Journal of Law, Medicine and Ethics 39 (1):70-78 (2011)
|Abstract||The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed over 20 years ago with a goal of harmonizing research regulations among the European Union, United States, and Japan. Harmonization was intended to speed approval of pharmaceuticals, avoid unnecessary repetition of studies, and ensure protection of research participants. This paper examines United States, European Union, and ICH pediatric research regulations in five domains: parental permission, assent/dissent, payment, risk/benefit and inclusion of disabled children/wards of state. The purpose is to examine similarities and differences among the regulations to help investigators, policy makers and the public to understand what each regulatory framework can learn from the others. Additionally, the paper suggests philosophical differences in how these entities view pediatric research which may serve as barriers to harmonization in the future|
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
|Through your library||Configure|
Similar books and articles
Eric Chwang (2010). Against Risk-Benefit Review of Prisoner Research. Bioethics 24 (1):14-22.
Celia B. Fisher, Susan Z. Kornetsky & Ernest D. Prentice (2007). Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations. American Journal of Bioethics 7 (3):5 – 10.
David Wendler (2004). Risk Standards for Pediatric Research: Rethinking The. Kennedy Institute of Ethics Journal 14 (2):187-198.
Paul Litton, Non-Beneficial Pediatric Research and the Best Interests Standard: A Legal and Ethical Reconciliation.
Ghiath Alahmad, Mohammad Al-Jumah & Kris Dierickx (2012). Review of National Research Ethics Regulations and Guidelines in Middle Eastern Arab Countries. [REVIEW] BMC Medical Ethics 13 (1):34-.
Annette Rid & David Wendler (2011). A Framework for Risk-Benefit Evaluations in Biomedical Research. Kennedy Institute of Ethics Journal 21 (2):141-179.
David Wendler (2012). A New Justification for Pediatric Research Without the Potential for Clinical Benefit. American Journal of Bioethics 12 (1):23 - 31.
Denise Avard, Karine Sénécal, Parvaz Madadi & Daniel Sinnett (2011). Pediatric Research and the Return of Individual Research Results. Journal of Law, Medicine and Ethics 39 (4):593-604.
Karen J. Maschke & Thomas H. Murray (2004). Ethical Issues in Tissue Banking for Research: The Prospects and Pitfalls of Setting International Standards. Theoretical Medicine and Bioethics 25 (2):143-155.
Jonas D. Policarpio (2008). Good Clinical Practice (GCP) International Conference on Harmonization. In Angeles Tan-Alora (ed.), Introduction to Health Research Ethics: Philippine Health Research Ethics Board. Philippine National Health Research System.
Lillian M. Range & C. Randy Cotton (1995). Reports of Assent and Permission in Research with Children: Illustrations and Suggestions. Ethics and Behavior 5 (1):49 – 66.
Jessica Masty & Celia Fisher (2008). A Goodness-of-Fit Approach to Informed Consent for Pediatric Intervention Research. Ethics and Behavior 18 (2 & 3):139 – 160.
Added to index2011-02-12
Total downloads4 ( #188,662 of 722,700 )
Recent downloads (6 months)1 ( #60,006 of 722,700 )
How can I increase my downloads?