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2. European Medicines Agency http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
3. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products;Commission of the European Communities;OJEU,2005
4. European Commission Enterprise Directorate General 2002
5. Guidelines for informed consent in biomedical research involving paediatric populations as research participants;Gill;Eur J Pediatr,2003