When is IRB Review Required?

All proposed research that involves:

(1) Intervention or interaction with human subjects, tissues/specimens from humans).
(2) The collection of identifiable private data on living individuals, or surveys of human subjects.
[and/or]
(3) Data analysis of identifiable private information on living individuals
requires review and approval by the IRB prior to the initiation of the research.

Activities that do not fall under the purview of the IRB: include operational activities such as: medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, program audits, journalism, history, biography, philosophy, “fact-finding” inquiries such as criminal, civil and congressional investigations, and intelligence gathering.

·      This list does not include all possible activities, so the IRB should be consulted to verify that an activity does not fall under the purview of the IRB.