HRPP Updates to RNI Process


Office for Research Protections     |     Institutional Review Board (IRB)      

The Human Research Protections Program (HRPP) will enact changes to the Reportable New Information (RNI) process on July 5. These changes are meant to reduce researcher burden while better aligning with regulatory requirements for external reporting. Three primary changes will occur:

  1. The scope of the information that needs to be reported to the IRB will be narrowed to only things that involve Penn State researchers, locations, and participants, or external sites relying on the Penn State IRB. In the CATS IRB system, the RNI category titles will remain the same, but the information that must be reported may have changed.  
  2. There will be a focus shift in the Non-Compliance and Researcher Error categories.  Only non-compliance or researcher error that potentially impacts the subject’s rights, safety, welfare or integrity of the study, or an allegation of such non-compliance, must be reported.
    • The PI is ultimately responsible for assessing whether deviations/non-compliance impacts the subject's rights, safety, welfare, or integrity of the study
    • Issues that are determined not to be reportable to the IRB should still be tracked and monitored by the study team and/or sponsor accordingly
  3. RNIs must now be submitted for review within 10 business days, except for certain unreviewed changes. The following unreviewed changes must be submitted to the IRB within 5 business days:
    • Changes to the protocol to eliminate an apparent immediate hazard to a subject without prior IRB review and approval
    • The emergency use of drugs or devices without IRB approval

For more information, please see the Investigator Manual or view this informational video.