In 1975 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission) began its studies of the ethics and regulation of research involving children as subjects. In its report, Research Involving Children, published in 1977, the National Commission presented its recommendations for the ethical conduct of research involving children [22]. These recommendations formed the basis of federal regulations that were proposed in 1978 [21] and promulgated in final form in 1983 [19].