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If a project does not meet the definition of “research” at 45 CFR 46.102(d), it is not
subject to IRB review regardless of whether human participants are involved.
An element of the definition of research may be lacking when the conduct of research
activities are solely to fulfill a course requirement. The purpose of the assignment may
be for learning purposes only and there is no intent for the assignment’s outcome to
contribute to generalizable knowledge. Generalizable knowledge refers to the intent of
the research to add information to your field of study or to obtain and apply results to
other settings beyond the subject population or the classroom assignment. Research is
considered “designed to contribute to generalizable knowledge” if the goal of the activity
is to share the results of your study with others, by contributing to or changing a body of
knowledge. This activity is distinct from a classroom research project where the goal of
the activity is to help teach students how to perform research. When meeting specific
criteria, the University of Iowa IRB considers classroom assignments educational in
nature and not subject to IRB review. However, some classroom assignments may
intend to contribute to generalizable knowledge or could have procedures that place
people at risk. The University of Iowa IRB has determined that these classroom
assignments may require IRB review.
The University of Iowa is not required to apply the regulations at 45 CFR 46 subpart A
to human subjects research conducted by University faculty, staff, or students if the
research is not supported by a federal department or agency which has adopted
subpart A (referred to as the Common Rule). Regardless of the funding source, the
University’s Federalwide Assurance (FWA) requires the conduct of all human subjects
in accordance with the ethical principles of the Belmont Report. Therefore, the
University of Iowa may draft institutional policies to permit the conduct of some
classroom research without IRB review so long as it complies with the conditions of the
University’s FWA.
January 2014