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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.  Events that may meet the definition of a Unanticipated Problem Involving Risk to Human Subjects or Others, Serious Non-compliance, and/or Continuing Non-compliance must be promptly reported to the IRB as Reportable New Information.  A general summary of the IRB reporting requirements is provided below.  

  • Unanticipated Problem Involving Risk to Human Subjects or Others:  Events that may meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others must be reported to the IRB as Reportable New Information.
  • Adverse Events that are Unanticipated Problems Involving Risk to Human Subjects or Others: Adverse Events (medical occurrences) that meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others must be reported to the IRB as Reportable New Information.

The majority of Adverse Events will not meet the definition of an Unanticipated Problem Involving Risk to Human Subjects or Others. For example, expected Adverse Events or Adverse Events which are determined by the Investigator to be unrelated to the research intervention do not need to be reported to the University IRB as Reportable New Information.

  • Reportable Non-compliance: Incidents of Non-compliance (including protocol deviations) that may meet any of the definition of Serious Non-compliance and/or Continuing Non-compliance must be reported to the IRB as Reportable New Information. 
  • Incidents of Non-compliance that do not meet the IRB reporting requirements should be documented in a Non-compliance/deviation log and managed as part of the Data and Safety Monitoring Plan.  The maintenance of a Non-compliance/deviation log is mandatory for research studies that are greater than minimal risk and meet the federal definition of a clinical trial, or if it is required by the funding agency.  It is strongly recommended that a Non-compliance/deviation log (or similar documentation) be kept for all other studies.  This documentation should be made available upon request. 

5/14/2021