An ethics approval statement is the paragraph in a paper or thesis that names the committee that approved your study, the reference number, and how participants consented. Below are wordings for 10 study types you can copy and adapt, an IRB submission checklist on risk, consent and data protection, and a way to draft the application itself.
What every ethics approval statement includes
Whatever the study type, a reviewer or journal editor looks for the same five facts. Missing any of them is a common reason for a query before review.
| Element | Example | Notes |
|---|---|---|
| Committee name | [University] Research Ethics Committee | Use the committee's full name, not "the IRB" |
| Reference number | Ref. [ABC-2026-041] | Some journals ask you to blind it for review |
| Date of approval | [12 March 2026] | Before data collection started |
| Consent | Written, verbal, online or waived, and by whom | For minors: parental consent and child assent |
| Standard followed | Declaration of Helsinki, local law, ARRIVE | Medical research usually cites Helsinki [1] |
Ethics approval statement wordings by study type
Replace everything in square brackets. Keep the wording factual; the statement records what happened, so write it in the past tense.
1. Human participants, full approval, written consent
This study was approved by the [committee name], [institution] (reference [number], [date]). All participants gave written informed consent before taking part.
2. Exempt determination (US)
The [institution] Institutional Review Board reviewed this study and determined it exempt under 45 CFR 46.104(d)([category]) (protocol [number], [date]). Participants received an information sheet and consented by [method].
The exempt categories are set out in the US Common Rule [2].
3. Medical records, consent waived
This retrospective study of de-identified records was approved by the [committee] (reference [number]), which waived the requirement for individual consent because [reason, e.g. the data were anonymized before the researchers received them]. The study followed the Declaration of Helsinki.
4. Anonymous online survey
The [committee] approved this study (reference [number]). Participants read an information page and indicated consent by selecting "I agree" before starting the anonymous survey. No identifying data were collected.
5. Children or young people
The study was approved by the [committee] (reference [number]). Parents or guardians gave written informed consent, and each child gave assent in age-appropriate language before taking part. [School or organization] gave permission for recruitment.
6. Interviews and focus groups
Ethical approval was granted by the [committee] (reference [number], [date]). Participants gave written consent, including consent to audio recording. Recordings were deleted after transcription, and transcripts were pseudonymized.
7. Clinical trial
The trial was approved by [committee(s)] (reference [number]) and registered at [registry] ([registration number]) on [date], before the first participant gave consent. All participants gave written informed consent. The trial was conducted in accordance with the Declaration of Helsinki.
Journals that follow ICMJE recommendations require trial registration at or before the first participant's consent [3].
8. Public or secondary data, no approval needed
This study used publicly available, de-identified data from [source]. The [institution] research ethics office confirmed on [date] that ethical approval was not required [reference, if any].
9. Animal research
All procedures were approved by the [IACUC or animal ethics body] (protocol [number]) and carried out in accordance with [national law]. The study is reported following the ARRIVE guidelines.
ARRIVE 2.0 sets what animal studies should report [4].
10. Case report
Written informed consent was obtained from the patient [or legal guardian] for publication of this case report and any accompanying images.
A filled example (invented)
Example only. The university, committee and reference number are invented.
This study was approved by the Northfield University Human Research Ethics Committee (reference HREC-2026-118, 4 February 2026). All participants gave written informed consent, including consent to audio recording. Data were stored on the university's encrypted server and pseudonymized before analysis.
IRB submission checklist: risk, consent, data protection
Use this before you submit. It is grouped the way committees read an application. For how to write each section, see how to write an IRB application, which also has a checklist of the documents to attach.
Risk
| Check | Done |
|---|---|
| Every risk named: physical, psychological, social, legal, economic, privacy | ☐ |
| Each risk rated for likelihood and severity, with a mitigation | ☐ |
| Distress protocol: what you do if a participant becomes upset, with referral contacts | ☐ |
| Risks to researchers covered (lone fieldwork, sensitive topics) | ☐ |
| Deception, if any, justified with a debrief plan | ☐ |
Consent
| Check | Done |
|---|---|
| Information sheet in plain language, at a reading level your participants can follow | ☐ |
| Key facts first: purpose, what taking part involves, time, risks, right to withdraw | ☐ |
| Withdrawal: until when, and what happens to data already collected | ☐ |
| Separate consent for recording, quotes and future use of data | ☐ |
| Assent and guardian consent for minors; capacity plan for adults who may lack it | ☐ |
| Payment or incentive amount, and that it does not pressure people to take part | ☐ |
| Contact for complaints that is independent of the research team | ☐ |
Data protection
| Check | Done |
|---|---|
| What personal data you collect, and why each item is needed | ☐ |
| Where it is stored, who has access, and how it is encrypted | ☐ |
| When identifiers are removed (anonymized or pseudonymized) | ☐ |
| How long data are kept, and how they are destroyed | ☐ |
| Transfers outside your country or to cloud tools named | ☐ |
| Data sharing plan matches what the consent form says | ☐ |
How to draft the ethics statement in AI for Research
The statement for your manuscript has its own module:
- Open Proposal Studio and choose Ethics statement.
- Enter the committee's name, the approval reference number and date, how consent was obtained, or that a waiver was granted and by whom, and the journal you are submitting to.
- You get the statement in the journal's wording, ready to paste into the methods or the declarations section. Check that every name, number and date matches your approval letter before you submit. 1 credit.
If you have not applied yet, start with the application, and use the checklist above with the clinical research checklists, which include an IRB submission checklist you can tailor to your study:
- Open Proposal Studio and choose Ethics application.
- Describe the study: aim, design, who takes part, how they are recruited, what they do, what data you collect. Or upload your protocol.
- Choose the Board: generic ethics committee, US IRB, UK Research Ethics Committee or Australian HREC.
- Choose Participants: adults at low risk, children or vulnerable groups, patients or clinical data, or online or secondary data.
- The draft has a plain-language summary, participants and recruitment, procedures, risks and how they are reduced, benefits, informed consent with a short draft consent statement, confidentiality and data protection, withdrawal and conflicts of interest. Anything you must confirm is in [square brackets].
- Open it in the editor, then copy each section into your institution's form.
| Task | Where | Credits |
|---|---|---|
| Copy a wording or the checklist | This page | 0 |
| Ethics statement for a manuscript, in the journal's wording | Proposal Studio, Ethics statement | 1 |
| IRB submission checklist, blank or tailored to your study | Proposal Studio, Checklists | 0 blank, 3 tailored |
| Ethics application draft | Proposal Studio | 15 |
| Data management plan (generic, NIH, NSF, Horizon Europe, UKRI) | Proposal Studio | 3 |
| Ethical considerations section of a proposal | Proposal Studio, Research proposal | 3 |
What this page and the tool do not do
- This is not legal advice, and neither the wordings nor the checklist replace your institution's rules. Your IRB or ethics office decides what applies.
- The tool does not submit to any board, check compliance or produce an approval. Never state an approval, reference number or exemption you have not received.
- It does not know your institution's form. Copy the content into the form your committee uses.
- Clinical, patient and legal content needs review by a qualified person at your institution before submission.
Who it is for
Students and researchers whose study involves people, their data or animals: health and clinical researchers (see AI for medical research), social scientists running surveys and interviews, and PhD students writing a thesis methods chapter. If the study is still being planned, start with the research proposal template, which has an ethics section.
Learn more
- How to write an IRB or ethics application
- How to write a research proposal
- How to write a methodology chapter
Sources
Checked November 2026.
- World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human participants. https://www.wma.net/policies-post/wma-declaration-of-helsinki/
- US Code of Federal Regulations, 45 CFR 46.104, Exempt research. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.104
- International Committee of Medical Journal Editors. Clinical trials: registration. https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
- Percie du Sert N, et al. The ARRIVE guidelines 2.0: updated guidelines for reporting animal research. PLOS Biology. 2020;18(7):e3000410. https://doi.org/10.1371/journal.pbio.3000410
Last updated 2026-11-13