Reports of New Information

Reports of New Information (RNI) are used to submit problems, events, or information issues to the IRB for review. These may include Adverse Events, Protocol Deviations, Reports of Non-Compliance, and Unanticipated Problems.

Reports of New Information can only be submitted for projects once they have been approved or activated (i.e., “Active”). They cannot be submitted if the project has not yet completed its initial review.  However, report forms can be submitted on projects that have been closed or have expired.

Reports of New Information can be submitted at any time, meaning they can be submitted even if another submission (i.e., Modification or Continuing Review) is currently open.  Additionally, more than one RNI can be submitted at a time if separate events need to be reported.

Reports of New Information are submitted from the Dashboard of the individual project.

Examples of problems or events include, but are not limited to, the following:

• Unanticipated problems or events
• Adverse events (if the AE meets the criteria for an unanticipated problem)
• Deviations
• Adverse device effects
• Breaches of confidentiality or privacy

Examples of information include, but are not limited to, the following:

• Data and safety monitoring reports
• Incarceration of a participant
• Complaints from participants (if the complaint meets the criteria for an unanticipated problem)
• New information about the study (for example, from the sponsor, the FDA, other regulatory agencies, etc.)
• Changes in FDA labeling, drug or device withdrawal from marketing
• Warning or determination letters

Do not attach revised or updated protocols, consent forms, or other documents that have been changed in the Report of New Information (RNI). These documents must be submitted via a Modification application, which can be submitted at the same time as the RNI. Revised protocols, consent forms, or other documents will not be approved if attached in the RNI. The RNI is a mechanism for the IRB to review information, not approve updated or revised documents.

Only problems, information, or events that meet the definition of a possible Unanticipated Problem, possible serious non-compliance, or possible continuing non-compliance need to be submitted via Report of New Information. The PI is responsible for reviewing all problems, new information, or events to determine if they meet the criteria for a possible UP or possible serious or continuing non-compliance.

All problems, information, or events that occur should be documented as part of the research records, and the PI should document their determination on whether it meets the criteria or not. Templates are available to assist with this documentation.

When in doubt, it is better to submit the event, allowing the IRB to make the determination rather than failing to submit a report that should have been submitted.

If the problem, information, or event requires submission via a report of new information, the RNI must be submitted as soon as possible following the event, but in all cases within 10 business days after the researchers learn of the event.