A doctoral researcher plans to interview four participants before launching a dissertation study to determine whether the interview questions are understandable. Another investigator consults healthcare professionals to assess whether a proposed research project is feasible. A third researcher tests an online questionnaire with a small group before beginning a larger survey. Although these activities occur before the main investigation, they may serve different purposes and involve different ethical responsibilities. Understanding those differences is essential for determining when IRB review may be necessary.
Researchers sometimes assume that activities described as preliminary research or pilot testing are automatically excluded from formal ethical oversight. However, the timing, size, or informal description of an activity does not independently determine whether review is required. A study involving only a few participants may still qualify as human subjects research, while some preparatory activities may not meet the applicable criteria. Researchers must examine the purpose of the activity, the procedures involved, the individuals participating, and how the collected information will be used.
Recent methodological literature emphasizes the importance of clearly defining pilot and feasibility activities. Bond et al. (2023) address the conceptual framework used to distinguish pilot and feasibility studies, while Teresi et al. (2022) provide guidance on designing and evaluating feasibility pilot studies. These publications support the need for investigators to establish clear methodological objectives before beginning preliminary data collection. However, methodological classification and ethical review classification are separate decisions.
For doctoral candidates, understanding this distinction can prevent delays and protect research participants. An Institutional Review Board (IRB) may need to evaluate certain pilot activities, while other preparatory tasks may require only an institutional determination or no formal review under the applicable policies. Researchers seeking IRB services or considering an independent IRB should describe their proposed activities accurately rather than assuming that the terms pilot study or preliminary research determine the review outcome.
I. Understanding Pilot Studies and Preliminary Research
Pilot studies and preliminary research are closely related, but they are not interchangeable. A pilot study generally tests selected procedures or components of a planned investigation, while preliminary research encompasses a broader range of activities that inform study development. Understanding these differences helps researchers select appropriate methods and determine when ethical oversight should be considered.
What Is a Pilot Study?
A pilot study is a smaller-scale investigation designed to evaluate whether procedures for a future study can be implemented successfully. Researchers may conduct pilot testing to assess recruitment strategies, participant retention, survey usability, interview procedures, or data collection logistics. The primary purpose is often to identify practical issues before committing resources to the larger investigation. Pilot studies may also provide information that helps investigators refine their research design.
Bond et al. (2023) extend the conceptual framework for pilot and feasibility studies, emphasizing the importance of defining their purposes and relationships. Teresi et al. (2022) likewise address methodological considerations involved in designing and evaluating feasibility pilot studies. Together, these sources provide a foundation for distinguishing pilot testing from activities intended primarily to answer a study’s main research question.
Consider a doctoral researcher investigating nurses’ experiences with electronic health records. Before conducting 25 interviews, the researcher proposes interviewing four nurses to assess the clarity of questions, interview duration, and recording procedures. This activity may be classified methodologically as a pilot study because it tests components of the planned investigation. Whether IRB approval is necessary depends on the nature of participant involvement and the applicable institutional requirements.
What Is Preliminary Research?
Preliminary research refers broadly to activities conducted before a formal investigation to clarify the research problem, evaluate available information, and develop suitable procedures. These activities may include reviewing published literature, consulting methodological experts, identifying potential research sites, or assessing the availability of relevant information. Some activities involve no direct interaction with prospective research participants. Others may include interviews, surveys, or collection of identifiable information and therefore require closer ethical consideration.
For example, a doctoral candidate may meet with a faculty advisor to discuss the wording of proposed interview questions. The researcher may also consult a statistician about sample size considerations or ask a hospital administrator whether the organization permits external dissertation research. These activities may support research preparation without necessarily constituting human subjects research. However, researchers should avoid assuming that every activity described as preliminary falls outside ethical oversight.
The intended purpose of information collection is particularly important. Asking an expert to provide professional feedback on a questionnaire may differ from interviewing individuals to generate findings about their experiences. If the investigator systematically collects information from living individuals to answer a research question, the activity may require an institutional determination. Researchers should therefore describe preliminary activities according to what they actually involve rather than relying on informal terminology.
How Pilot Studies Differ From Feasibility Assessments
Pilot studies and feasibility assessments overlap, but their objectives may differ. A feasibility assessment considers whether a proposed investigation can be conducted successfully, while a pilot study typically involves testing selected components of the planned research process. Feasibility questions may address recruitment availability, organizational cooperation, instrument performance, or required resources. A pilot study can examine these questions through limited implementation.
According to Teresi et al. (2022), designing and evaluating feasibility pilot studies requires attention to the methodological purpose of the activity. Mellor et al. (2023) also address progression criteria for external randomized pilot trials, highlighting the importance of establishing criteria that inform decisions about proceeding to a larger investigation. These methodological considerations help researchers determine what information should be collected and how it will support future study planning.
For example, contacting a school district to ask whether teachers may be available for future recruitment is an administrative feasibility inquiry. Conducting structured interviews with teachers to test a proposed research instrument involves a different set of procedures. Both activities may inform the same dissertation, but their ethical requirements may differ. Appropriate IRB training can help investigators recognize when feasibility planning becomes participant-based research.
II. When Pilot Studies and Preliminary Activities Require IRB Review
Determining whether an activity requires ethical review involves examining its purpose, procedures, and relationship to human subjects research. Researchers should not assume that a pilot study is exempt simply because it precedes the main investigation. Similarly, not every activity conducted during preliminary planning automatically requires formal approval. The appropriate determination depends on the applicable oversight framework and institutional policies.
When a Pilot Study May Require IRB Approval
A pilot study may require IRB approval when it constitutes human subjects research under applicable requirements. For example, researchers may recruit individuals, administer surveys, conduct interviews, introduce interventions, or collect identifiable information to evaluate research procedures. The limited number of participants does not independently eliminate the need for review. Investigators should consider what participants will experience and how their information will be handled.
Suppose a researcher plans to interview five patients about their experiences receiving telehealth services. The interviews will be recorded and used to determine whether the questions are suitable for a larger study. Although the investigator’s immediate objective is instrument refinement, the activity involves direct interaction with living individuals and the collection of information about their experiences. The researcher should seek an appropriate institutional determination before recruitment begins.
Ethical considerations remain relevant even when a pilot study focuses on feasibility. Participants may need clear information about the purpose of the activity, the procedures involved, and the intended use of their responses. Khan et al. (2021) specifically examine transparency of informed consent in pilot and feasibility studies, making their publication relevant to this concern. Researchers should ensure that consent materials accurately describe the pilot activity rather than treating it as an informal extension of study preparation.
When Preliminary Activities May Not Require Formal Review
Some preliminary activities may fall outside the scope of human subjects research because they do not involve the relevant forms of investigation or participant involvement. Examples may include reviewing published literature, consulting research advisors, or examining publicly available documents without obtaining private identifiable information. Administrative inquiries about research site availability may also be preparatory rather than research activities. However, institutional policies may still require investigators to request an official determination.
For example, a doctoral researcher may contact a hospital administrator to ask whether the organization permits external researchers to recruit employees. The discussion may focus on organizational policies, available facilities, and application requirements. If the researcher is not collecting information from the administrator as a research participant, the activity may be an administrative inquiry. The investigator should nevertheless reconsider the oversight requirements if the conversation develops into systematic collection of information for analysis.
Researchers should distinguish professional consultation from participant interviews. Asking a faculty member to evaluate whether interview questions align with research objectives may be methodological consultation. Conducting structured interviews with faculty members to analyze their professional experiences may serve a substantive research purpose. When the distinction is uncertain, an IRB or designated institutional office should provide guidance.
Why Preliminary Research and Quality Improvement Are Sometimes Confused
Researchers working in healthcare and organizational settings may also encounter uncertainty when distinguishing preliminary research from quality improvement activities. Quality improvement generally focuses on assessing or improving practices within a particular setting, while research may aim to produce knowledge beyond the immediate operational context. However, the distinction cannot always be established through a single characteristic. Activities may share similar methods while serving different purposes.
Carter et al. (2021) examine the differentiation of research and quality improvement activities and its implications for clinical scholarship. Their review is relevant because investigators may conduct surveys, interviews, or record reviews as part of either type of activity. The use of a familiar research method does not independently establish the classification. Researchers must consider the objectives, design, and intended application of the information collected.
For example, a hospital department may evaluate staff satisfaction with an existing scheduling procedure to guide an internal operational decision. A doctoral researcher may propose collecting similar information to examine a broader research question about workplace experiences. Although both activities could involve surveys, their purposes and oversight requirements may differ. Researchers should seek an institutional determination rather than assuming that describing an activity as quality improvement or preliminary assessment resolves the issue.
Why Publication Plans Do Not Determine Review Requirements
Another common misconception is that ethical review is necessary only when investigators intend to publish their findings. Publication plans may provide useful context about the purpose of an activity, but they are not the sole deciding factor. A dissertation study may require review even when the researcher does not plan to submit a journal article. Conversely, an activity may be suitable for publication without necessarily meeting the applicable definition of human subjects research.
Hicks et al. (2021) discuss the role of the institutional review board and provide an educational foundation for understanding research oversight. Their publication is relevant to researchers who are uncertain about the responsibilities of ethics committees. Investigators should describe the purpose, procedures, and participant involvement of their proposed activities when requesting a determination. Relying exclusively on whether the results might eventually be published is not an adequate substitute.
For doctoral candidates, this means that coursework, preliminary interviews, and dissertation preparation activities should be evaluated according to their actual characteristics. A researcher should not assume that an activity is excluded from review merely because it is described as practice or exploratory work. Appropriate IRB training for students can help investigators recognize these distinctions and identify when institutional guidance is necessary.
What About Testing Interview Questions and Survey Instruments?
Instrument testing is one of the most common situations in which researchers encounter uncertainty. A doctoral candidate may want to ask several individuals whether survey questions are understandable or whether interview instructions are clear. The ethical requirements depend on the nature of the activity, who participates, and how the information will be used. Expert feedback on instrument wording may differ from administering the proposed research instrument to members of the intended participant population.
For example, a researcher may ask two faculty members to review an interview guide for clarity and relevance. This activity may be professional consultation rather than human subjects research. If the researcher instead conducts recorded interviews with prospective participants and analyzes their responses, the activity may warrant formal ethical consideration. Investigators should clarify the purpose of instrument testing before contacting potential participants.
Researchers should also decide whether pilot responses will be retained or incorporated into the final dataset. Bond et al. (2023) and Teresi et al. (2022) provide methodological context for planning pilot and feasibility studies, while Khan et al. (2021) highlight informed consent as an important concern within such studies. These considerations support describing the intended use of pilot information before data collection begins. Any proposed use of pilot data should be consistent with the approved protocol and participant consent arrangements.
Can Researchers Conduct a Pilot Study Before IRB Approval?
Researchers should not assume that pilot testing can begin before ethics review simply because it occurs before the main study. If the proposed pilot constitutes human subjects research requiring approval, investigators should obtain that approval before initiating the relevant activities. If the classification is uncertain, researchers should request an institutional determination. Beginning participant-based research without the necessary authorization may create compliance problems and affect the acceptability of collected information.
Hicks et al. (2021) provide guidance relevant to understanding institutional review boards and their responsibilities. Mayes (2026) also addresses the IRB application process and the importance of helping researchers approach submission with greater confidence. These publications are relevant to the practical need for clear communication with reviewing institutions. Researchers should not interpret uncertainty about classification as permission to begin data collection.
An independent IRB may provide review for eligible studies, depending on the research arrangement and institutional requirements. However, an external IRB does not automatically replace permissions required by participating hospitals, schools, or other organizations. Researchers who need to find an IRB should clarify whether the reviewing organization is appropriate for their proposed activities. These arrangements should be confirmed before recruitment begins.
III. Practical Steps for Determining Whether IRB Review Is Necessary
Researchers can reduce uncertainty by using a structured decision-making process before beginning pilot testing or preliminary activities. The objective is not to classify every preparatory task as human subjects research. Instead, investigators should accurately describe their activities and obtain the appropriate institutional guidance when needed. The following steps can support responsible planning.
Step 1: Define the Purpose of the Proposed Activity
Researchers should begin by explaining what the activity is intended to accomplish. Is the objective to assess recruitment feasibility, improve survey wording, evaluate interview procedures, or answer a substantive research question? These purposes may involve different methods and ethical considerations. Investigators should avoid relying on labels such as informal interview or practice survey without explaining what participants will actually do.
Bond et al. (2023) provide a conceptual foundation for distinguishing pilot and feasibility studies. Mellor et al. (2023) also emphasize the role of progression criteria in planning external randomized pilot trials. These publications support the importance of specifying the methodological objectives of preparatory investigations. A clear purpose statement can help researchers explain their activities when seeking an institutional determination.
Step 2: Identify Who Will Participate and What Information Will Be Collected
The next step is to determine whether the activity involves living individuals and what information will be obtained. Researchers should consider whether they will interact with participants, introduce an intervention, collect identifiable information, or access private records. They should also identify whether responses will be recorded, stored, or analyzed. These details are more informative than the number of people involved.
For example, asking a research advisor to comment on an interview guide differs from conducting recorded interviews with patients about healthcare experiences. The first activity may be professional consultation, while the second may involve human subjects research. The distinction should be evaluated according to the actual procedures and objectives. Researchers seeking IRB services should provide these details when requesting guidance.
Step 3: Determine How the Information Will Be Used
Researchers should decide whether information collected during preliminary activities will be used solely to refine study procedures or contribute to substantive research findings. They should also establish whether pilot data may be included in the final dataset. These decisions can influence study design, participant information, and ethical review requirements. Investigators should avoid collecting information without first considering its intended use.
Teresi et al. (2022) address methodological guidance for designing and evaluating feasibility pilot studies. Their work is relevant to establishing clear objectives and evaluation plans before pilot testing begins. Researchers should document whether the activity will test procedures, assess feasibility, or contribute to answering the primary research question. This information can assist the reviewing IRB in evaluating the proposed activities.
Step 4: Request an Institutional Determination When Necessary
When researchers are uncertain whether an activity requires formal review, they should consult the office responsible for research oversight. Institutions may have procedures for determining whether a proposed activity qualifies as human subjects research or requires a particular review pathway. Investigators should follow those procedures rather than relying on informal assumptions. The determination may depend on institutional policies and the applicable oversight framework.
Hicks et al. (2021) offer educational guidance on understanding the institutional review board, while Mayes (2026) focuses on reducing uncertainty surrounding IRB application submission. These sources are relevant to the importance of preparing clear descriptions of proposed activities. Researchers should provide information about the study’s objectives, participant population, procedures, and intended use of collected information. Written documentation of the resulting determination should be retained.
Step 5: Address Consent and Participant Protections During Pilot Testing
When a pilot study involves human subjects research, participant protections should be considered from the beginning. Researchers should explain what participants will be asked to do, how their information will be used, and whether participation involves foreseeable risks or inconveniences. Consent materials should accurately describe the pilot phase rather than suggesting that it is an informal activity without research implications. The appropriate consent process should follow the requirements established for the study.
Khan et al. (2021) examine transparency of informed consent in pilot and feasibility studies. Their publication is directly relevant to the importance of communicating the purpose and procedures of pilot participation. Researchers should consider whether participants understand that the activity is intended to test research procedures and whether their information may be retained for subsequent analysis. Appropriate IRB review can help evaluate these protections before recruitment begins.
Step 6: Establish Clear Criteria for Moving From Pilot Testing to the Main Study
Researchers should identify what information will determine whether a pilot study has achieved its objectives. These criteria may involve recruitment success, completion rates, participant feedback, instrument usability, or the practicality of data collection procedures. Establishing expectations before the pilot begins can reduce the temptation to reinterpret results afterward. It also helps investigators determine which modifications may be necessary before the larger study proceeds.
Mellor et al. (2023) address recommendations for progression criteria during the design, conduct, analysis, and reporting of external randomized pilot trials. Their work provides methodological support for making progression decisions explicit. Although those recommendations arise from randomized pilot trials, the broader planning principle can inform other research designs when applied appropriately. Researchers should also determine whether changes following pilot testing require additional ethics review before implementation.
Step 7: Document Decisions and Monitor Changes to the Study
Researchers should maintain records of institutional determinations, approved protocols, consent materials, and relevant correspondence. Documentation is particularly important when a project includes several preparatory stages. Investigators should also track modifications to recruitment procedures, instruments, and eligibility criteria. A change that appears minor from a methodological perspective may still affect the conditions under which the study was reviewed.
For example, a researcher may initially obtain guidance that a professional consultation does not require formal review. If the activity later expands into recorded interviews with members of the intended participant population, the original determination may no longer address the revised procedures. The investigator should seek additional guidance before implementing the change. Appropriate human-subject research training can help researchers recognize when modifications require renewed consideration.
Step 8: Seek Support Before Beginning Participant-Based Activities
Researchers should seek clarification early rather than waiting until recruitment is scheduled. This is especially important for doctoral candidates conducting their first independent study or working with organizations outside their universities. Early consultation can help investigators distinguish preliminary preparation from pilot research involving participants. It can also clarify whether site permission or additional institutional authorization is required.
Researchers who need to find an IRB should verify that the reviewing organization is appropriate for their proposed study. An independent IRB may provide ethical review for eligible research, while participating institutions may retain their own administrative responsibilities. Appropriate IRB services can support application preparation and help investigators understand the review process. Researchers should nevertheless obtain the required determinations before initiating activities that may involve human subjects research.
Conclusion
Pilot studies and preliminary research both contribute to effective research planning, but they serve different purposes. Pilot studies generally test components of a proposed investigation, while preliminary research includes a broader range of activities used to refine questions, assess feasibility, and develop procedures. Some activities may involve human subjects research, while others may not. The terminology assigned to an activity does not independently establish whether ethical review is necessary.
Recent methodological publications emphasize the importance of clearly defining pilot and feasibility objectives. Bond et al. (2023), Teresi et al. (2022), and Mellor et al. (2023) provide guidance relevant to the design, evaluation, and progression of pilot investigations. Carter et al. (2021) contribute to the discussion of distinguishing research from quality improvement, while Khan et al. (2021) address informed consent transparency in pilot and feasibility studies. Together, these sources support careful planning and attention to the ethical implications of preparatory research activities.
Researchers should evaluate the purpose of each activity, the individuals involved, the information collected, and the intended use of the findings. They should also confirm institutional requirements before beginning activities that may constitute human subjects research. When uncertainty exists, seeking a formal determination is more reliable than assuming that small-scale or exploratory work does not require review. This approach helps protect participants and reduces the risk of conducting research without appropriate authorization.
For doctoral researchers, IRB training for students can strengthen understanding of pilot testing, research classification, and ethical oversight. Experienced investigators may also benefit from continued IRB training when conducting studies in unfamiliar settings or coordinating activities across institutions. Understanding the relationship between methodological planning and IRB approval helps researchers make informed decisions before data collection begins.
BeyondBound IRB provides IRB services to support researchers preparing protocols and navigating ethical review requirements. Whether investigators are planning a pilot study, evaluating preliminary activities, or considering an external IRB, early guidance can help clarify the appropriate review pathway. Through IRB Heart, researchers can also strengthen their understanding of ethical research practices through practical human-subject research training.
Responsible research preparation involves more than deciding when to launch the main investigation. It requires recognizing when preliminary activities involve research participants and when institutional oversight may be necessary. By making these determinations before collecting information, researchers can strengthen their study design, protect participants, and proceed with greater confidence.
References
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Carter, E. J., Usseglio, J., Pahlevan-Ibrekic, C., Vose, C., Rivera, R. R., & Larson, E. L. (2021). Differentiating research and quality improvement activities: A scoping review and implications for clinical scholarship. Journal of Clinical Nursing, 30(17–18), 2480–2488. https://doi.org/10.1111/jocn.15668
Hicks, R. W., Hines, K., & Henson, B. (2021). Demystifying the institutional review board. AORN Journal, 114(4), 309–318. https://doi.org/10.1002/aorn.13498
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Mellor, K., Albury, C., Dutton, S. J., Eldridge, S., & Hopewell, S. (2023). Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot and Feasibility Studies, 9, Article 59. https://doi.org/10.1186/s40814-023-01291-5
Teresi, J. A., Yu, X., Stewart, A. L., & Hays, R. D. (2022). Guidelines for designing and evaluating feasibility pilot studies. Medical Care, 60(1), 95–103. https://doi.org/10.1097/MLR.0000000000001664