Is It Research?

DHHS defines research as

“a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(d)].

Not all projects fit easily into the definition of research. However, all relevant federal regulations make it clear that the ultimate decision about whether a given project constitutes research rests with the IRB.

To request a determination by the IRB:

• Submit requests for a research/non-research determination iva IRBNet.
• Follow the checklist in "Application Assistance" located in the forms library in IRBNet. 

Investigators may not act on any IRB decision that is not documented by the IRB Chair or Co-Chair. Opinions offered outside of the accepted review process may not be used as justification by an investigator to initiate research involving human subjects.

Disputed decisions may be submitted for review by the full Board at a convened meeting. However, decisions of the full IRB are final.

For more information about hte Federal definitions of research, and the IRB process, pelase read HSP#050 Defining Human Subject Research.