|
||||||||||||||||
|
||||||||||||||||
The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. 94. Field MJ, Behrman RE, eds. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press; 2004. 95. Lantos JD. The “inclusion benefit” in clinical trials. Journal of Pediatrics 1999; 134(2):130–131. 96. Silverman WA. Disclosing the “inclusion benefit.” Journal of Perinatology 2002; 22(4):261–262. 97. Choonara I, Conroy S. Unlicensed and off-label drug use in children: implications for safety. Drug Safety 2002;25(1):1–5. 98. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatrica 1999; 88(9):965–968. 99. Tyson JE, Knudson PL. Views of neonatologists and parents on consent for clinical trials. Lancet 2000;356(9247):2026–2067. 100. Manning DJ. Presumed consent in emergency neonatal research. Journal of Medical Ethics 2000;26(4):249–253. 101. Rogers CG, Tyson JE, Kennedy KA, Broyles RS, Hickman JF. Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. Journal of Pediatrics 1998;132(4):606–611. 102. U.S. Department of Health and Human Services. 45 CFR Part 46: Protection of Human Subjects. Federal Register 2001;66(219):56775–56780. 103. Food and Drug Administration. Additional safeguards for children in clinical investigations of FDA-regulated products. Federal Register 2001;66(79):20589–20600. 104. Campbell AT. State regulation of medical research with children and adolescents: an overview and analysis. In: Field MJ, Behrman RE, eds. Ethical Conduct of Clinical Research Involving Children. Washington, DC: National Academies Press; 2004:320–387.
|
|
|||||||||||||||
