Ethical Principles

The journal is committed to the highest ethical standards for medical and health research involving human participants, human biological materials, and identifiable human data. Research submitted to the journal must respect the dignity, rights, safety, well-being, autonomy, privacy, and confidentiality of research participants.

Research involving human participants should be planned, conducted, and reported in accordance with the ethical principles of the World Medical Association Declaration of Helsinki, as revised in 2024, applicable national and international ethical and regulatory requirements, and relevant recommendations of the International Committee of Medical Journal Editors (ICMJE). The 2024 Declaration of Helsinki is the current official WMA version and applies to medical research involving human participants, including research using identifiable human material or data.

The journal applies the following fundamental principles:

• Respect for persons and human dignity. Every research participant must be treated with respect. Participation in research must not diminish an individual’s dignity, rights, or legitimate interests.
• Primacy of participant rights and welfare. The generation of scientific knowledge must not take precedence over the rights, safety, and interests of individual research participants.
• Scientific and social value. Research involving humans should address a scientifically meaningful question and use a methodologically sound design capable of generating valid and useful knowledge. Exposing participants to research that lacks adequate scientific justification is ethically unacceptable.
• Favourable risk–benefit assessment. Foreseeable risks and burdens must be carefully assessed in relation to anticipated benefits and the importance of the knowledge expected from the research. Risks should be minimized and appropriately monitored throughout the study.
• Fairness and justice. The selection of research participants and the distribution of research burdens and benefits should be fair. Groups should not be included merely because they are easily accessible, nor unfairly excluded from research from which they may reasonably benefit.
• Additional protection for vulnerable participants. Individuals and groups who may have an increased likelihood of being wronged or harmed require appropriate additional safeguards. Particular attention must be given to research involving newborns, infants, children, adolescents, participants with limited capacity to provide consent, and other vulnerable populations.
• Respect for developing autonomy. In pediatric research, the developing capacity, views, maturity, and best interests of the child should be appropriately considered. Requirements for parental or legally authorized representative permission and, where appropriate, the child’s assent are addressed in the journal’s specific policies.
• Independent ethical oversight. Human research must undergo appropriate review by an independent ethics committee, institutional review board, or other competent ethics review body when required. Ethical approval does not remove the responsibility of researchers or editors to consider whether participant protections are adequate.
• Voluntary participation and informed decision-making. Participation should be voluntary and based on appropriate information and valid consent, except where an ethically and legally justified waiver has been approved by an appropriate ethics review body.
• Privacy and confidentiality. Personal, clinical, genetic, and other sensitive information must be protected. The collection, use, storage, sharing, and publication of identifiable information must comply with applicable ethical, legal, consent, and data-protection requirements.
• Qualified and responsible research conduct. Human research must be conducted by persons with appropriate scientific and ethical education, training, qualifications, and supervision. Responsibility for protecting participants rests with researchers and cannot be transferred to participants merely because consent has been obtained.
• Transparency and research integrity. Research protocols, methods, analyses, results, funding, conflicts of interest, and other relevant information must be reported accurately and transparently. Negative, inconclusive, and positive findings should not be selectively concealed in a manner that distorts the scientific record.
• Compliance with applicable standards. Researchers must comply with applicable ethical, legal, institutional, and regulatory requirements in the jurisdictions where the research originates and is conducted. Such requirements must not be used to reduce protections established by internationally recognized ethical principles.

Ethical standards remain applicable during public-health emergencies, urgent clinical circumstances, and other exceptional situations. Scientific or clinical urgency does not justify bypassing essential protections for research participants. The Declaration of Helsinki expressly states that the rights and interests of participants take priority over the objectives of generating new knowledge and that its ethical principles remain applicable during public-health emergencies.

The journal reserves the right to request supporting ethical documentation and to form its own editorial judgment regarding the ethical acceptability of research, even where an ethics committee has granted approval. ICMJE similarly states that ethics committee approval does not prevent editors from independently assessing whether the conduct of the research was appropriate.