Ética de la investigaciónlas buenas prácticas

  1. López de la Vieja, María Teresa
Journal:
Arbor: Ciencia, pensamiento y cultura

ISSN: 0210-1963

Year of publication: 2008

Issue Title: Ética de la investigación

Issue: 730

Pages: 233-245

Type: Article

DOI: 10.3989/ARBOR.2008.I730.175 DIALNET GOOGLE SCHOLAR lock_openOpen access editor

More publications in: Arbor: Ciencia, pensamiento y cultura

Abstract

The Act 14/2007 regulates biomedical research, including research with stem cells and cloning for therapeutic purposes. The Spanish legislation about those controversial topics could also exemplify the changing perspective about ethical codes and ethical committees, because now they are not only centered on rights, and guarantees for the subjects involved in experimentation, but on good practice. Research Ethics has usually been related to norms, and especially to respect for human rights in the biomedical field. From the Nurmberg Code, the Helsinki Declaration, the Oviedo Convention to the Addition Protocol on biomedical research, the perspective of rights prevailed over a wider perspective, which now aims to promote the researchers' commitment and their responsibilities to health and welfare; the welfare of every subject, humans, and non-humans, and in every context, including the developing countries. The UNESCO Declaration could expand this perspective, including social justice issues in the agenda of research Ethics, usually centered on autonomy, as basic principle, and on the human rights approach. The article would analyze the good practice approach, with guidelines expanding the agenda of research Ethics in order to promote a better governance of scientific practice.

Bibliographic References

  • Advisory Committee on Human Radiation Experiments (ACHRE), Final Report, 1994. Carta de Derechos Fundamentales de la Unión Europea, 18.12.2000, C364/8 Código de Nürnberg, 1949.
  • Commission of the European Communities (2001): European Governance: A White Paper, COM (2001), 428, Brussels. Consejo de Europa (1997): Convenio para la protección de los derechos humanos y la dignidad del ser humano con respecto a las aplicaciones de la Biología y la Medicina, Oviedo. CORDIS FP7.
  • Council of Europe (2005): Additional Protocol to the Convention on Human Rights and Biomedicine, on Biomedical Research, Strasbourg.
  • Council of Europe (2006): Recommendation on Research on Biological Materials of Human Origin, Rec(2006)4, March.
  • Council for International Organizations of medical Sciences (CIOMS) (2002): International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva.
  • European Commission (2003): Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial, Brussels, April 2003, ENTR/FR/BL D.
  • European Commission (2007): Ethics for Researchers, Brussels.
  • European Science Foundation (ESF) (2000): “Good Scientific Practice in Research and Scholarship”, European Science Foundation Policy Briefings, December.
  • Habermas, J. (1998): “Learning by Disasters? A Diagnostic Look Back on the Short 20th Century”, Constellations, 307-320 doi:10.1111/1467-8675.00097
  • Harkness, J., Lederer, S., Wikler, D. (2001): “Laying Ethical Foundations for Clinical Research”, Bulletin of the World Health Organisation, 79. LEY 14/2007, de 3 de julio, de Investigación biomédica, BOE n.º 159, 4 julio 2007.
  • London, A. J. (2005): “Justice and the Human Development Approach to International Research”, The Hastings Center Report, January-February, 24-37.
  • López de la Vieja, M.ª T. (2005): “Dignidad, igualdad. La ‘buena política’ europea”, López de la Vieja, M.ª T. (ed.): Ciudadanos de Europa, Biblioteca Nueva, Madrid, 79-102.
  • López de la Vieja, M.ª T. (2005): “La Bioética y los ciudadanos”, López de la Vieja, M.ª T. (ed.): Bioética. Entre la Medicina y la Ética, Ediciones Universidad, Salamanca, 41-60.
  • López de la Vieja, M.ª T. (2005): “Derechos de los animales, deberes de los humanos”, Isegoria, 32, 157-174.
  • López de la Vieja, M.ª T. (2006): “Posguerra y contracultura. Identidades en la Ética aplicada”, Arbor, 722, 787-795.
  • Kovach, H.; Neligan, C. y Burall, S. (2003): The Global Accountability Report, The One World Trust, 2002/2003.
  • Medical Research Council (1997): MRC Guidelines for Good Clinical Practice in Clinical Trials, London.
  • Medical Research Council (MRC) (2004): Research Involving Human Participants in Developing Societies, London.
  • Medical Research Council (MRC) (2005): Medical Research Council Position on Research Regulation and Ethics, London.
  • Medical Research Council (MRC) (2005): Good Research Practice, London.
  • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979), The Belmont Report, April 18.
  • Nuttfield Council on Bioethics (2002): The Ethics of Research Related to Healthcare in Developing Countries, London.
  • Nuttfiel Council on Bioethics (2005): The Ethical Research Involving Animals, London.
  • Parlamento Europeo: Declaración por escrito sobre los experimentos científicos con primates, 23.4.2007, 0040/2007.
  • Rau, J.: Rede beim Kongress “Differenz annerkennen. Ethik und Behinderung”, Katholischen Akademie Berlin, 5.12.2003.
  • Real Decreto 1201/2005, de 10 de octubre, sobre protección de los animales utilizados para experimentación y otros fines científicos.
  • UNESCO (2005): Universal Declaration on Bioethics and Human Rights. United States Department of Health and Human Services (2005): Protection of Human Subjects.
  • The Weatherall Report (2006): The Use of Non-Humans Primates on Research, London.
  • Wild, V. y Biller-Andorno, N. (2006): “Mujeres embarazadas como participantes en ensayos clínicos. Dilemas, debates y la discusión ética”, Estudios multidisciplinares de género, 131-141.
  • World Medical Association (WMA) (1964): Declaration of Helsinki.