Ethical declarations for journal submission

Ethical declarations are formal statements confirming how your study was approved, funded, conducted, and reported. Journals reject papers when a declaration is missing, vague, or contradicts something else in the submission.

Editors treat declarations as evidence of accountability rather than paperwork. A statement that cannot be verified is worse than no statement at all, because it raises questions about everything else in the manuscript. Most declaration-related rejections happen before peer review, at the editorial screening stage, where staff check the submission against a fixed compliance list.

Table of Contents

The Core Ethical Declarations Every Author Must Submit

1. Ethics approval and institutional review statements

This declaration confirms that an independent committee reviewed and approved your protocol before the work began. It applies to research involving people, human tissue, identifiable personal data, and animals.

Include the following details.

Full name of the approving committee, IRB, or ethics board, including the institution it belongs to.
The approval reference or protocol number exactly as issued.
The date of approval, and confirmation that it preceded data collection.
The name of the framework followed, such as the Declaration of Helsinki for human research.
For multi-site studies, approval details for every site, or the name of the lead committee under a single-review arrangement.
For exempt or waived studies, the committee that granted the exemption and the ground on which it was granted.

2. Informed consent to participate

Consent to participate confirms that each participant freely agreed to take part after being told what the study involved. It is a separate requirement from ethics approval, and journals expect both.

State whether consent was written, verbal, or electronic, and why, if it was not written.
For participants under 18 years of age, state that consent came from a parent, guardian, or legal representative, and record assent from the child where appropriate.
For participants who cannot consent for themselves, name the process used with their legally authorized representative.
Where a committee waived consent, for example in a retrospective record review, state the waiver and the committee that granted it.
Describe consent for secondary use of stored data or biological samples separately, because reuse consent is now scrutinized closely.

3. How is consent for publication different from consent to participate?

Consent to participate covers taking part in the study. Consent for publication covers making identifiable material public: photographs, video, audio, case histories, pedigrees, or genomic data. Most journals require both.

Removing a name is not enough. A case report can identify someone through a rare diagnosis, a date, a hospital, or an occupation. Cropping eyes from a facial photograph is no longer accepted as anonymization by most publishers.

Obtain publication consent on the journal or publisher form where one exists.
Show the participant the version of the material that will be published, not a summary of it.
Retain the signed form; do not send it with the submission unless asked, because it contains personal data.
If the participant has died or cannot be traced, contact the journal before submitting; a next-of-kin process may apply.
For images of children, obtain consent from a parent or guardian and note this explicitly.

4. Authorship and contributorship declarations

Authorship disputes are among the most common ethics cases editors handle. A clear contributorship declaration at submission prevents most of them.

The ICMJE sets 4 criteria, and an author should meet all 4.

Substantial contribution to conception or design, or to acquisition, analysis, or interpretation of data.
Drafting the work or revising it critically for important intellectual content.
Final approval of the version to be published.
Agreement to be accountable for all aspects of the work, including the accuracy and integrity of any part of it.

Contributions that do not meet all 4 criteria belong in the acknowledgments, not the author list. Common examples include funding acquisition alone, general supervision of the research group, or technical assistance.

The CRediT taxonomy gives you a standard vocabulary of 14 roles for describing who did what, and many journals now require it.

Conceptualization, Methodology, Software, Validation, Formal analysis, Investigation, Resources, Data curation.
Writing (original draft), Writing (review and editing), Visualization, Supervision, Project administration, Funding acquisition.

Watch for the 3 authorship problems editors screen for most often.

Ghost authorship: someone who meets the criteria, often a medical writer or sponsor employee, is left off the list.
Guest or gift authorship: a senior colleague, department head, or collaborator is added without qualifying contributions.
Authorship for sale: positions bought from a paper mill, which is treated as serious misconduct and usually ends in retraction.

Also declare the practical points that journals now check.

The corresponding author, who handles communication, proofs, and post-publication queries.
Equal contribution statements, marking which authors share first or last position.
ORCID identifiers for every author, which several publishers require for the corresponding author at minimum.
Group or consortium authorship arrangements, including who is searchable in PubMed and who is listed in a collaborator group.
Any change to the author list after submission, which needs written agreement from every author, including the person being added or removed.

5. Declaration of competing interests

A competing interest is any relationship that a reasonable reader might think could have influenced the work. Having one is not misconduct; failing to disclose one is.

Disclose interests in these categories.

Financial: employment, consultancies, honoraria, stock or share options, patents, expert testimony, paid travel, and speaker fees.
Funding: grants, contract research, equipment or drug donations, and in-kind support from a party with an interest in the results.
Personal: family relationships, close friendships, and rivalries with people involved in the work or its review.
Professional: unpaid advisory roles, board memberships, membership of advocacy organizations, and editorial positions at the journal.
Intellectual: strongly held published positions that the paper defends or attacks.

Cover the standard 36-month look-back period used by the ICMJE disclosure form, and include interests held by immediate family members where the form asks for them. If there are none, say so explicitly; a blank section is treated as an omission.

6. Funding and financial support statements

A funding statement is not the same as a competing interest statement, and journals want both. The funding statement records who paid for the work; the competing interest statement records what that relationship might mean for objectivity.

Name every funder in full, using the registered name from the Crossref Funder Registry so the record can be linked automatically.
Give the exact award or grant number for each funder.
Add institutional identifiers such as ROR IDs where the journal requests them.
State the role of the funder in study design, data collection, analysis, interpretation, and the decision to publish, or state that the funder had no such role.
Declare internal or departmental support and scholarships, which authors often forget.
State explicitly if the work received no specific funding.

Check the mandates attached to your funding before you choose a journal, because they affect licensing and deposit obligations.

Funder or policy	Typical requirement	What to declare
NIH	Deposit the accepted manuscript in PubMed Central; public access on acceptance under current policy.	Grant number, PMCID once issued, and the deposit route used.
Wellcome	Immediate open access under a CC BY license; preprint expected for some calls.	Grant number, license chosen, and preprint DOI if posted.
Plan S and cOAlition S funders	Immediate open access with no embargo; rights retention language in the submission.	Funder name, grant number, and the rights retention statement.
European Research Council	Open access to publications and, where possible, to underlying data.	Project acronym, grant agreement number, and data repository details.
Industry sponsors	Author access to the full dataset and freedom to publish are increasingly required by editors.	Sponsor role, data access arrangements, and any publication approval clause.

7. Do you have to disclose AI use in your manuscript?

Yes. Journals following the January 2026 ICMJE Recommendations require disclosure of AI and AI-assisted tools used in drafting, editing, translation, image generation, or analysis, in both the cover letter and the manuscript.

The 2026 revision added a dedicated section on AI in publishing that applies to authors, reviewers, and editors. The principles below are now close to universal across major publishers, although the level of detail requested varies.

AI tools cannot be listed as an author or co-author, because they cannot take responsibility for accuracy, integrity, or originality.
Human authors remain fully accountable for every part of the manuscript, including anything an AI tool produced.
AI-generated material must not be cited as a primary source, and every factual claim and reference must be verified
Failure to disclose AI use may be treated as misconduct rather than an oversight.
Peer reviewers must not upload manuscripts to AI tools that cannot guarantee confidentiality.
AI-generated or AI-altered images are prohibited by most journals except where the image is itself the object of study.

Write the disclosure so a reader can tell what the tool did and what you did. Name the tool, the version, the date range of use, and the specific task. Language polishing, reference formatting, and code generation are all disclosable uses.

If your study is about AI or machine learning rather than assisted by it, use the reporting checklists built for that purpose, including TRIPOD+AI for prediction models and CLAIM for medical imaging.

8. Data availability statements

A data availability statement tells readers whether the data behind your results exist, where they are held, and on what terms they can be accessed. Most major publishers now require one in every research article, including those with no shareable data.

Aim for the FAIR principles: data that are Findable, Accessible, Interoperable, and Reusable. In practice that means a persistent identifier, a named repository, a license, and enough metadata for someone else to interpret the files.

Situation	What to write	Common mistake
Data are in a public repository	Name the repository, the accession or DOI, and the license.	Giving a personal website or a link that expires.
Data are in the article or supplement	State that all data generated or analyzed are included in the published article and its supplementary files.	Claiming this when only summary tables are included.
Data are sensitive or identifiable	Explain the restriction, name the committee or law that imposes it, and describe the controlled access process.	Saying only that data are confidential, with no route to access.
Data are available on request	Name the person or office, give an institutional contact route, and state the conditions and expected response time.	Writing the phrase alone, which editors increasingly reject.
Third-party data were used	Name the source, the license or agreement, and how another researcher could obtain the same data.	Implying you can share data you do not own.
No new data were generated	State this clearly and point to the sources analyzed.	Leaving the statement blank.

9. Code, software, and materials availability

Where results depend on analysis code, simulations, or custom software, journals increasingly ask for a separate availability statement. Reviewers may request the code during review.

Deposit code in a versioned repository and archive a release with a DOI so the exact version used is citable.
State the license, and choose one that permits reuse if your funder requires it.
List the software, packages, and version numbers needed to reproduce the analysis.
For biological materials, cell lines, plasmids, or reagents, state how other researchers can obtain them and note any material transfer agreement.
Authenticate and declare the provenance of cell lines, and check them against registries of misidentified lines.

10. Clinical trial registration statements

Prospective registration is a condition of publication at ICMJE-following journals, not a formality completed later. The January 2026 revision tightened the expectations around registration timing.

Register before the first participant is enrolled, in a WHO ICTRP primary registry or on ClinicalTrials.gov.
Common registries include ClinicalTrials.gov, CTRI in India, ISRCTN, ANZCTR, ChiCTR, and the EU Clinical Trials Information System.
Place the registration number and registry name at the end of the abstract, where most journals require it.
Report any change to the primary outcome, and explain when and why it changed.
Include a data-sharing plan, which the ICMJE requires for clinical trials as part of registration and reporting.
Follow CONSORT for the report itself and SPIRIT for the protocol.
For systematic reviews, register on PROSPERO and give the registration number.

Retrospective registration is not always fatal, but it must be disclosed openly, with the registration date and an explanation. Concealing it is treated far more seriously than the lapse itself.

11. Prior publication, duplicate submission, and salami slicing

Journals need to know everything about the manuscript history before they invest in peer review. Disclose at submission rather than waiting to be asked.

Confirm the manuscript is not under consideration anywhere else; simultaneous submission to 2 or more journals is prohibited.
Declare any preprint, including the server, DOI, and posting date.
Declare conference abstracts, posters, and proceedings papers, and state how much overlap exists.
Declare thesis or dissertation chapters that the manuscript draws on.
Declare related papers from the same dataset that are published, in press, or under review, and attach them if asked.
Avoid salami slicing: splitting 1 coherent study into several thin papers to lengthen a publication list.
For secondary publication, usually translation into another language, follow the ICMJE conditions, which include permission from both editors and a footnote citing the original.

12. Copyright, licensing, and permissions declarations

Reusing published material without written permission is a copyright breach, and it is caught routinely by editorial screening.

Obtain written permission for every figure, table, image, questionnaire, scale, or long quotation reproduced from another source.
Use the rights clearance service of the original publisher and keep the license number.
Add the required credit line to the caption in the exact wording the license specifies.
Check whether adapting a figure still needs permission; usually it does.
Confirm that your chosen license, such as CC BY or CC BY-NC, is compatible with your funder mandate.
Check your institution or employer does not hold rights that limit what you can sign.
Confirm the self-archiving terms, including which version you may deposit and after what period.

13. Acknowledgments and third-party contributions

Acknowledgments are an ethical declaration in their own right, because they record contributions that did not qualify for authorship.

Obtain written permission from everyone you name, since inclusion can imply endorsement of the findings.
Name medical writers and editorial assistance providers, state who paid for them, and follow Good Publication Practice where the study is industry-sponsored.
Acknowledge statisticians, technicians, data managers, and language editors whose input fell short of the authorship criteria.
Acknowledge participating communities, patient advisers, and data custodians where relevant.
Do not use the acknowledgments to hide a funder or a competing interest that belongs in its own statement.

Which ethical frameworks and bodies govern these declarations?

The Declaration of Helsinki, the Belmont Report, the CIOMS guidelines, and the Nuremberg Code set the underlying principles. ICMJE, COPE, WAME, and CSE translate those principles into the specific statements journals ask for.

Framework or body	What it covers	Why it matters at submission
Nuremberg Code (1947)	The founding statement that voluntary consent is essential in human experimentation.	The origin of the consent requirement journals still enforce.
Declaration of Helsinki (WMA, revised 2024)	Ethical principles for medical research involving human participants.	Most journals require you to state that the study complied with it.
Belmont Report (1979)	Respect for persons, beneficence, and justice, the basis of United States IRB review.	Underpins the exempt and expedited review categories you may cite.
CIOMS guidelines	International ethical guidelines for health-related research, with a focus on low-resource settings.	Used to judge cross-border and multi-country studies.
WMA Declaration of Taipei	Ethics of health databases, biobanks, and reuse of data and samples.	Relevant to secondary data analysis and biobank studies.
ICMJE Recommendations (revised January 2026)	Authorship, disclosure, trial registration, data sharing, AI use, and editorial process.	The single most widely adopted rulebook for submissions.
COPE	Flowcharts and guidance for handling suspected misconduct.	Determines what happens if a declaration is later found to be wrong.
WAME and CSE	Editorial policy statements, predatory publishing guidance, and integrity standards.	Shapes journal-level policies you must comply with.
EQUATOR Network	A registry of reporting guidelines for every major study design.	Journals often require the matching checklist as a submission file.

Which reporting guideline applies to your study design?

A completed reporting checklist is now a routine submission file. It is not an ethical declaration in the narrow sense, but journals treat an incomplete checklist as a transparency failure, and many titles will not send a manuscript out for review without one.

Guideline	Study type it covers
CONSORT	Randomized controlled trials, with extensions for cluster, pilot, and non-inferiority designs.
SPIRIT	Clinical trial protocols.
PRISMA	Systematic reviews and meta-analyses, with extensions for scoping reviews and network meta-analyses.
MOOSE	Meta-analyses of observational studies.
STROBE	Observational studies: cohort, case-control, and cross-sectional.
STARD	Diagnostic accuracy studies.
TRIPOD+AI	Prediction model studies, including those using machine learning.
CLAIM	Artificial intelligence applied to medical imaging.
CARE	Case reports.
ARRIVE 2.0	Research involving live animals.
COREQ and SRQR	Qualitative research, including interview and focus group studies.
CHEERS	Health economic evaluations.
SQUIRE	Quality improvement studies.
SAGER	Reporting of sex and gender across all designs.
CHERRIES	Web and internet-based surveys.

What declarations does animal research need?

Animal studies have their own approval, husbandry, and reporting declarations. Naming the committee is only the starting point.

Name the animal ethics committee that approved the work, with the protocol number and approval date. Examples include IACUC in the United States, AWERB in the United Kingdom, and CPCSEA in India.
Cite the national legislation followed, such as the Animals (Scientific Procedures) Act or the applicable European Union directive.
State compliance with ARRIVE 2.0 and submit the completed checklist.
Describe how the 3Rs were applied: Replacement, Reduction, and Refinement.
Report species, strain, sex, age, weight, source, and health status.
Describe housing, husbandry, enrichment, acclimatization, and the light cycle.
State anesthesia, analgesia, and euthanasia methods, with doses and routes.
Define humane endpoints and report how many animals reached them.
Give sample size justification, randomization method, and blinding of outcome assessment.
Report all animals excluded from analysis and the reason for each exclusion.

Data Protection and Privacy Declarations

Ethics approval does not discharge your legal obligations under data protection law. Journals increasingly ask for both.

Regime	Applies to	What to declare
GDPR (European Union and United Kingdom)	Personal data of people in the EU and UK, including pseudonymized data.	Lawful basis for processing, data controller, and whether a data protection impact assessment was done.
HIPAA (United States)	Protected health information held by covered entities.	De-identification method used: Safe Harbor removal of the 18 identifiers, or expert determination.
DPDP Act (India)	Digital personal data of individuals in India.	Consent notice used, purpose limitation, and any exemption relied on for research.
Institutional data agreements	Data obtained from registries, hospitals, or third parties.	The agreement in place, permitted uses, and publication restrictions.

De-identification is a claim you must be able to defend. Small cell sizes, rare conditions, precise dates, and geographic detail can all re-identify a person when combined, and the 2024 Declaration of Helsinki specifically flags this risk. State how you assessed it.

Preprints, Preregistration, and Registered Reports

These 3 practices are separate, and each carries its own disclosure obligation.

Practice	What it is	What to declare
Preprint	A manuscript posted publicly before peer review on a server such as medRxiv, bioRxiv, arXiv, SSRN, or Research Square.	Server name, DOI, posting date, and the license applied; check the journal accepts preprinted submissions.
Preregistration	A public, timestamped record of hypotheses, design, and analysis plan, filed before data collection.	Registry name, registration DOI or number, and any deviation from the registered plan.
Registered Report	A format in which methods are peer reviewed and accepted in principle before results exist.	Stage 1 acceptance details and confirmation that the approved protocol was followed.

Deviations from a preregistered plan are acceptable if you report them; concealing them is not.
Label exploratory analyses as exploratory, and keep them separate from confirmatory tests.
Check whether updating a preprint after acceptance is permitted or required by your journal.
Some funders now expect preprint posting; check before you choose a server or license.

Equity and Inclusion Declarations

A growing number of journals require a statement on how the research team was constituted and how affected communities were involved. These declarations are relatively new, so many authors miss them entirely.

Global research and helicopter research statements

If your study was carried out in a country other than your own, expect to explain the local partnership behind it.

State how local researchers were involved in design, implementation, analysis, and authorship.
Confirm that local ethics review took place in addition to any review at your home institution.
Explain how the research is relevant to local priorities and how findings will be returned to the community.
Note capacity-building elements such as training, equipment, or shared infrastructure.
Cite local and regional literature rather than only work from high-income countries.

Indigenous data governance and the CARE Principles

Where research involves Indigenous peoples or their data, FAIR principles alone are not sufficient. The CARE Principles add a governance layer.

Collective benefit: the research and its data should benefit the community that provided them.
Authority to control: communities decide how their data are used, shared, and represented.
Responsibility: researchers must show how the relationship supports self-determination.
Ethics: the rights and wellbeing of the community are the primary concern throughout the data lifecycle.
Declare community consent, data sovereignty arrangements, and any oversight body involved.

Sex, gender, race, and ethnicity reporting

Follow the SAGER guidelines: report sex and gender in the design, analysis, and reporting, and use the 2 terms accurately.
State whether findings apply to all participants or only to a subgroup.
Define race and ethnicity categories, explain who assigned them, and justify their use as variables.
Report the age range and any age-based exclusions, and justify excluding pregnant participants or older adults.
Explain how the study population reflects, or fails to reflect, the population affected by the condition.

How do publishers check image integrity and dual-use risk?

Publishers now screen images automatically before peer review. Declaring your image handling process protects you from an honest error being read as manipulation.

Retain unprocessed original files for every figure, and be ready to supply them on request.
Apply adjustments such as brightness and contrast to the whole image, never to a selected region.
Disclose any splicing in a blot or gel with clear dividing lines and a note in the legend.
Do not duplicate a panel across figures or papers without explicit labeling.
State the microscope, camera, magnification, and processing software used.
Confirm that no AI tool generated or altered a scientific image.

Dual-use research of concern needs its own risk statement. Studies in areas such as pathogen enhancement, toxin synthesis, or offensive security research may require institutional biosafety committee review, and some journals run an additional editorial risk assessment before publication.

Declare biosafety level, containment, and institutional biosafety committee approval.
State any export control, pathogen access, or material transfer restrictions.
Explain what methodological detail has been withheld and why, if anything has been.
For security research, describe the responsible disclosure process followed with the affected vendor.

What if you did not get ethics approval before you started?

Contact your institutional committee immediately and ask for a retrospective review, a formal waiver, or written confirmation that the study was exempt. Do not write an approval statement you cannot document.

Committees can often issue a determination after the fact for low-risk work, particularly retrospective record reviews, service evaluations, and analyses of fully anonymized existing datasets. What editors will not accept is silence or a vague claim that approval was not needed.

Ask the committee for a written statement, whatever the outcome, and quote it in the manuscript.
If the committee confirms the study was exempt, name the exemption category and the committee that granted it.
If approval was granted late, state the date and explain the circumstances in the cover letter.
If no committee exists at your institution, say so and name the national or regional body you approached instead.
Never state that approval was obtained when only a waiver or exemption was issued; the 2 are different.

Ethical Declarations Outside Biomedicine

Most published guidance is written for clinical research, which leaves authors in other fields guessing. The obligations still apply; the wording changes.

Social sciences and qualitative research

Declare approval from the relevant committee, and name the professional code you followed, such as those issued by national psychological or sociological associations.
Describe the consent process, including how you handled ongoing consent in longitudinal fieldwork.
Explain anonymization of quotations, pseudonyms, and any changed identifying details, and note that you changed them.
Address power imbalances between researcher and participant, and any incentive or payment offered.
Declare reflexivity and positionality where the field expects it, and follow COREQ or SRQR for reporting.
Explain data retention, secure storage, and destruction schedules for recordings and transcripts.

Research using social media and web-scraped data

State whether the data were public, semi-public, or private, and how you decided.
Declare compliance with platform terms of service and any application programming interface license.
Explain whether consent was sought, and justify the decision if it was not.
Describe how you prevented re-identification, including whether verbatim posts are quoted, since a quotation is searchable.
Note approval from an ethics committee even where the data are public, because many committees now require review.

Computer science, engineering, and applied AI research

Provide a broader impact or societal impact statement where the venue requires one.
Declare the provenance and license of every training dataset, and whether it contains personal data.
Declare human involvement in annotation or evaluation, including crowdworker recruitment, pay rates, and ethics review.
State model release decisions, safety evaluations, and any capability withheld.
Declare compute resources and estimated environmental cost where the venue asks for it.
Follow responsible disclosure norms for any vulnerability discovered.

Do you need ethics approval for your study?

If your work involves living people, identifiable personal data, human tissue, or animals, assume you need approval or a documented exemption. Only a committee can confirm that a study is exempt; the author cannot decide alone.

Work through the questions below in order, and record the answer to each.

Does the study involve living human participants, including through interviews, surveys, experiments, or observation? If yes, approval is required.
Does it use identifiable or re-identifiable personal data, including clinical records, images, or genomic data? If yes, approval or a documented waiver is required.
Does it use human tissue, cell lines of human origin, or biobank samples? If yes, approval and provenance documentation are required.
Does it involve live vertebrates or cephalopods? If yes, animal ethics approval is required.
Is it a secondary analysis of a fully anonymized public dataset? Approval may not be needed, but ask the committee for written confirmation.
Is it a service evaluation, audit, or quality improvement project? Local rules vary widely; obtain a written determination.
Does it involve vulnerable groups, deception, or sensitive topics? Expect full committee review rather than expedited review.
Is it a multi-country study? Obtain approval in every country where data are collected, not only at the lead institution.

Where Does Each Declaration Go in Your Submission?

The same information is often required in more than 1 place, and the copies must match. Editorial staff compare them.

Declaration	Usual location	Common mistake
Ethics approval	Methods section, plus the end matter and the submission form.	Approval number appears in the form but not in the Methods.
Consent to participate	Methods section and end matter.	Mentioned only in the cover letter.
Consent for publication	End matter; signed form retained by the author.	Sending the signed form as a public supplementary file.
Author contributions	End matter, entered as CRediT roles in the submission system.	Roles listed do not match the author order or the number of authors.
Competing interests	End matter, plus the ICMJE disclosure form for each author.	Only the corresponding author completes the form.
Funding	End matter and the funder fields in the submission system.	Grant number missing, or the funder name does not match the registry.
AI use disclosure	Cover letter and a named section in the manuscript.	Disclosed in the cover letter only, which the 2026 rules do not allow.
Data availability	End matter, before the references.	Placed in the supplementary material where indexers cannot find it.
Trial registration	End of the abstract, and repeated in the Methods.	Given only in the Methods, so it is invisible in databases.
Prior publication and preprints	Cover letter and the submission form.	Preprint not declared, then flagged by similarity screening.
Permissions and credit lines	Figure and table captions.	Credit line reworded rather than reproduced exactly as licensed.
Acknowledgments	End matter, before the references.	Naming people who did not give permission.

Copy-and-Paste Declaration Templates

Replace every bracketed placeholder with your own details, and delete any template you do not need. Check the journal instructions for required section headings, because the labels vary.

Ethics approval, granted

Ethics approval: This study was approved by the [name of committee or institutional review board], [institution], on [date] under reference number [number]. All procedures were carried out in accordance with the ethical standards of the institutional research committee and with the 2024 revision of the Declaration of Helsinki.

Ethics approval, waived or exempt

Ethics approval: The [name of committee], [institution], reviewed this study on [date] and determined that formal ethical approval was not required because [reason, for example: the study used fully anonymized existing data]. The determination is recorded under reference number [number].

Informed consent to participate

Consent to participate: Written informed consent was obtained from all individual participants included in the study. For participants under 18 years of age, written informed consent was obtained from a parent or legal guardian, and assent was obtained from the participant.

Consent for publication

Consent for publication: Written informed consent for publication of the clinical details and images in this article was obtained from the participant. A copy of the consent form is held by the corresponding author and is available for review by the Editor on request.

Competing interests, present

Competing interests: [Author name] has received consultancy fees from [company] and research funding from [company] within the past 36 months. [Author name] holds patent [number] related to [subject]. The remaining authors declare that they have no competing interests.

Competing interests, none

Competing interests: All authors declare that they have no financial, personal, or professional competing interests relating to the content of this article.

Funding, with support

Funding: This work was supported by [funder name, as listed in the Crossref Funder Registry] under grant number [number] awarded to [author initials]. The funder had no role in the study design, data collection, data analysis, interpretation of the results, preparation of the manuscript, or the decision to submit it for publication.

Funding, none

Funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

AI use, tools used

Use of artificial intelligence: During the preparation of this manuscript, the authors used [tool name and version] between [start date] and [end date] for [specific task, for example: language editing of the Discussion section]. The authors reviewed and edited all output, verified every factual statement and reference, and take full responsibility for the content of the published article. No artificial intelligence tool is listed as an author, and no image in this article was generated or altered using artificial intelligence.

AI use, no tools used

Use of artificial intelligence: The authors declare that no artificial intelligence or AI-assisted technologies were used in the conception, drafting, editing, analysis, or image preparation of this manuscript.

Data availability, public repository

Data availability: The datasets generated and analyzed during this study are openly available in [repository name] at [DOI or accession number], released under a [license] license. Metadata and a data dictionary are included in the deposit.

Data availability, restricted access

Data availability: The data supporting the findings of this study contain information that could compromise participant privacy and are therefore not publicly available. De-identified data may be made available to qualified researchers for [permitted purposes] following approval of a written request by [named committee or office] at [institutional contact route]. Requests are usually answered within [number] weeks.

Data availability, no new data

Data availability: No new data were created or analyzed in this study. All sources analyzed are cited in the reference list.

Code availability

Code availability: The analysis code used in this study is available at [repository URL], archived at [DOI] under a [license] license. Analyses were run using [software and version] with packages [names and versions].

Clinical trial registration

Trial registration: [Registry name], [registration number]. Registered [date], prospectively, before enrollment of the first participant. The full protocol and statistical analysis plan are available at [URL].

Prior publication and preprint

Prior publication: This manuscript is not under consideration at any other journal. An earlier version was posted as a preprint on [server] on [date] and is available at [DOI]. Preliminary findings were presented as a poster at [conference], [location], [date]. No part of this work has been published in a peer-reviewed journal.

Author contributions using CRediT

Author contributions: [Initials]: Conceptualization, Methodology, Writing (original draft). [Initials]: Investigation, Data curation, Formal analysis. [Initials]: Validation, Writing (review and editing). [Initials]: Supervision, Funding acquisition. All authors read and approved the final manuscript and agree to be accountable for all aspects of the work.

Permissions and reuse

Permissions: Figure [number] is reproduced from [author, title, journal, year, DOI] with permission from [rights holder], license number [number]. Table [number] is adapted from [source] under a [license] license.

Inclusion and ethics in global research

Inclusion and ethics: This study was designed and conducted in partnership with researchers based in [country], who contributed to the study design, data collection, analysis, and authorship. Ethical approval was obtained from [local committee] in addition to [home institution committee]. Findings will be shared with participating communities through [route]. Local and regional literature has been cited throughout.

Animal research

Animal ethics: All procedures involving animals were approved by the [committee name] at [institution] under protocol number [number] and were carried out in accordance with [legislation]. The study is reported in line with the ARRIVE 2.0 guidelines, and the completed checklist is submitted as a supplementary file. The 3Rs were applied through [brief description].

Acknowledgments

Acknowledgments: The authors thank [name] of [institution] for [contribution]. Medical writing support was provided by [name] of [organization] and was funded by [sponsor]. All named individuals have given written permission to be acknowledged.

This article was originally published on September 19, 2022, and updated on August 4, 2026.

Ethical Declarations for Journal Submission: Sample Statements and Publisher Requirements