Literature DB >> 17136516

Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE.

Christian J Wiedermann, Mauro Almici, Salvatore Mangione, Antonello Giarratano, Oswald Mayr.   

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Year:  2006        PMID: 17136516     DOI: 10.1007/s00134-006-0458-1

Source DB:  PubMed          Journal:  Intensive Care Med        ISSN: 0342-4642            Impact factor:   17.440


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  15 in total

1.  Implications of the EU directive on clinical trials for emergency medicine.

Authors:  Ernst A Singer; Marcus Müllner
Journal:  BMJ       Date:  2002-05-18

2.  The European Directive: a further blow to science in intensive care medicine in Austria.

Authors:  Christiane Druml; Ernst A Singer
Journal:  Intensive Care Med       Date:  2003-12-19       Impact factor: 17.440

3.  The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis.

Authors:  Henry J Silverman; Christiane Druml; Francois Lemaire; Robert Nelson
Journal:  Intensive Care Med       Date:  2004-06-30       Impact factor: 17.440

4.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

5.  The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient.

Authors:  F Lemaire; J Bion; J Blanco; P Damas; C Druml; K Falke; J Kesecioglu; A Larsson; J Mancebo; D Matamis; A Pesenti; J Pimentel; M Ranieri
Journal:  Intensive Care Med       Date:  2005-02-15       Impact factor: 17.440

6.  Recommendations in relation to the EU clinical trials directive and medical research involving incapacitated adults.

Authors:  Kathleen Liddell; Erwin J O Kompanje; François Lemaire; Bozidar Vrhovac; David K Menon; Julian Bion; Douglas Chamberlain; Christian J Wiedermann; Christiane Druml
Journal:  Wien Klin Wochenschr       Date:  2006-04       Impact factor: 1.704

7.  The European Clinical Trials Directive revisited: the VISEAR recommendations.

Authors:  Kathleen Liddell; Douglas Chamberlain; David K Menon; Julian Bion; Erwin J O Kompanje; François Lemaire; Christiane Druml; Bozidar Vrhovac; Christian J Wiedermann; Fritz Sterz
Journal:  Resuscitation       Date:  2006-03-02       Impact factor: 5.262

8.  Harmful impact of EU clinical trials directive.

Authors:  Akseli Hemminki; Pirkko-Liisa Kellokumpu-Lehtinen
Journal:  BMJ       Date:  2006-03-04

9.  [Harmonisation of regulatory requirements for clinical trials on medicinal products for human use in the Directive 2001/20/EC and complementary guidance. Implementation of the 12th Law Amending the German Drug Law].

Authors:  I Geisler; H-P Hofmann; L Nickel
Journal:  Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz       Date:  2005-02       Impact factor: 1.513

10.  [European guideline for the quality of non-commercial clinical trials: elegant implementation in the Netherlands via the amended Dutch Medical Research Involving Human Subjects Act].

Authors:  A F Cohen
Journal:  Ned Tijdschr Geneeskd       Date:  2003-08-02
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  2 in total

Review 1.  Medical research in emergency research in the European Union member states: tensions between theory and practice.

Authors:  Erwin J O Kompanje; Andrew I R Maas; David K Menon; Jozef Kesecioglu
Journal:  Intensive Care Med       Date:  2014-02-26       Impact factor: 17.440

2.  Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not?

Authors:  T C Jansen; E J O Kompanje; C Druml; D K Menon; C J Wiedermann; J Bakker
Journal:  Intensive Care Med       Date:  2007-03-07       Impact factor: 17.440

  2 in total

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