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Handbook of Research Ethics and Scientific Integrity pp 1–18Cite as

Research Ethics Governance

The European Situation

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Abstract

The chapter analyzes the gradual emergence of ethics and integrity as a new object of regulatory attention at the European Union (EU) level, especially in relation to research activities funded by the EU. The chapter first examines the reasons behind the gradual 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.

Furthermore, the chapter 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. The chapter further analyzes the various legal and sociopolitical features of “ethics” in the EU’s research initiatives and policies and identifies the inherent limitations of the gradual “Europeanization” of the process for the ethical scrutiny of EC-funded research proposals.

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Notes

  1. 1.

    https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31994D1110; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31994D0763

  2. 2.

    Fifth Framework Programme for Research, Technological Development and ... technological development and demonstration activities (1998–2002) OJ L26 – 01/02/1999; No 182/1999/EC.

  3. 3.

    Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 – the Framework Programme for Research and Innovation (2014–2020) and repealing Decision No 1982/2006/EC Text with EEA relevance, OJ L 347, 20.12.2013, pp. 104–173.

  4. 4.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC Text with EEA relevance, OJ L 158, 27.5.2014, pp. 1–76.

  5. 5.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ) OJ L 117, 5.5.2017, pp. 1–175.

  6. 6.

    Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products (Text with EEA relevance) OJ L 91, 9.4.2005, pp. 13–19.

  7. 7.

    Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) OJ L 119, 4.5.2016, pp. 1–88.

  8. 8.

    Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes Text with EEA relevance OJ L 276, 20.10.2010, pp. 33–79.

  9. 9.

    Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance) OJ L 268, 18.10.2003, pp. 1–23.

  10. 10.

    Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells OJ L 102, 7.4.2004, pp. 48–58.

  11. 11.

    EGE is the external advisory body which, since its inception in 1991, has provided the Commission with independent advice on ethics of science and new technologies. It convenes the interservice group on Ethics and EU Policies, coordinating Commission activities in the fields of ethics and bioethics.

  12. 12.

    Annex Commission Recommendation 2005/251/EC on the European Charter for Researchers

    and on a Code of Conduct for the Recruitment of Researchers, O.J. 2005, L 75/67.

  13. 13.

    Art. 14, para. 1 Regulation 1290/2013/EU.

  14. 14.

    Art. 14, para. 2 Regulation 1290/2013/EU.

  15. 15.

    Art. 23, para. 9 Regulation 1290/2013/EU, (note 9). See also Declaration No 34 on Art. 163 TFEU, O.J. 2007, C 306/261: “The Conference agrees that the Union’s action in the area of research and technological development will pay due respect to the fundamental orientations and choices of the research policies of the Member States.”

  16. 16.

    Art. 23, para. 9 Regulation 1290/2013/EU.

  17. 17.

    ECJ Case 121/85 EU:C:1986:114 margin number 2 – Conegate v. HM Customs & Excise; ECJ Case 34/79 EU:C:1979:295 margin numbers 15, 22 – Henn and Darby; Advocate General Bot Case C-34/10 EU:C:2011:669 margin number 45 – Brüstle; ECJ Case C-506/06 EU:C:2008:119 margin number 38 – Mayr; ECJ Case C-159/90 EU:C:1991:378 – Society for the Protection of Unborn Children Ireland v. Grogan and Others [SPUC].

  18. 18.

    31st recital (see also Art. 19, para. 4) Regulation 1291/2013/EU.

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Author information

Authors and Affiliations

  1. Institute of European Studies-Vrije Universiteit Brussel (VUB), Brussels, Belgium

    Mihalis Kritikos

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  1. Mihalis Kritikos
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Correspondence to Mihalis Kritikos .

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  1. Chatelaillon Plage, France

    Ron Iphofen

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Kritikos, M. (2019). Research Ethics Governance. In: Iphofen, R. (eds) Handbook of Research Ethics and Scientific Integrity. Springer, Cham. https://doi.org/10.1007/978-3-319-76040-7_1-1

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  • DOI: https://doi.org/10.1007/978-3-319-76040-7_1-1

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-76040-7

  • Online ISBN: 978-3-319-76040-7

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