Comment by dlgeek
4 years ago
How so?
It seems to qualify per §46.102(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.
rather than arguing about the technical details of the law, let me just clarify: IRBs would actively reject a request to review this. It's not in their (perceived) purview.
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.
If the law, as written, does actually classify this as human research, it seems like the correct response is to sue the University for damages under that law.
Since IRBs exist to minimize liability, it seems like that would be that fastest route towards change (assuming you have legal standing )
Woah woah woah, no need to whip out the litigation here. You could try that, but I am fairly certain you would be unsuccessful. You would be thrown out with "this does not qualify under the law" before it made it to court and it wouldn't have much bearing except to bolster the university.
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