Guidelines on Pilot Studies
Per 45 CFR 46.102, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A pilot study is a preliminary investigation of the feasibility of a study, usually intended to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. These pilot studies are not considered to contribute to generalizable knowledge and therefore would not be defined as research and would not require IRB review. Data collected from a pilot study cannot be used as research data.
Procedures that are not considered to be pilot research and do not need to be reviewed by the IRB include, but may not be limited to, the following:
- Training programs designed to teach proven methods that will be used during the conduct of research (i.e., blood drawing training, interview techniques training);
- Refining data collection procedures or preparation of an instrument, such as a survey. 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.