Publication System () is committed to protecting the rights, dignity, privacy, safety, and well-being of individuals involved in published research.
Research involving human participants, human biological materials, patient information, or identifiable personal data must comply with applicable institutional, national, and international ethical requirements. This includes the principles of the current World Medical Association Declaration of Helsinki and the Recommendations of the International Committee of Medical Journal Editors (ICMJE).
Ethics approval must normally be obtained before the research begins.
Human Research Ethics
Research involving human participants, human-derived materials, personal information, medical records, or identifiable data must be reviewed and approved by a recognized Institutional Review Board (IRB), research ethics committee, or equivalent authorized body.
The manuscript must include an Ethics Approval Statement specifying:
The full name of the approving institution or ethics committee.
The ethics approval or reference number, where available.
The date of approval, where required.
Confirmation that the research was conducted in accordance with applicable ethical standards.
If formal ethics approval was not required, the manuscript must explain the reason and identify the authority, regulation, or ethics committee that granted the exemption or waiver. Authors must not independently determine that ethical review was unnecessary where institutional or legal review requirements apply.
or the relevant journal may request copies of approval letters, consent documentation, study protocols, or other supporting records at any stage of the editorial process or following publication. Where verification is necessary, the publisher may contact the authors’ institution, ethics committee, or another responsible authority.
Informed Consent to Participate
Written informed consent must be obtained from participants before their involvement in research unless an authorized ethics committee has formally approved a waiver of consent in accordance with applicable laws and ethical standards.
The consent process must provide participants with appropriate information concerning:
The purpose and nature of the research.
The procedures involved.
Reasonably foreseeable risks and potential benefits.
Participation being voluntary.
The right to withdraw, where applicable.
How personal information and research data will be collected, used, protected, and shared.
Where participants are minors, lack decision-making capacity, or are otherwise unable to provide legally valid consent, consent must be obtained from a parent, guardian, or legally authorized representative. Where appropriate, the participant’s assent should also be obtained.
The manuscript must include a clear statement confirming that informed consent was obtained or explaining that an authorized ethics committee granted a waiver.
Consent for Publication
Consent to participate in research does not necessarily constitute consent to publish identifiable information.
Where a manuscript contains identifiable personal information, patient details, photographs, medical images, videos, case histories, or other material from which an individual could reasonably be recognized, authors must obtain explicit consent for publication from the participant or their legally authorized representative.
Identifying information that is not essential to the scholarly content must be removed. Altering or obscuring information must not compromise the accuracy or scientific meaning of the published material.
The manuscript must include a Consent for Publication Statement where applicable. may request evidence of consent but will not publish or make the consent document publicly available unless required by law and expressly authorized.
Vulnerable Populations
Research involving individuals or groups who may be particularly vulnerable requires additional ethical justification, appropriate safeguards, and careful oversight.
Vulnerable populations may include:
Children and minors
Individuals with cognitive or psychological impairments
Individuals with reduced decision-making capacity
Institutionalized individuals
Economically or socially disadvantaged groups
Individuals in dependent relationships
Patients in emergency or critical-care settings
Authors must clearly explain:
Why inclusion of the vulnerable population was scientifically necessary.
How informed consent and, where appropriate, assent were obtained.
How the possibility of coercion or undue influence was minimized.
What measures were taken to protect participants’ privacy, dignity, safety, and rights.
What additional safeguards or oversight were required by the responsible ethics committee.
The interests and welfare of participants must take priority over the interests of science, institutions, researchers, or sponsors.
Clinical Trials
Clinical trials must be prospectively registered in a publicly accessible clinical-trial registry before enrolment of the first participant, in accordance with applicable ICMJE requirements.
Acceptable registries may include ClinicalTrials.gov, a primary registry within the WHO International Clinical Trials Registry Platform, or another publicly accessible registry meeting applicable international requirements.
The manuscript must state:
The name of the clinical-trial registry.
The trial registration number.
The date of registration.
A link to the public registration record, where available.
Any significant discrepancy between the registered protocol and the submitted manuscript must be disclosed and explained. Registration does not replace the requirement to obtain ethics approval or informed consent.
Privacy and Confidentiality
Authors are responsible for protecting the confidentiality of research participants and complying with applicable privacy and data-protection requirements.
Personal or clinical data must be collected, stored, analyzed, and shared securely. Access should be limited to appropriately authorized individuals, and identifiable data must not be published unless scientifically necessary and supported by explicit consent.
Editors and reviewers must also maintain the confidentiality of personal, medical, and research information encountered during the editorial and peer-review process.
Compliance and Verification
Publication System reserves the right to return or reject manuscripts that do not provide adequate evidence of ethics approval, informed consent, consent for publication, or clinical-trial registration where required.
If an ethical concern is identified during peer review or after publication, may:
Request supporting documentation or clarification from the authors.
Suspend the review or publication process.
Contact the relevant institution, ethics committee, trial registry, funder, or regulatory authority.
Publish a correction or expression of concern.
Retract the article where serious ethical violations are confirmed.
Take other appropriate action in accordance with policies and relevant COPE and ICMJE guidance.
Authors are responsible for providing complete, accurate, and verifiable information concerning ethics approval and informed consent. Misrepresentation, fabrication, or concealment of ethical documentation may be treated as serious publication misconduct.
Publication System