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Research Involving Human Subjects

STEP 1: Does my proposed research activity need to be reviewed?

  • If your activity meets the definition of research and includes human subjects, it is subject to review and must be documented accordingly.
  • The definition of research is:
    • "A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge."
  • The definition of human subjects is:
    • "Living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

Generalized Knowledge: Most internal program evaluations to determine student satisfaction or knowledge gained through routine program/classroom activity do not meet the federal definitions of research. If the purpose of gathering the data is to publish the results or present the information outside of the group it was obtained (i.e. outside the classroom), the research is generalized.

Identifiable Private Information includes "information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)."

If the definitions of research and human subjects apply to your activity, you need to apply for human subjects research review.

STEP 2: How do I apply for human subjects research review?

Regardless of how your human subjects research is classified, it must be documented and reviewed by (1) your department, and (2) the IRB Chair.

It is recommended that all faculty and students proposing research involving human subjects apply for approval by the IRB 90 days prior to starting research, particularly if research will involve protected groups such as minors or international research.

  • Research classified as "exempt" IS STILL SUBJECT TO REVIEW and SHOULD BE DOCUMENTED.

Research Classification

Who Reviews/Approves?

Time Frame


Department and IRB Chair

Reviewed within 5 working days.


2 members of the IRB

Reviewed within 10 working days.


Majority of the IRB

Reviewed monthly during the academic year.

Follow the Research Proposal Process to apply for department and IRB review with proper documentation.