Informed Consent in Pediatric Research
Informed Consent in Pediatric Research
This chapter presents an overview of the informed consent requirements and waivers in pediatric research under current federal regulations. These consent policies were adopted by the Food and Drug Administration in April 2001 with the exception of parental waivers under Code of Federal Regulations section 46.408. The moral bases for these requirements are examined: whether the current policies are consistent with these moral foundations, and if not, how the policies should be modified.
Keywords: informed consent, waivers, pediatric research, Code of Federal Regulations, medical research
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