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• Determine if the activity meets the definition of research. Some activities such as QA/QI projects or types of scholarly and journalistic activities may not be research under the 2018 Common Rule. Please see the definition of research in the regulations (2018 requirements) for an expanded list of activities that are deemed not to be research under these regulations.
  
  

• Next, determine if the research is being conducted with living human subjects. If not, no IRB review is required because research with identifiable specimens and/or data from deceased individuals falls under the category of not human subjects research. 

  Footnote
  There is an exception to this statement when the safety and/or efficacy of Invitro Diagnostic Devices are being studied.  In such cases, the FDA does not differentiate whether the specimens are from living or deceased individuals.

  There is an exception to this statement when the safety and/or efficacy of Invitro Diagnostic Devices are being studied. In such cases, the FDA does not differentiate whether the specimens are from living or deceased individuals.
  
  

• Research that includes living human subjects as described above, or that meets the definition of clinical trial or clinical investigation above, is considered human subjects research that requires that a protocol be submitted in the electronic IRB management system for IRB review or consideration of an exemption from IRB review.
  
  
• See the following flow diagram:

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