Manuel B. Garcia

Manuel B. Garcia serves as the Senior Director for Educational Technology and Digital Learning at FEU Institute of Technology, Manila, Philippines. Read More

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Should Stakeholders Help Assess Study Feasibility Before the Research Protocol Is Finalized?

Stakeholders can help researchers identify feasibility problems before a protocol is finalized. Learn how to assess recruitment, procedures, resources, acceptability, and implementation constraints while maintaining scientific rigor and clear decision-making responsibilities.

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Stakeholder Assessment of Study Feasibility Guide 1005 of 1272
01 · The Question

Should Stakeholders Evaluate Whether a Study Can Actually Be Implemented?

You have developed a research protocol with a clearly defined question, appropriate design, sampling plan, measurement instruments, and statistical analysis strategy. On paper, the study appears methodologically sound.

However, implementation depends on people and institutions whose circumstances may not be fully represented in the protocol. Teachers may lack sufficient time to deliver the intervention. Students may find repeated assessments difficult to complete. Healthcare professionals may be unable to accommodate research procedures within existing service schedules.

Should these stakeholders evaluate the study before the protocol is finalized? Could their involvement reveal important feasibility problems, or would it introduce preferences that compromise the scientific design?

The issue is consequential because a technically rigorous protocol may still fail if its recruitment assumptions, procedures, resources, or implementation arrangements are unrealistic.

02 · The Short Answer

Yes, Stakeholder Assessment Can Identify Feasibility Problems Before They Become Study Failures

In Brief

Stakeholders should generally be involved in assessing study feasibility when their experiences, responsibilities, or institutional knowledge can reveal barriers to recruitment, participation, intervention delivery, measurement, or implementation. Early involvement may help researchers identify unrealistic assumptions and revise procedures before substantial resources are committed.

However, stakeholder consultation does not establish feasibility by itself. Recommendations should be evaluated alongside empirical feasibility evidence, methodological requirements, resource assessments, and applicable ethics or institutional approvals. A study is feasible only in relation to a specified design, setting, population, and implementation plan.

03 · What You Need to Know

How Stakeholders Can Strengthen Research Feasibility Assessment

What Does Study Feasibility Mean?

Study feasibility concerns whether a proposed research design and its procedures can be implemented under the anticipated conditions with sufficient scientific quality, ethical protection, and available resources.

It includes questions about whether participants can be recruited, interventions delivered, measurements completed, data managed, and follow-up maintained.

Feasibility is not equivalent to the importance of the research question or the theoretical appropriateness of the design.

A study may address an important question using a defensible methodology while remaining infeasible because the required population is inaccessible, the intervention cannot be delivered consistently, or the available time is insufficient.

Researchers should distinguish the scientific desirability of a study from the practical possibility of conducting it as proposed.

Why Should Feasibility Be Evaluated Before the Protocol Is Finalized?

Early feasibility assessment allows investigators to identify and address problems while the study design remains open to revision.

After recruitment begins, changes to eligibility, measurement schedules, intervention procedures, or follow-up may create comparability problems and require protocol amendments.

Some modifications may also affect sample-size assumptions or the intended estimand.

For example, discovering midway through an educational intervention that instructors cannot deliver the planned number of sessions may compromise intervention fidelity.

Consulting relevant stakeholders during protocol development may reveal such constraints before the study begins.

However, early consultation cannot guarantee that unexpected implementation problems will not occur.

Which Stakeholders Can Contribute to Feasibility Assessment?

The appropriate stakeholders depend on the study's design, setting, and procedures.

Potential contributors include prospective participants, research partners, practitioners, teachers, clinicians, community representatives, institutional administrators, technical personnel, data managers, and individuals responsible for implementing the intervention.

Different stakeholders may identify different feasibility constraints.

For example, participants may identify burdens associated with travel or repeated assessments, while institutional staff may identify scheduling, staffing, or infrastructure limitations.

Researchers should avoid relying exclusively on senior decision-makers when implementation depends heavily on frontline personnel or participants.

Stakeholder selection should reflect who possesses relevant knowledge and whose circumstances could affect implementation.

What Dimensions of Feasibility Should Be Examined?

Feasibility is multidimensional. Bowen and colleagues describe several areas that can be considered when designing feasibility studies, including acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing.

Not every research project needs to evaluate every dimension. The relevant questions should follow the uncertainties most likely to threaten the proposed study.

Feasibility dimension Practical question Potential stakeholder contribution
Recruitment Can the intended population be reached and enrolled? Identify communication barriers and access limitations.
Acceptability Are the procedures appropriate to those expected to participate or implement them? Explain concerns about burden, relevance, or perceived fairness.
Implementation Can procedures be delivered as specified? Identify staffing, scheduling, and workflow constraints.
Practicality Are the necessary resources and infrastructure available? Assess equipment, connectivity, space, and personnel requirements.
Measurement Can the required data be collected with adequate quality? Review instrument clarity, assessment conditions, and accessibility.
Retention Can participants reasonably remain involved through follow-up? Identify cumulative demands and barriers to continued participation.
Organizational integration Can research activities coexist with normal operations? Identify conflicts with service delivery or institutional responsibilities.

Feasibility assessment should identify which uncertainties are most consequential rather than produce an undifferentiated list of possible implementation difficulties.

What Is the Difference Between Stakeholder Consultation and a Feasibility Study?

Stakeholder feasibility consultation Uses relevant stakeholder knowledge and perspectives to identify, interpret, and potentially address implementation concerns.
Formal feasibility study Systematically investigates specified uncertainties about conducting a proposed study, often through empirical testing of procedures and prespecified feasibility objectives.

Consultation may reveal that a recruitment target appears unrealistic, but it does not necessarily establish the actual recruitment rate.

A feasibility study may test recruitment procedures and estimate relevant operational quantities, although its estimates may remain imprecise.

Stakeholder involvement and empirical feasibility testing can complement each other. Neither automatically replaces the other.

How Is a Feasibility Study Different From a Pilot Study?

Feasibility research broadly investigates whether and how a proposed study can be conducted.

A pilot study generally implements part or all of the proposed future study on a smaller scale to examine its operation.

Under the framework discussed by Eldridge and colleagues, pilot studies can be understood as a subset of feasibility studies.

For example, a feasibility study might investigate whether students and instructors consider an intervention acceptable, while a pilot randomized trial might test the planned allocation, delivery, assessment, and follow-up procedures.

The terms are sometimes used inconsistently in published research, so investigators should describe what was actually tested rather than rely on the label alone.

Stakeholders may contribute to both activities by identifying relevant uncertainties and helping interpret the findings.

How Can Stakeholders Assess Recruitment Feasibility?

Stakeholders can help identify whether proposed recruitment channels are accessible, credible, and appropriate for the intended population.

They may also explain why eligible individuals might decline participation or why particular institutions are unlikely to cooperate.

However, stakeholder estimates of recruitment potential should be checked against available population information, institutional records, previous recruitment experience, or pilot evidence where feasible.

For example, a community organization may express strong support for recruitment without having access to enough eligible individuals to meet the study's target.

Researchers should distinguish enthusiasm for a study from demonstrated recruitment capacity.

Detailed decisions about stakeholder involvement in recruitment methods should remain aligned with the sampling design and intended population inference.

Can Stakeholders Evaluate Whether an Intervention Is Deliverable?

Yes. Individuals responsible for implementing an intervention may identify constraints that researchers overlook.

For example, teachers may explain that an intervention requiring three additional activities every week cannot be accommodated within the existing course schedule.

Healthcare personnel may identify conflicts between research procedures and patient care responsibilities.

Technical staff may identify software compatibility, equipment, cybersecurity, or maintenance requirements.

These contributions can inform revisions to delivery arrangements, staffing plans, or training procedures.

However, researchers should distinguish adaptations that preserve the intervention's essential functions from changes that create a substantively different intervention.

How Can Stakeholders Assess Measurement Feasibility?

Stakeholders may review whether proposed instruments and assessment procedures can be administered under realistic conditions.

For example, a performance assessment may require equipment unavailable in some participating institutions, while a lengthy questionnaire may be difficult to complete during normal service delivery.

Participants can identify confusing instructions, accessibility barriers, or assessment demands that are not apparent to instrument developers.

Researchers should evaluate proposed modifications for their effects on measurement validity, reliability, and comparability.

A more convenient instrument is not automatically an acceptable substitute for the original measure.

When essential measurements cannot be collected, the research team may need to revise the design rather than conceal the limitation through an inappropriate proxy.

Can Stakeholders Help Determine Whether Follow-Up Is Realistic?

Yes. Longitudinal research depends on participants remaining accessible and willing to complete assessments over time.

Stakeholders may identify predictable barriers, such as academic holidays, seasonal employment, relocation, caregiving demands, or changes in service access.

They may recommend appropriate contact intervals, reminders, or flexible assessment arrangements.

However, these recommendations should be evaluated against the required outcome timing and the possibility of differential missing data.

Shortening follow-up solely because retention is difficult may prevent the study from answering its original question.

What Role Does Participant Burden Play in Feasibility?

Participant burden is one important component of feasibility, but it does not encompass every implementation constraint.

A study may be acceptable to participants while remaining impossible for institutions to deliver with available staffing or infrastructure.

Conversely, a study may be operationally convenient for researchers but impose unreasonable demands on participants.

Researchers should evaluate both perspectives and avoid treating institutional efficiency as evidence of participant acceptability.

Stakeholder consultation about acceptable participant burden can help identify necessary revisions before the protocol is finalized.

How Should Feasibility Criteria Be Established?

Where a formal feasibility or pilot study is conducted, researchers should identify the uncertainties being investigated and specify criteria for interpreting the findings.

These may concern recruitment rates, retention, intervention fidelity, assessment completion, or other operational indicators.

Progression criteria can help determine whether a future definitive study should proceed unchanged, proceed with modifications, or require substantial reconsideration.

However, thresholds should be justified according to the proposed study rather than borrowed mechanically from unrelated research.

Stakeholders can help determine whether proposed targets are realistic and whether particular difficulties are important enough to affect progression decisions.

Statistical uncertainty should also be considered. An observed recruitment or retention proportion from a small pilot study may provide only an imprecise estimate of future performance.

What Are Progression Criteria?

Progression criteria are prespecified considerations used to evaluate whether a study can move from feasibility or pilot work to a larger definitive investigation.

They may be expressed through quantitative thresholds, qualitative conditions, or a combination of evidence.

A traffic-light approach is sometimes used to distinguish conditions favoring progression, modification, or substantial reconsideration.

However, progression decisions should not depend solely on one arbitrary numerical cutoff. Investigators should consider uncertainty, the causes of feasibility problems, and whether proposed solutions are credible.

Stakeholder input may help explain why a target was missed and whether the difficulty is likely to recur.

Can Stakeholders Help Set Realistic Feasibility Targets?

They can contribute, particularly when targets depend on local workflows or participant circumstances.

For example, teachers may explain how many intervention sessions can realistically be delivered during an academic term.

Community representatives may identify recruitment periods that conflict with seasonal work or major community obligations.

However, stakeholder expectations should be compared with empirical information whenever available.

A target should reflect the minimum operational performance required for the proposed study to answer its question, not simply the level stakeholders find comfortable.

What If Stakeholders Disagree About Feasibility?

Disagreement may reveal different operational responsibilities or unequal exposure to implementation demands.

For example, institutional leaders may believe that a study is feasible because resources have been allocated, while frontline staff may identify scheduling conflicts that remain unresolved.

Researchers should investigate the basis of disagreement rather than assume that organizational authority establishes feasibility.

Where possible, the team may test competing assumptions through a limited pilot or operational assessment.

Unresolved disagreements should be documented, especially when they concern essential study procedures.

How Do You Prevent Stakeholder Preferences From Weakening the Design?

Feasibility recommendations should be evaluated against the scientific requirements of the research question.

For example, stakeholders may recommend removing a follow-up assessment because it creates scheduling difficulties. If that assessment is essential for measuring the primary outcome, the proposed change may undermine the study.

The research team should consider alternatives such as revised scheduling, additional resources, or a different recruitment period.

Where no feasible alternative preserves the necessary information, the appropriate response may be to redesign or postpone the study.

Stakeholder involvement should make methodological constraints more visible, not remove the obligation to address them.

How Should Feasibility Findings Influence the Final Protocol?

Feasibility findings may justify changes to recruitment procedures, staffing, intervention delivery, training, assessment schedules, data management, or participant communication.

Each consequential change should be evaluated for its effects on the target population, outcome definitions, sample-size assumptions, and analysis plan.

Researchers should document which concerns were identified, the evidence considered, the resulting decisions, and any remaining uncertainties.

When changes affect essential design features, the protocol may require substantive revision and renewed review.

A final protocol should reflect procedures that can reasonably be implemented, not merely procedures that appear ideal in abstraction.

Does Stakeholder Approval Mean the Study Is Feasible?

No. Stakeholder support can strengthen confidence in acceptability and identify important practical considerations, but it does not demonstrate that recruitment targets, data collection requirements, or intervention delivery can be achieved.

Likewise, successful pilot implementation does not guarantee that a larger study will succeed under different conditions.

Feasibility conclusions should identify the evidence available, the assumptions remaining, and the conditions under which the proposed study is expected to operate.

Researchers should avoid presenting stakeholder endorsement as a substitute for operational evidence.

How Should Stakeholder Feasibility Contributions Be Documented?

Documentation should identify the stakeholders involved, the feasibility questions they considered, their recommendations, and the resulting protocol decisions.

It should also record important disagreements and recommendations that were not adopted.

Where stakeholder contributions influence a pilot or feasibility study, the team should distinguish those contributions from empirical findings generated by the study.

The GRIPP2 reporting checklists can support transparent reporting of patient and public involvement, while pilot and feasibility reporting guidance addresses the empirical design and results of such studies.

Clear documentation helps readers understand whether stakeholders genuinely influenced the research or were consulted only after important decisions had already been made.

Watch Out

Do not treat stakeholder enthusiasm as evidence that recruitment, retention, or implementation targets are achievable. A feasible study requires credible operational assumptions and, where uncertainty is consequential, empirical testing. Support for the research question is not the same as capacity to implement the protocol.

04 · A Practical Example

Using Stakeholder Feedback to Evaluate an Educational Intervention Before Launch

Hypothetical Example

A Multisite Study of AI-Assisted Formative Feedback

A research team plans to evaluate an AI-assisted feedback intervention across four universities. The proposed protocol requires weekly intervention activities, baseline and final writing assessments, and recruitment of 100 students per university.

Before finalizing the protocol, researchers consult students, instructors, course coordinators, and technical personnel.

Stakeholder Feasibility concern Potential response
Students Repeated activities may conflict with major assessments. Review scheduling and cumulative participation burden.
Instructors Weekly feedback procedures may exceed available preparation time. Evaluate workload and delivery arrangements.
Course coordinators Eligible enrollment varies across universities. Reassess site-specific recruitment projections.
Technical personnel Some learning platforms may not support the proposed integration. Test compatibility and establish appropriate technical alternatives.
Identify critical feasibility uncertainties

The team prioritizes recruitment capacity, intervention delivery, technical compatibility, and completion of the primary writing assessments.

Define the necessary scientific requirements

The researchers identify the intervention components and measurements that must be preserved to estimate the intended effect.

Conduct limited feasibility testing

Under appropriate authorization, participating institutions test relevant technical and operational procedures and examine whether the proposed schedule can be implemented.

Review the findings with stakeholders

Students and staff explain which difficulties are likely to recur and which may be addressed through scheduling, training, or resource adjustments.

Revise the protocol

The team modifies nonessential operational procedures while preserving the primary outcome and essential intervention components. Recruitment targets are reassessed against actual eligible populations.

Establish progression decisions

The researchers document the operational conditions required before full implementation, including acceptable recruitment capacity, technical readiness, and assessment completion.

Suppose the original recruitment target is 400 students, distributed equally across the four universities. During feasibility assessment, one university identifies only 70 eligible students under the proposed criteria.

This does not automatically mean the entire study is infeasible. The team may investigate alternative recruitment arrangements, additional sites, or a revised sample allocation.

However, any change must be evaluated for its consequences for statistical power, site balance, the target population, and the intended analysis.

The example illustrates how stakeholder assessment can reveal an operational limitation before it becomes a recruitment failure, while methodological review determines which revisions remain scientifically defensible.

05 · What Researchers Often Get Wrong

Common Misconceptions About Stakeholder Feasibility Assessment

Misconception

A Methodologically Sound Protocol Is Automatically Feasible

Scientific appropriateness does not guarantee that recruitment, staffing, intervention delivery, or follow-up can be implemented under actual institutional conditions.

Misconception

Stakeholder Support Proves That the Study Will Succeed

Stakeholder enthusiasm may indicate acceptability but does not establish recruitment capacity, technical readiness, or reliable implementation. Empirical evidence may still be necessary.

Misconception

Only Researchers Can Assess Study Feasibility

Researchers provide methodological expertise, but participants, practitioners, and institutional personnel may identify implementation constraints that are otherwise overlooked.

Misconception

Every Stakeholder Recommendation Should Be Adopted

Recommendations should be evaluated against scientific requirements, ethical obligations, resources, and the intended estimand. Some changes may undermine the study despite improving convenience.

Misconception

A Successful Small Pilot Guarantees a Successful Definitive Study

Pilot results provide evidence under particular conditions. Scaling up may introduce new staffing, recruitment, or implementation difficulties.

Misconception

Feasibility Problems Can Always Be Solved After Recruitment Begins

Late changes may affect measurement, intervention fidelity, comparability, and statistical planning. Consequential uncertainties should be addressed before full implementation whenever possible.

06 · What This Means for You

How to Incorporate Stakeholder Feasibility Assessment Into Protocol Development

Begin by identifying the study procedures most vulnerable to operational failure. Consult the people who will participate in, deliver, or support those procedures.

Evaluate their concerns using available evidence and, where necessary, targeted feasibility testing.

A simple decision framework

If stakeholders identify an avoidable operational barrier
Revise the relevant procedure while checking that the scientific requirements remain intact.
If recruitment capacity is uncertain
Review eligible population estimates and consider pilot recruitment or additional sites before finalizing sample targets.
If intervention delivery depends on unavailable resources
Assess whether resources can be secured or whether a defensible adaptation is possible.
If stakeholder recommendations affect essential measurements
Evaluate the consequences for validity, timing, the estimand, and statistical power before approving changes.
If critical feasibility uncertainties remain unresolved
Conduct appropriate feasibility testing, redesign the study, or defer implementation rather than proceed on unsupported assumptions.

Feasibility assessment should produce decisions, not merely a list of stakeholder opinions. Each major concern should have a documented response and an explanation of how the final protocol addresses it.

07 · A Quick Checklist

Before Finalizing a Stakeholder-Informed Research Protocol

Before approving the study for implementation, check:
Identify the recruitment, intervention, measurement, follow-up, and resource assumptions most likely to threaten feasibility.
Consult stakeholders with direct knowledge of participant experiences and implementation conditions.
Distinguish stakeholder expectations from empirically demonstrated recruitment or operational capacity.
Evaluate whether essential intervention components and outcome measurements can be delivered as planned.
Assess participant burden, accessibility, staffing, scheduling, equipment, and institutional support.
Conduct targeted feasibility or pilot testing when consequential uncertainties cannot be resolved through existing evidence.
Establish justified progression criteria where a formal feasibility study is conducted.
Evaluate the methodological consequences of proposed changes to eligibility, sampling, outcomes, and intervention delivery.
Document stakeholder recommendations, final protocol decisions, unresolved risks, and necessary approvals.
08 · Frequently Asked Questions

Frequently Asked Questions About Stakeholder Assessment of Study Feasibility

Should stakeholders assess feasibility before the research protocol is finalized?

Generally, yes, when they have relevant knowledge about recruitment, participation, implementation, or institutional conditions. Early assessment allows researchers to address problems before procedures become difficult to change.

Is stakeholder consultation the same as a feasibility study?

No. Consultation gathers relevant perspectives, while a formal feasibility study systematically investigates specified uncertainties, often using empirical evidence. The approaches can complement each other.

Can stakeholders determine whether recruitment targets are realistic?

They can provide useful contextual information, but recruitment projections should also be evaluated using eligible population data, previous experience, or pilot evidence where feasible.

Must every research project conduct a pilot study?

No universal requirement applies. Pilot or feasibility testing is particularly useful when important implementation uncertainties remain and cannot be adequately addressed through existing evidence.

Can stakeholder recommendations justify changing the study design?

They can identify reasons to reconsider a design, but changes require methodological evaluation and appropriate authorization. Feasibility improvements should not undermine the intended research question.

What are progression criteria in feasibility research?

They are prespecified considerations used to decide whether a proposed definitive study should proceed, proceed with modifications, or undergo substantial reconsideration. They should reflect the study's actual feasibility uncertainties.

Does successful feasibility testing guarantee that a larger study will work?

No. Feasibility findings provide evidence under particular conditions. Scaling up may introduce additional recruitment, staffing, technical, or organizational challenges.

09 · The Bottom Line

Assess Feasibility With the People Who Must Make the Study Work

The Bottom Line

Stakeholders should help assess study feasibility when their knowledge can identify barriers to recruitment, participation, intervention delivery, measurement, or institutional implementation. Their involvement can improve protocol decisions before costly or scientifically consequential problems emerge.

Combine stakeholder perspectives with empirical evidence, explicit feasibility criteria, and methodological review. A feasible protocol is not merely one that stakeholders support, but one that can reasonably be implemented while preserving the scientific and ethical requirements necessary to answer the research question.

10 · Sources and Further Reading

Foundational Research and Guidance on Study Feasibility and Stakeholder Involvement

11 · Cite this Guide

How to Cite This Guide

This guide is intended to be read, shared, and used in research, teaching, and academic work. If you draw on its ideas, explanations, or other content, please acknowledge the source by citing the guide. Doing so gives appropriate credit and helps your readers locate the original resource.

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