Human Subject Regulation Decision Charts
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chart 2:
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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.
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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.
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| Will this research use solely existing data or specimens? |
| Yes. |
| Are those data or specimens publicly available? |
If Yes, click here If No, click here |
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