Ethical Approval

Ethical approval (also called ethics approval) is the umbrella term for the prospective authorization a research ethics body grants before a study involving human participants may start recruiting or collecting data. It is a single underlying requirement — independent, prior review of a study’s risks, benefits, and consent arrangements — implemented under different national names and regulatory frameworks. A researcher who asks ‘do I need ethical approval for this?’ is asking about the general requirement described on this page; a researcher who asks ‘what is an IRB’ or ‘what is an REC’ is asking about one specific national committee that grants it (see the cross-links below).

Why ethical approval exists

The requirement traces to the same historical and ethical foundations across jurisdictions: research abuses that predate formal oversight (documented in instruments such as the Nuremberg Code and the case history of the Tuskegee syphilis study) led to the principle that a study should not proceed on the strength of the investigator’s own judgment alone. In the US, the Belmont Report (1979) set out the three governing principles — respect for persons, beneficence, and justice — that the US Common Rule (45 CFR 46) and the FDA’s human-subjects regulations (21 CFR 50/56) still codify today. Internationally, the World Medical Association’s Declaration of Helsinki and the ICH E6 Good Clinical Practice guideline articulate closely related principles for clinical research specifically. Ethical approval is the operational mechanism by which those principles are actually checked, case by case, before a study starts.

What granting ethical approval actually decides

A committee reviewing a protocol is deciding, at minimum, whether: the anticipated risks to participants are reasonable relative to the anticipated benefits (to participants and to knowledge generally); the process for obtaining informed consent is adequate and understandable; participant selection is equitable, including any protections needed for vulnerable groups; and privacy and confidentiality safeguards for participant data are adequate. Depending on the level of risk, the review pathway may be exempt, expedited, or full-board — CASRAI’s guide on the IRB/REC approval process covers which pathway applies and what triggers each one in more detail than fits here.

Who grants it: the same function, four national names

None of the following bodies are interchangeable as a matter of law — approval from one does not substitute for approval from another, even for a single multi-site study spanning more than one country:

• United States: the IRB (Institutional Review Board), operating under the Common Rule (45 CFR 46) and, for FDA-regulated research, 21 CFR 56.
• United Kingdom / much of the EU: the REC (Research Ethics Committee), most visibly the NHS Health Research Authority’s Research Ethics Service in the UK.
• Canada: the REB (Research Ethics Board), operating under the Tri-Council Policy Statement (TCPS2).
• Australia: the HREC (Human Research Ethics Committee), operating under the NHMRC’s National Statement on Ethical Conduct in Human Research.

A study recruiting participants at sites in more than one of these jurisdictions typically needs a separate, valid approval in each — a common point of delay in multi-national protocols that research administrators plan for well ahead of the target recruitment date.

Ethical approval vs. ethical oversight

The two phrases are often used loosely as synonyms, but they describe different points in a study’s life. Ethical approval is the point-in-time authorization granted before a study begins. Ethical oversight is the broader, ongoing function that continues for the life of the study — the same committee’s continuing review of amendments, adverse events, and periodic renewal, plus the institution’s wider compliance infrastructure (research integrity offices, monitoring, audit). A study can have received ethical approval at the outset and still fall out of compliance with its ongoing ethical oversight obligations if, for example, it fails to report a protocol deviation. In practice, most day-to-day usage of ‘ethical oversight’ online is really referring to this same approval-and-monitoring system as a whole rather than a separate mechanism.

What ethical approval does not cover

Ethical approval from a human-research ethics body is a distinct requirement from several adjacent approvals a study may also need: animal research goes through a separate committee (an IACUC in the US, or equivalent), institutional biosafety review covers work with biohazardous materials or agents, and data-sharing or data-transfer agreements govern how data may move between institutions after collection. A study can hold valid ethical approval and still be blocked from proceeding by a missing biosafety sign-off or data agreement — they are parallel, not nested, requirements.

When ethical approval is not required

Not all research involving people requires this review. Common exclusions (subject to the specific regulatory text in each jurisdiction) include analysis limited to existing, publicly available, de-identified data; internal quality-improvement activity not intended to produce generalizable knowledge; and certain low-risk survey or observational designs that qualify for exemption. ‘Exempt’ is a formal determination made by the reviewing body itself, not something a researcher may decide unilaterally — the correct first step is always to ask the local IRB, REC, REB, or HREC, not to assume exemption applies.

Worked example

A university-based researcher planning semi-structured interviews with adult patients about their care experience must submit a protocol, consent materials, and a recruitment plan to their institution’s IRB (or REC/REB/HREC, depending on country) and receive approval before contacting a single prospective participant. If the same researcher later adds a second recruitment site in another country, that site’s own ethics body must separately approve the study before recruitment can begin there.

Counter-example

A researcher conducting a secondary analysis of a fully public, de-identified government dataset — with no new contact with individuals and no realistic path to re-identification — will often not need new ethical approval, but that determination should still come from the relevant ethics body’s exemption process, not from the researcher’s own judgment.