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Electronic Code of Federal Regulations

e-CFR data is current as of May 28, 2020

Title 16Chapter IISubchapter APart 1028 → §1028.119


Title 16: Commercial Practices
PART 1028—PROTECTION OF HUMAN SUBJECTS


§1028.119   Research undertaken without the intention of involving human subjects.

Except for research waived under §1028.101(i) or exempted under §1028.104, 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 policy, 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.

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