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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Summary: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 of the Council explicitly recognised the ethics committees’ duty to protect the rights, safety and well-being of human subjects involved in trials and to provide public assurance of that protection. Regulation (EU) 536/2014, which repealed the aforesaid directive, provides that a clinical trial must be subjected to scientific and ethical review, without specifically defining what they consist in. The divide between the evaluation of the ethical value and the scientific value of a study is very faint and, for some, it may even appear a meaningless distinction. While Regulation (EU) 536/2014 requires Member States to ensure that ethics committees are involved in the assessment process within their national territory, it does not require such ethical assessment to be binding. This article proposes a possible system for interaction between ethics committees and local regulatory authorities in which the meaning and purpose of the ethical assessment are conceptually clearly defined and not narrow.
Bibliography:Communication
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None declared.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-073451