5 ms·

> When you do something to people to see how they act, it's a human experiment. That's not the official definition an IRB would use. The official definition is

by seoaeu 5y ago

> When you do something to people to see how they act, it's a human experiment. 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 https://grants.nih.gov/policy/humansubjects/research.htm

gpm 5y ago
You're misreading it, the definition quoted on that page is very broad, specifically a human subject is the following with irrelevant clauses in or's removed and replaced with [or ...]: > 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/45-cfr-46/revised-common-rule-regulatory-text/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...
- 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
  - 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.
ineedasername 5y ago
IRB's emerged as mandated bodies governing the intersection of research & humans in the wake of the 1974 NRA and subsequent Belmont Report. That report explicitly states that it is more that just biomedical, but also behavioral research that is covered. "do something to people to see how they act" fits pretty well within the domain of "behavior". 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.

by seoaeu 5y ago

gpm 5y ago

You're misreading it, the definition quoted on that page is very broad, specifically a human subject is the following with irrelevant clauses in or's removed and replaced with [or ...]: > 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/45-cfr-46/revised-common-rule-regulatory-text/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...

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
- 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.

ineedasername 5y ago

IRB's emerged as mandated bodies governing the intersection of research & humans in the wake of the 1974 NRA and subsequent Belmont Report. That report explicitly states that it is more that just biomedical, but also behavioral research that is covered. "do something to people to see how they act" fits pretty well within the domain of "behavior". 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.