Do You Need IRB Review?
IMPORTANT NOTE! "Exempt" human research is different from "not human research." Activities which are "not human research" do not fall under the IRB's oversight. In contrast, exempt human research is still considered "human research" and requires IRB review (see Applying to the IRB).
Activities must meet the institutional definition of Human Research to fall under IRB oversight. Use the following two steps to determine whether your project qualifies as human research. Always begin with Step 1.
- Human Research Determination Worksheet (HRP-310)
- Engagement Determination Worksheet (HRP-311)
- Definitions SOP (HRP-001)
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
If you answer YES to all of the following questions, your project is considered research. Go to Step 2 below.
If you answer NO to any of the following questions, then skip to RESULTS below.
- Is the activity an investigation? (Investigation: A searching inquiry for facts; detailed or careful examination.)
- Is the investigation systematic? (Systematic: Having or involving a system, method, or plan.)
- Is the systematic investigation designed to develop or contribute to knowledge? (Designed: observable behaviors used to develop or contribute to knowledge. Develop: to form the basis for a future contribution. Contribute: to result in. Knowledge: truths, facts, information.)
- Is the knowledge the systematic investigation is designed to develop or contribute generalizable? (Generalizable: Universally or widely applicable.)
Note: Generally, classroom research projects which are intended solely for educational purposes (such as for learning research methods) do not meet this definition of research. In addition, the federal regulations do not consider certain activities to be "Research as Defined by DHHS" (see Definitions SOP HRP-001 or HRPP Plan HRP-101).
Human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through Intervention or Interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
If you answer YES to all of the following questions, the research involves human subjects.
- Is the investigator gathering information or biospecimens for the research about living individuals?
- Will the investigator use, study, or analyze information or biospecimens (regardless of identifiers) obtained through either interventions (for example, venipuncture) or interactions (for example, survey) with the individual? OR, Will the investigator obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens (for example, secondary research use)?
- If you answer YES to BOTH steps 1 and 2 above, then you are conducting research with human subjects. IRB review is required.
- If you answer YES to step 1, but NO to step 2, then you are conducting research but not with human subjects. IRB review is not required.
- If you answer NO to step 1, then you are not conducting research per the IRB definition. Step 2 does not apply. IRB review is not required.