Is my project "research" that requires IRB Review?
Before submitting an application to the IRB for review, you must first determine if your project is research, according to the federal definition (45 CFR 46.102(d)). In order for projects to be considered human subject research, it must develop or intend to contribute to the generalizable knowledge. If you wish to publish your project, the IRB should review your proposed activity and send an official determination letter.
The following items can be used to assist in determining if a project is research:
- Decision Tree
- Decision Charts from the Office of Human Research Protections (OHRP)
- Research Determination Worksheet
- NIH Portal to Human Subjects Protections Information
If you are unsure if your project involving human subjects or human subject data/specimens requires IRB review, contact the IRB for assistance.