Except for research waived under § 225.101(i) or exempted under § 225.104, 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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