Pediatric Advisory Subcommittee’s November 15, 1999 FDA Ethics Working Group Consensus Statement on the Meeting
(patients vs. subjects in pediatric trials) (continued)
3) FDA should adopt the principles described in Subpart D-Additional Protections for Children Involved as Subjects in Research (45 CFR Subtitle A: 46.401-46.409). This recommendation has been endorsed by the American Academy of Pediatrics and PhRMA.
Update
Children’s Health Act of 2000 mandated that all regulated research be in compliance with Subpart D of part 46 of Title 45 CFR (IRB requirements addressing risk, assent of child, and permission of parent). FDA published an interim rule on April 24, 2001, effective April 29, 2001.