Children and Vulnerable Participants
Research involving children and persons in situations of vulnerability requires enhanced ethical protection while avoiding unjustified exclusion from scientifically important research.
The journal recognizes that vulnerability may arise from fixed, contextual, or changing circumstances and may increase the risk of harm, exploitation, coercion, undue influence, loss of autonomy, or unfair distribution of research burdens. The 2024 Declaration of Helsinki emphasizes that both the harms of inclusion and the harms of exclusion must be considered and that persons in situations of vulnerability should receive specifically tailored support and protections.
Pediatric Participants
Because the journal focuses on pediatrics, perinatology, and child health, particular attention is given to research involving newborns, infants, children, and adolescents.
A child’s inclusion in research must have a legitimate scientific and ethical justification. Pediatric participants should not be included merely because they are readily available, dependent on healthcare institutions, or less able to refuse participation.
At the same time, children should not be systematically excluded from ethically and scientifically appropriate research when such exclusion would prevent the development of reliable evidence for pediatric prevention, diagnosis, treatment, rehabilitation, or healthcare.
Research involving children should therefore be designed specifically around their health needs, developmental characteristics, and best interests.
Scientific Necessity and Relevance
The inclusion of children or other participants in situations of particular vulnerability must be scientifically justified.
Research involving such participants should be responsive to their health needs or priorities and should have the prospect of producing knowledge, practices, or interventions relevant to them. Under the 2024 Declaration of Helsinki, research involving persons in situations of particular vulnerability is generally justified when it cannot appropriately be carried out in a less vulnerable population, or where excluding them would perpetuate or worsen health disparities.
Researchers must not use vulnerability as a matter of convenience for recruitment.
Additional Safeguards
The level of protection should correspond to the participant’s circumstances, the nature of the research, and the foreseeable risks and burdens.
For pediatric and other vulnerable participants, appropriate safeguards may include enhanced ethics committee review, age- and development-appropriate information, parental or legally authorized representative permission where required, child assent when the child is capable of providing it, careful risk minimization, protection from coercion or undue influence, enhanced privacy protections, safety monitoring, and procedures for responding to changes in the participant’s condition or decision-making capacity.
Safeguards should be described sufficiently in the research protocol and, where relevant, in the manuscript.
Children’s Developing Autonomy
Children should not be treated merely as passive subjects of decisions made by adults.
Their developing autonomy, maturity, understanding, preferences, and ability to participate in decisions should be respected to the extent appropriate to their age, developmental level, health condition, and applicable ethical and legal requirements.
Information about the research should be provided in language and a format that the child can reasonably understand.
Where a child or another participant who cannot provide full informed consent is nevertheless capable of providing assent, the 2024 Declaration of Helsinki requires that assent be sought in addition to permission from the legally authorized representative and states that the participant’s dissent should be respected.
Detailed requirements are provided in the journal’s Parental Permission and Child Assent section.
Participants Unable to Provide Informed Consent
Persons who cannot provide free and informed consent are entitled to additional safeguards.
Their inclusion must not be based merely on convenience or ease of recruitment. Permission must be obtained from a legally authorized representative where required, with appropriate consideration of the participant’s own expressed preferences and values.
Under the 2024 Declaration of Helsinki, persons incapable of giving free and informed consent should be included only where the research is likely to provide them with personal benefit or involves only minimal risk and minimal burden, together with the protections applicable to persons in situations of particular vulnerability.
Changes in decision-making capacity during a study should be addressed appropriately. Where a participant becomes capable of providing consent, or where capacity is regained, consent should be obtained as required by applicable ethical standards.
Dependent Relationships and Undue Influence
Particular caution is required where potential participants have a dependent relationship with the researcher, treating clinician, institution, caregiver, teacher, employer, or another person capable of influencing their decision.
Participation must not be obtained through coercion, pressure, threat, inappropriate inducement, or fear that refusal could negatively affect medical care or other legitimate interests.
The 2024 Declaration of Helsinki requires special caution when consent may be influenced by a dependent relationship or duress and provides that consent in such circumstances should be sought by an appropriately qualified person who is independent of that relationship.
Clinical and Social Vulnerability
Vulnerability may arise not only from age or legal capacity but also from serious illness, critical care, disability affecting decision-making, emergency circumstances, social or economic disadvantage, institutional dependency, displacement, limited access to healthcare, communication barriers, or other circumstances.
Researchers and ethics committees should evaluate vulnerability in the specific context of the study rather than relying only on broad labels.
Additional safeguards should address the actual source of vulnerability and should not unnecessarily restrict participation, autonomy, or access to potentially beneficial research.
Risk and Burden in Pediatric Research
Risks and burdens must be carefully minimized in research involving children.
The protocol should take account of the child’s age, developmental status, clinical condition, invasiveness and frequency of procedures, discomfort, pain, psychological stress, privacy risks, cumulative burden, and any additional demands placed on the child or family.
Where a study does not offer a prospect of direct benefit to a participant who cannot provide informed consent, the ethical acceptability of the research requires particular scrutiny, including compliance with applicable limits on risk and burden.
The interests, safety, and well-being of the child must remain more important than recruitment targets, study timelines, commercial objectives, or scientific convenience.
Fair Inclusion
Enhanced protection should not become automatic exclusion.
Children and other persons in situations of vulnerability should have fair access to appropriately designed research relevant to their health needs. Excluding these populations without scientific or ethical justification may itself contribute to gaps in evidence and health inequalities.
The 2024 Declaration of Helsinki therefore requires researchers to consider the potential harms caused by exclusion as well as those associated with participation.
Journal Assessment
Authors must describe relevant safeguards for children and other vulnerable participants when these are necessary to understand the ethical conduct of the study.
The journal may request ethics committee documentation, consent and assent procedures, participant information materials, risk assessments, protocol provisions, or other relevant evidence when ethical protection is unclear.
The existence of ethics approval does not prevent the journal from independently assessing whether the rights and welfare of participants were adequately protected. ICMJE’s current Recommendations, updated in January 2026, require human research to follow the 2024 Declaration of Helsinki and permit editors to form their own judgment regarding the appropriateness of the research conduct.
Research that unjustifiably exploits vulnerable participants, lacks required safeguards, or materially fails to comply with ethical requirements may be rejected or addressed under the journal’s Research Misconduct, Editorial Actions, and Corrections and Retractions policies.