'Safeguarding children: pediatric medical countermeasure research' Summary

In response to a request from the Secretary of Health and Human Services, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) undertook a thorough investigation into the ethical implications of pediatric medical countermeasure (MCM) research, particularly focusing on anthrax vaccine trials with children. The Commission's findings revealed that conducting such research with children necessitates stringent ethical considerations, including the careful weighing of potential risks and benefits, the need for robust scientific evidence, and the paramount importance of informed consent and parental involvement. The report underscores the need for comprehensive pre-event testing in adults before considering pediatric trials and emphasizes the importance of rigorous ethical review processes to ensure the safety and well-being of children. The report also emphasizes the need for ongoing ethical oversight throughout the research process, including monitoring for adverse effects and ensuring that the rights and interests of children are protected. The Commission’s conclusion was that more stringent guidelines for clinical research involving children are necessary to ethically justify and safeguard the conduct of such trials.