Determine if your project requires IRB review

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The University of Oregon uses the federal criteria at 45 CFR 46 to determine what requires IRB review. Therefore, the first question we ask is does the project fit the definition of human subject research.

45 CFR 46.102 states that:

  • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
    1. Data through intervention or interaction with the individual, or
    2. Identifiable private information

If, for example, your research is not designed to contribute to generalizable knowledge, you may not need to seek IRB approval. If you are uncertain as to whether your research requires review, please email Research Compliance Services with a brief description of your project. A staff member will reply to you with guidance on how to proceed. Additionally, we have developed a worksheet to help guide you in the decision making process.