Abstract

: Subpart D of 45 CFR 46 focuses on research involving children. Section 46.407 addresses research that is not otherwise approvable. The research is not otherwise approvable because either (1) it seeks to enroll healthy children, but offers no prospect of direct benefit and entails more than minimal risk; or (2) it seeks to enroll children with a disorder or condition, but offers no prospect of direct benefit and entails more than a minor increase over minimal risk. According to 46.407, such research can be permissible if it is approved by a panel of experts. Prior to 2000, only two 407 panels had been convened, but in 2001, the Office for Human Research Protections received more than 20 protocols for 407 review. The first, entitled "Precursors to Diabetes in Japanese American Youth," serves here as a case study in human subject protections