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Oklahoma State University

Human Subjects Research (IRB) - Application Exempt

Determining the Level of Review

Exempt Status

Federal regulations allow some human subject research to be exempted from review by the full IRB (45 CFR 46.101 (b)). However, OSU does not authorize investigators to make this determination. Researchers must submit an IRB application for review to the Office of University Research Compliance to determine exempt status.

Approval of research as exempt does not absolve the investigator(s) from ensuring that the welfare of the subjects is protected and that methods used to gain subjects' informed and voluntary consent are appropriate.

To be considered for approval for exempt status, the research must meet the requirements of one or more of six categories listed in the federal regulations (45 CFR 46.101 (b)). A flow chart to assist with determining if a research project qualifies for exempt review is available at http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c2.