An editor cannot verify ethical oversight from a vague sentence. A statement that gets accepted names the committee, the decision, and how consent was handled.
Why editors stop at this paragraph
The ethics approval statement is usually two or three sentences, and a vague one is an easy reason for an editorial office to send a submission back before review.
Editors are not re-running your ethics review. They are checking that your statement lets them confirm one happened. The ICMJE Recommendations ask authors to seek approval from an independent local, regional or national review body and to be prepared to provide documentation when editors request it. They also note that a review body's approval does not stop editors forming their own judgment about whether the research was conducted appropriately.
So test your draft. Could an editor who has never heard of your institution identify the committee, trace its decision, and see how consent was handled, without emailing you? If not, expect a query. Our first manuscript submission checklist shows where this statement fits alongside your funding, conflicts and data statements.
The five details a complete statement needs
- The committee's full name and institution. "The local ethics committee" or "our IRB" identifies nothing. Write the name exactly as it appears on the approval letter, with the university, hospital or health authority it belongs to.
- The approval or reference number. Copy it from the letter, not from memory. If the committee did not issue a number, say so and give the decision date, so the editor does not assume you left it out.
- The date of the decision. Next to your recruitment or data collection period, it shows that approval came first. If the protocol was later amended, for example to add a site or an outcome, cite the amendment approval too. The Declaration of Helsinki states that no amendment to the protocol may be made without the committee's consideration and approval.
- How consent was handled. Written, oral, electronic, or waived. If it was waived, say which committee waived it and why.
- The ethical standard followed. ICMJE expects human research to be planned, conducted and reported in accordance with the Declaration of Helsinki, most recently revised in October 2024. If the journal asks you to cite a revision, use the one named in your approved protocol.
Put the statement where the journal's instructions say. ICMJE places it in the Methods. If the journal also has a declarations section or a submission form field for ethics, make every version match word for word. Three slightly different versions invite a query about which one is correct.
Wording to adapt
Replace every bracket with the exact detail from your approval letter. Do not add adjectives such as "strict" or "rigorous"; they carry no information.
Prospective study with written consent
This study was approved by the [full committee name], [institution] (approval number [number], [date]). All participants gave written informed consent before taking part. The study was conducted in accordance with the Declaration of Helsinki.
Approved study with a consent waiver
The [full committee name], [institution], approved this study (reference [number], [date]) and waived the requirement for individual informed consent because [reason given in the approval, for example that the study used existing records and obtaining consent was impracticable].
Animal research
All procedures were approved by the [committee name], [institution] (protocol [number]) and were carried out under [licence or national regulation].
For animal studies, item 14 of the ARRIVE guidelines asks for the name of the ethical review committee or equivalent, any relevant licence or protocol numbers, and a justification if ethical approval was not sought or granted.
Exempt, waived, or not research: say which, and who decided
These are three different outcomes, and statements that blur them are the ones that get queried.
| Situation | What it means | What to write |
|---|---|---|
| Exempt from review | A committee or authorised office decided the study did not need full review | Who decided, the reference number, and the category or reason |
| Consent waived | A committee reviewed and approved the study without individual consent | The approval details, plus who waived consent and why |
| Not research | The activity was classed as audit, service evaluation or similar under local rules | Who made that classification and on what basis |
The weakest version is "Ethical approval was not required for this study." It hands the editor a conclusion with no authority and no reason attached.
Who decided matters. In the US, the Common Rule lists exemption categories at 45 CFR 46.104(d), and the regulations do not specify who at an institution makes the determination. The Office for Human Research Protections recommends, because of the potential for conflict of interest, that investigators not be given the authority to make an independent determination that their own research is exempt. An exemption issued by your IRB office, with a category and a reference, is what you want to cite:
The [institution] Institutional Review Board determined that this study was exempt under [category, for example 45 CFR 46.104(d)(4)] (determination [number], [date]).
In the UK, the Health Research Authority's online tool "Do I need NHS REC review?" answers only that question. When it says you do not need NHS REC review, it adds that you may still need another type of ethics review, such as from a university committee. Check your institution's policy and cite what it decided.
Retrospective chart reviews and other secondary data
Retrospective studies invite the assumption that no ethics review is needed because nobody was recruited. The records still came from patients.
The Declaration of Helsinki says that where consent is impossible or impracticable to obtain, secondary research on stored data or biological material may be done only after a research ethics committee has considered and approved it. National rules may route the study to an exemption instead. The US Common Rule exempts some secondary research uses of identifiable private information, for example where the investigator records information so that subjects cannot readily be identified, does not contact them, and will not re-identify them. Either way, someone with authority decides, and they decide before you extract data.
A chart review statement should cover four things:
- the source of the records and the date range
- whether the research team could identify patients from the data
- which committee approved or exempted the study, with its reference
- whether consent was waived, and by whom
This retrospective review of medical records from [hospital, date range] was approved by the [committee name] (reference [number], [date]), which waived the requirement for individual informed consent because [reason]. [Describe how the data were de-identified and who had access to identifiers.]
Multi-site and international studies
The editor's question is whether every site that recruited participants or supplied data had ethical oversight. How that was arranged depends on where the sites are.
- US cooperative research. Under the revised Common Rule, a US institution engaged in cooperative research covered by the policy must rely on a single IRB for the US portion, unless law requires more than one review or the supporting federal agency documents that a single IRB is not appropriate.
- NHS research in the UK. Studies that need NHS REC review receive a single UK-wide ethical opinion instead of a separate review at each site.
- International collaborations. The Declaration of Helsinki says that when collaborative research is performed internationally, the protocol must be approved by research ethics committees in both the sponsoring and host countries.
- Everywhere else. Requirements differ by country and sometimes by institution. Ask each site lead what their local rules require before recruitment starts, not when the journal asks.
In the statement, name the committee whose approval covered each site. If one committee acted for several sites, say so and describe the reliance arrangement. If many committees were involved, list them in a supplementary table and point to it.
The study was approved by the [lead committee], [institution] (reference [number]), which served as the single IRB for all US sites under reliance agreements. The [committee name], [country], approved the study for the [site name] site (reference [number]). All approving committees are listed in Supplementary Table [X].
When approval came late
The Declaration of Helsinki says the protocol must be submitted to the research ethics committee for consideration and approval before the research begins. Journals apply that at submission: BMC's editorial policies, for example, state that retrospective ethics approval usually cannot be obtained for a study that started without approval, and that whether such a manuscript goes to peer review is at the editor's discretion.
If this is your situation:
- Stop collecting data and contact your institution's research ethics or integrity office.
- Do not describe a later letter as prior approval, and do not blur the dates.
- Tell the editor plainly at submission what was approved, when, and what happened before that.
- Expect that some journals will decline the paper. That is far less damaging than a problem found after publication.
If you supervise students, confirming approval before a single record is opened is part of the research integrity responsibilities of a lab lead.
Consent to publish is a separate statement
Consent to take part in a study is not consent to publish details that could identify someone. ICMJE says identifying information such as names, initials or hospital numbers should not be published in written descriptions, photographs or pedigrees unless it is essential for scientific purposes and the patient, or a parent or guardian, gives written informed consent for publication. That consent requires the patient to be shown the manuscript. ICMJE also notes that masking the eye region in patient photographs is inadequate protection of anonymity.
Written informed consent for publication of [these details or images] was obtained from [the patient / the patient's parent or guardian], who was shown the manuscript before submission.
Why statements get sent back
| The statement says | What the editor needs | Fix |
|---|---|---|
| "Approved by the institutional ethics committee" | Which committee | Full committee name and institution |
| No reference number | A traceable decision | The number, or "no reference number was issued" plus the date |
| "Ethics approval was not required" | Authority and reason | Who decided, the category, and the reference |
| "Informed consent was obtained" in a records study | Consistency | State the waiver and who granted it |
| Approval dated after data collection began | Evidence of prior oversight | Explain honestly and tell the editor |
| Different wording in Methods, declarations and form | One version | Paste the same text everywhere |
Before you submit
- Committee name matches the approval letter exactly
- Reference number and date copied from the letter
- Approval date comes before recruitment or data extraction
- Amendment approvals covering the reported work are cited
- Consent type stated, and any waiver attributed to the committee that granted it
- Any exemption names who decided and why
- Every approving committee for every site is named or listed in a supplement
- Written consent for publication held for any identifiable patient detail
- Approval letters saved where you can send them the day an editor asks
- Identical wording in the Methods, declarations and submission form
If you find a wrong reference number or a missing statement after publication, ask the journal for a correction as soon as you notice; our guide to correcting the published record explains the process.
Directive Publications brings its author guidelines and its research ethics and integrity pages together on the For Authors page. Read the ethics requirements there with your approval letter open beside you, and draft the statement from the letter itself.
Frequently asked questions
What details should an ethics statement in a research paper include?
Give the full name of the ethics committee or review board and its institution, the approval or reference number, and the date of the decision. Then say how consent was handled: written, oral, electronic, or waived, and if it was waived, which committee waived it and why. Add any further statement the journal asks for, such as conduct in accordance with the Declaration of Helsinki.
Do retrospective chart reviews need ethics committee approval?
Usually they need some form of review, because they use patient information for research, although the outcome may be an exemption or a consent waiver rather than full approval. The Declaration of Helsinki says that where consent is impossible or impracticable to obtain, secondary research on stored data may be done only after a research ethics committee has considered and approved it. Rules differ by country and institution, so ask your committee or research office before you extract any data.
How do I word the statement if my study was exempt from ethics review?
Say who made the exemption decision, name the committee or office, give any reference number and date, and state the reason or the regulatory category used. A sentence such as the committee reviewed the protocol and determined it exempt under a named category, with a reference number, is checkable. A sentence saying only that ethics approval was not required is not, and editors are likely to query it.
Does a multi-site study need approval from every participating institution?
It depends on where the sites are. US institutions in cooperative research covered by the Common Rule generally rely on a single IRB for the US portion, NHS research in the UK receives a single UK-wide ethics opinion, and other countries set their own rules. For international collaborations, the Declaration of Helsinki expects approval in both the sponsoring and host countries. In the paper, name every committee that approved the study, or the lead committee and how the other sites relied on it.
Can ethics approval be obtained after data collection has started?
Generally no. The Declaration of Helsinki requires the protocol to be submitted to a research ethics committee before the research begins, and some publishers state that retrospective approval usually cannot be obtained and that such manuscripts may not be sent for review. If this has happened, speak to your institution's research ethics office and tell the journal editor plainly, rather than presenting a later letter as prior approval.