Clinical research into the ICU: Clouds at the horizon, once again

Intensive Care Medicine

Volumn 39, Issue 8, 2013, Pages 1479-1480

  Matei, Mihaela ^a   Kompanje, Erwin J O ^a   Maas, Andrew I R ^a   Menon, David K ^a   Lemaire, Francois ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); EDITORIAL; HUMAN; INFORMED CONSENT; INTENSIVE CARE UNIT; LAW; LEADERSHIP; MEDICAL ETHICS;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; EUROPEAN UNION; HUMANS; INFORMED CONSENT; INTENSIVE CARE UNITS;

EID: 84880305861     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-013-2974-0     Document Type: Editorial

References (7)

1. European commission (2001) 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
2. Lemaire F, Bion J, Blanco J et al (2005) The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med 31:476-479. doi: 10.1007/s00134-005-2574-8
3. Liddell K, Chamberlain D, Druml C, Kompanje EJO, Lemaire F, Menon DK, Vrhovac B, Widermann C (2006) Medical research involving incapacitated adults: implications of the EU clinical trials directive 2001/20/EC. Med Law Rev 14:367-417
4. Liddell K, Kompanje EJO, Lemaire F, Vrhovac B, Menon DK, Bion J, Chamberlain D, Wiedermann CJ, Druml C (2006) Recommendations in relation to the EU Clinical Trials Directive and Medical Research Involving Incapacitated Adults. Wien Klin Wochenschr 118:183-191
5. Liddel K, Chamberlain D, Menon DK, Bion J, Kompanje EJO, Lemaire F, Druml C, Vrhovac B, Wiedermann CJ, Sterz F (2006) The European Clinical Trials Directive revisited: the VISEAR recommendations. Resuscitation 69:9-14
6. Coats TJ, Shakur H (2005) Consent in emergency research: new regulations. Emergency Med J 22:683-685
7. European commission (2012) Regulation (proposal for a) of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC