How do I determine if my research involves human subjects?
Determining this can be surprisingly complicated and depends on a variety of factors. There are a number of questions to think about as you determine whether you will need IRB approval:
- Does my work involve human subjects? For purposes of IRB review, a "human subject" is defined as "a living individual about whom an investigator conducting research obtains (1) data through interaction or intervention with the individual or (2) identifiable private information." (45.CFR 46.102).
- Is my work research? For purposes of IRB review, "research" is defined as "a systematic investigation designed to develop or contribute to generalizable knowledge." (45.CFR 46.102).
- Do you intend to collect information and then present it to a public audience or at a conference?
- Do you intend to publish findings or disseminate information based upon your work?
- Will you be conducting interviews, surveys or focus groups?
- Will you need access to sensitive data or records?
- Is there any way to link the data you plan to collect with identifying information?
- Are you seeking grant funding?