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Human Subjects Involvement

Does the research involve human subjects?

  • A human subject is involved if:
  • The person is alive and
  • Data pertaining to the person will be obtained through:
  • Intervention (e.g. taking a blood sample).
  • Interaction (e.g. taking a medical history).
  • A private/confidential source (e.g. from medical records).

In most cases, the determination of whether a particular research activity involves human subjects is not difficult. In some cases, however, the issue is not clear. When in doubt, seek advice from the MHRI Office of Regulatory Affairs (ORA).


STOP. If your research does not involve humans, IRB approval is not required.


If your answers to the previous questions are YES, then IRB approval is usually required

In some instances, research may be Exempt from IRB approval.

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