Article Text
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
Statistics from Altmetric.com
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.
Request Permissions
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Copyright information:
Read the full text or download the PDF:
Other content recommended for you
- Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities
- Division and discord in the Clinical Trials Regulation
- Problems and development strategies for research ethics committees in China ’s higher education institutions
- Ethical review reporting of Chinese trials records in WHO primary registries
- Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe
- ‘ The ethics approval took 20 months on a trial which was meant to help terminally ill cancer patients. In the end we had to send the funding back ’: a survey of views on human research ethics reviews
- More guidelines on research ethics
- Health policy and systems research: towards a better understanding and review of ethical issues
- Implementation of the process of ethical review of improvement activities at the Children 's Hospital at Westmead
- Legislative regulation and ethical governance of medical research in different European Union countries