You will require IRB oversight if you answer YES to one of the following questions:
- Are you “engaged in research” under Federal Regulations?
- Does your research involve human subjects?
Briefly, you are engaged in research if you are involved in a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge. “Human subject” is defined differently by FDA and DHHS. DHHS defines a human subject as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. However, FDA defines human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.