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  • RE: Publishing in website/magazine on student reflections/class ...

    Jun 11, 2021 8:37 AM
    Posted in: IRB Forum

    Kara, There is no such thing as retroactive IRB approval; however, there is no need to consider it. This is not human subject research, but a compilation of student ideas which may be interesting to others. There is no research design or systematic ...

  • Accepting Exempt/NHSR Determinations from an External ...

    Jun 11, 2021 8:09 AM
    Posted in: IRB Forum

    Hi, I am the Administrative Director of a Research department at an organization that has it's own FWA, but our IRB of record is that of our local hospital. We work closely with several academic institutions that have IRBs and we are developing a process ...

  • RE: Emergency Use of a Drug, aftermath?

    Jun 10, 2021 6:08 PM
    Posted in: IRB Forum

    I am presuming you are referring to this regulation for emergency use rather than emergency research. 21 CFR 56.104 Exemptions from IRB Requirements (c) Emergency use of a test article, provided that such emergency use is reported to the IRB within ...

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