REPORTABLE NEW INFORMATION
Reportable New Information (RNI) refers to any new information that may impact on the conduct of an IRB-approved, human subjects research study or the safety and welfare of the participants in that study. RNIs must be reported to the IRB. In general, RNIs are classified into the following categories:
- Adverse events (AE): Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
- Unanticipated Problems (UP) : An event that occurs in the research that may cause harm to participants (including physical, psychological, economic or social) and is: 1) unexpected; 2) related or possibly related to participation in the research; and, 3) potentially increases the risk of harm to the subject or others.
- Non-compliance: Failure to adhere to federal, state, or local regulations governing research, organizational policies, or determinations made by the IRB.
- Protocol Deviations (PD): Unplanned excursion, either intentionally or non-intentionally, from the protocol, by either the study team or the subject, that is not implemented or intended as a systematic change.
- Other Information: Miscellaneous reportable new information that should be reported to the IRB but does not fit into the above categories.
Please Note: an RNI can fall into more than one category listed above.
Methods of Recording and Reporting New Information
Prompt Reporting of RNIs
Events or new information that meet the regulatory criteria for Reportable New Information that requires prompt reporting to the IRB should be submitted using the Reportable Event form in the Kuali Research (KR) electronic submission platform within 5 business days of becoming award of an event.
RNIs Not Requiring Prompt Reporting
RNIs not requiring prompt reporting should be documented on an Event Tracking Log (ETL) and submitted with the next Continuing Review or Closure Request. There should be a single ELT for each study and the consolidated log should list ALL events that have occurred during the study by the time of ETL submission.
Amendments as a Result of RNI
Submit, as soon as practical, a request for study modification if the RNI elicits, in the judgement of the PI, a change in the study status, protocol, procedures or documents such as the consent form or recruitment material. If appropriate to maintaining safety of the participants, new participant enrollment should be temporarily stopped by the investigator until the modification is approved. The IRB may require additional/different changes as a result of its review even if the PI has concluded that no changes are warranted. NOTE: UPs generally will warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others.
Resources
Use the following resources to identify, determine the method of reporting, and submit RNIs to the IRB.
