Office Of Sponsored Programs

 

Human Subject Regulation Decision Charts


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chart 2:

 

    Exemption at Section 46.101(b)(4) regarding research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens.

 

Is the research exempt in accordance with Section 46.101(b)(4)? The regulation at 45 CFR Part 46 do not apply if the critreia for exemption under Section 46.101(b)(4) are met.

 

          Will this research use solely existing data or specimens?
             Yes.
          Are those data or specimens publicly available?
             No.
          Will information be recorded by the investigator in such a way that it can be linked to the subject?
             If No, This research is exempt from 45 CFR Part 46.

 

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