45 CFR 2584.119
§ 2584.119 Research undertaken without the intention of involving human subjects.
United States · 45 CFR — Public Welfare · Status: effective
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- Citation
- 45 CFR 2584.119, § 2584.119 Research undertaken without the intention of involving human subjects, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/223040
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Full text
Except for research waived under § 2584.101(i) or exempted under § 2584.104, in the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this part, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.