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Erschienen in: Intensive Care Medicine 7/2008

01.07.2008 | News

Clinical research in critically ill patients: the situation in Italy

verfasst von: Nereo Zamperetti, Nicola Latronico

Erschienen in: Intensive Care Medicine | Ausgabe 7/2008

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Excerpt

Clinical research in critically ill patients is a particularly complex issue, due to the frequent incompetence of such patients and their consequent inability to give valid consent. Under the European Parliamentary Directive 2001/20/EC, informed consent may be granted either by the patient or by the legal representative of the incompetent patient [1]. In Italy, a legislative decree gave implementation to such directive; yet, it failed to specify who should be identified as legal guardian [2]. Concerns have been expressed that such a directive would bring research to a halt in critically ill incompetent patients [3], i.e., the majority of ICU patients [4]. …
Literatur
1.
Zurück zum Zitat (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 (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.
Zurück zum Zitat (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 (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.
Zurück zum Zitat 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 30:517–518PubMedCrossRef 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 30:517–518PubMedCrossRef
4.
Zurück zum Zitat Lemaire F (2002) European Society of Intensive Care Medicine statement. Clinical research in intensive care unit. Intensive Care Med 28:1218–1219PubMedCrossRef Lemaire F (2002) European Society of Intensive Care Medicine statement. Clinical research in intensive care unit. Intensive Care Med 28:1218–1219PubMedCrossRef
5.
Zurück zum Zitat 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 13:1062–1072PubMed 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 13:1062–1072PubMed
6.
Zurück zum Zitat Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31:S153–S160PubMedCrossRef Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31:S153–S160PubMedCrossRef
7.
Zurück zum Zitat Grande AM, Rinaldi M, Goggi C, Politi P, Vigano M (1998) Heart transplantation without informed consent: discussion of a case. Intensive Care Med 24:251–254PubMedCrossRef Grande AM, Rinaldi M, Goggi C, Politi P, Vigano M (1998) Heart transplantation without informed consent: discussion of a case. Intensive Care Med 24:251–254PubMedCrossRef
8.
Zurück zum Zitat Lemaire F, Ferrand E (1998) Refusal of care in the ICU any meaning for doctors? Intensive Care Med 24:204–205PubMedCrossRef Lemaire F, Ferrand E (1998) Refusal of care in the ICU any meaning for doctors? Intensive Care Med 24:204–205PubMedCrossRef
9.
Zurück zum Zitat Appelbaum PS (2007) Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med 357:1834–1840PubMedCrossRef Appelbaum PS (2007) Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med 357:1834–1840PubMedCrossRef
10.
Zurück zum Zitat 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 31:476–479PubMedCrossRef 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 31:476–479PubMedCrossRef
11.
Zurück zum Zitat 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 32:1845–1850PubMedCrossRef 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 32:1845–1850PubMedCrossRef
12.
Zurück zum Zitat 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 32:2020–2025PubMedCrossRef 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 32:2020–2025PubMedCrossRef
13.
Zurück zum Zitat 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 33:807–813PubMedCrossRef 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 33:807–813PubMedCrossRef
14.
Zurück zum Zitat Zamperetti N, Conti G (2004) New regulations for the care of the critically ill patients in Italy. Intensive Care Med 30:1660–1661PubMed Zamperetti N, Conti G (2004) New regulations for the care of the critically ill patients in Italy. Intensive Care Med 30:1660–1661PubMed
15.
Zurück zum Zitat Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30:321–324PubMedCrossRef Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30:321–324PubMedCrossRef
16.
Zurück zum Zitat Clifton GL, Knudson P, McDonald M (2002) Waiver of consent in studies of acute brain injury. J Neurotrauma 19:1121–1126PubMedCrossRef Clifton GL, Knudson P, McDonald M (2002) Waiver of consent in studies of acute brain injury. J Neurotrauma 19:1121–1126PubMedCrossRef
17.
Zurück zum Zitat Truog RD (2005) Will ethical requirements bring critical care research to a halt? Intensive Care Med 31:338–344PubMedCrossRef Truog RD (2005) Will ethical requirements bring critical care research to a halt? Intensive Care Med 31:338–344PubMedCrossRef
18.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 333:1025–1032PubMedCrossRef 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 333:1025–1032PubMedCrossRef
20.
Zurück zum Zitat 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 347:1579–1582PubMedCrossRef 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 347:1579–1582PubMedCrossRef
21.
Zurück zum Zitat 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 339:429–435PubMedCrossRef 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 339:429–435PubMedCrossRef
22.
Zurück zum Zitat 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 345:568–573PubMedCrossRef 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 345:568–573PubMedCrossRef
23.
Zurück zum Zitat 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 29:834–840PubMedCrossRef 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 29:834–840PubMedCrossRef
24.
Zurück zum Zitat 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 293:589–595CrossRef 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 293:589–595CrossRef
25.
Zurück zum Zitat Council of Europe (2005) Additional Protocol to the Convention of Human Right and Biomedicine, concerning Biomedical Research, Strasbourg, 25 January 2005 Council of Europe (2005) Additional Protocol to the Convention of Human Right and Biomedicine, concerning Biomedical Research, Strasbourg, 25 January 2005
Metadaten
Titel
Clinical research in critically ill patients: the situation in Italy
verfasst von
Nereo Zamperetti
Nicola Latronico
Publikationsdatum
01.07.2008
Verlag
Springer-Verlag
Erschienen in
Intensive Care Medicine / Ausgabe 7/2008
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-008-1096-6

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