Consensus Statement-1999 (cont.)
2) In general, children who can give assent should be enrolled in a study in preference to, or prior to, children who cannot give assent. Careful consideration must be given to the importance of the potential benefit of the study. In certain circumstances, the potential benefit that may be derived from studying children who cannot give assent may override the preference for first enrolling assenting children.
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. Note: The Pediatric Ethics Working Group agreed that it is appropriate for FDA to consider adoption of a similar statement. A committee has been established to address this issue.