Journal of Medical Ethics 39 (6):408-409 (2013)

Authors
Marcin Waligora
Jagiellonian University
Abstract
On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial assessment. However, it seems that we probably have already lost our chance regarding the consistency and quality of functioning of research ethics committees in the EU
Keywords Regional Ethics Committees  Ethics Commision  Clinical Trials Directive
Categories (categorize this paper)
DOI 10.1136/medethics-2012-101228
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 60,901
Through your library

References found in this work BETA

Emergency Research Without Consent Under Polish Law.Joanna Różyńska & Marek Czarkowski - 2007 - Science and Engineering Ethics 13 (3):337-350.

Add more references

Citations of this work BETA

Add more citations

Similar books and articles

The Protection of Patients' Rights in Clinical Trials.Marek Czarkowski - 2006 - Science and Engineering Ethics 12 (1):131-138.
Uncertainty and the Ethics of Clinical Trials.Sven Ove Hansson - 2006 - Theoretical Medicine and Bioethics 27 (2):149-167.
The Research Misconception.Maurie Markman - 2004 - International Journal of Applied Philosophy 18 (2):241-252.
Informed Consent in Emergency Research: A Contradiction in Terms.Malcolm G. Booth - 2007 - Science and Engineering Ethics 13 (3):351-359.

Analytics

Added to PP index
2012-12-09

Total views
28 ( #382,509 of 2,439,108 )

Recent downloads (6 months)
1 ( #434,440 of 2,439,108 )

How can I increase my downloads?

Downloads

My notes