Tutorial - Ethics of children in clinical trials

Tutorial - Ethics of children in clinical trials

Further reading

Freely available articles

International Ethical Guidelines for Biomedical Research Involving Human Subjects
Council for International Organizations of Medical Sciences (CIOMS) 2002 : pp.63.
International references on ethics and science
European Commission, 2007
Retrieved 13. August 2007, from http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=362.
Ethical and legal aspects on clinical trials with children
European Information Network Ethics in Medicine and Biotechnology Eureth.net 2004, Retrieved 08. August 2007, 2007, from http://www.eureth.net/literature/EthicalLegalAspects.pdf.
CHMP guideline of clinical trials in small populations
European Medicine Agency EMEA, 2006

Retrieved 22 Feb 2010, 2010, from http://www.ema.europa.eu/pdfs/human/ewp/8356105en.pdf.
Europe's pediatric rules in force - at last
O'Donnell, P. 2007, Applied Clinical Trials Online
Rare Diseases as a public health priority
Hagger L; Woods S. Children and research: a risk of double jeopardy? The International Journal of Children's Rights 2005, 13(1-2), 51-72.


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Clinical trials of orphan medicines
B M Buckley, Lancet 2008 371(9629): 2051-2055
Seen but not heard? Children in clinical trials
E Cave, Medical Lew Review 2010 18:1-27
Why “Underpowered” Trials are not Necessarily Unethical.
Edwards, S. J. L., R. J. Lilford, et al., Lancet 1997 350: 804-07.
Children as Guinea Pigs: Historical Perspectives
Lederer, S. 2003, Accountability in Research: Policies & Quality Assurance 10(1): 1.
Ethical principles and legal requirements for pediatric research in the EU: an analysis of the European normative and legal framework surrounding pediatric clinical trials
Pinxten, W., K. Dierickx, et al. 2009, European Journal of Pediatrics 168(10): 1225-1234.
The ethics of clinical trials: A child's view
Rosato, J. 2000, Journal of Law Medicine & Ethics 28(4): 362-378
Lest we forget… research ethics in children: perhaps onerous, yet absolutely necessary
Brierley J, Larcher V 2010,



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12 Apr 2017