Ethics Committee Approval

Research involving human participants, identifiable human biological materials, or identifiable human data must undergo appropriate independent ethical review in accordance with applicable ethical, legal, institutional, and regulatory requirements.

Authors are responsible for obtaining all required approvals from an appropriate Research Ethics Committee (REC), Institutional Review Board (IRB), or equivalent independent ethics review body before commencing research for which prospective ethical approval is required.

The journal follows the principles of the World Medical Association Declaration of Helsinki (2024) and the current ICMJE Recommendations. The Declaration of Helsinki requires the research protocol to be submitted to the relevant research ethics committee for consideration, guidance, and approval before the research begins. ICMJE likewise states that authors should seek approval from an independent local, regional, or national review body and be prepared to provide supporting documentation to editors.

Information Required in the Manuscript

For research requiring ethical review, the manuscript should include an Ethics Approval Statement specifying, as applicable:

  • the full name of the ethics committee, IRB, or equivalent review body;
  • the institution or jurisdiction with which the committee is associated;
  • the approval/reference number, when one has been issued;
  • the date of approval, where relevant or required;
  • confirmation that the research was conducted in accordance with the approved protocol and applicable ethical standards;
  • information about informed consent, parental or legally authorized representative permission, child assent, or an approved waiver, where applicable.

If no approval/reference number was issued, authors should state this rather than create or infer one.

Approval Before Research Begins

Where prospective ethics approval is required, it must normally be obtained before participant recruitment, data collection, or other research procedures begin.

Authors should not seek retrospective approval merely to legitimize research that required prior ethical authorization.

If local regulations legitimately permit a different process, or if an ethics committee has formally determined that prospective approval was not required, the authors must clearly explain the circumstances and provide supporting documentation if requested by the journal.

Under the 2024 Declaration of Helsinki, changes to an approved research protocol should also undergo appropriate ethics committee consideration and approval before implementation, except where immediate action is necessary to eliminate an urgent hazard and subsequent reporting is required under applicable procedures. The Declaration also gives ethics committees authority to monitor ongoing research and to recommend changes, suspend, or withdraw approval.

Exemptions and Waivers

Some types of research may be exempt from formal ethics committee approval, or specific requirements such as informed consent may be waived, under applicable law, regulation, or institutional policy.

Authors must not determine exemption solely on their own when an official determination by an ethics committee or other competent body is required.

Where an exemption or waiver applies, the manuscript should state:

  • the body that granted or confirmed the exemption or waiver, where applicable;
  • the nature of the exemption or waiver;
  • the relevant reference number, if issued;
  • the ethical or regulatory basis for the determination where clarification is necessary.

The journal may request the relevant exemption or waiver documentation.

An exemption from ethics review and a waiver of informed consent are not the same determination and should be reported separately when both are relevant.

Retrospective and Secondary-Data Research

Retrospective medical-record reviews, registry studies, database studies, and research involving previously collected biological materials or data may still require ethics committee review, approval, exemption, or waiver depending on the identifiability of the information, the nature of the research, applicable regulation, and institutional requirements.

Authors should not assume that a study is ethically exempt merely because data were collected previously or because the research is observational.

Where an ethics committee has determined that approval or consent was not required, this determination should be reported transparently in the manuscript.

Pediatric Research

Because the journal publishes research involving newborns, infants, children, and adolescents, particular attention is given to the adequacy of independent ethical review for pediatric research.

Ethics review should take appropriate account of the participant population, including:

  • age and developmental capacity;
  • vulnerability and dependency;
  • anticipated risks and burdens;
  • prospect of direct benefit where relevant;
  • parental or legally authorized representative permission;
  • the child’s assent where appropriate;
  • privacy and confidentiality;
  • safeguards against coercion or undue influence.

Detailed requirements concerning children and vulnerable participants, parental permission, child assent, and informed consent are provided in the relevant sections of the journal’s Research Ethics Policy.

Multicentre and International Research

For multicentre studies, authors must comply with the ethical-review requirements applicable to all participating centres or jurisdictions.

The manuscript should accurately describe the ethical-review arrangement, particularly where approval is centralized, coordinated, or granted separately by participating institutions.

For international collaborative research, applicable ethical requirements in both the host and sponsoring settings must be respected. The 2024 Declaration of Helsinki states that international collaborative research protocols should receive ethics committee approval in both the sponsoring and host countries.

Protocol Amendments

Material changes to an approved protocol that may affect participants, research procedures, risk–benefit assessment, consent, data use, or other ethically relevant aspects should receive any additional ethics review or approval required by the responsible committee before implementation.

Authors must not present substantially modified research as though all procedures were covered by an earlier approval when this was not the case.

Where relevant to interpretation of the published research, substantial amendments and their approval should be disclosed.

Journal Verification

The journal may request documentation relating to ethical oversight at any stage of editorial assessment, including:

  • ethics approval letters or certificates;
  • exemption or waiver decisions;
  • protocol versions;
  • documentation of approved amendments;
  • informed-consent or assent procedures;
  • confirmation from the responsible ethics committee;
  • other materials reasonably necessary to assess compliance with ethical requirements.

Documents containing confidential or personally identifiable participant information should be appropriately protected. Authors should not send identifiable patient information unless specifically and lawfully required.

The existence of ethics committee approval does not automatically establish that a study is ethically acceptable for publication. ICMJE expressly notes that approval by a responsible review body does not prevent editors from independently judging whether the conduct of the research was appropriate.

Ethical Concerns and Non-Compliance

If the journal has reasonable concerns about the authenticity, scope, timing, or adequacy of ethical approval, it may:

  • request clarification or additional documentation;
  • suspend editorial consideration while the matter is assessed;
  • seek independent ethical expertise;
  • request confirmation from the relevant ethics committee or institution;
  • reject the manuscript if appropriate ethical compliance cannot be established;
  • refer serious concerns to the responsible institution, ethics committee, or other competent authority.

Suspected fabrication or alteration of ethics approvals, false statements concerning exemption or consent, conducting research materially outside the scope of an approval, or deliberate concealment of required ethical oversight may be investigated under the journal’s Research Misconduct Policy.

For published articles, serious ethical concerns may result in action under the journal’s Editorial Actions and Corrections and Retractions policies.

ISSN 2181-3353 (Print)
ISSN 2181-3353 (Online)