Hostname: page-component-745bb68f8f-f46jp Total loading time: 0 Render date: 2025-01-12T01:45:51.720Z Has data issue: false hasContentIssue false
  • English
  • Français

Harmonization of Ethics Policies in Pediatric Research

Published online by Cambridge University Press:  01 January 2021

Valarie Blake ,
Steve Joffe  and
Eric Kodish
Get access Rights & Permissions [Opens in a new window]

Extract

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.

FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 39 , Issue 1 , Spring 2011 , pp. 70 - 78
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

“FDA, European Medicines Agency Launch Good Clinical Practices Initiative,” U.S. Food and Drug Administration (2009), available at <http://www.fda.gov/NewsEvents/News-room/PressAnnouncements/ucm174983.htm> (last visited December 20, 2010).+(last+visited+December+20,+2010).>Google Scholar
Rose, K., “Ethical, Regulatory and Scientific Challenges in Pediatric Drug Development,” Pharmaceutical Medicine 22, no. 4 (2008): 221–234.CrossRefGoogle Scholar
Juillet, Y., “Internationalization of Regulatory Requirements,” Fundamental & Clinical Pharmacology 17, no. 1 (2003): 21–25, at 21.CrossRefGoogle Scholar
Kodish, E., ed., Ethics and Research with Children: A Case-based Approach (New York: Oxford University Press, 2005): At 3.Google Scholar
“Ethical Guidelines for Clinical Studies,” Japanese Ministry of Health, Labour and Welfare (2003), available at <http://www.ncgm.go.jp/rinri/main/03english.htm> (last visited December 20, 2010).+(last+visited+December+20,+2010).>Google Scholar
“Structure of ICH,” International Conference on Harmonization, available at <http://private.ich.org/cache/html/510-272-1.html> (last visited December 20, 2010)+(last+visited+December+20,+2010)>Google Scholar
Ell Clinical Investigation of Medicinal Products in the Pediatric Population, ICH E11 2.6 (2000), available at <http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129477pdf> (last visited December 20, 2010).+(last+visited+December+20,+2010).>Google Scholar
See Rose, , supra note 2.Google Scholar
Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use, Directive 2001/20/EC, European Parliament (April 2001), available at <http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF> (last visited December 24, 2010).+(last+visited+December+24,+2010).>Google Scholar
21 CFR §§ 50.50-50.55 (2009).Google Scholar
45 CFR § 46, subpart D (2009)Google Scholar
Wendler, D. and Varma, S., “Minimal Risk in Pediatric Research,” Journal of Pediatrics 149, no. 6 (2006): 855–61.CrossRefGoogle Scholar
See E11 Clinical Investigation of Medicinal Products, supra note 7, at 2.6.5.Google Scholar
Jonsen, A. R., “Nontherapeutic Research with Children: The Ramsey and McCormick debate,” Journal of Pediatrics 149, no. 1 (2006): S12-S14.CrossRefGoogle Scholar
Unguru, Y., Coppes, M. J., Kamani, N., “Rethinking Pediatric Assent: From Requirement to Ideal,” Pediatric Clinics of North America 55, no. 1 (2008): 211–222, at 212.CrossRefGoogle Scholar
See Unguru, , supra note 15.Google Scholar
Shaddy, et al., “Clinical Report-Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations,” Pediatrics 125, no. 4 (2010): At 850, 856–57CrossRefGoogle Scholar
Wendler, D., Rackoff, J. E., Emanuel, E. J., and Grady, C., “The Ethics of Paying for Children's Participation in Research,” Journal of Pediatrics 141, no. 2 (2002): 166–71.CrossRefGoogle Scholar
Id.Google Scholar
Id.Google Scholar
Emanuel, E. J., “Undue Inducement: Nonsense on Stilts?” American Journal of Bioethics 5, no. 5 (2005): 9–13.Google Scholar
Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric Population, Recommendations of the Ad Hoc Group for the Development of Implementing Guidelines for Directive 2001/20/EC Relating to Good Clinical Practice in the Conduct of Clinical Trials on Medical Products for Human Use, 2008, available at <http://ec.europa.eu/health/files/eudralex/vol-10/ethicalconsiderations_en.pdf> (last visited December 24, 2010).+(last+visited+December+24,+2010).>Google Scholar
Krugman, S., “The Willowbrook Hepatitis Studies Revisited: Ethical Aspects,” Reviews of Infectious Disease 8, no. 1 (1986): 157–62.CrossRefGoogle Scholar
Levine, C., Faden, R., Grady, C., and Hammerschmidt, D., “The Limitation of Vulnerability’ as a Protection for Human Research Participants,” American Journal of Bioethics 4, no. 3 (2004): 44–49.CrossRefGoogle Scholar