Do I need IRB approval for my pilot study?
Many disciplines use pilot studies prior to collecting data for a full-scale research project. While data from a pilot study can be useful, it is important to understand whether your pilot study is considered research and requires IRB review and approval before starting data collection. Per federal regulation 45 CFR 46.102 (l), research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Generalizable knowledge is defined as information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
- Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
- Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
In many cases, a pilot study is a preliminary investigation of the feasibility of a study (also referred to as a feasibility pilot study), usually intended to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. These types of feasibility pilot studies are not considered research if they are not intended to contribute to generalizable knowledge. Therefore, these feasibility pilot studies would not be defined as research per federal regulations and would not require IRB review. As a reminder, data collected from a feasibility pilot study cannot be used as research data.
There are certain elements that are required for pilot studies to be considered a feasibility study:
- Feasibility pilot studies are conducted on a small scale and exploratory in nature.
- The purpose is to refine data collection procedures, instruments or research design. For instance, “How could this survey question be misunderstood?”, or “In what order should survey instruments be distributed?” This type of study development does not contribute to generalizable knowledge, and therefore is not considered research and does not require IRB review.
If the data collected in a pilot study will be used solely or in combination with other data for generalizable or publication purposes, IRB review and approval is required BEFORE data collection begins. For example, collecting human subjects data to test a new scale as part of a publication will require IRB review and approval before data collection, even if the data is labeled a pilot study in the publication. Pilot data collected for the purpose of research process refinement without inclusion in an IRB approved protocol may not be repurposed as study data. The HRPP/IRB cannot provide retroactive review. Researchers are cautioned not to confuse pilot data with preliminary data collection. Preliminary data collection requires HRPP/IRB Review.
If you have any questions regarding this policy, please contact our Research Compliance Specialist.
Original Version: 09.09.24