Article Text
PDF
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
- Ethical review reporting of Chinese trials records in WHO primary registries
- Research ethics committees: the role of ethics in a regulatory authority
- Problems and development strategies for research ethics committees in China’s higher education institutions
- Partnership as an ethical model for medical research in developing countries: the example of the “implementation trial”
- Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees
- Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?
- Contesting the science/ethics distinction in the review of clinical research
- Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards
- New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants’ interest
- Cross-sectional analysis of UK research studies in 2015: results from a scoping project with the UK Health Research Authority