dennis roberts wrote:
>
> robert's comments lead me to ask: what makes research research? just
> because i say it is? or say it isn't?
There are two ways people sometimes seek to avoid IRB oversight.
They have to do with "research" and "human subjects".
There is a formal definition of research, at least in the Code of
Federal Regulations (45 CFR 46) "A systematic investigation,
including research development, testing, and evaluation, designed to
develop or contribute to generalizable knowledge". From a
technical/legal standpoint, one could in theory collect data without
IRB approval on the grounds that it isn't research, find the result
so compelling that one then decides publication is "essential", and
apply for exemption #4 ("Research involving the collection or study
of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if
the information is recorded by the investigator in such a manner
that participants cannot be identified, directly or through
identifiers linked to the subjects.") because it's an existing data
set. This is the sort of thing that cheapens all of scientific
research and invites all sorts of regulations to see that it doesn't
happen again.
The second is to argue over what constitutes a human subject. If it
were only the instructor using the software, I could see some trying
to argue that it's only the instructor who is the human subject. If
the instructor fabricated a set of data, I would agree. However,
students using the software should be considered human subjects.
People can argue over what constitutes research. However, for
*anything* that involved students, it would be a serious mistake to
not run it by the local IRB for their official determination of
whether the work requires its review.
Given that the vendor is seeking to obtain data to show that the
software is effective, my opinion based on the information at hand
is that the data are being collected to contribute to generalizable
knowledge (the effectiveness of the software--results that would be
disseminated to market the product) and IRB review should be
sought. I could also easily imagine unstated details that would
lead the IRB to conclude that it is not research and no review is
necessary. However, it's the IRB's call, not the instructor's.
FWIW...
.
.
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