Worksheet: Do I Need IRB Approval of My Study?
Determining if your idea meets the FDA definition of a clinical investigation
In order for a study to be eligible to submit to the Institutional Review Board (IRB), it must meet the definition of human subject research. Human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Not sure if you should submit your idea to the IRB? Download the worksheet to help you determine whether or not to submit it.
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