4 ms·

In another part of the thread, a commenter linked the response from the department which pointed out that the definition of human subject research and even IRBs

by seoaeu 6y ago

In another part of the thread, a commenter linked the response from the department which pointed out that the definition of human subject research and even IRBs themselves are governed by federal statute. A bunch did go wrong in this case, but the actions of the IRB weren't one of them. They were acting exactly as directed by the law. The fault lies with the researchers who conducted the experiment, and perhaps broadly with the academic community for not establishing guidelines for ethical oversight of non-human subject research.

josefx 6y ago
The definition of human subject is literally "a human a researcher collects information on", as far as I can find the law doesn't even try to over complicate that point. Claiming that researching the Linux review process does not involve human subjects seems to be willfully ignorant.
- seoaeu 6y ago
  The letter [0] explains it better than I could: > Crucially, an essential requirement for research to be considered as “human subjects research” (and thus within the purview of the IRB) is that it involves collecting information about human subjects themselves, such as age, blood pressure, or related. No such information was sought or collected here. [...] Importantly, even if one believed the study did involve human research subjects (perhaps due to the interactions and the incidental collection of email addresses), the study would clearly be exempt from IRB oversight pursuant to 45 CFR 46.104(D). [0] https://drive.google.com/file/d/1z3Nm2bfR4tH1nOGBpuOmLyoJVEiO9cUq/view https://drive.google.com/file/d/1z3Nm2bfR4tH1nOGBpuOmLyoJVEi...
  - josefx 6y ago
    > such as age, blood pressure, or related So they try to cite the law, giving the relevant section, but the law contains a generic "information or biospecimens" instead of restricting itself to the clearly medical subset they provide. It would be better if they actually cited a source or the exact paragraph that results in their interpretation, because I can't find it. Even worse they give 46.104(D) as reason why it would be excluded anyway. That is literally the list of all possible reasons something could be excluded. Which of the reasons listed do they refer to?

by seoaeu 6y ago

josefx 6y ago

The definition of human subject is literally "a human a researcher collects information on", as far as I can find the law doesn't even try to over complicate that point. Claiming that researching the Linux review process does not involve human subjects seems to be willfully ignorant.

seoaeu 6y ago
The letter [0] explains it better than I could: > Crucially, an essential requirement for research to be considered as “human subjects research” (and thus within the purview of the IRB) is that it involves collecting information about human subjects themselves, such as age, blood pressure, or related. No such information was sought or collected here. [...] Importantly, even if one believed the study did involve human research subjects (perhaps due to the interactions and the incidental collection of email addresses), the study would clearly be exempt from IRB oversight pursuant to 45 CFR 46.104(D). [0] https://drive.google.com/file/d/1z3Nm2bfR4tH1nOGBpuOmLyoJVEiO9cUq/view https://drive.google.com/file/d/1z3Nm2bfR4tH1nOGBpuOmLyoJVEi...
- josefx 6y ago
  > such as age, blood pressure, or related So they try to cite the law, giving the relevant section, but the law contains a generic "information or biospecimens" instead of restricting itself to the clearly medical subset they provide. It would be better if they actually cited a source or the exact paragraph that results in their interpretation, because I can't find it. Even worse they give 46.104(D) as reason why it would be excluded anyway. That is literally the list of all possible reasons something could be excluded. Which of the reasons listed do they refer to?