Human Research Protection Program and Institutional Review Board

Feasibility study: "Feasibility studies are pieces of research done before a main study to answer the question ‘Can this study be done?’ They are used to estimate important parameters that are needed to design the main study”[1]. Data collected would not be analyzed or included in publications.

Examples:

1. Going to a potential site to see if the research is possible
2. Checking to see what is the best approach to the research
3. Going through a consent process with friends to see if the information is comprehensible
4. Sending your survey instrument to a few experts in the field for their feedback as to whether or not the questions are appropriate for the topic and/or cohort of the research
5. Feedback from colleagues and peers about research design
6. Student researcher designs questionnaire for their study’s target population and asks someone from a different population to test the questionnaire

Scenario:

A researcher planning to conduct interviews regarding landowner perspectives of land use regulations contacts the US Forest Service to ask how they have typically approached land owners in the past and asks for feedback on their planned questions.

Pilot testing: “A small scale-study conducted prior to conducting an actual experiment; designed to test and refine procedures.”

 Examples:

1. Checking to see if the designed tool works
2. Asking people to complete a survey to find out whether a question results in the requested information
3. Testing the intervention with four people before trying it with 60 people
4. Asking people to complete your survey and then revising the questions based on their responses
5. Revising the study after analyzing preliminary data and determining that the data do not address their research question
6. Student researcher designs questionnaire for their study’s target population, asks the population to try out the questionnaire, and the questions are revised based on the responses

Scenario:

A researcher planning to conduct interviews regarding landowner perspectives of land use regulations conducts interviews with 5 people to test the questions and see if they get answers that make sense. The researchers may revise their interview guides based on the initial data collected.

Q: Does my feasibility study/pilot testing require IRB Review?

A: The federal regulations indicate that pilot testing meets the definition of research involving human subjects and requires IRB review. However, feasibility studies typically do not meet the definition of research involving human subjects and therefore would not require IRB review.

In order for the IRB to determine whether your activities constitute a feasibility study or pilot testing, and subsequently, whether they require IRB review, please complete and submit the initial sections of the HRPP application and protocol form in Cayuse. Instructions can be found on the "Preparing an Initial Submission" page. In this form, it is helpful to note with whom the study or testing is going to be done and how the data will be used.