
Human and Animal Subjects Guidelines
Human and Animal Subjects Guidelines
To ensure ethical integrity, all research involving human or animal subjects must comply with the highest standards of ethical conduct. Authors are required to provide a clear ethical statement in the Methods section of their manuscript. Submissions that do not meet these criteria will not be considered for review.
1. Research Involving Human Subjects
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All studies involving human participants must have prior approval from an Institutional Review Board (IRB), Ethics Committee, or an equivalent body.
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A statement confirming informed consent must be included. If the study involved minors, consent must be obtained from parents or legal guardians.
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Authors should explicitly state:
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The name of the approving ethics committee.
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The reference/approval number.
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That participants gave informed consent (written or verbal).
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Research must adhere to the Declaration of Helsinki and follow ICMJE guidelines.
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For studies using identifiable human data (e.g., images, personal health information), explicit consent for publication must be obtained and documented.
2. Research Involving Animals
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Animal experiments must comply with institutional and national guidelines for the care and use of laboratory animals (e.g., NIH, ARRIVE, OECD, or local governing bodies).
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Authors must:
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State the ethical approval obtained from the appropriate animal care and use committee (IACUC or equivalent).
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Include approval/reference numbers.
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Provide justification for animal use and steps taken to minimize suffering.
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Authors are encouraged to follow the ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines when reporting animal experiments.
3. Ethical Statement Example (for authors to include in manuscript):
“All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments. The study protocol was approved by [Name of IRB] (Approval No. XXXXX), and written informed consent was obtained from all participants.”
“All applicable international, national, and/or institutional guidelines for the care and use of animals were followed. The experimental protocol was approved by the [Institutional Animal Ethics Committee] (Approval No. XXXXX).”
4. Exceptions and Retrospective Studies
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If the study was exempt from ethical approval, authors must clearly state the reason (e.g., analysis of publicly available data).
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For retrospective studies using existing data or records, institutional approval and waiver of consent must be disclosed.
5. Non-Compliance
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Submissions lacking adequate ethical compliance documentation will be rejected.
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The journal reserves the right to request copies of approval letters, consent forms, or other relevant documentation at any time.