3 ms·

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 th

• 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?