Although the Belmont Report1 significantly advanced the course of human subjects in research, it was not until 1983 that the guidelines “Additional Protections for Children Involved as Subjects in Research” were added.2 As a result, a major, albeit belated, imperative to actively recruit children for clinical research studies developed. With this imperative, however, came the added responsibility for institutional review boards (IRBs) to balance the risks and benefits of a study in such a way as to respect the right of children to participate in meaningful research while also ensuring the children's safety and welfare.
Tait AR. Weighing the Risks and Benefits of Pediatric ResearchA Risky Business. Arch Pediatr Adolesc Med. 2010;164(6):579–581. doi:10.1001/archpediatrics.2010.58