Office of Human Research Ethics SOP 3601: Pilot Studies

Summary

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 to determine that the larger study of the same subject matter has the greatest potential to successfully test the intended research hypotheses.

Body

Title

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

Name: Kimberly Brownley
Title:  Associate Director of Policy and Initiative
Unit: Office of Human Research Ethics (OHRE)
Email: kim_brownley@med.unc.edu

Details

Details

Article ID: 132254
Created
Thu 4/8/21 9:27 PM
Modified
Fri 6/28/24 9:54 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Research-IRB and Human Research Ethics
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
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Vice Chancellor
Policy Contact
Person who handles document management. Best person to contact for information about this policy. In many cases this is not the Issuing Officer. It may be the Policy Liaison, or another staff member.
Next Review
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07/01/2025 12:00 AM
Last Review
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03/18/2022 12:00 AM
Last Revised
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06/02/2017 12:00 AM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
06/02/2017 12:00 AM
Origination
Date on which the original version of this document was first made official.
06/02/2017 12:00 AM
Flesch-Kincaid Reading Level
19.3