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The key phrase is: > a living individual about whom an investigator (whether professional or student) conducting research: The mere fact that you're interacti

by seoaeu 5y ago

The key phrase is: > 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

wtallis 5y ago
Can you explain a bit more why you added emphasis to "about whom" in the clause you quoted? I don't see how those two words create any kind of exception; this research gathered information about how the humans behaved in response to the requests and threats. 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.
adminprof 5y ago
This is actually the most technically correct answer on this page. Everyone is going by their own opinions about definitions of what constitutes human subjects research, rather than starting from the primary sources. IRB guidelines are dictated by the federal government "common rule", a common standard adopted by all institutions that receive federal funding. "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-Learning-Module-Lesson2.pdf 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.
- wtallis 5y ago
  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 5y ago
    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 https://hso.research.uiowa.edu/defining-human-subjects
    - wtallis 5y ago
      > 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.
munchler 5y ago
It's pretty clear that the living individuals about whom the investigators were conducting research are the operators of the websites targeted by the study. The researchers perhaps misled their IRB by stating that they were studying the behavior of "websites", rather than people, but websites don't read and respond to email.

by seoaeu 5y ago

wtallis 5y ago

Can you explain a bit more why you added emphasis to "about whom" in the clause you quoted? I don't see how those two words create any kind of exception; this research gathered information about how the humans behaved in response to the requests and threats. 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.

adminprof 5y ago

This is actually the most technically correct answer on this page. Everyone is going by their own opinions about definitions of what constitutes human subjects research, rather than starting from the primary sources. IRB guidelines are dictated by the federal government "common rule", a common standard adopted by all institutions that receive federal funding. "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-Learning-Module-Lesson2.pdf 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.

wtallis 5y ago
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 5y ago
  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 https://hso.research.uiowa.edu/defining-human-subjects
  - wtallis 5y ago
    > 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.

munchler 5y ago

It's pretty clear that the living individuals about whom the investigators were conducting research are the operators of the websites targeted by the study. The researchers perhaps misled their IRB by stating that they were studying the behavior of "websites", rather than people, but websites don't read and respond to email.