Two questions decide whether an editor trusts your study before they have judged its results: did the right body approve it, and did the people in it agree to take part? Ethics approval and informed consent are not paperwork to bolt on at submission — they are the foundation that makes human and animal research publishable at all. Get them right, and say so clearly, and you remove one of the most common reasons manuscripts are sent straight back.
What needs ethics approval
If your study involves any of the following, it almost certainly needs review by a research ethics committee (also called an Institutional Review Board, or IRB) before the research begins:
- People — through interventions, samples, questionnaires or interviews.
- Identifiable human data or tissue, including existing records and biobank samples.
- Animals.
Approval must come before data collection. An ethics committee cannot retroactively bless a study that already ran without it — and editors know this, which is why a mismatch between your study dates and your approval date is a red flag.
Which approval route fits your study
| Study | What you usually need | What to report |
|---|---|---|
| Prospective study with participants | Committee approval before recruitment, plus written informed consent | Committee name, reference number, consent statement |
| Retrospective chart review | Committee approval, or a documented waiver from the committee | Committee name, reference number, whether consent was waived and why |
| Single case report | Often no full review, but always written consent for publication from the patient or their representative | Consent-for-publication statement |
| Clinical audit or service evaluation | Local rules differ; the decision that it is not research should come from your institution, in writing | Who made that decision, and its reference |
Rules differ by country; the committee that covers your site decides, not the authors.
Informed consent
Consent means participants understood what the study involved and agreed freely, without pressure. For most human research this is written informed consent. Two points trip authors up. First, consent to take part in a study is not the same as consent to publish identifiable details — case reports and any identifiable images need explicit consent for publication. Second, if participants cannot consent for themselves (children, or adults lacking capacity), consent comes from a parent or legal representative, and you should say so.
Keep three things apart, because editors check each separately: consent to treatment (clinical care), ethics approval (given to the study by a committee) and consent for publication. A patient who agreed to surgery has not agreed to appear in print. Our guide to patient consent for case reports and clinical photographs covers the publication form in detail.
A child or an adult without capacity may still be able to agree or refuse. The Declaration of Helsinki asks researchers to seek that assent as well as the representative's consent. If you obtained assent, report it.
The Declaration of Helsinki
Research involving people is expected to follow the World Medical Association's Declaration of Helsinki, the accepted statement of ethical principles for medical research on human participants. You do not need to reproduce it — you need to comply with it and state that you did.
Trials also need registration
The International Committee of Medical Journal Editors (ICMJE) treats any study that prospectively assigns people to an intervention to evaluate a health outcome as a clinical trial, randomised or not. ICMJE expects such trials to be registered in a public registry at or before the time of first patient enrolment. Acceptable registries are a WHO ICTRP primary registry or ClinicalTrials.gov. Ethics approval does not replace registration, so report both. The details are in our guide to clinical trial registration.
What to write in your methods
Editors are looking for a short, specific statement. Adapt one of these to your study:
Interventional / human study: "This study was approved by the [Name] Research Ethics Committee (approval no. XXXX) and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants."
Retrospective / records-based: "The [Name] Ethics Committee reviewed the study and granted a waiver of consent (ref. XXXX) given the retrospective use of anonymised records."
Case report: "Written informed consent for publication of this case and any accompanying images was obtained from the patient."
Name the committee, give the reference number, and name the consent you obtained. Vague phrases like "ethical standards were followed" invite exactly the follow-up questions you were trying to avoid.
Check your ethics statement before you submit
- The reference number matches the approval letter exactly.
- The approval date precedes the data-collection start in your methods.
- Every recruiting site is covered by its own approval or one its committee accepts.
- The type of consent is stated: written, waived (with the reason), or given by a parent or representative.
- For a case report or any identifiable image, consent for publication is stated separately.
- For a trial, the registry name and number appear.
- Any change to the protocol after approval was approved as an amendment.
Common errors and their fixes
| Error | Fix |
|---|---|
| "Ethical approval was not required", with no reason | Say who decided that and cite their written decision |
| Approval dated after recruitment began | Do not alter any date; disclose the sequence to the editor, who decides |
| "Anonymised data" given as the reason for no review | Ask the committee for a waiver or exemption decision in writing |
The special cases
- Case reports — often exempt from full committee approval, but always require written consent for publication.
- Retrospective studies — usually need approval or a documented waiver; do not assume "existing data" means "no ethics".
- Animal research — needs institutional animal-care approval and should be reported following the ARRIVE guidelines.
- Surveys and interviews — still involve human participants; anonymity does not automatically remove the need for approval.
When you are unsure, ask your institution's ethics committee early — long before submission. It is the one part of a study that cannot be fixed after the fact, and the one editors will not compromise on.
Updated 17 September 2026: We expanded this guide with an approval-route table, the three kinds of consent, trial registration, a pre-submission checklist and common errors.