Comment by alxlaz
4 years 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.
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 )
2 replies →
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.
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.