Responsible Office/Unit

Office of Research Compliance

Division

Academic and Student Affairs

Document Type

Procedure

Effective Date

1-1-2018

Status

Active

Approving Authority

Provost

Supersedes

n/a

Summary/Comments

This procedure outlines when human subject studies may be classified as Exempt under 45 CFR 46.104, summarizing the federal exemption categories and the conditions required for each. It explains that exempt research is still subject to EMU policy and that “investigators are not permitted to determine their own exemption,” as all determinations are made by the Office of Research Compliance. Exempt projects must involve no more than minimal risk, protect confidentiality, ensure equitable subject selection, and so on.

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