Botkin, J., O'Lonergan, T., Wilfond, B., et al. (2013). Pediatric Ethics Subcommittee Meeting of the Pediatric Advisory Committee Meeting: September 9-10, 2013. U.S. Food and Drug Administration.
This meeting transcript from September 9, 2013 includes a discussion of the Ethical Framework of 21 CFR Subpart D (which provides for the ethical protection of children in research), and pediatric-specific risk considerations related to countermeasure research.