Teaching GuideTerm Faculty of Health Sciences |
Mestrado Universitario en Asistencia e Investigación Sanitaria (plan 2012) |
Subjects |
Ethical and Legal Research in Health Sciences |
Sources of information |
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Identifying Data | 2019/20 | |||||||||||||
Subject | Ethical and Legal Research in Health Sciences | Code | 653862203 | |||||||||||
Study programme |
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Descriptors | Cycle | Period | Year | Type | Credits | |||||||||
Official Master's Degree | 1st four-month period |
First | Optional | 3 | ||||||||||
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Basic |
Baruch A. Brody (1998). The ethics of biomedical research. An international perspective. New York: Oxford University Press Daniel Callahan (2003). What price better health. Hazards of research imperative. Berkeley: University of California Press, New York: The Milbank Memorial Fund Ezequiel J. Emanuel, David Wendler, Christine Grady (2000). What makes clinical research ethical?. JAMA 283/20 (2000), 2701-2711 Ezequiel J. Emanuel et al. (ed.) (2003). Ethical and regulatory aspects of clinical research. Baltimore and London: Johns Hopkins University Press Robert J. Levine (1986). Ethics and regulation of clinical research (second edition). New Haven: Yale University Press Javier Sánchez-Caro, Fernando Abellán (cords.) (2006). Ensayos clínicos en España. Aspectos científicos, bioéticos y jurídicos. Granada: Comares Javier Sánchez-Caro, Fernando Abellán (cords.) (2007). Investigación biomédica en España: aspectos bioéticos, jurídicos y científicos. Granada: Comares Adil E. Shamoo, David B. Resnik (2009). Responsible conduct of research (second edition). New York: Oxford University Press Ezequiel J. Emanuel et al. (ed.) (2011). The Oxford Textbook of clinical research ethics. New York: Oxford University Press |
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) |
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Complementary |
Stephen G. Post (ed.) (2004). Encyclopedia of bioethics (3rd edition. New York: Macmillan Reference Carlos M. Romeo Casabona (2011). Enciclopedia de Bioderecho y Bioética. Granada: Comares; Deusto: Cátedra Interuniversitaria Fundación BBVA-Diputación Foral de Bizkaia de D |
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