Office Of Sponsored Programs


Human Subject Regulation Decision Charts

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    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?
          Are those data or specimens publicly available?


If Yes, click here                                        If No, click here
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