Comment by ineedasername
4 years ago
I'm surprised it passed their IRB. Any research has to go through them, even if it's just for the IRB to confirm with "No this does not require a full review". Either the researchers here framed it in a way that there was no damage being done, or they relied on their IRB's lack of technical understanding to realize what was going on.
According to one of the researchers who co-signed a letter of concern over the issue, the Minnesota group also only received IRB approval retroactively, after said letter of concern [1].
[1] https://twitter.com/SarahJamieLewis/status/13848713855379087...
In the paper they state that they received an exemption from the IRB.
I'd love to see what they submitted to their IRB to get the determination of no human subjects:
It had a high human component because it was humans making decisions in this process. In particular, there was the potential to cause maintainers personal embarrassment or professional censure by letting through a bugged patch. If the researchers even considered this possibility, I doubt the IRB would have approved this experimental protocol if laid out in those terms.
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.
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I have to admit, I can completely understand how submitting source code patches to the linux kernel doesn't sound like human testing to the layman.
Not to excuse them at all, I think the results are entirely appropriate. What they're seeing is the immune system doing its job. Going easy on them just because they're a university would skew the results of the research, and we wouldn't want that.
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This research is not exempt.
One of the important rules you must agree to is that you cannot deceive anyone in any way, no matter how small, if you are going to claim that you are doing exempt research.
These researchers violated the rules of their IRB. Someone should contact their IRB and tell them.
This was (1) research with human subjects (2) where the human subjects were deceived, and (3) there was no informed consent!
If the IRB approved this as exempt and they had an accurate understanding of the experiment, it makes me question the IRB itself. Whether the researchers were dishonest with the IRB or the IRB approved this as exempt, it's outrageous.
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lol it didn't. looks like some spots are opening up at UMN's IRB. :)
Yeah, I don't think they can claim that human subjects weren't part of this when there is outrage on the part of the humans working at the targeted organization and a ban on the researchers' institution from doing any research in this area.