Is IRB Review Required?
The first question one should consider when assessing the requirement for IRB review is whether the activity meets the regulatory definitions (DHHS and FDA) of human research. These definitions are outlined in detail in the IRB’s guidance linked below.
Anyone unsure about IRB review requirements and whether their proposed activity constitutes “human research” should review the Is IRB Review Required? Guidance and contact the IRB with any follow up questions.
If needed, the IRB staff will determine if the activity is human research upon submission of the Human Subjects Research Determination form. Given the complexities noted in the guidance under Research with Existing Private Data or Specimens, investigators are not allowed to self-determine that research with existing private data or specimens is not human subjects research. A request for verification should be submitted to the IRB with the Human Subjects Research Determination Form or through HSERA.
If an activity does not meet the regulatory definition of human research, the IRB will, upon request, issue a letter stating that the project does not require IRB review or approval.