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Volumn 13, Issue 3, 2007, Pages 371-381

'No time to be lost!' Ethical considerations on consent for inclusion in emergency pharmacological research in severe traumatic brain injury in the European Union

Author keywords

Clinical ethics; Deferred consent; Pharmacological trial; Proxy consent; Traumatic brain injury; Waiver of consent

Indexed keywords

NEUROPROTECTIVE AGENT;

EID: 38349194837     PISSN: 13533452     EISSN: 16605454     Source Type: Journal    
DOI: 10.1007/s11948-007-9027-4     Document Type: Article
Times cited : (12)

References (47)
  • 2
    • 0033015939 scopus 로고    scopus 로고
    • Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations
    • Maas, A. I. R., Steyerberg, E. W., & Murray, G. D. (1999). Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations. Neurosurgery, 44, 1286-1298.
    • (1999) Neurosurgery , vol.44 , pp. 1286-1298
    • Maas, A.I.R.1    Steyerberg, E.W.2    Murray, G.D.3
  • 3
    • 38349122529 scopus 로고    scopus 로고
    • European Union Directive 2001/20/EC of the European Parliament and 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
    • European Union (2001) Directive 2001/20/EC of the European Parliament and 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. Oficial Journal of the European Community L 121/34.
    • (2001) Oficial Journal of the European Community L , vol.121 , Issue.34
  • 4
    • 0742320298 scopus 로고    scopus 로고
    • 'Treat first, ask later?' Emergency research in acute neurology and neurotraumatology in the European Union
    • Kompanje, E. J. O., & Maas, A. I. R. (2004). 'Treat first, ask later?' Emergency research in acute neurology and neurotraumatology in the European Union. Intensive Care Medicine, 30, 168-169.
    • (2004) Intensive Care Medicine , vol.30 , pp. 168-169
    • Kompanje, E.J.O.1    Maas, A.I.R.2
  • 5
    • 4644350368 scopus 로고    scopus 로고
    • The European Union directive and the protection of incapacitated subjects in research: An ethical analysis
    • Silverman, H. J., Druml, C., Lemaire, F., & Nelson, R. (2004). The European Union directive and the protection of incapacitated subjects in research: An ethical analysis. Intensive Care Medicine, 30, 1723-1729.
    • (2004) Intensive Care Medicine , vol.30 , pp. 1723-1729
    • Silverman, H.J.1    Druml, C.2    Lemaire, F.3    Nelson, R.4
  • 7
    • 0035901242 scopus 로고    scopus 로고
    • Non-therapeutic research in the EU in adults incapable of giving consent?
    • Visser, H. K. A. (2001). Non-therapeutic research in the EU in adults incapable of giving consent? The Lancet, 357, 818-819.
    • (2001) The Lancet , vol.357 , pp. 818-819
    • Visser, H.K.A.1
  • 8
    • 0036072609 scopus 로고    scopus 로고
    • Implementation of the clinical trials directive: Pitfalls and benefits
    • Baeyens, A. J. (2002). Implementation of the clinical trials directive: Pitfalls and benefits. European Journal of Health Law, 9, 31-47.
    • (2002) European Journal of Health Law , vol.9 , pp. 31-47
    • Baeyens, A.J.1
  • 9
    • 18744409613 scopus 로고    scopus 로고
    • The European Union directive on clinical research: Present status of implementation in EU member states' legislation with regard to the incompetent patient
    • Lemaire, F., Bion, J., Blanco, J., Damas, P., Druml, C.,& Falke, K. L. (2005). The European Union directive on clinical research: Present status of implementation in EU member states' legislation with regard to the incompetent patient. Intensive Care Medicine, 31, 476-479.
    • (2005) Intensive Care Medicine , vol.31 , pp. 476-479
    • Lemaire, F.1    Bion, J.2    Blanco, J.3    Damas, P.4    Druml, C.5    Falke, K.L.6
  • 11
    • 0042825896 scopus 로고    scopus 로고
    • Klinisch geneesmiddelenonderzoek bij acuut beslissingsonbekwame patiënten in de neurologie en de neurochirurgie; Implicaties van nieuwe Europese regelgeving
    • Kompanje, E. J. O., Maas, A. I. R., & Dippel, D. W. J. (2003). Klinisch geneesmiddelenonderzoek bij acuut beslissingsonbekwame patiënten in de neurologie en de neurochirurgie; implicaties van nieuwe Europese regelgeving. Nederlands Tijdschrift voor Geneeskunde, 147, 1585-1589.
    • (2003) Nederlands Tijdschrift voor Geneeskunde , vol.147 , pp. 1585-1589
    • Kompanje, E.J.O.1    Maas, A.I.R.2    Dippel, D.W.J.3
  • 12
    • 21244476405 scopus 로고    scopus 로고
    • Ethical considerations on consent procedures for emergency research in severe and moderate traumatic brain injury
    • Kompanje, E. J. O., Maas, A. I. R., Hilhorst, M. T., Slieker, F. J. A., & Teasdale, G. M. (2005). Ethical considerations on consent procedures for emergency research in severe and moderate traumatic brain injury. Acta Neurochirurgica, 147, 633-640.
    • (2005) Acta Neurochirurgica , vol.147 , pp. 633-640
    • Kompanje, E.J.O.1    Maas, A.I.R.2    Hilhorst, M.T.3    Slieker, F.J.A.4    Teasdale, G.M.5
  • 13
    • 14944375041 scopus 로고    scopus 로고
    • Collateral damage or apocalypse now for European academic research
    • Singer, E. A., & Druml, C. (2005). Collateral damage or apocalypse now for European academic research. Intensive Care Medicine, 31, 271.
    • (2005) Intensive Care Medicine , vol.31 , pp. 271
    • Singer, E.A.1    Druml, C.2
  • 14
    • 0242593847 scopus 로고    scopus 로고
    • A European directive for clinical research
    • Lemaire, F. J. P. (2003). A European directive for clinical research. Intensive Care Medicine, 29, 1818-1820.
    • (2003) Intensive Care Medicine , vol.29 , pp. 1818-1820
    • Lemaire, F.J.P.1
  • 16
    • 10244255015 scopus 로고    scopus 로고
    • Informed consent of incapable (ICU) patients in Europe: Existing laws and the EU directive
    • Druml, C. (2004). Informed consent of incapable (ICU) patients in Europe: Existing laws and the EU directive. Current Opinion Critical Care, 10, 570-573.
    • (2004) Current Opinion Critical Care , vol.10 , pp. 570-573
    • Druml, C.1
  • 17
    • 23044476283 scopus 로고    scopus 로고
    • Will ethical requirements bring critical care research to a halt?
    • Truog, R. D. (2005). Will ethical requirements bring critical care research to a halt? Intensive Care Medicine, 31, 338-344.
    • (2005) Intensive Care Medicine , vol.31 , pp. 338-344
    • Truog, R.D.1
  • 18
    • 29844439586 scopus 로고    scopus 로고
    • Further restrictions for ICU research
    • Klepsted, P., & Dale, O. (2006). Further restrictions for ICU research. Intensive Care Medicine, 32, 175.
    • (2006) Intensive Care Medicine , vol.32 , pp. 175
    • Klepsted, P.1    Dale, O.2
  • 19
  • 20
    • 33646888204 scopus 로고    scopus 로고
    • ICU research in Denmark: Difficult but possible
    • Larsson, A., & Tønnesen, E. (2006). ICU research in Denmark: Difficult but possible. Intensive Care Medicine, 32, 934.
    • (2006) Intensive Care Medicine , vol.32 , pp. 934
    • Larsson, A.1    Tønnesen, E.2
  • 21
    • 38349194541 scopus 로고    scopus 로고
    • The Working Party for Implementation of Directive 2001/20/EC Ministry of Welfare and Sport
    • The Working Party for Implementation of Directive 2001/20/EC (2005). Clinical Research with medicinal products in the Netherlands. Ministry of Welfare and Sport.
    • (2005) Clinical Research with Medicinal Products in the Netherlands
  • 22
    • 0034075541 scopus 로고    scopus 로고
    • Patients preferences concerning medical information and surrogacy: Results of a prospective study in a French emergency department
    • Roupie, E., Santin, A., Boulme, R., Wartel, J. S., Lepage, E., Lemaire, F., Lejonc, J. L., & Montagne, O. (2000). Patients preferences concerning medical information and surrogacy: Results of a prospective study in a French emergency department. Intensive Care Medicine, 26, 52-56.
    • (2000) Intensive Care Medicine , vol.26 , pp. 52-56
    • Roupie, E.1    Santin, A.2    Boulme, R.3    Wartel, J.S.4    Lepage, E.5    Lemaire, F.6    Lejonc, J.L.7    Montagne, O.8
  • 23
    • 0035116532 scopus 로고    scopus 로고
    • Do surrogate decision makers provide accurate consent for intensive care research?
    • Coppolino, M., & Ackerson, L. (2001). Do surrogate decision makers provide accurate consent for intensive care research? Chest, 119, 603-612.
    • (2001) Chest , vol.119 , pp. 603-612
    • Coppolino, M.1    Ackerson, L.2
  • 24
    • 0028291847 scopus 로고
    • More talk, less paper: Predicting the accuracy of substituted judgments
    • Sulmasy, D. P., Haller, K., & Terry, P. B. (1994). More talk, less paper: Predicting the accuracy of substituted judgments. American Journal of Medicine, 96, 432-438.
    • (1994) American Journal of Medicine , vol.96 , pp. 432-438
    • Sulmasy, D.P.1    Haller, K.2    Terry, P.B.3
  • 25
    • 0035189947 scopus 로고    scopus 로고
    • Patients experiences of intervention trials on the treatment of myocardial infarction: Is it time to adjust the informed consent procedure to the patients capacity?
    • Ågård, A., Hermerén, G., & Herlitz, J. (2001). Patients experiences of intervention trials on the treatment of myocardial infarction: Is it time to adjust the informed consent procedure to the patients capacity? Heart, 86, 632-637.
    • (2001) Heart , vol.86 , pp. 632-637
    • Ågård, A.1    Hermerén, G.2    Herlitz, J.3
  • 26
    • 0034676823 scopus 로고    scopus 로고
    • Obtaining informed consent to neonatal randomised controlled trials: Interviews with parents and clinicians in the Euricon study
    • Mason, S. A., & Allmark, P. J. (2000). Obtaining informed consent to neonatal randomised controlled trials: Interviews with parents and clinicians in the Euricon study. The Lancet, 356, 2045-2051.
    • (2000) The Lancet , vol.356 , pp. 2045-2051
    • Mason, S.A.1    Allmark, P.J.2
  • 27
    • 0036798944 scopus 로고    scopus 로고
    • Waiver of consent in studies of acute brain injury
    • Clifton, G. L., Knudson, P., & McDonald, M. (2002). Waiver of consent in studies of acute brain injury. Journal of Neurotrauma, 19, 1121-1126.
    • (2002) Journal of Neurotrauma , vol.19 , pp. 1121-1126
    • Clifton, G.L.1    Knudson, P.2    McDonald, M.3
  • 28
    • 0742274715 scopus 로고    scopus 로고
    • Necessary time to achive next of kin proxy consent for acutely injured altered status patients
    • Wright, D. W., Lancaster, R. T., & Lowery, D. W. (2001). Necessary time to achive next of kin proxy consent for acutely injured altered status patients. Academic Emergency Medicine, 8, 419-420.
    • (2001) Academic Emergency Medicine , vol.8 , pp. 419-420
    • Wright, D.W.1    Lancaster, R.T.2    Lowery, D.W.3
  • 29
    • 8644255839 scopus 로고    scopus 로고
    • Research in emergency situations: With or without relatives consent
    • CRASH trial management group
    • CRASH trial management group. (2004). Research in emergency situations: With or without relatives consent. Emergency Medicine Journal, 21, 703.
    • (2004) Emergency Medicine Journal , vol.21 , pp. 703
  • 30
    • 0037350241 scopus 로고    scopus 로고
    • Is the concept of informed consent applicable to clinical research involving critically ill patients?
    • Suppl.
    • Luce, J. M. (2003). Is the concept of informed consent applicable to clinical research involving critically ill patients? Critical Care Medicine, 31(Suppl.), S153-S160.
    • (2003) Critical Care Medicine , vol.31
    • Luce, J.M.1
  • 31
    • 0034910146 scopus 로고    scopus 로고
    • Surrogate consent by family members for out-of-hospital cardiac arrest research
    • Hsieh, M., Dailey, M. W., & Callaway, C. W. (2001). Surrogate consent by family members for out-of-hospital cardiac arrest research. Academic Emergency Medicine, 8, 851-853.
    • (2001) Academic Emergency Medicine , vol.8 , pp. 851-853
    • Hsieh, M.1    Dailey, M.W.2    Callaway, C.W.3
  • 32
    • 0037351813 scopus 로고    scopus 로고
    • Ethical considerations for research in critically ill patients
    • Bigatello, L. M., George, E., & Hurford, W. E. (2003). Ethical considerations for research in critically ill patients. Critical Care Medicine, 31, S178-S181.
    • (2003) Critical Care Medicine , vol.31
    • Bigatello, L.M.1    George, E.2    Hurford, W.E.3
  • 33
    • 0033740087 scopus 로고    scopus 로고
    • Proxy informed consent in pediatric research: A review
    • Cuttini, M. (2000). Proxy informed consent in pediatric research: A review. Early Human Development, 60, 89-100.
    • (2000) Early Human Development , vol.60 , pp. 89-100
    • Cuttini, M.1
  • 34
    • 0033941825 scopus 로고    scopus 로고
    • Is the emperor really wearing new clothes? Informed consent for acute coronary syndromes
    • Sugarman, J. (2000). Is the emperor really wearing new clothes? Informed consent for acute coronary syndromes. American Heart Journal, 140, 2-3.
    • (2000) American Heart Journal , vol.140 , pp. 2-3
    • Sugarman, J.1
  • 35
    • 0037443839 scopus 로고    scopus 로고
    • Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): A prospective observational study
    • Williams, B. F., French, J. K., & White, H. D. (2003). Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): A prospective observational study. The Lancet, 361, 918-922.
    • (2003) The Lancet , vol.361 , pp. 918-922
    • Williams, B.F.1    French, J.K.2    White, H.D.3
  • 36
    • 0029058996 scopus 로고
    • Parental perceptions and attitudes about informed consent in clinical research involving children
    • Harth, S. C., & Thong, Y. H. (1995). Parental perceptions and attitudes about informed consent in clinical research involving children. Social Science and Medicine, 40, 1573-1577.
    • (1995) Social Science and Medicine , vol.40 , pp. 1573-1577
    • Harth, S.C.1    Thong, Y.H.2
  • 37
    • 0037387799 scopus 로고    scopus 로고
    • Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation and public notification
    • McClure, K. B., Delorio, N. M., Gunnels, M. D., Ochsner, M. J., Biros, M. H., & Schmidt, T. A. (2003). Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation and public notification. Academic Emergency Medicine, 10, 352-359.
    • (2003) Academic Emergency Medicine , vol.10 , pp. 352-359
    • McClure, K.B.1    Delorio, N.M.2    Gunnels, M.D.3    Ochsner, M.J.4    Biros, M.H.5    Schmidt, T.A.6
  • 38
    • 27144559205 scopus 로고    scopus 로고
    • Stroke patients preferences and values about emergency research
    • Blixen, C. E., & Agich, G. J. (2005). Stroke patients preferences and values about emergency research. Journal of Medical Ethics, 31, 608-661.
    • (2005) Journal of Medical Ethics , vol.31 , pp. 608-661
    • Blixen, C.E.1    Agich, G.J.2
  • 40
    • 29044436727 scopus 로고    scopus 로고
    • Efficacy and safety of dexanabinol in sever traumatic brain injury: Results of a phase III randomized placebo controlled clinical trial
    • Maas, A. I. R., Murray, G., Henney, H., Kassem, N., Legrand, V., Mangelus, M., Muizelaar, J. P., Stocchetti, N., Knoller, N, on behalf of the Pharmos TBI Investigators. (2006). Efficacy and safety of dexanabinol in sever traumatic brain injury: Results of a phase III randomized placebo controlled clinical trial. The Lancet-Neurology, 5, 38-45.
    • (2006) The Lancet-neurology , vol.5 , pp. 38-45
    • Maas, A.I.R.1    Murray, G.2    Henney, H.3    Kassem, N.4    Legrand, V.5    Mangelus, M.6    Muizelaar, J.P.7    Stocchetti, N.8    Knoller, N.9
  • 41
    • 0022978408 scopus 로고
    • Cerebral protection
    • Hoff, J. T. (1986). Cerebral protection. Journal of Neurosurgery, 65, 579-591.
    • (1986) Journal of Neurosurgery , vol.65 , pp. 579-591
    • Hoff, J.T.1
  • 42
    • 0028920429 scopus 로고
    • Long-term effect of HU-211, a novel competitive NMDA antagonist, on motor and memory functions after closed head injury in the rat
    • Shohami, E. (1995). Long-term effect of HU-211, a novel competitive NMDA antagonist, on motor and memory functions after closed head injury in the rat. Brain Research, 674, 55-56.
    • (1995) Brain Research , vol.674 , pp. 55-56
    • Shohami, E.1
  • 43
    • 34347326048 scopus 로고    scopus 로고
    • Ethical implications of time frames in a randomized controlled trial in severe traumatic brain injury
    • Kompanje, E. J. O., Maas, A. I. R., Slieker, F. J. A., & Stocchetti, N. (2007). Ethical implications of time frames in a randomized controlled trial in severe traumatic brain injury. Progress Brain Research, 161, 237-244.
    • (2007) Progress Brain Research , vol.161 , pp. 237-244
    • Kompanje, E.J.O.1    Maas, A.I.R.2    Slieker, F.J.A.3    Stocchetti, N.4
  • 44
    • 32844455840 scopus 로고    scopus 로고
    • Is the Glasgow coma scale score protected health information? the effect of new United States regulations (HIPAA) on completion of screening logs in emergency research trials
    • Kompanje, E. J. O., & Maas, A. I. R. (2006). Is the Glasgow coma scale score protected health information? The effect of new United States regulations (HIPAA) on completion of screening logs in emergency research trials. Intensive Care Medicine, 32, 313-314.
    • (2006) Intensive Care Medicine , vol.32 , pp. 313-314
    • Kompanje, E.J.O.1    Maas, A.I.R.2
  • 45
    • 0035880156 scopus 로고    scopus 로고
    • Safeguarding patients in clinical trials with high mortality rates
    • Freeman, D. B. (2001). Safeguarding patients in clinical trials with high mortality rates. American Journal of Critical Care Medicine, 164, 190-192.
    • (2001) American Journal of Critical Care Medicine , vol.164 , pp. 190-192
    • Freeman, D.B.1
  • 46
    • 0034784681 scopus 로고    scopus 로고
    • Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: The Diaspirin cross-linked hemoglobin traumatic hemorrhagic shock efficacy trial
    • Lewis, R. J., Berry, D. A., Cryer, H., Fost, N., Krome, R., Washington, G. R., Houghton, J., Blue, J. W., Bechhofer, R., Cook, T., & Fisher, M. (2001). Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: The Diaspirin cross-linked hemoglobin traumatic hemorrhagic shock efficacy trial. Annals of Emergency Medicine, 38, 397-404.
    • (2001) Annals of Emergency Medicine , vol.38 , pp. 397-404
    • Lewis, R.J.1    Berry, D.A.2    Cryer, H.3    Fost, N.4    Krome, R.5    Washington, G.R.6    Houghton, J.7    Blue, J.W.8    Bechhofer, R.9    Cook, T.10    Fisher, M.11


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