Does Quality Improvement, Audit, or Program Evaluation Need Research Ethics Approval?

When Is Improvement or Evaluation Actually Research?

A hospital monitors infection rates after introducing a new procedure. A university evaluates a student-support program. A department audits compliance with institutional policy. A government office measures whether a public service is reaching its intended population.

These activities can look remarkably similar to research. They may have objectives, datasets, sampling strategies, statistical analyses, questionnaires, interviews, and formal reports. So when do quality improvement, audit, or program evaluation require research ethics approval?

Not Every QI, Audit, or Evaluation Project Is Research

How to Distinguish Research From QI, Audit, and Program Evaluation

What Is Quality Improvement?

Quality improvement, commonly shortened to QI, generally seeks to improve the performance, safety, effectiveness, efficiency, or quality of an existing service or practice within a particular setting.

A hospital might monitor medication errors and introduce a checklist to reduce them. A university might redesign an advising process after reviewing student waiting times. A laboratory might measure reporting delays and modify its workflow.

Under U.S. OHRP guidance, activities limited to implementing an accepted practice and collecting patient or provider data for clinical, practical, or administrative purposes such as improving care generally do not satisfy the Common Rule definition of research. OHRP emphasizes, however, that some QI activities can also be research when they are designed to accomplish a research purpose.

What Is an Audit?

An audit typically examines current practice against an established standard, criterion, policy, benchmark, or expectation.

The central question is often some version of: Are we doing what we are supposed to be doing?

A clinical audit might compare actual hand-hygiene compliance with an established institutional standard. An academic audit might examine whether required documentation is completed according to university policy.

Audits can involve systematic data collection and analysis without necessarily being designed as research. Again, however, terminology varies across sectors and jurisdictions, so the label alone should not determine ethics status.

What Is Program Evaluation?

Program evaluation generally examines how a particular program is implemented, whether it achieves its objectives, how participants experience it, what resources it uses, or how it could be improved.

Questions might include whether a university mentoring program reaches its intended students, whether a public-health campaign is being implemented as planned, or whether a community service achieves specified local outcomes.

Program evaluation can be rigorous, systematic, quantitative, qualitative, or mixed-methods. Methodological sophistication does not automatically transform evaluation into research.

These Activities Can Look Almost Identical to Research

This is where researchers get into trouble. A QI project can use statistical testing. An audit can analyze hundreds of records. A program evaluation can use validated questionnaires, interviews, focus groups, comparison groups, and regression models.

Research methods are tools. Using them does not, by itself, establish the regulatory purpose of the activity.

Purpose Is Central, but Purpose Is Not Always Simple

Under the U.S. Common Rule, research is a systematic investigation designed to develop or contribute to generalizable knowledge. OHRP therefore distinguishes many ordinary QI activities from research based largely on what the activity is designed to accomplish.

A hospital collecting its own infection-rate data solely to identify local problems and improve current practice may be conducting QI. A systematic project designed simultaneously to test a novel infection-control strategy and generate evidence about its effectiveness beyond the institution may also contain a research purpose.

The categories are therefore not mutually exclusive.

A Project Can Be Both Quality Improvement and Research

This point deserves emphasis. Researchers sometimes assume that if a project has a legitimate improvement purpose, it cannot also be research.

OHRP explicitly rejects that assumption. Its guidance states that some quality-improvement activities are designed both to improve care and to accomplish a research purpose. When the research component involves human subjects and is not exempt, the human-subject protection regulations can apply to that component.

Calling a protocol “Quality Improvement Project” on the cover page does not settle the matter.

Publication Does Not Automatically Turn QI Into Research

Publication is another tempting shortcut. Researchers may assume that QI becomes research as soon as someone plans to publish the results.

OHRP explicitly states that intent to publish is insufficient to determine whether a QI activity meets the regulatory definition of research. People publish useful descriptions of nonresearch improvement activities, while some genuine research is never published.

Publication intention can provide contextual evidence about the project's goals, but it should not replace examination of how the project was designed.

Generalizability Is More Than “Someone Else Might Find This Useful”

The phrase generalizable knowledge can also be misunderstood. Almost any successful improvement project might teach someone elsewhere something useful. That does not necessarily mean the project was designed as research.

Under OHRP's approach, the focus is on what the systematic investigation was designed to accomplish. An activity intended to solve a local operational problem does not automatically become research because another institution might later learn from it.

Conversely, a project designed from the outset to test a hypothesis or produce evidence intended to answer a broader scientific question can constitute research even if it occurs at only one institution.

The Philippine Framework Recognizes Some QI and Evaluation Activities as Potentially Exempt

The 2022 Philippine National Ethical Guidelines identify specified institutional quality-assurance activities, evaluation of public-service programs, public-health surveillance, and certain educational evaluation activities among protocols that may be considered for exemption when the applicable conditions are satisfied and the activities involve no more than minimal risks or harms.

This is an important nuance. Under that framework, some activities described as quality assurance or evaluation can enter an REC exemption-determination process rather than simply being assumed to exist outside research ethics altogether.

Researchers working in the Philippines should therefore follow the national and institutional process applicable to their project rather than importing a U.S. research-versus-QI distinction as though it were a universal rule.

Risk Still Matters Even When an Activity Is Not Research

A determination that an activity is not research under a particular research-ethics regulation does not mean the activity has no ethical responsibilities.

QI, audit, and evaluation can involve sensitive records, intrusive questionnaires, surveillance, employee performance data, patient information, or changes to services that affect people. Privacy law, professional duties, institutional governance, data-protection requirements, informed communication, and ordinary ethical responsibilities may still apply.

Routine Data Collection Can Become Research Data

A hospital may legitimately collect outcome information for ordinary service monitoring. A university may collect student feedback for program improvement. Those records can later become attractive research datasets.

If researchers subsequently propose a new systematic analysis for research purposes, that secondary use may require a separate ethics assessment even though the original data collection was operational.

The same principle applies to existing data collected for another purpose.

Adding a Research Component Can Change the Project

Suppose a hospital introduces an accepted checklist to improve local practice and monitors routine outcomes. That may be ordinary QI. Researchers then add random assignment of clinical units, additional questionnaires administered only for the study, and a hypothesis-driven comparison designed to determine the checklist's causal effect.

The project now contains features that may constitute research even though improvement remains one of its purposes.

What happens when a project begins as evaluation but later develops a research purpose should therefore be addressed before the new research activities begin.

Novel Interventions Deserve Particular Attention

QI often involves changing practice. That does not automatically make every change research, but introducing an untested intervention primarily to evaluate its effects can move the activity closer to a research design.

OHRP guidance distinguishes implementing a practice to improve care from testing an intervention to establish scientific evidence about its effectiveness. The boundary can become difficult when both objectives exist.

When the distinction is genuinely uncertain, an institutional determination is more defensible than a convenient project label.

Randomization Is a Strong Signal to Look More Closely, Not an Automatic Definition

Randomization, control groups, prospective hypotheses, research-specific data collection, and formal comparison across sites can all suggest a research purpose. None should be used as a universal one-factor test, but together they may indicate that a project is doing more than routine local improvement.

Likewise, absence of randomization does not establish that a project is nonresearch. Observational research can be research too.

Who Benefits From the Activity Can Help Clarify Its Purpose

QI and evaluation commonly aim to benefit the service, program, institution, or population being evaluated directly. Research often seeks knowledge whose relevance extends beyond the immediate operational decision.

This distinction can be useful, but it is not absolute. Research can benefit the local institution, and evaluation findings can have value elsewhere. Purpose should be assessed from the complete design rather than a single indicator.

Do Not Ask Only “Is This Research?”

A more useful sequence is:

• What is the activity designed to accomplish?
• Does it meet the applicable definition of research?
• If it is research, does it involve human participants or covered information?
• If so, does an exemption apply?
• What other governance requirements apply even if it is not research?

This mirrors the logic used in formal human-research determination rather than forcing every activity into a simple research versus nonresearch box.

When a Hospital Improvement Project Also Becomes Research

The label “QI” did not become false. The project acquired another purpose. Ethical classification should follow what the project actually does rather than forcing it into one administrative box.

Common Misunderstandings About QI, Audit, and Evaluation

Classify the Purpose Before Choosing the Ethics Pathway

When a project sits near the boundary between operations and research, describe it concretely. Avoid beginning with “This is QI” or “This is research.” Start with what you will actually do and why.

The goal is not to force every improvement project through a research-review process. It is to prevent genuine research from bypassing prospective review simply because it shares a practical improvement objective.

Before Calling a Project QI, Audit, or Evaluation

Frequently Asked Questions About QI, Audit, Evaluation, and Ethics Review

Purpose and Design Matter More Than the Project Label

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