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Clinical Research Times

January 31, 2024

Dear Colleague:

Projects that do not meet the definition of human subjects research, known as “Not Human Subjects Research” (NHSR) or “Non-Engagement in Human Subjects Research” (Non-Engagement), generally do not need to be submitted to the IRB.  However, there are certain circumstances where formal IRB review of these projects is required. This month’s Feature Article describes when you need to submit these projects to the IRB, and provides detailed step-by-step instructions on how to complete the IRB application for this type of study.

Also check out:

  • “Things to Know” on new and revised HRPP Policies and Procedures that took effect this month; a reminder about the revised requirements for Marketing/Communications review of recruitment materials; and a reminder about the release of a new version of INSPIR and the availability of updated step-by-step INSPIR instructions
  • “The CRRO Corner” on best practices and tools for successful study documentation, as well as information on the improvements that have been made to the CRRO’s Study Documentation Templates and Tools Library
  • “Getting to Know” on the next and final steps in the CTgov Modernization Initiative, including the continued testing and evaluation of the Beta sites (Part 3 in a 3-part series)
  • “Spotlight on SOPs” on monitoring, assessing, documenting, and reporting on adverse events
  • “Dear IRB” for locating Human Research Protection Program (HRPP) policies and guidance on the enrollment of non-English speaking participants.

Learn more at

Matthew Ogrodnik, MS, CIP, Editor, CR TIMES
Director, Office of Human Research Affairs