Office Of Sponsored Programs


Human Subject Regulation Decision Charts

Chart-1 Chart-2 Chart-3

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?
             If No, This exemption does not apply. This research may be eligible for IRb waiver of informed consent ( Section 46.116(d)). See Chart 3.


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