same full board meeting as the relevant event report.
  • Review by the NIH Research Compliance Review Committee (RCRC): If the reported event is thought by OHSRP leadership to constitute possible serious and/or continuing noncompliance, it is referred for review by the RCRC. See additional information about the RCRC in the next question.
  • For events that are not referred to the NIH IRB or NIH RCRC, an outcome acknowledgement letter is sent to the PI and study contacts acknowledging indicating that the report form has been reviewed and includes any additional actions that must be taken by the study team.

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  • Provide complete and comprehensive answers to the required questions on the RNI form used to submit information about the event or to follow-up questions posed by the Compliance Analysts after their review of your submission.
  • If the event form being submitted reports that consent was not obtained prior to the start of research, list all of the research procedures that occurred without the subject's consent.
  • Compliance and Training as well as OHSRP leadership who initially review the RNI event forms submitted in the electronic IRB system, as well as the IRB or RCRC members who review the event(s) referred to their board pay particular attention to what corrective action has been taken or will be taken to mitigate the problem and prevent it from recurring. In most cases, these entities will require a robust explanation of what investigators will do in this regard. If an inadequate plan for corrective steps to be taken is submitted, it is likely to be sent back to the team with request for a more thorough plan.
  • Electronically attach any relevant supporting documents when you submit the event report RNI form in the electronic IRB system. For example, if the event was reviewed by the DSMB, attach the DSMB's follow-up report of its review.

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