Clinical research in critically ill patients: The situation in Italy

Intensive Care Medicine

Volumn 34, Issue 7, 2008, Pages 1330-1332

  Zamperetti, Nereo ^a   Latronico, Nicola ^b  

^a SAN BORTOLO HOSPITAL   (Italy)

^b UNIVERSITY OF BRESCIA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CRITICALLY ILL PATIENT; HUMAN; INFORMED CONSENT; INTENSIVE CARE UNIT; ITALY; LEGAL ASPECT; NOTE;

CLINICAL TRIALS AS TOPIC; CRITICAL ILLNESS; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; ITALY; MENTAL COMPETENCY;

EID: 46149105201     PISSN: 03424642     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00134-008-1096-6     Document Type: Note

References (25)

1. (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. Official J Eur Commun L 121:34-44
2. (2003) Attuazione della direttiva 2001/20/CE relativa all'applicazione della buona pratica clinica nell'esecuzione delle sperimentazioni cliniche di medicinali per uso clinico. Decreto legislativo 24/06/2003, no. 211
3. Stocchetti N, Dearden M, Karimi A, Lapierre F, Maas A, Murray GD, Ohman J, Persson L, Servadei F, Trojanowski T, Unterberg A (2004) New European directive on clinical trials: implications for traumatic head injury research. Intensive Care Med 30:517-518
4. Lemaire F (2002) European Society of Intensive Care Medicine statement. Clinical research in intensive care unit. Intensive Care Med 28:1218-1219
5. Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, Siegler M (1995) Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062-1072
6. Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31:S153-S160
7. Grande AM, Rinaldi M, Goggi C, Politi P, Vigano M (1998) Heart transplantation without informed consent: discussion of a case. Intensive Care Med 24:251-254
8. Lemaire F, Ferrand E (1998) Refusal of care in the ICU any meaning for doctors? Intensive Care Med 24:204-205
9. Appelbaum PS (2007) Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med 357:1834-1840
10. Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M (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
11. Veelo DP, Spronk PE, Kuiper MA, Korevaar JC, van der Voort PH, Schultz MJ (2006) A change in the Dutch Directive on Medical Research Involving Human Subjects strongly increases the number of eligible intensive care patients: an observational study. Intensive Care Med 32:1845-1850
12. Harvey SE, Elbourne D, Ashcroft J, Jones CM, Rowan K (2006) Informed consent in clinical trials in critical care: experience from the PAC-Man Study. Intensive Care Med 32:2020-2025
13. Ciroldi M, Cariou A, Adrie C, Annane D, Castelain V, Cohen Y, Delahaye A, Joly LM, Galliot R, Garrouste-Orgeas M, Papazian L, Michel F, Barnes NK, Schlemmer B, Pochard F, Azoulay E (2007) Ability of family members to predict patient's consent to critical care research. Intensive Care Med 33:807-813
14. Zamperetti N, Conti G (2004) New regulations for the care of the critically ill patients in Italy. Intensive Care Med 30:1660-1661
15. Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30:321-324
16. Clifton GL, Knudson P, McDonald M (2002) Waiver of consent in studies of acute brain injury. J Neurotrauma 19:1121-1126
17. Truog RD (2005) Will ethical requirements bring critical care research to a halt? Intensive Care Med 31:338-344
18. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI) (1986) Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet 1:397-402
19. Gattinoni L, Brazzi L, Pelosi P, Latini R, Tognoni G, Pesenti A, Fumagalli R (1995) A trial of goal-oriented hemodynamic therapy in critically ill patients. SvO2 Collaborative Group. N Engl J Med 333:1025-1032
20. Latronico N, Fenzi F, Recupero D, Guarneri B, Tomelleri G, Tonin P, de Maria G, Antonini L, Rizzuto N, Candiani A (1996) Critical illness myopathy and neuropathy. Lancet 347:1579-1582
21. Antonelli M, Conti G, Rocco M, Bufi M, de Blasi RA, Vivino G, Gasparetto A, Meduri GU (1998) A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med 339:429-435
22. Gattinoni L, Tognoni G, Pesenti A, Taccone P, Mascheroni D, Labarta V, Malacrida R, di Giulio P, Fumagalli R, Pelosi P, Brazzi L, Latini R (2001) Effect of prone positioning on the survival of patients with acute respiratory failure. N Engl J Med 345:568-573
23. Bertolini G, Iapichino G, Radrizzani D, Facchini R, Simini B, Bruzzone P, Zanforlin G, Tognoni G (2003) Early enteral immunonutrition in patients with severe sepsis: results of an interim analysis of a randomized multicentre clinical trial. Intensive Care Med 29:834-840
24. Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM (2005) Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. J Am Med Assoc 293:589-595
25. Council of Europe (2005) Additional Protocol to the Convention of Human Right and Biomedicine, concerning Biomedical Research, Strasbourg, 25 January 2005