Ethical documents

The Nuremberg Code (1947).

Declaration of Helsinki (World Health Association, Ethical Principles forMedical Research Involving Human Subjects 1964; 7th revisión, Seoul 2008).

The Belmont Report (TheNational Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principlesand Guidelines for the Protection of Human Subjects of Research (1979)

Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization(WHO), International Ethical Guidelines for Biomedical Research Involving Humanubjects (2002).

UNESCO, Universal Declaration on bioethics and human rights (2005).

Legal norms

General legal norms

Spanish Constitution (1978) (BOE nº 311, 29.12.1978).

Basic Law 41/2002, of 14 November, regulating patient’s autonomy and rights and obligations regarding clinical information and documentation (BOE nº 274,15.11.2002).

Organic Law 15/1999, of 13 December, on personal data protection (BOE nº298, 14.12.1999).

Royal Decree 1720/2007, of 21 December, passing the development Regulation of Organic Law 15/1999, of 13 December, on personal data protection (BOE nº 17, 19.1.2008).

Convention for the protection of human rights and dignity of the human being with regard to the application of Biology and Medicine (Convention on human rights and b iomedicine). (BOE nº 251, 20.10.1999.Rectification BOE n.º 270, 11.11.1999).

Council of Europe, Additional Protocol to the Convention on human rights and biomedicine concerning biomedical research (Strasbourg, 25.1.2005).

Research with human beings

Law 14/2007, of 3 July, on biomedical research (BOE nº 159, 4.7.2007)

Law 14/2006, of 26 May, on assisted human reproduction techniques (BOE nº 126, 27.5.2006)

Royal Decree 223/2004, of 6 February, regulating clinical trials with drugs (BOE nº 33, 7.2.2004)

Law 29/2006, of 26 July, of guarantees and rational use of drugs and health products (BOE nº 178, 27.7.2006)

Royal Decree 1716/2011, of 18 November, establishing the basic requirements on biobanks with biomedical research purposes... (BOE nº 290, 2.12.2011)

Animal research

Law 8/2003, of 24 April, of animal health

Royal Decree 1201/2005, of 10 October, on protection of animals used for experimentation and other scientific purposes (BOE nº 252, 21.10.2005)

Law 32/2007, of 7 November, for the care of animals regarding their exploitation, transportation, experimentation, and sacrifice (BOE nº 268, 8.11.2007).

Directive 2010/63/EU of the European Parliament and of the Council, of 2 September 2010, on the protection of animals used for scientific purposes (OJEU L276, 20.10.2010)

Research with biological agents and genetically modified organisms

Law 9/2003, of 25 April, establishing the legal conditions for confined use, intentional release, and commercialization of genetically modified organisms (BOE nº 100, 26.4.2003)

Royal Decree 178/2004, of 30 January, passing the general Regulation developing and executing the Law 9/2003, of 25 April, establishing the legal conditions for confined use, intentional release, and commercialization of genetically modified organisms (BOE nº 37, 31.1.2004. Correction: BOE nº 42, 18.2.2004)

Royal Decree 1369/2000, of 19 July, modifying the Royal Decree 822/1993, of 28 May, establishing the principles of laboratory good practices and their implementation in non-clinical studies on chemical substances and products (BOE nº 173, 20.6.2000)

Royal Decree 1697/2003, of 12 December, creating the National Commission on Biovigilance (BOE n.º 310, 27.12.2003)