Does the IRB/human subject protection guidance also apply to pilot studies, questionnaire development, and testing efforts conducted with members of the population?
A. Yes. The definition of research in the Federal regulations includes research development, testing, and evaluation (45 CFR 46.102(d)). Some IRBs might not consider such studies research if they are not systematic but overall, pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily the data collected from subjects in a pilot or feasibility study are not used for study findings.
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