Study Compliance and Monitoring

Activities of the Yale Human Research Protection Program (HRPP) Compliance and Quality team include, but are not limited to:

  • Conducting Not-For-Cause (NFC) reviews of human subjects research (HSR) studies approved by the Yale IRB to assess compliance with University policies, procedures and the Federal regulations
  • Conducting For-Cause (FC) reviews of HSR studies in response to concerns of potentially serious and/or continuing noncompliance
  • Work with the Yale Health Insurance Portability and Accountability Act (HIPAA) Office to investigate HIPAA research noncompliance concerns
  • Report noncompliance to Federal agencies (when appropriate)
  • Investigate and respond to HSR concerns/complaints
  • Assist the research community in preparing for and responding to external audits (including FDA audits)