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.
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.
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.
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.
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.