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by dlgeek
1889 days ago
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How so? It seems to qualify per ยง46.102(e)(1)(i) ("Human subject means a living individual about whom an investigator [..] conducting research: (i) Obtains information [...] through [...] interaction with the individual, and uses, studies, or analyzes the information [...]") I don't think it'd qualify for any of the exemptions in 46.104(d): 1 requires an educational setting, 2 requires standard tests, 3 requires pre-consent and interactions must be "benign", 4 is only about the use of PII with no interactions, 5 is only about public programs, 6 is only about food, 7 is about storing PII and not applicable and 8 requires "broad" pre-consent and documentation of a waiver. |
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It's not worth arguing about this; if you care, you can try to change the law. In the meantime, IRBs will do what IRBs do.