Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards.

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.

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Déclaration de conflit d'intérêts

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).