Comment by sonofgod
4 years ago
https://research.umn.edu/units/irb/how-submit/new-study , find the document that points to "determining that it's not human research", leads you to https://drive.google.com/file/d/0Bw4LRE9kGb69Mm5TbldxSVkwTms...
The only relevant question is: "Will the investigator use ... information ... obtained through ... manipulations of those individuals or their environment for research purposes?"
which could be idly thought of as "I'm just sending an email, what's wrong with that? That's not manipulating their environment".
But I feel they're wrong.
https://grants.nih.gov/policy/humansubjects/hs-decision.htm would seem to agree that it's non-exempt (i.e. potentially problematic) human research if "there will be an interaction with subjects for the collection of ... data (including ... observation of behaviour)" and there's not a well-worn path (survey/public observation only/academic setting/subject agrees to study) with additional criteria.
Agreed: sending an email is certainly manipulating their environment when the action taken (or not taken) as a result has the potential for harm. Imagine an extreme example of an email death-threat: That is an undeniable harm, meaning email has such potential, so the IRB should have conducted a more thorough review.
Besides, all we have to do is look at the outcome: Outrage on the part of the organization targeted, and a ban by that organization that will limit the researcher's institution from conducting certain types of research.
If this human-level harm was the actual outcome means the experiment was a de fact experiment including human subjects.