The federal regulations include a very specific definition for what constitutes “research” (see 45 CFR 46.102(d)) and for what is meant by a “human subject” (see 45 CFR 46.102(f)). A formal determination from the IRB can be made if their project either is not research and/or does not involve human subjects (e.g., as may be required by a student’s doctoral dissertation committee, a funding agency, or a journal editor). The IRB will not provide a formal written determination after the project has been initiated.
If you are unsure whether your project meets this criteria, contact the IRB staff before submitting your application for review.
- The federal research regulations [45 CFR 46] do not require the IRB to make a formal determination that projects are not research, or do not involve human subjects. Thus, this Non-Research Determination Form should be used only if a formal determination is required by a university entity (e.g., dissertation committee) or by an external agency.