An email asking an organization for answers to questions is human experimentation?
I must be missing something.
* The participants / subjects of the study are people, not "websites" as the study claims. Websites don't read and respond to emails, people do.
* The participants of this study were selected without their consent
* The participants were not told that they are in a study, nor the purpose of that study
* The participants were lied to, as the researcher pretended to be someone else
* The researcher deliberately communicated in a way that heavily implied legal consequences if they don't get what they demand
* The researcher's threats and demands do not actually match what is afforded to them by the law
* The study caused undue stress and financial losses (e.g. hiring lawyers) to the participants, including those that were not subject to CCPA at all.
I don't care what labels you choose to put or not put on it, it's a shitty, abusive study that should have never passed ethics review.
That's not the official definition an IRB would use. The official definition is a lot less broad than a lot of people on this thread seem to think. It requires that are collecting biospecimens, identifiable private information, or certain kinds of information about a specific person. [0]
[0]: https://grants.nih.gov/policy/humansubjects/research.htm
> a living individual about whom an investigator (whether professional or student) conducting research:
> - Obtains information [or ...] through [... or] interaction with the individual, and uses, studies, or analyzes the information [or ...]; or
> - [...]
The actual legal definition is here [1], and further clarifies that "interaction" is very broad, specifically "Interaction includes communication [or ...] between investigator and subject."
This clearly qualifies OP as a human subject and this as human subjects research.
[1] Search "(e)(1) Human subject": https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...
> a living individual about whom an investigator (whether professional or student) conducting research:
The mere fact that you're interacting with a human doesn't trigger it. If you're associated with a university, I'd encourage you to reach out to your IRB and ask them. The fact that the researchers in this case specifically were told by their IRB that it wasn't human subject research should be a good hint
Are you accidentally reading an "is" into that clause to interpret it as "about whom an investigator is conducting research"? What matters is not whether the researcher considers the human to be the target of the research, but whether the human (or their privacy) is actually affected by the research.
"about whom" is a key criteria from the federal government to determine whether something fits the definition of human subjects research. Here's a quote from HHS:
"The phrase ‘about whom’ is important. A human subject is the person that the information is about, not necessarily the person providing the information. In the case of biospecimens, the human subject is the person from whom the specimen was taken."
https://www.hhs.gov/ohrp/sites/default/files/OHRP-HHS-Learni...
Reading that, it's clear that the Princeton study does not fit the definition of human subjects research. The complainants may be able to sue for damages to the university, but not because the study was improperly classified as human subjects.
> 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.
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."
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.
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 contact@company.com 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...
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
To be a bit more pithy, here is one example of such an analysis (admittedly, I'm not sure comments on twitter count): https://twitter.com/RossTeixeira/status/1471249559879929861
If you are doing research with an institution governed by an IRB then you cannot do anything involving a human being without it getting reviewed by the IRB. There are criteria whereby the IRB may exempt the research from a full review, but only the IRB can make that determination.
Perhaps the #1 absolute goal of the IRB is to assess potential adverse impacts of the research on any humans involved. It should be clear from the comments here, and if you read through any of the links to twitter threads, that people were adversely impacted by this study either through anxiety, time spent unecessarily, and perhaps money. I might understand (though disagree) with a point of view that said these adverse results were not foreseeable, but review of the study itself under an IRB for its involvement of humans was absolutely required.
When they email a single person who runs a website, that's very different.
All AB testing is a human experiment?
No. Obviously not. How could you have missed the fact that they were "collecting information" under false pretenses?
We don't even need to get into the weeds on this just being "answers to questions". All you need to do is look at the human impact: This research study has caused anxiety, time, and potentially money to many people being asked to unknowingly participate in the study. IRB's exist to evaluate-- among other things-- potential adverse impacts on people involved in a study. This has had an adverse impact and should not have been allowed through IRB review in this form.
Organizations are made up of humans.
Human experimentation is very broadly defined, for IRB purposes. As I understand it, if you're going to be asking humans to interact with researchers, in any way, and gathering data based on those interactions, that's human subjects research, and requires reasonable scrutiny from the IRB.
Source: I have worked fairly extensively with my own university's IRB, as I put together and maintain the website that they use to handle submissions.
[1] https://researchdata.princeton.edu/research-lifecycle-guide/...
> A human subject means a living individual about whom an investigator (whether professional or student) who is conducting research:
> (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens
The information they were looking for is 'how does this person respond when they receive an email threatening legal action under CCPA?'
A human subject means ... a living individual ... about whom an investigator... obtains information... through intervention or interaction... and studies... the information.
That they mistakenly thought they were investigating how "an organization" responds when they receive an email is based on an erroneous assumption that an organization is itself an autonomous, sentient entity whose behavior can be studied independently of its human constituents.
Your interpretation would make most of the definition redundant. They could just say any individual an investigator interacts with. IRBs don't interpret it like that.
Not quite, because the definition needs to also encompass individuals that researchers acquire information about without directly interacting—eg. getting patient data from a healthcare provider.
This was clearly seeking a human response and is a human experiment.
You can think the study is poorly designed, unethical, etc. But if they're not obtaining data about a living individual, then it's not human subjects research.
>But if they're not obtaining data about a living individual, then it's not human subjects research.
Sure, if you completely ignore the other half of the definition, per the NIH:
https://grants.nih.gov/policy/humansubjects/research.htm
> Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
They are absolutely collecting information to analyze by interacting with the individual.