Office of Human Research Ethics SOP 3601: Pilot Studies


Office of Human Research Ethics SOP 3601: Pilot Studies

1. Pilot Studies

A pilot study is typically defined as an initial or smaller-scale investigation or a study to either test out new experimental designs (including survey or instrument development) or methods of treatment. Pilot studies are synonymous with feasibility studies, where the investigation proposed is planned to identify various issues (e.g., relating to design of an instrument, analysis of power concerns and recruitment strategies) to determine that the larger study of the same subject matter has the greatest potential to successfully test the intended research hypotheses. Pilot studies involving human subjects are considered human subject research and require IRB review. A researcher planning to conduct a pilot study must provide sufficient details to address how a smaller scale investigation is worth pursuing with a goal of obtaining results that may add to the generalizable knowledge while minimizing any anticipated risks to the subjects. There must be a well-detailed literature review and the researcher must justify the need for the number of subjects required.

Contact Information

Policy Contact

Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599-7097

Ph: 919-966-3113
Fax: 919-966-7879


Article ID: 132254
Thu 4/8/21 9:27 PM
Tue 10/31/23 1:19 PM
Effective Date
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06/02/2017 12:00 AM
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Vice Chancellor
Last Review
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03/18/2022 12:00 AM
Last Revised
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06/02/2017 12:00 AM
Next Review
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07/01/2025 12:00 AM
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06/02/2017 12:00 AM
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Research-IRB and Human Research Ethics