> But because we were recording data, it qualified as a study; because it qualified as a study, we needed to go through the IRB.
I'm not sure when Scott did his work, but this reasoning (at least after 2019) would have been wrong. IRB review only considers "generalizable" research, and is exempted from IRB review according to federal regulations and as encoded into specific institutional procedure. [1] Federally binding standards about specific exempt categories exist, but they aren't exhausitive. [2] Part of the point of IRB training – well, human subjects research training specifically – is to get drilled into you what's within and not within the scope of IRB.
I'm not sure when Scott did his work, but this reasoning (at least after 2019) would have been wrong. IRB review only considers "generalizable" research, and is exempted from IRB review according to federal regulations and as encoded into specific institutional procedure. [1] Federally binding standards about specific exempt categories exist, but they aren't exhausitive. [2] Part of the point of IRB training – well, human subjects research training specifically – is to get drilled into you what's within and not within the scope of IRB.
[1] https://ori.hhs.gov/content/chapter-3-The-Protection-of-Huma...
[2] https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/exempt%20cate...