Determination Criteria 45 CFR 46.102(d) and 45 CFR 46.102(f)
The federal regulations include a very specific definition for what constitutes “research” (45 CFR 46.102(d)) and for what is meant by a “human subject” (see 45 CFR 46.102(f)). Often investigators will require that a formal determination from the IRB be made that 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.
Note that many specimen studies, medical record reviews, and projects involving existing documents or records may actually meet the “no human subjects” criteria. Please utilize the appropriate specimen, medical record or existing data form, and if appropriate, the “no human subjects” determination will be made automatically by the IRB staff during its review. If you unsure whether your project meets this criteria, contact the IRB staff before submitting your application for review.
- If the project includes biological specimens, investigators should complete the “Research with Biological Specimens” Form and not the “Request for a Determination that Planned Activity does not Involve Human Subjects Research” form. The “Research with Biological Specimens” Form includes an item where it can be indicated that a “No Human Subjects” determination is requested.
- 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 application form should be used only if a formal determination is required by a university entity (e.g., dissertation committee) or by an external agency.
- The project should not involve intervention or interaction with living persons, except in cases where the person is not providing any information about their self or any other identifiable individual. For example, when interviewing a CEO about an organization, not including their personal experiences or history, the organization is the subject of the interview and therefore there are no human subjects.
Determination Form: Planned Activity Does NOT Involve Human Subjects OR is Not Research