Ethical considerations for medical countermeasure research with children

The Presidential Commission for the Study of Bioethical Issues (the Commission) enumerated the ethical and regulatory considerations of conducting pediatric clinical trials of medical countermeasures (MCM), including anthrax vaccine adsorbed (AVA) trials. Pediatric research presents ethical contours distinct from research with adults. Children's incomplete autonomy and related vulnerability obligate us to provide additional protections during research. Based on foundational work of the National Commission of the 1970s, four ethical principles—respect for persons, beneficence, justice, and democratic deliberation—provided the basis for the Commission's deliberations. Respect for persons recognizes persons as autonomous and capable of self-determination. Disregard for well-being or using persons only to further interests of others, which can stem from inadequately protecting the vulnerable, reflects lack of respect. In the case of children who are unable to ethically or legally consent to bear research risks on behalf of others, it is essential to limit risk to a narrow increase above minimal that does not pose significant threat to a child's health or well-being. Beneficence obligates us to safeguard children by being prepared in the case of an event as well as to protect them from undue harm during research. Justice requires us to distribute burdens and benefits of MCM research equitably, attending to fair subject selection and robust distribution plans for successful research results. Democratic deliberation provides a process to clarify key issues and to create consensus. It includes transparency, inclusion, reciprocity, and accountability. It obligates us to engage communities and protects against exploitation.