Ethics and Consent

Last Updated: May 2026

This policy is part of the Editorial Policies.

ETFLIN is committed to maintaining the highest standards of research ethics, participant protection, and publication integrity. Authors are responsible for ensuring that their research complies with applicable ethical principles, institutional requirements, and relevant national and international regulations. This policy outlines the ethical requirements for research involving humans and animals, informed consent, data protection, research integrity, and the handling of ethical concerns throughout the publication process. For information on institutional responsibilities and editorial procedures, please refer to our Publication Ethics policy.

Human Research Ethics

All research involving human participants, identifiable human biological materials, or identifiable personal data must comply with applicable ethical standards and regulations. Medical research involving human participants should follow the principles of the Declaration of Helsinki and other relevant standards, including the Belmont Report and applicable Good Clinical Practice (GCP) guidelines.

Research involving human participants must receive approval from an appropriate Institutional Review Board (IRB) or recognized Research Ethics Committee before the study begins, where required by applicable regulations. Authors must identify the approving committee, provide the approval or reference number and approval date where applicable, and describe the relevant ethical safeguards in the manuscript. ETFLIN may request copies of approval letters, protocols, consent forms, or other supporting documentation to verify compliance.

If a study is exempt from ethical review or does not require formal approval under applicable regulations, authors must provide the basis for that determination and identify the authority responsible for granting the exemption or determining that review is unnecessary, where applicable. Authors must not independently declare a study exempt solely on the basis of their own assessment. The editorial team reserves the right to request additional documentation or clarification when the ethical status of a study is uncertain.

For research involving multiple institutions or countries, authors must ensure compliance with the ethical and regulatory requirements applicable to each research setting. Where required, approval must be obtained from the relevant committees in both the sponsoring and host institutions or countries.

Informed Consent and Consent for Publication

Authors must obtain voluntary and informed consent from all participants before their involvement in research, unless a waiver or alternative procedure has been appropriately authorized under applicable ethical and regulatory requirements. Participants must receive understandable information about the study's purpose, procedures, foreseeable risks and benefits, data collection and use, confidentiality protections, and their right to decline participation or withdraw where applicable.

Consent must be documented in an appropriate form, including written, electronic, or verbal consent when justified by the study design and permitted by the relevant ethics committee or applicable regulations. Authors must explain any approved waiver of consent in the manuscript and provide supporting documentation upon request.

Research involving children or individuals who cannot independently provide legally valid consent must follow the applicable requirements for consent from a parent, guardian, or legally authorized representative. Assent must also be obtained from children or other participants when appropriate to their age, maturity, decision-making capacity, and applicable regulations. Additional safeguards must be implemented for vulnerable populations, including individuals who may be subject to coercion, undue influence, or limitations on their autonomy.

Consent to participate in research is distinct from consent to publication. When a manuscript contains identifiable information, photographs, clinical images, case descriptions, or other material through which an individual may reasonably be recognized, authors must obtain explicit consent for publication from the individual or an appropriately authorized representative, as applicable. Identifying details should be omitted unless their inclusion is scientifically necessary and appropriately authorized. Authors must confirm that the required consent has been obtained and retain the supporting documentation. Consent forms containing personal information should not be submitted for publication; they may be provided confidentially to the editorial team when requested.

Privacy, Confidentiality, and Sensitive Data

Authors must protect participants' privacy and maintain the confidentiality of personal, medical, and other sensitive information throughout the research and publication process. Data should be collected, processed, stored, and shared in accordance with applicable data protection laws, approved research protocols, and the consent provided by participants.

Identifiable information must be removed or appropriately protected unless its inclusion is scientifically necessary and legally and ethically justified. Authors must assess the risk of re-identification when sharing datasets, supplementary materials, images, or case descriptions. Data access should be restricted to authorized individuals, and appropriate safeguards must be used when transferring or storing sensitive information.

Where data sharing is required or encouraged, authors must ensure that shared data do not violate participant consent, confidentiality obligations, or applicable legal requirements. Any restrictions on data availability should be explained transparently. Research involving public databases, secondary data, archived specimens, health records, or previously collected biological materials must comply with the applicable requirements for ethical review, consent, and data use. The use of publicly available or anonymized data does not automatically exempt a study from ethical review.

Clinical Trials and Human Intervention Studies

Clinical trials and other human intervention studies must receive the required ethics approval before commencement and comply with applicable registration requirements. Clinical trials must be registered in an appropriate publicly accessible registry before recruitment of the first participant, where required by applicable standards and journal policy. Authors must provide the registry name, registration number, and registration date in the manuscript.

Authors must report the ethical approval, informed consent procedures, and relevant participant safety measures. Significant protocol amendments, serious adverse events, and other matters requiring ethics committee notification must be handled in accordance with applicable requirements.

Manuscripts reporting clinical trials should follow the CONSORT reporting guidelines or other appropriate reporting guidelines for the relevant study design. Reporting guidelines support transparent and complete reporting but do not replace ethical approval, informed consent, or clinical trial registration.

Authors should also consult ETFLIN's Clinical Trial Registration Policy.

Animal Research Policy

Research involving live animals must comply with applicable animal welfare legislation, institutional requirements, and recognized international standards, including the Guide for the Care and Use of Laboratory Animals, where applicable.

Authors must obtain approval from an appropriate institutional animal care and use committee or equivalent ethics body before conducting animal experiments, where required. The manuscript must identify the approving body and provide the approval or protocol number where applicable. Any exemption from review must be justified according to the relevant regulatory framework and supported by appropriate documentation when necessary.

All animal studies must follow the 3Rs Principle: Replacement, Reduction, and Refinement. Authors must justify the use of animals, provide a scientifically appropriate rationale for the number of animals used, and describe relevant measures to minimize pain, distress, and unnecessary suffering. Where applicable, manuscripts should report the use of anesthesia, analgesia, monitoring procedures, humane endpoints, and euthanasia methods.

Procedures involving substantial pain, distress, invasive interventions, or genetically modified animals must be scientifically justified and conducted under appropriate safeguards and approvals. Authors must disclose relevant deviations from approved protocols and explain their justification. ETFLIN may request additional documentation when animal welfare compliance is uncertain.

Scholarly Misconduct and Data Integrity

ETFLIN does not tolerate fabrication, falsification, plagiarism, image manipulation that misrepresents research findings, or other forms of research misconduct. Authors must ensure that all reported findings are supported by authentic data, appropriate analytical methods, and transparent research practices. Data must not be selectively altered, fabricated, or presented in a misleading manner.

Authors must disclose potential conflicts of interest, including financial, institutional, professional, or personal relationships that could influence the research design, conduct, analysis, interpretation, or publication of the findings. Funding sources and the role of sponsors in the research should also be reported where applicable.

The use of artificial intelligence tools in data analysis, manuscript preparation, or image generation must be transparently disclosed in accordance with the journal's requirements. AI-generated or AI-assisted content must not compromise data integrity, originality, participant confidentiality, or the accuracy of scientific interpretation. AI tools must not be listed as authors. For detailed requirements, authors should consult ETFLIN's Use of Artificial Intelligence policy.

Plagiarism and Attribution Standards

All submitted manuscripts may be screened using similarity-detection software. Similarity reports are used as screening tools and are not, by themselves, definitive evidence of plagiarism. Editorial assessment will consider the nature, extent, attribution, and context of overlapping text or material.

Authors must properly acknowledge all sources, obtain permissions for third-party material where required, and ensure that reused text, figures, tables, datasets, and other materials are appropriately cited and disclosed. Unattributed paraphrasing, inappropriate reuse of previously published material, citation manipulation, and duplicate or redundant publication are prohibited.

Authorship must reflect substantial scholarly contributions, and all listed authors must approve the final manuscript and agree to its submission. Ghost authorship, guest authorship, honorary authorship, and the omission of eligible contributors are unacceptable. Any relevant overlapping publications, prior dissemination of findings, or reuse of data must be disclosed to the editorial team.

Responsible Communication and Research Transparency

Authors must ensure that manuscripts present research findings accurately, objectively, and respectfully. Defamatory statements, personal attacks, unsupported allegations, and misleading representations of individuals or organizations are unacceptable. Claims must be supported by appropriate evidence, and identifiable images, quotations, clinical records, or case descriptions must comply with applicable consent and confidentiality requirements.

Authors must disclose relevant funding, competing interests, and any circumstances that could affect the independence or interpretation of their work. Research registration, data availability statements, reporting guidelines, and other transparency requirements must be followed where applicable to the study design.

Editors and reviewers must also disclose relevant conflicts of interest and withdraw from editorial assessment when their impartiality may reasonably be compromised. Confidential manuscript materials and reviewer identities must be protected in accordance with the journal's editorial policies.

Ethical Investigation and Sanctions

ETFLIN takes allegations of research misconduct, violations of informed consent, breaches of confidentiality, and other ethical concerns seriously, whether raised before or after publication. Concerns may be identified by editors, reviewers, authors, institutions, research participants, or other parties.

When an ethical concern arises, the editorial team may request explanations, original data, ethics approval documents, consent documentation, study protocols, or other relevant evidence. Where appropriate, the journal may contact the responsible institution, ethics committee, funder, or other competent authority to seek clarification or support an investigation. Authors will ordinarily be given an opportunity to respond to allegations, subject to the circumstances and the need to protect participants or preserve evidence.

The journal may suspend editorial processing or publication decisions while a concern is being assessed. Depending on the findings and the seriousness of the issue, actions may include rejection of a manuscript, correction of the published record, publication of an expression of concern, retraction, or notification of relevant institutions and authorities. Decisions will be proportionate to the evidence and guided by the need to protect participants and maintain the integrity of the scientific record.

Post-publication concerns may be investigated even when no formal institutional finding has been issued. Retractions and other corrective actions are intended to preserve the accuracy and reliability of the scholarly record, rather than to serve as punishment in themselves. ETFLIN will handle such cases in accordance with its editorial procedures and relevant publication ethics guidance, including guidance from the Committee on Publication Ethics (COPE).