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Pediatric Information |
U.S. Food and Drug Administration • Center for Drug Evaluation and Research |
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Pediatric Information |
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FDA Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee’s November 15, 1999 Meeting 4/19/00 FINAL On November 15, 1999, the Pediatric Advisory Subcommittee met and was supplemented by a number of ethicists. The committee was charged with providing guidance on the ethical consideration for the conduct of pediatric clinical trials, namely the role of pediatric volunteers who do not have the disease under study. The FDA Pediatric Ethics Working Group has summarized the discussion of the Pediatric Advisory Subcommittee meeting on ethical issues relating to trials involving "normal volunteers." The consensus areas of the discussion are as follows: 1) In general, pediatric studies should be conducted in subjects who may benefit from participation in the trial. Usually this implies the subject has or is susceptible to the disease under study. The Advisory Subcommittee utilized a broad definition of potential benefit. For example, any child has the potential to benefit from a treatment for otitis media. 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.
FDA/Center for Drug Evaluation and Research |
