Article Text
Clinical ethics
Paper
Division and discord in the Clinical Trials Regulation
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.
Read the full text or download the PDF:
Other content recommended for you
- Ethical review reporting of Chinese trials records in WHO primary registries
- Diversity and inclusion for rodents: how animal ethics committees can help improve translation
- 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
- Regulatory approval of clinical trials: is it time to reinvent the wheel?