IRB FAQ_Pilot Study vs Field Test_V8.9.23(1)

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University of the Cumberlands *

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839

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Information Systems

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Feb 20, 2024

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docx

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I NSTITUTIONAL R EVIEW B OARD F REQUENTLY A SKED Q UESTIONS : P ILOT S TUDY VS F IELD T EST P ILOT S TUDY What is a pilot study? A pilot study is typically a precursor to a primary study to assess study feasibility or to evaluate the study instrumentation and protocols. Pilot study results are not used for generalizability and do not contribute to generalizable knowledge ( 45 CFR 46.102(l) ); therefore, pilot studies are not considered systematic research. However, as human subjects are recruited for pilot studies, IRB review is expected. Does a pilot study require IRB review? Yes What types of instruments may require a pilot study? Researcher-designed, Likert-type or other numeric survey instrument Researcher-designed numeric data collection tool Adapted or changed pre-validated numeric survey instrument Feasibility of a study recruitment protocol Feasibility of a study data collection protocol What are other requirements for a pilot study? Pilot studies are small scale and require a minimum sample size 30, depending upon statistics used for feasibility, validity, and/or reliability analyses. Pilot study participants cannot be included as sample participants for a primary or other subsequent studies. A pilot study cannot be used as a pre-test of a study hypothesis. Data gathered from a pilot study may not be used as research data for other purposes. A summary of the pilot study results is typically included in the primary study with the description of the instrumentation and protocols. F IELD T EST What is a field test? A field test typically involves the examination of a researcher-designed instrument and protocols prior to using the instrument or protocol in a research study. The field test should be preceded by a review by an expert panel of 2 – 3 researchers within the specific discipline. The experts may identify and inform problems within the instrument for potential biases, confusing questions or instructions, and/or misalignment of instrument questions with the study research questions. After the instrument is approved by the expert panel, the field test should be completed.  The   field   test   involves using the instrument to gather data, sample responses, and feedback on the instrument itself from 2-3 individuals   from the target population. This step is necessary to assess the quality of the instrument construction before implementation.   If the research includes any of the items below, a Field Test is required. What types of instruments may require a field test? Interview questions and protocol Open-ended questionnaire Focus group questions and protocol Needs assessment or other evaluation questionnaire Does a field test require IRB review? Yes What are other requirements for a field test? A summary of the field test results is typically included in the primary study with the description of the study instrumentation and protocols. V8.8.23
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