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Ethical Standards for Clinical Trials

  • Annagrazia Altavilla
Reference work entry

Abstract

The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy and privacy. These ethical concerns have been translated into a complex regulatory apparatus, containing specific ethical/legal provisions concerning such matters as participant safety, informed consent and confidentiality. This chapter will deal with main ethical standards adopted in international ethical and legal texts. Debate about the globalization of clinical research will also be addressed taking into account specific ethical concerns related to trials in vulnerable persons/population.

Keywords

Ethical Standard European Medicine Agency Distributive Justice Independent Ethic Committee Legal Text 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

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Further Reading

  1. Emanuel EJ, Grady C, Robert A, Crouch RA, Lie R, Miller F, Wendler D. The Oxford textbook of clinical research ethics. Oxford\New York: Oxford University Press; 2008. 848 p.Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Espace Éthique Méditerranéen (Bioethics Research Centre UMR 7268)Aix-Marseille University, Hôpital Adultes de la TimoneMarseilleFrance

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