Article Text
Abstract
The Clinical Trials Regulation is intended to harmonise and streamline the review and conduct of clinical trials in the European Union. In this paper, we identify and analyse several serious issues concerning the division imposed by the Regulation between scientific review and ethical review. We conclude that these problems may compromise the objectives of the Regulation.
- Clinical trials
- Ethics Committees/Consultation
- Policy Guidelines/Inst. Review Boards/Review Cttes.
Statistics from Altmetric.com
Footnotes
Correction notice This article has been corrected since it first published Online First. The title has been amended.
Contributors DS and DT conceived the article together and DS wrote the first draft. Both authors revised the intellectual content.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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
- Problems and development strategies for research ethics committees in China ’s higher education institutions
- Research involving adults who lack capacity: how have research ethics committees interpreted the requirements
- Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards
- Can an ethics officer role reduce delays in research ethics approval? A mixed - method evaluation of an improvement project
- Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe
- Results of a self-assessment tool to assess the operational characteristics of research ethics committees in low - and middle - income countries
- What do research ethics committees say about applications to conduct research involving children
- The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries — a case study
- An analysis of decision letters by research ethics committees: the ethics / scientific quality boundary examined
- Ethics committees and the legality of research