Globalisation processes and harmonisation of the work of ethics committees in EU

Authors: L. Zamykalová ;  J. Šimek
Authors‘ workplace: Katedra filosofie a etiky v pomáhajících profesích ;  Jihočeská univerzita v Českých Budějovicích ;  Zdravotně sociální fakulta ;  Vedoucí: doc. MUDr. Jiří Šimek, CSc.
Published in: Prakt. Lék. 2009; 89(1): 25-29
Category: In diferent


The paper is a reflection on current attempts to harmonise the work of ethics committees in the EU within the context of ongoing globalisation. The question of the universality of the Euro-Atlantic universal ethical principles and their applicability in everyday practices in countries outside Europe and North America is discussed. The process of harmonisation, globalisation and standardisation in the area of clinical research is necessary but not without its problems. In the discussion of three institutional attempts at the globalisation of research ethics principles (Global Forum on Bioethics, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, and harmonisation of ethics committees in the EU) authors argue that dichotomisations of global and local, centralisation and decentralisation are not justified. It is possible to harmonise, standardise and globalise the area of ethical decision making in clinical research; but the meaning of various seemingly neutral concepts will always be open to local reinterpretations and political and power conflicts and debates.

Key words:
globalisation, harmonisation, research ethics, ethics committees.


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