5. Ethics

5.1 Ethics Statement

Authors are required to complete the Ethical Statement Form and upload it during the Attach/Upload Files step in the submission system. (NOTE: An ethical statement is mandatory for all submissions, regardless of whether the study involves animal or human research.)

5.2. If the study does not involve animals or humans

No ethical approval was required for this study as it did not involve human or animal subjects.

5.3. Research Involving Animals

For studies involving animal subjects, authors must provide a statement confirming that the research was reviewed and approved — or granted an exemption — by the relevant institutional or national ethics committee. Authors are strongly encouraged to follow the 3Rs principles (Replacement, Reduction, Refinement). Further information is available at: https://nc3rs.org.uk/who-we-are/3rs.

5.4. Research Involving Humans

For studies involving human participants, human-derived materials, or related data, authors must confirm that appropriate ethical approval or exemption has been obtained and certify that the study was conducted in accordance with the ethical standards outlined in the 1964 Declaration of Helsinki and its subsequent amendments, or in compliance with comparable ethical standards.

An Ethical Statement must be included and should cover the following:

✔ Ethics Committee Approval

• State the full name of the Institutional Review Board (IRB) or relevant institutional/national ethics committee that approved the study.

• If the study was granted an exemption, provide official documentation from the ethics committee.

✔ Informed Consent

• Consent to participate: Confirm that informed consent was obtained from all participants involved in the study. (For participants under the age of 16, informed consent must be obtained from their legal guardians.)

- Authors should obtain informed consent from all human participants in their research prior to the commencement of the study.

- Authors are expected to describe the research project clearly and in appropriate detail to participants, explain what data will be collected and how it will be anonymized (if relevant) and stored, and explain how the interviews, surveys, and/or other data collected and the results of the study will be used and distributed.

- Authors are also responsible for clearly explaining benefits or risks associated with participation in the study.

-Studies involving human participants should include a statement within the manuscript confirming that informed consent was provided by the research subjects (or their parents/ guardians). This statement should explain how consent was given – ideally, written informed consent – and what the agreement covered.

• Consent to publish: Where applicable, confirm that participants provided consent for publication of identifiable images (e.g., “The authors affirm that human participants provided informed consent for publication of the images in Figure XXX.”).

For clinical studies or case reports, confirm that patients signed informed consent for the publication of their data and photographs. 

5.5 Clinical Trials Registration

To ensure the integrity of reporting in patient-centered trials, prospective clinical trials (phase II to IV) must be registered by authors in appropriate publicly accessible repositories, such as www.clinicaltrials.gov or any of the primary registries participating in the WHO International Clinical Trials Registry Platform.

The trial registration number (TRN) along with the date of registration should appear as the final line of the manuscript abstract.

For clinical trials that were not prospectively registered, authors are encouraged to complete retrospective registration to allow full reporting of the study results. In such cases, the last line of the abstract should include the trial registration number (TRN), the date of registration, and the statement “retrospectively registered.”