When researchers search “ethical considerations,” they are usually looking for one of a few different things, and it is worth being explicit about which one this page answers. It could mean the broad field of research ethics governing human-subjects work (informed consent, IRB review, risk-benefit assessment), the publishing-ethics policies journals and editors follow (COPE’s guidelines on misconduct, authorship disputes, and retraction), or — the most common intent behind the bare phrase, and the one this guide addresses — the specific “Ethical Considerations” statement that many journals require as a labeled section or sub-section of a submitted manuscript. If you are looking for the underlying human-subjects framework itself rather than how to write the manuscript statement, see informed consent in research. If you are looking for the editorial-integrity guidance publishers and editors follow, see COPE Guidelines explained.
What the “Ethical Considerations” section of a manuscript is for
Most reputable journals, particularly in biomedical, behavioral, and social-science fields, require authors to state — briefly and specifically, not as a general reflection — how the reported research complied with recognized ethical standards. The ICMJE Recommendations address this as part of what belongs in a manuscript before submission, and most journal author guidelines build directly on that expectation. The section exists so an editor, reviewer, or reader can verify compliance without having to track down the underlying protocol: it is a compliance statement, not an essay arguing that the research was conducted ethically.
Journals vary in where they place this content. Some ask for a single “Ethical Considerations” or “Ethics Statement” paragraph, typically at the end of the Methods section or in a “Declarations” block near the end of the article (alongside funding, conflicts of interest, and data availability statements). Others split the same information across separate labeled fields in the submission system itself. The content expected is broadly consistent even when the label and placement are not — check the specific journal’s author guidelines for its preferred structure before drafting.
What to include
Ethics committee / IRB approval
State which institutional review board (IRB) or research ethics committee reviewed and approved the study, and include the approval or protocol reference number and, where relevant, the approval date. For work not conducted in the United States, name the equivalent body (a Research Ethics Committee under a national framework, an institutional Human Research Ethics Committee, etc.). If the study was determined exempt from full review, say so explicitly rather than leaving the sentence ambiguous between “exempt” and “not reviewed” — those are not the same thing and reviewers will ask if it is unclear.
Informed consent
State whether written or verbal informed consent was obtained from participants (or from a legally authorized representative, for participants unable to consent themselves), and note any waiver of consent granted by the reviewing IRB and the basis for that waiver. For retrospective or registry-based studies where obtaining consent is impractical, this is usually where a documented waiver is cited. See informed consent in research for what the underlying requirement covers in more depth — voluntariness, disclosure, comprehension, capacity, and the ongoing right to withdraw.
Confidentiality and data protection
Describe how participant data were de-identified or anonymized, how identifiable data were stored and secured, and — where applicable — which data-protection regime governs the data (for research involving EU/UK participants, this typically means a GDPR-compliant lawful basis and data-handling description).
Conflicts of interest and funding
Disclose financial and non-financial conflicts of interest for all authors, and identify the funding source(s) for the study. ICMJE maintains a standard disclosure-of-interest form that many journals require authors to complete and that this section (or an adjacent “Declarations” field) typically summarizes. Note that a conflict-of-interest disclosure is not an admission of wrongdoing — it is a transparency requirement that lets readers weigh potential bias for themselves.
Animal research (where applicable)
For studies involving non-human animals, state which institutional animal care and use committee approved the protocol, and confirm the work followed the applicable reporting framework — the ARRIVE guidelines are the most widely referenced standard for reporting in vivo animal research.
Vulnerable populations and special protections
If the study involved a population subject to additional protections — children, pregnant individuals, prisoners, people with diminished decision-making capacity, or other groups specifically addressed by the reviewing framework — note what additional safeguards applied. This is frequently the detail reviewers scrutinize most closely, precisely because standard consent and risk-benefit assumptions do not automatically transfer to these populations.
Illustrative example
The paragraph below is an illustrative composite written for this guide, not a statement from any real published study, and should not be copied verbatim into a submission — always match the exact wording your target journal’s author guidelines require.
“This study was approved by the [Institution] Institutional Review Board (Protocol #XXXX, approved [date]). Written informed consent was obtained from all participants prior to enrollment. Data were de-identified prior to analysis and stored on a password-protected, institution-managed server. The authors declare no competing financial or non-financial interests. This work was funded by [funder/grant number], which had no role in study design, data analysis, or the decision to publish.”
How this differs from research ethics and publishing ethics more broadly
It is easy to conflate three related but distinct things under the same phrase:
- The manuscript’s Ethical Considerations statement (this guide) — a short, specific compliance disclosure written into the paper itself.
- Research ethics / human-subjects ethics — the underlying regulatory and institutional framework (IRB review, the Belmont Report’s principles, the Common Rule in the US) that the statement is reporting compliance with. See informed consent in research.
- Publishing ethics — the norms and processes editors, journals, and publishers follow to prevent and address misconduct, authorship disputes, plagiarism, and similar issues after or independent of any individual manuscript’s ethics statement. See COPE Guidelines explained and ICMJE authorship criteria.
A manuscript can have a technically complete Ethical Considerations statement and still raise publishing-ethics concerns (for example, an authorship dispute), and vice versa — they are checked by different people at different points in the editorial process.
Common mistakes
- Restating study design instead of compliance. The section should confirm what ethical safeguards were followed, not re-explain the methodology already covered in the Methods section.
- Omitting the approval/protocol number. “This study was approved by the IRB” without a reference number is not verifiable and is a common reason for an editorial query before a paper proceeds to review.
- Leaving consent status ambiguous. State plainly whether consent was obtained, waived, or not applicable (e.g., for secondary analysis of fully de-identified public data) — do not leave a reader to infer it.
- Treating it as boilerplate copied between papers. Approval numbers, consent procedures, and funding details are study-specific; reusing another paper’s wording (even your own prior paper’s) without updating the specifics is a documentation error reviewers do catch.
Frequently asked questions
Is “Ethical Considerations” the same as an “Ethics Statement” or “Declarations” section?
Often, yes — journals use different labels for largely the same required content. Some place it as its own labeled section; others fold it into a broader “Declarations” block alongside funding, conflicts of interest, author contributions, and data availability. Follow the specific journal’s author guidelines for the label and placement it expects.
What if my study didn’t involve human or animal subjects?
Many journals still expect a brief statement to that effect (e.g., confirming the work used only publicly available, de-identified data, or was purely computational/theoretical) rather than omitting the section entirely — check whether the target journal requires an explicit “not applicable” statement.
Where does the Ethical Considerations statement go in the manuscript?
Most commonly at the end of the Methods section or in a Declarations/back-matter block near the References — journal formatting templates specify which.
Does this section need its own citations?
Not usually for the compliance statement itself, though some journals expect a citation to the relevant regulatory framework (e.g., the Declaration of Helsinki for human-subjects research, or ARRIVE for animal research) if the study explicitly follows one.
