Do I Need Ethics Approval for My Research? A Practical Guide for Researchers

Does Your Research Need Ethics Approval?

You have a research question, a method, and perhaps even participants ready to recruit. Then comes a deceptively simple question: do you actually need ethics approval before you begin?

The answer is not determined by whether your study seems harmless, whether it is qualitative or quantitative, or whether you intend to publish it. Ethics requirements depend on what the project is, who or what it involves, what information or materials you will obtain, and the laws, regulations, institutional policies, and ethical guidelines that apply to your research.

This distinction matters because some projects require formal ethics review, some may qualify for an exemption or another form of determination, and some activities may fall outside a particular research-ethics framework altogether. Those categories should not be decided casually after data collection has already begun.

When Ethics Approval Is Likely to Be Required

How to Determine Whether Your Study Needs Ethics Review

Start With the Activity, Not the Label You Give the Project

Calling something a “survey,” “evaluation,” “class project,” “audit,” or “secondary analysis” does not by itself determine whether ethics review is required. What matters is what you are actually doing.

A useful first question is whether the activity qualifies as research under the rules that govern you. Definitions differ across jurisdictions, but research frameworks commonly distinguish systematic investigation intended to produce knowledge from activities performed primarily for another purpose, such as some routine service, administrative, quality-assurance, or public-health activities.

The boundary can become difficult when an activity has more than one purpose. A program evaluation, for example, may be conducted to improve a local service but also be designed to answer a broader research question. Rather than relying on the project's name, examine its objectives, design, intended use of the findings, and applicable institutional rules.

Does the Research Involve People?

Direct involvement of people is one of the clearest signals that ethics requirements need to be checked. This can include recruiting participants for experiments, surveys, interviews, focus groups, observations, behavioral tasks, educational interventions, clinical procedures, or other forms of interaction.

Importantly, research does not need to involve a drug, medical procedure, or physical intervention to raise ethical issues. Asking questions can expose participants to psychological, social, economic, reputational, legal, or privacy risks. This is why research with no physical intervention may still require ethics review.

Are You Using Private or Identifiable Information?

You can conduct human-participant research without ever meeting the people concerned. Existing medical records, educational records, personnel files, research databases, archived interview transcripts, identifiable photographs, and other datasets may contain information about living individuals.

Whether a particular secondary use requires ethics review depends on factors such as identifiability, how the information was obtained, the conditions under which researchers receive it, applicable privacy rules, and the relevant ethics framework. The fact that you did not collect the original data does not automatically remove the ethical question. The requirements for research using existing data therefore need to be assessed before analysis begins.

Are You Using Human Biological Materials?

Research involving human tissue, blood, DNA, stored specimens, or other biological materials may fall within research-ethics requirements even when researchers have no direct interaction with the individuals from whom those materials originated. Identifiability, how specimens were collected, consent arrangements, secondary-use provisions, and applicable regulations may all matter.

Different regulatory systems define the scope of human-subject or human-participant research differently, so a rule from one country should not simply be transplanted into another.

Low Risk Does Not Automatically Mean No Review

A common source of confusion is the relationship between risk and review. A study can present very little foreseeable risk and still fall within an ethics-review system.

Risk often affects the type or intensity of review rather than answering the threshold question by itself. Depending on the applicable framework, research might qualify for exemption, expedited review, limited review, or another pathway instead of full committee review.

This is why exempt, expedited, and full ethics review should not be treated as synonyms for “ethical,” “slightly risky,” and “dangerous.” They are review classifications defined by particular systems.

“Anonymous” Does Not Automatically Settle the Question

Suppose you create an online survey that asks no names, email addresses, student numbers, or other obvious identifiers. It may seem reasonable to conclude that ethics approval cannot be necessary because the responses are anonymous.

That conclusion is too quick. Ethics review can address more than confidentiality. Recruitment, voluntariness, consent, participant vulnerability, sensitive questions, data handling, potential harms, and the relationship between researcher and participant can also matter. Whether an anonymous survey requires ethics review therefore depends on the applicable rules and the design of the study.

Exemption Is Not Simply Another Word for “No Ethics”

Some ethics systems identify categories of research that may be exempt from specified review requirements. The exact categories and procedures are jurisdiction-specific.

For example, the U.S. Common Rule identifies categories of human-subject research that may qualify for exemption. In the Philippines, the 2022 National Ethical Guidelines for Research Involving Human Participants state that a Research Ethics Committee chair or representative determines exemption from review or the required type of review. The guidelines define “Exempt from Review” as a status reached after preliminary assessment and expressly describe it as a decision made by the Research Ethics Committee.

That distinction is practical as well as semantic. Researchers should not assume that believing a study fits an exemption is equivalent to having whatever exemption determination their institution, funder, regulator, or publisher may require. The specific authority that determines exemption should be checked before the project begins.

Publication Is Not the Test for Whether Ethics Review Is Required

A plan to publish can make ethics documentation particularly visible because journals may ask authors to report ethics approval, exemption, or the basis on which review was not required. But publication itself is not a universal test for whether a project is research requiring ethics review.

Conversely, saying “I don't plan to publish this” does not automatically remove ethical obligations. A study may require review because of its activities and participants regardless of whether its findings eventually appear in a journal.

Your Jurisdiction and Institution Matter

There is no single worldwide decision rule that can determine the ethics status of every project. National law, regulatory definitions, institutional policies, funding conditions, professional standards, research setting, and the nature of the participants may alter the answer.

For example, the revised implementing rules and regulations of the Philippine National Health Research System Act state that research involving human participants must undergo ethical review and clearance before implementation. The Philippine national guidelines then provide procedures through which a Research Ethics Committee determines whether a submitted protocol is exempt from review or requires expedited or full review.

In the United States, the Common Rule uses its own definitions of research and human subject and specifies categories of research exempt from particular requirements. Other regulatory regimes may apply different definitions or additional requirements.

So when someone says, “This kind of study doesn't need ethics approval,” an essential follow-up question is: under which rules?

Ethics Approval and Informed Consent Are Different Questions

Another common mix-up is to treat participant consent as a substitute for ethics approval. They serve different functions.

Informed consent concerns whether and how an individual voluntarily agrees to participate after receiving appropriate information. Ethics review considers the study more broadly, including matters such as scientific and social value, participant selection, risks and potential benefits, privacy, confidentiality, consent arrangements, safeguards for vulnerable participants, and researcher responsibilities.

A signed consent form therefore does not, by itself, make an otherwise reviewable study exempt from ethics oversight. Likewise, an ethics committee may under defined circumstances approve an alteration or waiver of consent. The two requirements are related, but they are not interchangeable.

What This Decision Looks Like in Practice

The important lesson is not that every student survey necessarily receives the same classification. It is that researchers should not infer the formal review status from one reassuring feature, such as “anonymous,” “online,” “just a questionnaire,” or “minimal risk.”

Common Mistakes When Deciding Whether Ethics Approval Is Needed

What to Do Before You Begin Your Study

The safest practical approach is not to ask, “Can I find a reason to avoid ethics review?” Ask instead, “Which rules apply to this project, and who is authorized to determine its status?”

You do not need to become an expert in every national ethics framework before starting a study. You do need enough information to recognize when a formal determination should be obtained.

If your project appears to fall outside ordinary review or within an exemption category, keep the formal determination or institutional documentation when one is issued. It may later be relevant to funders, collaborators, institutions, auditors, or journals.

And if you are wondering exactly what the committee will examine once you submit, understanding what an ethics committee reviews in a research study can make the submission process considerably less mysterious.

Before Deciding That You Do or Do Not Need Ethics Approval

Frequently Asked Questions About Research Ethics Approval

Determine the Requirement Before You Start

How to Cite This Guide

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