[wtallis]

The bit you've quoted is intended to clarify that "about whom" means the subject is the patient, even if the researcher gets the information indirectly through the patient's doctor. Earlier in the document you linked, it states:

> If for the purpose of a research study [...] An investigator [...] interacts with a living individual, [...] Then The research likely involves human subjects.

What's up for debate here is whether this research qualifies for one of the specific exemptions in the regulation. The general definition in the regulation is broad enough to include all interaction with living humans that produces information used for the study, and is only narrowed by later enumerated exemptions.

[adminprof]

Not at all,

1) this is clearly not an exempt study, which is a category of its own that the IRB reviews and makes a judgment on. The authors would immediately have been able to point out the protocol number of the exempt study if it were exempt. Rather it's not considered human subjects as the authors clearly state on their FAQ.

2) it seems like you're thrown off by the example, because if you ended your sentence as "The bit you've quoted is intended to clarify that "about whom" means the subject is the patient" then we would be in agreement, and it'd be more obvious that the subject is, in fact, the website's policies/procedures. Here's an excerpt from the written text of the common rule,

"“About whom” – a human subject research project requires the data received from the living individual to be about the person."

https://hso.research.uiowa.edu/defining-human-subjects

[wtallis]

> this is clearly not an exempt study, which is a category of its own that the IRB reviews and makes a judgment on. The authors would immediately have been able to point out the protocol number of the exempt study if it were exempt. Rather it's not considered human subjects as the authors clearly state on their FAQ.

Please don't use such circular logic. We're debating whether the research properly qualifies as human subject research; we're not debating about what the IRB actually decided on that question, because they may have gotten it wrong.

> then we would be in agreement, and it'd be more obvious that the subject is, in fact, the website's policies/procedures.

The policy itself is certainly the intended subject of the research. But the methods they've chosen mean they are also collecting and analyzing information about the responses of real live humans to their interactions and interventions, and that qualifies this as human subject research irrespective of the naive intentions of the researchers. Having a non-human subject does not preclude also having a human subject.

[adminprof]

> Please don't use such circular logic. We're debating whether the research properly qualifies as human subject research; we're not debating about what the IRB actually decided on that question, because they may have gotten it wrong.

Yes that's what we're debating. But you used the word "exemption" which has a specific technical meaning in human subjects research, and I'm saying that it's not an exemption. There are 8 tests for exemption, and I'm pointing out that this is not an IRB exemption.

> The policy itself is certainly the intended subject of the research. But the methods they've chosen mean they are also collecting and analyzing information about the responses of real live humans to their interactions and interventions, and that qualifies this as human subject research irrespective of the naive intentions of the researchers. Having a non-human subject does not preclude also having a human subject.

Do you have a source for this interpretation? It sounds like this is your interpretation, but not the federal one. Following your interpretation, surveys of companies (e.g. emailing [e-mail] to ask how many employees they have) would fall under the definition of human subjects.

Thanks for the continued conversation, but I think this is my last comment. Nothing personal, but this is a bit exhausting. It seems like you're debating two other people on this forum about this exact definition, and you might consider that maybe you're just wrong about your interpretation?

Here's one final source, if it helps provide closure:

To meet the definition of human subjects, you must ask “about whom” questions. Questions about your respondents' attitudes, opinions, preferences, behavior, experiences, or characteristics, are all considered “about whom” questions. Questions about an organization, a policy, or a process are “about what” questions.

https://campusirb.duke.edu/resources/guides/defining-researc...

[wtallis]

> Do you have a source for this interpretation? It sounds like this is your interpretation, but not the federal one. Following your interpretation, surveys of companies (e.g. emailing [e-mail] to ask how many employees they have) would fall under the definition of human subjects.

Sure. Click through the NIH's Decision Tool [1], and you'll find that collecting information only through surveys or interviews leads to the tool saying "Your study is most likely considered exempt from the human subject's regulations, category 2 (Exemption 2)." That particular exemption requires that the research qualify under at least one of three further criteria. (I'll also note that for someone who complained about people not referring to primary sources, you seem to be citing more .edu sources than .gov sources.)

Furthermore, this particular research unquestionably went beyond mere surveys and interviews. Legal threats under false pretenses are way outside those bounds. So even if a mere survey about how many employees a company has doesn't qualify as human research (which I'm willing to concede), that doesn't help settle the question about this research.

[1] https://grants.nih.gov/policy/humansubjects/hs-decision.htm