Regulation (EU) 536/2014 and the role of ethics committees: a proposal for a review system model

Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and...

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Bibliographic Details
Published in:	BMJ open Vol. 14; no. 11; p. e073451
Main Authors:	Riva, Luciana, Petrini, Carlo
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 07.11.2024 BMJ Publishing Group LTD BMJ Publishing Group
Subjects:	Clinical medicine Clinical Trial Clinical trials Clinical Trials as Topic Committees Communication Compliance Corporate sponsorship Ethics Ethics (see Medical Ethics) Ethics Committees - ethics Ethics Committees - legislation & jurisprudence Human subjects Informed consent Law (see Medical Law) Medical research Models, Theoretical Regulation Research Design - legislation & jurisprudence Social Control, Formal Validation Studies as Topic Clinical Trial Law (see Medical Law) Ethics (see Medical Ethics)
ISSN:	2044-6055, 2044-6055
Online Access:	Get full text
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