Comment by asciident
4 years ago
Yes, your comment is the only one across the two threads which understands the nuance of the definition of human subjects research. This work is not "about" human subjects, and even the word "about" is interpreted a certain way in IRB review. If they interpret the research to be about software artifacts, and not human subjects, then the work is not under IRB purview (it can still be determined to be exempt, but that determination is from the IRB and not the PI).
However, given that, my interpretation of the federal common rule is that this work would indeed fit the definition of human subjects research, as it comprises an intervention, and it is about generalizable human procedures, not the software artifact.
Other note...different irbs treat not research vs exempt differently.
One institution I worked with conflated “exempt” and “not human subjects research” and required the same review of both.
Another institution separated them and would first establish if something was human subjects research. If it was, they would then review whether it was exempt from irb review based on certain categories. If they determined it was not human subjects research they would not review whether it met the exempt criteria, because in their mind they could not make such a determination for research that did not involve human subjects
I agree with your last paragraph, although I can totally understand how somebody who doesn’t know much about programming or open source would see otherwise.