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    45 CFR Sec. 46.119

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    Title 45
    SUBTITLE A
    PART 46
    Subpart A

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    Sec. 46.119 Research undertaken without the intention of involving
        human subjects.

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      In the event research (conducted or funded by the Department) is
    undertaken without the intention of involving human subjects, but
    it is later proposed to use human subjects in the research, the
    research shall first be reviewed and approved by an IRB, as
    provided in these regulations, a certification submitted to the
    Department, and final approval given to the proposed change by the
    Department.