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Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards
  1. Vilma Lukaseviciene1,
  2. Joerg Hasford2,3,
  3. Dirk Lanzerath4,
  4. Eugenijus Gefenas1
  1. 1Centre for Health Ethics, Law and History, Vilnius University Faculty of Medicine, Vilnius, Lithuania
  2. 2Institut für Med. Informationsverarbeitung, Biometrie und Epidemiologie, LMU München, Munchen, Germany
  3. 3Association of Medical Ethics Committees in Germany, Berlin, Germany
  4. 4German Reference Centre for Ethics in the Life Sciences, University of Bonn, Bonn, Germany
  1. Correspondence to Vilma Lukaseviciene, Centre for Health Ethics, Law and History, Vilnius University Faculty of Medicine, Vilnius 03101, Lithuania; vilma.lukaseviciene{at}gmail.com

Abstract

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

  • research ethics
  • clinical trials

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Footnotes

  • Contributors VL wrote the first draft of the manuscript. EG made substantial revisions. JH and DL suggested further changes for important intellectual content. All authors approved the final version of the manuscript and are accountable for all aspects included in it.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests DL is Secretary General and Eugenijus Gefenas is a vice chair of the European Network of Research Ethics Committees (EUREC). EUREC serves as a platform for the exchange of information between European Ethics Committees. VL is employed at the Lithuanian Bioethics Committee and JH is a chairman of the Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland (Association of Medical Ethics Committees in Germany).

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article.

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