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  1. Policies & Procedures

Chapter 17 - Reportable New Information

Overview

During the conduct of human subject research, unanticipated events and instances of Non-compliance may occur.  It is the policy of the University IRB to:

  • Require the reporting of Adverse Events and Unanticipated Events that may meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others.
     
  • Require reporting of Non-compliance that may meet the definition(s) of Serious Non-compliance and/or Continuing Non-compliance.  
     
  • Review reports of Reportable New Information (RNI) and determine which constitute Serious Non-compliance, Continuing Non-compliance and/or an Unanticipated Problem Involving Risk to Human Subjects or Others
     
  • Fulfill reporting requirements to the appropriate entities (institutional officials, federal departments, or agencies)

Events that may meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others, Serious Non-compliance, and/or Continuing Non-compliance must be promptly reported to the University IRB as an RNI.

 

7/3/2024