Ethics approval statement

An ethics approval statement is a manuscript-level disclosure, not the review process itself. The process of obtaining that approval — what triggers review, which of the three review pathways applies, how long it takes — is covered separately in IRB/REC Approval Process: What Needs Review and What Doesn’t. This entry defines the narrower, single-concept question: once approval has been granted, what does the sentence reporting it need to contain to actually function as evidence?

This is the same disclosure researchers variously call an ethics approval statement, ethical approval statement, IRB statement, or IRB approval statement — the label varies by publisher, journal, and country, but the underlying requirement (name of the reviewing body, a reference number, and a date) is identical. “IRB” (Institutional Review Board) is the US term; see ethical approval for how IRB, REC, REB, and HREC map to the same underlying role in different countries.

Where it appears

Most journals place it in the Methods section of the manuscript itself, and separately require it (often in more detail, including the reviewing body’s contact information) in a structured ‘Ethics declarations’ or ‘Declarations’ section, and again as a standalone field at submission. Some publishers also require the underlying approval letter or certificate to be uploaded as a confidential supporting document, even though only the summary statement is published.

What the statement has to contain

Author-instruction pages from major publishers (Wiley, SAGE, Elsevier, Springer Nature, among others) converge on the same three components as the minimum for the statement to be independently verifiable: the name of the approving ethics committee or institutional review board, an approval or protocol reference number, and the date of approval. Wiley’s own guidance states this directly: “The name of the approving ethics committee or institutional review board must also be included, along with any associated approval numbers.” The ICMJE’s Protection of Research Participants recommendations similarly require that authors seek approval from an independent local, regional, or national review body and separately require that, where informed consent was obtained, this is indicated in the published article — a related but distinct declaration from the ethics-approval statement itself (see informed consent).

Template wording by scenario

The three required components (reviewing body, reference number, date) stay the same across every outcome — what changes is how the statement names the outcome itself. Replace the bracketed placeholders with your institution’s actual committee name, protocol/reference number, and date; each of these can also be adapted for a REC, REB, or HREC outside the US.

1. Full review, approved (prospective, human subjects)

“This study was approved by the Institutional Review Board of [Institution] (Protocol No. [XXXX-XXXX]; approved [date]). All participants provided written informed consent before enrollment, in accordance with the Declaration of Helsinki.”

2. Exempt determination

“This study was reviewed by the [Institution] Institutional Review Board and determined to be exempt from further review under [applicable exemption category] (Exemption reference [XXXX-XXXX], determined [date]).”

3. Waiver of informed consent (not a full exemption)

“This study was approved by the [Institution] Institutional Review Board (Protocol No. [XXXX-XXXX]; approved [date]), which granted a waiver of informed consent under 45 CFR 46.116(f) for minimal-risk research using existing, de-identified records.”

4. Retrospective study design, approved before data collection began

“Ethical approval for this retrospective cohort study was obtained from the [Institution] Institutional Review Board (Reference [XXXX-XXXX]) prior to data extraction; the requirement for individual patient consent was waived given the use of de-identified administrative health data.” Note the distinction: the study design is retrospective, but the approval still has to predate the researchers accessing or extracting the data — see “Timing matters” below. A statement describing approval obtained only after data collection or analysis had already begun is not adequate, regardless of study design.

5. Determination that the study is not human subjects research (no formal review required)

“This study relied exclusively on publicly available, de-identified aggregate data and did not involve identifiable private information. The [Institution] Institutional Review Board determined that the activity did not meet the regulatory definition of human subjects research (Determination No. [XXXX-XXXX], [date]) and therefore did not require full board review.” A not-human-subjects-research (NHSR) determination is still a documented outcome of institutional review — it is not the same as never having submitted anything for review, and the statement should still name the reviewing body and cite the determination.

6. Animal research (IACUC)

“All procedures involving animals were approved by the [Institution] Institutional Animal Care and Use Committee (IACUC Protocol #[XX-XXX]; approved [date]) and were conducted in accordance with the institution’s guidelines for the care and use of laboratory animals.”

Approval, exemption, and waiver are all valid outcomes — silence is not

Not every study that goes through ethics review comes out with a full-board approval. A review body can determine a study is exempt from further review, or grant a waiver of a specific requirement (most commonly a waiver of informed consent for minimal-risk secondary analysis of existing de-identified data). A complete ethics approval statement names which of these three outcomes applied, and still identifies the reviewing body and a reference/determination number for that outcome — an exemption or waiver determination is not the same thing as “no ethics oversight was involved,” and shouldn’t be written as though it were.

Timing matters as much as content

A statement can name the right committee, include a real reference number, and still fail its actual purpose if the date shows approval came after the study was already underway or completed. Retrospective approval is generally treated by publishers as inadequate evidence that ethical oversight preceded the research — the statement exists to demonstrate prior authorization, not to document that a committee eventually reviewed what already happened.

Animal research and the Declaration of Helsinki

For research involving animals, the equivalent statement names the IACUC (US) or the applicable institutional animal-welfare body, with the same name/reference/date components. For human-subjects research, statements commonly cite compliance with the Declaration of Helsinki — the World Medical Association’s ethical framework for medical research involving human subjects, first adopted in 1964 and most recently revised in October 2024 (its eighth revision) — as the ethical standard the named committee’s review was conducted against, not as a substitute for naming the committee itself.

Frequently Asked Questions

What information does an ethics approval statement need to include?

At minimum, it needs to name the approving ethics committee or institutional review board, give the approval or protocol reference number, and state the date approval was granted. Major publishers’ author instructions converge on these same three elements as the baseline for a statement to be independently verifiable.

Is an ethics approval statement the same as the approval letter?

No. The statement is the short summary published in the manuscript itself, while the approval letter or certificate is the underlying document some publishers require to be uploaded separately as a confidential supporting file. Only the summary statement is published; the letter typically is not.

If my study was exempt or received a waiver, do I still need an ethics approval statement?

Yes. An exemption or a waiver — for example, a waiver of informed consent for minimal-risk secondary analysis of existing de-identified data — is still an outcome of ethics review, and the statement should name the reviewing body and give the relevant reference or determination number for that outcome. An exemption or waiver determination is not the same as no ethics oversight, and shouldn’t be written as though it were.

Does the ethics approval statement also need to cover informed consent?

They are related but distinct declarations. Ethics committee approval and informed consent are typically reported separately, with the ICMJE recommending that authors indicate in the published article whether informed consent was obtained, in addition to naming the body that approved the study.

Can ethics approval be granted after a study has already started?

Publishers generally do not accept approval dated after the study began, or after it was completed, as adequate evidence of ethical oversight. The statement exists to show that authorization came before the research started, not that a committee reviewed it retroactively.

Is an “IRB statement” the same thing as an “ethics approval statement”?

Yes. “IRB statement” and “IRB approval statement” are the US-specific names for the same manuscript disclosure covered on this page — IRB (Institutional Review Board) is simply the US term for the reviewing body. Outside the US, the equivalent bodies are called a REC, REB, or HREC (see ethical approval), but the statement itself needs the same three components regardless of which body approved the study.

What if my study didn’t need IRB or ethics committee review at all?

If a reviewing body formally determined that the activity did not meet the regulatory definition of human subjects research, that determination is itself a documented outcome and should still be named in the statement (see scenario 5 above), rather than omitting an ethics statement entirely. If no determination was ever sought or documented, say so plainly rather than writing a statement that implies review occurred when it didn’t — most journals will ask for the reasoning during editorial or peer review regardless.