Fourteen 407 panels have been convened in the more than two decades since passage of Subpart D. The first two were in the early 1990s, and the remainder since 2001. This chapter provides a brief history of the first ten 407 panels, and then examines three of the last four panels. It concludes with several observations that can be gleaned from an historical and ethical analysis of the 407 process: observations that may be instructive for future 407 panels and for the protection of pediatric research subjects.

Fourteen 407 panels have been convened in the more than two decades since passage of Subpart D. The first two were in the early 1990s, and the remainder since 2001. This chapter provides a brief history of the first ten 407 panels, and then examines three of the last four panels. It concludes with several observations that can be gleaned from an historical and ethical analysis of the 407 process: observations that may be instructive for future 407 panels and for the protection of pediatric research subjects.