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,
- Non-adverse events,
- Updated study information or written reports, and
- Other information
Events and non-compliance that meet the regulatory criteria for an Unanticipated Problem (UP) must be reported promptly to the IRB (within 3-5 days of becoming aware of an event). Similarly, updated study information or other information that identifies a deficiency, recommends a change in the research procedures, potentially alters the risk/benefit analysis or impacts on the safety and welfare of participants, also must be reported promptly to the IRB.
RNIs that do not qualify as an UP or otherwise do not meet the criteria for prompt reporting typically are submitted to the IRB in conjunction with the Continuing Review/Renewal Application.
It is the responsibility of the Principal Investigator, based on his/her scientific and medical expertise and judgment, to assess if an event or non-compliance/deviation qualifies as a UP requiring prompt reporting. The criteria for UPs is provided here: Guidelines for Identifying Unanticipated Problems. Documents listed below under "Resources" also provide examples of UPs and other RNIs, and their corresponding reporting requirements.
Methods of Recording and Reporting New Information
Recording RNIs: The study team should maintain a record of all study-specific events, incidences and deviations, preferably in the regulatory binder. We highly recommend use of the Event Tracking Log (ETL) template to facilitate reporting but use of this specific form is not mandatory.
Prompt Reporting of RNIs: RNIs are submitted using the Reportable Event form in the Kuali Research (KR) electronic submission platform. Links to instructional material are provided below under Resources. Complete and submit the form
- within 5 business days of becoming aware of an event requiring prompt reporting, or
- within 3 business days if the UP involves a fatality, is an emergency deviation, or is an imposed hold, suspension or termination.
RNIs Not Requiring Prompt Reporting: RNIs not requiring prompt reporting should be submitted in summary form when submitting the next Continuing Review or Closure Request. For example, attachment of a consolidated ETL may be used to submit minor protocol deviations and other Non-UPs. The consolidated log should contain only those events occurring during the applicable approval period and not previously submitted to the IRB. Continuing Reviews and Closure Requests are submitted using the Renewal or the Closure Request form, respectively, in KR. Links to instructional material are provided below under Resources.
- Study Modifications: 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. 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. If appropriate to maintain safety of the subjects, new subject 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. Request for study modifications are submitted using the Amendment form in KR. Links to instructional material are provided below under Resources.
Use the following resources to identify, determine the method of reporting, and submit RNIs to the IRB.
Types and examples of RNIs and their reporting requirements
Schematic algorithm for submitting RNIs to the IRB
Common examples of non-compliance and protocol deviations
Examples of adverse events that represent Unanticipated Problems and need to be reported promptly
Examples of adverse events that do not represent Unanticipated Problems and do not need to be reported promptly
Examples of non-adverse events that represent Unanticipated Problems and need to be reported promptly
Event Tracking Log (ETL)
Kuali Quickguide: Reportable Event
Kuali Quickguide: Renewal
Kuali Quickguide: Closure Request
- Kuali Quickguide: Amendment