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by thaeli
1884 days ago
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They obtained an "IRB-exempt letter" because their IRB found that this was not human research. It's quite likely that the IRB made this finding based on a misrepresentation of the research during that initial stage; once they had an exemption letter the IRB wouldn't be looking any closer. |
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Each institution, and each IRB is made up of people and a set of policies. One does not have to meaningfully misrepresent things to IRBs for them to be misunderstood. Further, exempt from IRB review and 'not human subjects research' are not actually the same thing. I've run into this problem personally - IRB declines to review the research plan because it does not meet their definition of human subjects research, however the journal will not accept the article without IRB review. Catch-22.
Further, research that involves deception is also considered a perfectly valid form of research in certain fields (e.g., Psychology). The IRB may not have responded simply because they see the complaint as invalid. Their mandate is protecting human beings from harm, not random individuals who email them from annoyance. They don't have in their framework protecting the linux kernel from harm any more than they have protecting a jet engine from harm (Sorry if that sounds callous). Someone not liking a study is not research misconduct and if the IRB determined within their processes that it isn't even human subjects research, there isn't a lot they can do here.
I suspect that this is just one of those disconnects that happens when people talk across disciplines. no misrepresentation was needed, all that was needed was for someone reviewing this, who's background is medicine and not CS, to not understand the organizational and human processes behind submitting a software 'patch'.
The follow up behavior...not great...but the start of this could be a serious of individually rational actions that combine into something problematic because they were not holistically evaluated in context.
[0] https://oprs.usc.edu/irb-review/types-of-irb-review/