Research Involving Human Participants

All research involving human participants, including patients and healthy volunteers, must be conducted in a manner that protects their dignity, rights, safety, well-being, autonomy, privacy, and legitimate interests.

For the purposes of this policy, human-participant research includes interventional and observational studies and, where applicable, research involving identifiable or re-identifiable clinical information, medical records, biological materials, images, genetic information, or other data derived from individuals.

The journal requires human research to comply with the World Medical Association Declaration of Helsinki (2024), applicable ethical and regulatory requirements, and the current ICMJE Recommendations. The Declaration of Helsinki applies to medical research involving human participants, including research using identifiable human material or data.

Scientific Justification

Research involving humans must have a scientifically sound and ethically justified purpose.

The study should:

• address a meaningful research question;
• be based on appropriate scientific knowledge and, where relevant, adequate prior evidence;
• use a methodologically appropriate design;
• involve only the number and type of participants reasonably necessary to answer the research question;
• avoid exposing participants to procedures, burdens, or risks that cannot be scientifically justified.

A scientifically invalid or inadequately designed study may itself be ethically unacceptable because it can expose participants to risk or burden without a reasonable prospect of producing reliable knowledge.

Independent Ethical Review

Research requiring ethical oversight must receive appropriate approval from an independent Research Ethics Committee, Institutional Review Board, or equivalent competent body before the relevant research procedures begin.

Authors must accurately report the ethical-review arrangements in the manuscript and be prepared to provide supporting documentation if requested by the journal.

ICMJE requires investigators conducting human research to seek approval from an independent local, regional, or national review body and permits editors to form their own judgment about whether the research was ethically appropriate even when formal approval exists.

Detailed requirements are provided in the journal’s Ethics Committee Approval section.

Risk, Burden and Benefit

Human-participant research may proceed only when anticipated risks and burdens have been appropriately assessed in relation to the potential benefits to participants and the scientific or social value of the knowledge expected from the study.

Researchers must:

• identify reasonably foreseeable physical, psychological, social, privacy-related, or other relevant risks;
• minimize avoidable risks and burdens;
• establish appropriate safety monitoring where required;
• continuously consider whether emerging information changes the risk–benefit balance;
• take appropriate action if risks become unacceptable.

The 2024 Declaration of Helsinki requires that the importance of the objective be proportionate to the risks and burdens to research participants and requires appropriate arrangements for participants harmed as a result of research.

Voluntary Participation

Participation in research must be voluntary.

Individuals capable of making their own decisions must be free to:

• decide whether to participate;
• refuse participation without penalty;
• ask questions and receive understandable information;
• withdraw consent in accordance with applicable ethical requirements.

Refusal to participate or a decision to withdraw must not inappropriately affect a patient’s access to appropriate healthcare or the patient–healthcare professional relationship.

The Helsinki Declaration specifically states that refusal to participate or withdrawal from research must not adversely affect the provision of standard care.

Detailed requirements concerning the consent process are provided in the journal’s Informed Consent section.

Participant Selection and Justice

The selection of participants must be scientifically justified and ethically fair.

Researchers should avoid:

• exploiting individuals or groups because they are readily available, dependent, disadvantaged, or less able to protect their own interests;
• systematically excluding populations without valid scientific or ethical justification;
• distributing research risks and burdens unfairly;
• recruiting participants primarily because of vulnerability or dependency when the research could appropriately be conducted in a less vulnerable population.

Research involving groups in situations of particular vulnerability should be responsive to their health needs or priorities and should include safeguards proportionate to their circumstances. The 2024 Declaration of Helsinki states that inclusion of particularly vulnerable individuals or communities must be justified and appropriately protected.

Clinical Care and Research

Clinical care and research must be appropriately distinguished.

Where patients are recruited from clinical settings, they must be informed which aspects of their care are part of research. A clinical relationship must not be used to exert inappropriate influence on participation.

A patient’s decision about research participation should not compromise access to necessary clinical care.

Research interventions must not be presented as established treatment when their effectiveness or safety remains investigational.

Vulnerability and Additional Safeguards

Some participants may require additional protection because of age, health status, impaired decision-making capacity, dependency, socioeconomic circumstances, institutionalization, emergency conditions, or other circumstances that may increase the risk of harm, coercion, exploitation, or undue influence.

Safeguards must be proportionate to the nature of the vulnerability and the research.

For this pediatric journal, particular attention is required for research involving newborns, infants, children, and adolescents.

Detailed requirements are addressed in Children and Vulnerable Participants and Parental Permission and Child Assent.

Payments, Reimbursement and Undue Influence

Payments, reimbursements, gifts, access to services, or other incentives must not be structured in a manner that constitutes coercion or creates inappropriate undue influence.

Reasonable reimbursement for expenses or compensation for time and inconvenience may be ethically appropriate when permitted by the responsible ethics committee and applicable requirements.

Any relevant incentive arrangements should be transparent to the ethics committee and appropriately described to participants.

Privacy and Confidentiality

Researchers must protect the privacy of participants and the confidentiality of personal information throughout recruitment, data collection, analysis, storage, sharing, and publication.

Only information reasonably necessary for the legitimate scientific purpose should be collected and used, subject to applicable ethical and legal requirements.

ICMJE states that patients have a right to privacy that should not be violated without informed consent.

Detailed requirements are provided in the journal’s Privacy and Confidentiality section.

Research Conduct and Safety Monitoring

Research should be performed by appropriately qualified personnel under adequate scientific and ethical supervision.

Where appropriate to the study design and level of risk, researchers should have procedures for:

• monitoring participant safety;
• recording and managing adverse events;
• responding to unexpected risks;
• reporting serious ethical or safety concerns to the responsible ethics body or regulatory authority;
• modifying or stopping research when participant protection requires it.

Ethics approval does not remove the researchers’ continuing responsibility for participant welfare throughout the study.

Emergency and Exceptional Circumstances

Public-health emergencies, outbreaks, disasters, urgent clinical circumstances, or other exceptional situations do not remove the obligation to protect research participants.

Any modified consent or research procedures used in exceptional circumstances must have an appropriate ethical and legal basis and, where required, prior approval from a competent ethics review body.

Scientific urgency must not be used to circumvent ethical review or fundamental participant protections.

Reporting Human-Participant Research

Manuscripts reporting human research should provide sufficient information for readers and editors to understand the ethical framework under which the research was conducted.

Where applicable, authors should report:

• ethics committee approval, exemption, or waiver;
• informed-consent arrangements;
• parental or legally authorized representative permission;
• child assent;
• relevant participant privacy and confidentiality protections;
• clinical-trial registration when required;
• other ethically significant safeguards relevant to the study.

Authors must not state that a study complied with a particular ethical standard or declaration unless that statement is accurate and supportable.

Journal Assessment

The journal may request additional information or documentation when concerns arise regarding participant protection, ethical review, consent, risk–benefit balance, privacy, or other aspects of human research.

If adequate ethical compliance cannot be established, the journal may suspend consideration, request clarification, obtain independent ethical advice, reject the manuscript, or refer serious concerns to an appropriate institution or ethics body.

Reports of research that materially fails to meet fundamental ethical requirements may be subject to the journal’s Research Misconduct, Editorial Actions, and Corrections and Retractions policies. The 2024 Declaration of Helsinki states that reports of research inconsistent with its principles should not be accepted for publication.