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Determining if IRB Review is Required

Not all research falls under IRB oversight. To determine if a project requires submission to the IRB, you must assess two criteria:

  1. Is the project research? AND,
  2. Does the project involve human subjects?

If the answer to both questions is “yes”, then the project is human subjects research and falls under IRB oversight.

UCSD faculty, staff, or students or researchers at UCSD-affiliated institutions (i.e. RCHSD) conducting human subjects research are required to submit an IRB application for initial review to OIA. All human subjects research projects require IRB review, regardless of funding (even in instances where there is no funding).

For human subject research that falls under IRB oversight, some projects may qualify for an IRB exemption determination.

IRB Review is Not Required Because My Project Does NOT Fall Under IRB Oversight

In some instances, projects do not meet the definition of human subjects research, and in others, projects can be human subjects research but the institution and institutional faculty, staff, and/or students may not be engaged in human subjects research activities. This means these projects do not fall under IRB oversight. However, publishers, financial sponsors or others may require an official OIA/IRB determination of not human subjects research (NHSR) or a Non-Engagement letter. If you need an official NHSR or Non-Engagement determination letter you must submit an abbreviated IRB application for initial review. See section on Other Admin Determinations or Registrations for more information.

NOTE: Please note that IRBs do not have the option of granting “retroactive” approval after research is done. You should err on the side of submitting or consulting with OIA if there is any doubt.