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by alxlaz 1888 days ago
In the restricted sense of Title 45, Part 46, it's probably not quite human subject research (see https://www.hhs.gov/ohrp/regulations-and-policy/regulations/... ).

Of course, there are other ethical and legal requirements that you're bound to, not just this one. I'm not sure which requirements IRBs in the US look into though, it's a pretty murky situation.
3 comments
dlgeek 1887 days 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.

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dekhn 1887 days ago
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.

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shkkmo 1887 days ago
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 )

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dekhn 1887 days ago
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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thu2111 1887 days ago
It obviously qualifies and the guy just quoted the law at you to prove it.

Frankly universities and academics need to be taken to court far more often. Our society routinely turns a blind eye to all sorts of fraudulent and unethical practices inside academia and it has to stop.

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Tobu 1887 days ago
That's still 10 thousand words you're linking to…

I had a look at section §46.104 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/... since it mentioned exemptions, and at (d) (3) inside that. It still doesn't apply: there's no agreement to participate, it's not benign, it's not anonymous.

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dfranke 1888 days ago
If there's some deeply legalistic answer explaining how the IRB correctly interpreted their rules to arrive at the exemption decision, I believe it. It'll just go to show the rules are broken.

IRBs are like the TSA. Imposing annoyance and red tape on the honest vast-majority while failing to actually filter the 0.0001% of things they ostensibly exist to filter.

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