Protection of Human Subjects and Animals in Research Policy

BM-Publisher · Applicable to all journals published under BM-Publisher

BM-Publisher is firmly committed to upholding the highest ethical standards in research involving human participants, human data, and animals. All studies published in BM-Publisher journals must comply with internationally recognized ethical frameworks, institutional review procedures, and relevant national laws. This policy outlines the responsibilities of authors, reviewers, and editors in ensuring the humane, ethical, and lawful conduct of scientific research.

1. Ethical Principles for Human Research

  • All research involving human subjects must comply with the Declaration of Helsinki (2013 revision) and the Belmont Report principles of Respect for Persons, Beneficence, and Justice.
  • Research must be conducted under the supervision of qualified investigators and within institutions that provide appropriate oversight and ethical review.
  • Participants must not be exposed to unnecessary physical, psychological, or social risks, and benefits must outweigh potential harms.
  • Authors must confirm compliance with local/national human research protection regulations (e.g., U.S. 45 CFR 46, EU Directive 2001/20/EC, or equivalents).

3. Vulnerable Populations

  • Special protection must be provided for vulnerable groups such as minors, pregnant women, prisoners, or individuals with impaired decision-making capacity.
  • Research involving these groups requires both guardian consent and, where appropriate, participant assent.
  • Authors must explicitly describe the additional ethical safeguards employed.

4. Institutional Review Board (IRB) / Ethics Committee Approval

  • All studies involving humans or human data must have prior approval from an Institutional Review Board (IRB) or Ethics Committee (EC).
  • The manuscript must include:
    • The name of the approving institution or committee,
    • The approval reference number or code, and
    • The date of approval.
  • Editors may request official approval letters during the review process for verification.

5. Clinical Trials Registration

6. Animal Research Ethics

  • Research involving animals must follow internationally accepted guidelines for animal welfare and experimental care, including the:
    • Guide for the Care and Use of Laboratory Animals (National Academies Press, USA),
    • European Directive 2010/63/EU on the protection of animals used for scientific purposes, and
    • ARRIVE Guidelines 2.0 for animal research reporting.
  • Authors must state:
    • The species, strain, sex, and age of animals used;
    • The ethical review body approving the protocol and the approval number;
    • Compliance with humane endpoints, anesthesia, and euthanasia procedures.
  • Manuscripts should include a statement such as:

    “All animal experiments were conducted in accordance with institutional guidelines and approved by the Animal Ethics Committee of [Institution Name] (Approval No. XXXX).”

7. International Guidelines and Standards

  • BM-Publisher journals endorse the following standards and declarations:
    • Declaration of Helsinki (2013)
    • CIOMS International Ethical Guidelines
    • Belmont Report (1979)
    • ARRIVE Guidelines for Animal Research
    • OECD Principles of Good Laboratory Practice (GLP)
    • ICMJE Recommendations
  • Authors must confirm adherence to these ethical standards in their manuscripts.

8. Editorial and Reviewer Responsibilities

  • Editors ensure that all manuscripts contain clear ethics statements regarding human or animal use.
  • Reviewers are instructed to evaluate compliance with ethical guidelines during peer review.
  • Any suspicion of ethical misconduct will trigger investigation under BM-Publisher’s Publication Ethics Policy.

9. Research Misconduct and Reporting

  • Research found to have violated ethical principles may be rejected or retracted after publication.
  • Editors will notify the authors’ institutions or regulatory authorities if human or animal welfare violations are suspected.
  • All retractions or corrections will follow COPE Retraction Guidelines (2019).

© 2025 BM-Publisher Ltd. This policy follows the Declaration of Helsinki, ARRIVE Guidelines, and COPE/ICMJE standards and is reviewed annually for compliance with international ethical requirements.