The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

Core Principles in Safeguarding Children

In 1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) published the Belmont Report, which established the three central principles of human subjects research protections—respect for persons, beneficence, and justice—and implicitly endorsed a fourth principle, democratic deliberation. These foundational principles guided the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) in responding to Secretary of Health and Human Services Kathleen Sebelius’s charge to examine the ethics of pediatric medical countermeasure (MCM) research – research that would inform the safety and proper dosing of pediatric interventions in the event of a public health emergency.

The principle of respect for persons requires research be conducted with regard for both autonomous individuals and those with diminished autonomy. Informed consent is the preferred process for assuring respect for autonomy and voluntary participation. However, within the context of pediatric research, informed consent, as an ethical and legal matter, is not possible due to the ongoing physical, mental, and moral development of adolescents and children. Respect for persons requires that pediatric research implement additional safeguards, ensuring that no child be treated merely as a means to pursue scientific or social progress. Three critical protections uphold the principle of respect for children:

  1. Parental Permission: The permission of legal guardians must be obtained, as they are responsible for acting in the best interests of the children in their care.
  2. Meaningful Child Assent: Children or adolescents must be included in the decision making process through age-appropriate agreement to research participation.
  3. Restrictions on Risk: The psychological and physical risks of research must be limited and low, in order to show respect for the current and future interests of children.

 The principle of beneficence has two parts: first, it requires that research seeks to secure the well-being of individuals and communities; second, it includes the corollary principle of non-maleficence, the obligation to “do no harm.” In pediatric MCM research, beneficence and non-maleficence entail both an obligation to minimize harm to children participating in research—to the extent that is ethically and practically possible—and the duty to safeguard children as a class against potential attacks.

The principle of justice requires fair treatment of participants and the equitable distribution of the benefits and burdens of research. In pediatric MCM research especially, the principle of justice reinforces the obligation to avoid exploiting children, who are members of a vulnerable population. Research may include children only when the knowledge sought requires including pediatric participants and cannot be acquired using animal studies or computer models. Furthermore, children must never be used for research when the same information could be obtained through voluntary adult participation.

Democratic deliberation, the final principle, is implicit in the Belmont Report and the National Commission’s other work. Since its first project, democratic deliberation has been the approach of this Bioethics Commission. This principle provides for an inclusive and respectful process of collaborative decision making, achieved by involving stakeholders such as parents, community members, and other interested parties, or their representatives. For MCM research, the most ethically complex cases must undergo a case-by-case national-level review. As acknowledged by the National Commission, this process ensures careful and open consideration of the ethical principles discussed, especially in circumstances during which “any debate about their application should be held at the most public level of discourse.”[1]

Through the reaffirmation of these four principles, the Bioethics Commission has made clear the firm ethical requirements that must be met in order to proceed with any pediatric MCM research protocol. As expressed by the National Commission, “[u]nless research can be designed which reflects all [these principles], it cannot be called ethical.”[2] MCM research with children does not involve balancing competing principles; rather, joint consideration of all four is necessary to establish the highest ethical standards, ensuring all children are protected from both unethical research and the tragedy of attacks.

[1] The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1977). Research Involving Children (DHEW Publication OS 77-0004). Washington, DC: Department of Health, Education, and Welfare, p. 141. Retrieved from

[2] Ibid, p. 136.

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This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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