Ethics Approval Statement Generator
Write the ethics approval and consent statement for your methods section. Choose human participants, animals or an exempt study, enter the committee, approval number and date, pick how consent was obtained — written, electronic, oral, implied or waived — and copy the statement.
Its full name, as on the approval letter.
Consent
Your statement
Ethics statement
Ethics approval: This study was approved by [committee name]. The study was conducted in accordance with the Declaration of Helsinki.
Consent to participate: Written informed consent was obtained from all participants.
- Replace each bracketed placeholder before you submit.
- Name the committee in full. Nature Portfolio asks for the approving committee's name and reference number, and PLOS for the committee's name.
- Add the approval or protocol number — journals such as Nature Portfolio and PLOS ask for it.
How to Use the Ethics Approval Statement Generator
- 1. Choose the kind of study. Human participants (including their data or samples), animals, or a study for which approval was not required or that a committee declared exempt.
- 2. Enter the approval. Give the committee's full name as it appears on the approval letter, the reference or protocol number, and the date. For an exempt study, say who decided and why.
- 3. Describe consent. Pick written, electronic, oral, implied or waived consent. Oral and waived consent ask for the reason, which journals expect you to state. Tick the boxes for participants under 18 or for identifiable images.
- 4. Copy the statement. Paste it into your methods section or the journal's declarations, and replace any bracketed placeholder the notes point out.
What an Ethics Statement Must Include
Human participants. Nature Portfolio requires research with human participants to have been carried out in accordance with the Declaration of Helsinki, the manuscript to name the approving ethics committee with its reference number — or the committee that granted an exemption — and a statement that informed consent was obtained. PLOS asks for the name of the approving institutional review board or equivalent and whether consent was written or oral, and wants the ethics statement in the Methods section.
Animals. Journals ask which institutional or licensing committee approved the experiments; PLOS asks for its full name and the permit numbers. Nature Portfolio recommends the ARRIVE guidelines 2.0 for reporting, and ARRIVE's own ethical statement item asks for the name of the ethical review body, the relevant license or protocol numbers, and — if no approval was obtained — an explanation.
The committee's name differs by country and field: an Institutional Review Board (IRB) or Research Ethics Committee (REC) for human research, an Institutional Animal Care and Use Committee (IACUC) in the United States or an Animal Welfare and Ethical Review Body (AWERB) in the United Kingdom for animal work. Use the name on your letter. The Declaration of Helsinki itself is the World Medical Association's statement of ethical principles for medical research involving human participants; its latest revision was adopted at the 75th WMA General Assembly in Helsinki in October 2024.
| Consent | What the statement should say |
|---|---|
| Written | That written informed consent was obtained from all participants. |
| Electronic | That participants gave consent electronically — an online form, for example — before taking part. The Declaration of Helsinki accepts consent documented on paper or electronically. |
| Oral | Why written consent was not used, that the committee approved oral consent, and how it was documented. Where consent cannot be given on paper or electronically, the Declaration of Helsinki requires it to be formally witnessed and documented. |
| Implied | That participants consented by completing an anonymous questionnaire after reading the study information — an approach used for anonymous surveys where the committee allows it. |
| Waived | Which committee waived the requirement and why — for example, that the study used de-identified records collected for routine care. |
Example Statement
Try an example loads an illustrative psychology study approved by a university research ethics committee, with written consent. The generator writes:
Ethics approval
This study was approved by the University of Eastbrook School of Psychology Research Ethics Committee on March 5, 2024 (reference number PSY-2024-117). The study was conducted in accordance with the Declaration of Helsinki.
Consent to participate
Written informed consent was obtained from all participants.
For an animal study the same fields produce "All procedures involving animals were approved by…" with a protocol number, followed by the regulations you followed and a sentence on ARRIVE reporting.
Common Mistakes
- Writing "ethical approval was obtained" and stopping. Name the committee and give the reference number; editors and readers need to be able to trace the approval.
- Declaring your own study exempt. An exemption is a committee's decision. Say which committee or office made it, as Nature Portfolio asks.
- Getting the order wrong. Approval comes before the research begins — the Declaration of Helsinki requires the protocol to go to a research ethics committee for approval first.
- Confusing the two consents. Consent to take part in a study is not consent to publish a photograph or a detailed case description. Tick the identifiable-images box when the article includes them.
- Citing the Declaration of Helsinki for animal work. It concerns research involving human participants. Animal studies cite the animal-welfare regulations that applied and, for reporting, ARRIVE.
Frequently Asked Questions
- What is an ethics approval statement?
- A short statement in a research article saying which ethics committee approved the study, with its reference number, and how informed consent was obtained. Journals use it to confirm that research with people or animals was reviewed before it began.
- What should an ethics statement include?
- The full name of the approving committee, the approval or protocol number, ideally the date, the guidelines followed — such as the Declaration of Helsinki — and how consent was obtained or why it was waived. For animal studies, add the regulations followed and, if your journal asks, ARRIVE reporting.
- What do I write if my study did not need ethics approval?
- Say why, and who decided. For example: "Ethical approval was not required for this study because it analyzed only publicly available, anonymized data, as confirmed by the Eastbrook Research Ethics Office." Choose Approval not required, or exempt to build it.
- Do I need informed consent for an anonymous survey?
- Your ethics committee decides. Many accept implied consent for a low-risk anonymous questionnaire — taking part after reading the information sheet counts as consent — while others require an explicit tick box. State whichever your committee approved.
- Is the Declaration of Helsinki still current?
- Yes. The World Medical Association adopted it in 1964 and has revised it many times; the most recent revision was adopted at its 75th General Assembly in Helsinki in October 2024. Citing "the Declaration of Helsinki" refers to the current version unless you name an earlier one.
- Where does the ethics statement go in a paper?
- Usually in the Methods section — PLOS asks for it there — or in a declarations section at the end, depending on the journal. Some journals also ask for the approval letter at submission.