What Counts as Research
But is it research? The answer to this question determines whether your activity requires IRB review. Your ordinary understanding of what is human subjects research is a good starting point, but the definition under federal regulations may be both broader and narrower than you think.
"Research" is defined in the federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [45 CFR 46.102(d)]
On the one hand, the criterion of intent to contribute to generalizable knowledge may be broader than your ordinary understanding of research. It means that preparatory work in a research project is included. On the other, it also means that systematic investigations to develop local knowledge would not be considered research, which is perhaps different from how this word, "research," is sometimes used.
And so, the IRB definition of research may include:
But also, generally, research would not include:
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