Does a pilot or feasibility study require IRB review and approval?
Frequently Asked Question
A pilot study is usually a preliminary investigation of the feasibility of a study, usually done a small scale and exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Sometimes pilot studies are conducted to collect initial data in support of or preparation for a grant submission.
Pilot studies, sometimes called feasibility studies, involving human subjects require the same scrutiny as full-scale research projects and therefore, must be submitted for IRB review and approval. It is recommended to explicitly identify in an IRB submission when a study is intended as a pilot or feasibility study, because it helps the committee to contextualize the research, particularly when it comes to justification for the sample size or research design. In regard to sample size, in particular instead of requiring a formal power calculation for the sample size, the IRB may be satisfied with a rationale as to why the proposed number of subjects was chosen (e.g., "15 is the number of available subjects and is expected to provide enough data to determine whether the questionnaires are understandable").