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Journal of Long-Term Effects of Medical Implants
SJR: 0.145 SNIP: 0.491 CiteScore™: 0.89

ISSN Imprimer: 1050-6934
ISSN En ligne: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v18.i1.100
12 pages

Abstract of "Research Ethics and the European Union"

Mihail Kritikos
The University of Exeter, The Queen's Drive, Exeter, Devon, EX4 4QJ UK


The paper analyses the gradual emergence of ethics as a new object of regulatory attention at the EU level, especially in relation to research activities funded by the EU. The paper first examines the reasons behind the development of an institutional and legal governance framework on research ethics at the EC level. It is argued that those research ethics committees created for the purposes of EU-wide ethical evaluations constitute a sui generis institutional structure that highlights both the opportunities and the limitations that this supranational rule-making platform offers. Their operation seems to constitute a delicate political exercise that is based on a vaguely defined subsidiarity test. On the one hand, the gradual strengthening of the ethical component of the EU's research policies and the centralization of the correspondent review controls indicate the vast potential for institutional initiatives at the EU level as evidenced in the establishment of the European Group on Ethics in Science and New Technologies and the formulation of EC-wide ethical standards in the frame of EC's research Framework Programs. On the other hand, this de facto centralization of the ethical control of research activities at the EC level brings to the surface the EU's lack of power to supervise the implementation of the set ethical requirements in an effective manner and to conduct the necessary ethical controls and the absence of deliberative, public-engagement exercises for the purposes of the ethics review procedures. Furthermore, the paper seeks to answer whether the process for the establishment of an EU-wide institutional framework for the ethical review of research proposals indicates a tendency for the establishment of centralized Community ethical standards or instead reflects the need for a multilevel regulatory control of ethical standards and principles beyond the national level. Moreover, the mechanisms under which either of these is taking place will be identified, approaching the problem from an institutional and regulatory perspective. The paper argues that the need for an exhaustively harmonized framework for EU-wide research ethics controls is neither necessary nor desirable for a variety of reasons, mostly related to the EU's institutional features. The paper further analyzes the various legal and sociopolitical features of "ethics" in the EU's research initiatives and policies, and identifies the tensions that have emerged as a "response" to the gradual "Europeanization" of the process for the ethical scrutiny of EC-funded research proposals.

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