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Research Compliance

IRB Procedure for Procedure 18: Review and Approval for Pilot and Feasibility Work

by Office of the Vice Provost for Research |  August 19, 2026

Effective Date: 19 August 2026

Responsible Office: Office of the Vice Provost for Research

Last Updated: 03 September 2026

I. Scope & Purpose

This procedure applies to all faculty, staff, students, and affiliated researchers, working within the scope of their roles at William & Mary (W&M), to complete research with human subjects. 

The purpose of this procedure is to detail W&M’s procedure to address the review and approval of pilot studies and feasibility work.

II. Definitions

  • Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this regulation, whether they are conducted or supported under a program that is considered research for other purposes (see 45 CFR 46.102(l)).
  • Human subject (or “participant”): a living individual about whom an investigator (whether professional or student) is conducting research:
    • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens
      • “Interactions” include communication or interpersonal contact between the investigator and participant (e.g., surveys, interviews, focus groups).
      • “Intervention” includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the participant or the participant’s environment that are performed for research purposes (e.g., an educational experiment).
    • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
      • “Identifiable biospecimen” means a biospecimen for which the identity of the participant is or may readily be ascertained by the investigator or associated with the biospecimen.
      • “Identifiable private information” means private information for which the identity of the participant is or may readily be ascertained by the investigator or associated with the information. This includes re-identification of the participant due to access, expertise, use of technology, and consideration of all data and information available.
  • Pilot Study: A preliminary investigation usually conducted on a small scale that may be exploratory in nature, designed to test or develop procedures, to test study design (including survey or instrument development), or to test methods that are intended for a larger study. A pilot study is usually (but not always) completed with a participant group related to the intended target population. Reasons to complete a pilot study include exploring a new topic, testing instruments, testing study design and procedures, and preparation for a grant application.
  • Feasibility Study: An assessment of the practicality of a proposed plan, method, or use of an instrument for data collection, often involving colleagues or experts who can evaluate if the proposed method/design/instrument will result in sufficient information to answer the research questions. Reasons to complete a feasibility study include: assessing the practicality of a research plan is practicable, assessing whether the research is needed, and garnering feedback regarding methods/instruments used in data collection.[

III. Procedure

A. Pilot Studies and the IRB

Pilot studies are considered research with human subjects and will require IRB review and approval before implementation, including when researchers participate in their own research.

B. Feasibility Studies and the IRB

A feasibility study often does not require IRB review. However, there are occasions in which it does meet the definition of “human subjects research.”  

  1. A feasibility study will not need IRB approval when individuals (e.g. experts, colleagues, peers, or lab members) provide feedback on the methods, procedures, or instruments. The individuals included in the “study” do not provide information about themselves (e.g. thoughts, feelings, opinions, physiological responses, etc.).
    1. Information collected for a feasibility study that did not meet the definition of research may not be repurposed as a research study, nor can that information be used as data for the main research study.
  2. A feasibility study will need IRB approval when individuals (e.g. experts, colleagues, peers, or lab members) provide feedback on the methods/procedures/instruments. The individuals included are asked to provide information about themselves (e.g. thoughts, feelings, opinions, physiological responses, etc.).[GE3.1][OJ3.2]
    1. Examples of “feedback” include responses such as: “The responses provided do not match the question being asked,” “this should be a Likert scale and not open ended,” “the formatting should differentiate between sections,” “your population may not understand this term,” “you should ask additional questions like ....”
    2. Examples of “information about themselves” include their actual responses to the questions being posed.

 C. IRB Application Preparation

A researcher planning to conduct a pilot study or feasibility study that requires IRB approval must submit an IRB protocol.
  1. Submissions that are considered pilot/feasibility activities must be clearly identified. Explicitly identifying the study as a pilot/feasibility study in an IRB submission helps the committee to contextualize the research, particularly when it comes to justification for the sample size or research design.
  2. The submission must include sufficient information about how the information generated can be used as part of the larger study or its design.
  3. The researcher must justify the number of participants required and the participant sample to be selected if different from the target population.
    1. For sample size in a pilot or feasibility study, the IRB may be satisfied with a rationale as to why the proposed number of was chosen. For example,"15 is the number of available participants and is expected to provide enough data to determine whether the questionnaires are understandable."
    2. Sometimes it is appropriate to use the research team as the pilot participants.
      1. This approach can serve as a participant protection for both pilot or feasibility study participants and future participants due to the expertise of the pilot or feasibility study participants.
      2. If research team members are used in this way, they are considered participants and not just researchers.
  4. During the consent process, potential participants must be notified that they are participating in a pilot or feasibility study including the purpose of those activities and how the data from the pilot or feasibility study will be used (such as refining procedures or instruments).
  5. Once approved, a pilot or feasibility study can be modified to include the main study’s procedures, or the protocol can be closed and a new initial submission describing the main study can be submitted.
    1. The investigator can make the initial assessment of the appropriate submission route for the main study, and they can discuss options with the IRB.
    2. The IRB may determine that the changes needed to transition from a pilot/feasibility study to a main study significantly impact the design and/or risk assessment; therefore, a modification is not appropriate, and a new initial submission must be submitted.

D. IRB Review and Approval for Pilot and Feasibility Studies

The IRB will review the submission to determine if part or all of the study meets the definition of a pilot study or a feasibility study requiring IRB review and approval.

Activities proposed as preliminary to the main research project will be evaluated to determine if the activities meet the definition of human subject research.

IV. Authority & Amendment

This procedure was approved by the W&M Institutional Review Board on August 19, 2026. This procedure will be reviewed every 2 years to ensure it remains relevant, usable, and in compliance with university policy and relevant law.

V. Related Policy & Procedures