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1
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0037417240
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The therapeutic orientation to clinical trials
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Miller FG, Rosenstein DL. The therapeutic orientation to clinical trials. N Engl J Med 2003; 348:1383-1386.
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(2003)
N Engl J Med
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, pp. 1383-1386
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Miller, F.G.1
Rosenstein, D.L.2
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2
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0036072666
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Medical research in clinical emergency settings in Europe
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Lötjönen S. Medical research in clinical emergency settings in Europe. J Med Ethics 2002; 28:183-187.
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(2002)
J Med Ethics
, vol.28
, pp. 183-187
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Lötjönen, S.1
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3
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0028927463
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Levine RJ. Research in emergency situations: the role of deferred consent. JAMA 1995; 273:1300-1302.
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Levine RJ. Research in emergency situations: the role of deferred consent. JAMA 1995; 273:1300-1302.
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4
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33751508458
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Lemaire F. The inability to consent in critical care research: emergency or impairment of cognitive function? Intensive Care Med 2006; 32:1930-1932. This is an editorial to an article [24] on research on patients unable to consent and the distinction between two possibilities: first, when there is no time for granting consent (emergency) and second when patients' cognitive function is impaired.
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Lemaire F. The inability to consent in critical care research: emergency or impairment of cognitive function? Intensive Care Med 2006; 32:1930-1932. This is an editorial to an article [24] on research on patients unable to consent and the distinction between two possibilities: first, when there is no time for granting consent (emergency) and second when patients' cognitive function is impaired.
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5
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33847262352
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Hearn J, Sullivan R. The impact of the 'Clinical Trials' directive on the cost and conduct of noncommercial cancer trials in the UK. 2007. Eur J Cancer 2006; Nov 20 [Epub ahead of print]. This article shows how cancer research promoted by academia is suffering after implementation of directive 2001/20/CE; since 2004, costs have doubled and the number of new trials has declined.
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Hearn J, Sullivan R. The impact of the 'Clinical Trials' directive on the cost and conduct of noncommercial cancer trials in the UK. 2007. Eur J Cancer 2006; Nov 20 [Epub ahead of print]. This article shows how cancer research promoted by academia is suffering after implementation of directive 2001/20/CE; since 2004, costs have doubled and the number of new trials has declined.
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6
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0028963589
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Biros MH, Lewis RJ, Olson CM, et al. Informed consent in emergency research: Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Research. JAMA 1995; 273:1283-1287.
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Biros MH, Lewis RJ, Olson CM, et al. Informed consent in emergency research: Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Research. JAMA 1995; 273:1283-1287.
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7
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33750203265
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Silverman H, Lemaire F. Ethics and research in critical care. Intensive Care Med 2006; 32:1697-1705. Specificities of critical care research (including emergency research), from the points of view of ethics and legislation; a special analysis of the risk/benefit balance: the so called component analysis.
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Silverman H, Lemaire F. Ethics and research in critical care. Intensive Care Med 2006; 32:1697-1705. Specificities of critical care research (including emergency research), from the points of view of ethics and legislation; a special analysis of the risk/benefit balance: the so called component analysis.
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8
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0033579126
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Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: A randomized controlled efficacy trial
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Sloan EP, Koenigsberg M, Gens D, et al. Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: a randomized controlled efficacy trial. JAMA 1999; 282:1857-1864.
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(1999)
JAMA
, vol.282
, pp. 1857-1864
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Sloan, E.P.1
Koenigsberg, M.2
Gens, D.3
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9
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22744458546
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A detailed description of a trial on resuscitation during cardiac arrest and the implications of the US federal regulations on emergency research
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Cone DC, O'Connor RE. Are US informed consent requirements driving resuscitation research overseas? Resuscitation 2005; 66:141-148. A detailed description of a trial on resuscitation during cardiac arrest and the implications of the US federal regulations on emergency research.
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(2005)
Are US informed consent requirements driving resuscitation research overseas? Resuscitation
, vol.66
, pp. 141-148
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Cone, D.C.1
O'Connor, R.E.2
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10
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11144355628
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Conducting research using the emergency exception from informed consent: The Public Access Defibrillation (PAD) Trial experience
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Mosesso JVN, Brown LH, Greene HL, et al. Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience. Resuscitation 2004; 61:29-36.
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(2004)
Resuscitation
, vol.61
, pp. 29-36
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Mosesso, J.V.N.1
Brown, L.H.2
Greene, H.L.3
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11
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0037225183
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Protecting research subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community
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Shah AN, Sugarman J. Protecting research subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community. Ann Emerg Med 2003; 41:72-74.
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(2003)
Ann Emerg Med
, vol.41
, pp. 72-74
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Shah, A.N.1
Sugarman, J.2
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12
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33750608423
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McKenna M. PolyHeme and the ethics of informed consent. Ann Emerg Med 2006; 48:563-566. New difficulties with the US regulation on emergency research and its 2006 revision; specifically, media reports of misconduct concerning a current blood substitute trial.
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McKenna M. PolyHeme and the ethics of informed consent. Ann Emerg Med 2006; 48:563-566. New difficulties with the US regulation on emergency research and its 2006 revision; specifically, media reports of misconduct concerning a current blood substitute trial.
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13
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33747884773
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Nichol G, Powell J, van Ottingham L, et al. Consent in resuscitation trials: Benefit or harm for patients and society? Resuscitation 2006; 70:360-368. An article describing the harm to research that allowing withdrawal of data could induce.
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Nichol G, Powell J, van Ottingham L, et al. Consent in resuscitation trials: Benefit or harm for patients and society? Resuscitation 2006; 70:360-368. An article describing the harm to research that allowing withdrawal of data could induce.
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14
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1842430968
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Impracticability of informed consent in the Registry of the Canadian Stroke Network
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and the Investigators in the Registry of the Canadian Stroke Network
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Tu JV, Willison DJ, Silver FL, et al., and the Investigators in the Registry of the Canadian Stroke Network. Impracticability of informed consent in the Registry of the Canadian Stroke Network. N Engl J Med 2004; 350:1414-1421.
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(2004)
N Engl J Med
, vol.350
, pp. 1414-1421
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Tu, J.V.1
Willison, D.J.2
Silver, F.L.3
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15
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32844455840
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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
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The enforcement of HIPAA regulation in the US has jeopardized data research; a well documented example
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Kompanje E, Maas A. 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 Med 2006; 32:313-314. The enforcement of HIPAA regulation in the US has jeopardized data research; a well documented example.
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(2006)
Intensive Care Med
, vol.32
, pp. 313-314
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Kompanje, E.1
Maas, A.2
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16
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0037129618
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Implications of the EU directive on clinical trials for emergency medicine
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Singer EA, Müllner M. Implications of the EU directive on clinical trials for emergency medicine. BMJ 2002; 324:1169-1170.
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(2002)
BMJ
, vol.324
, pp. 1169-1170
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Singer, E.A.1
Müllner, M.2
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17
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0035901242
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Non therapeutic research in the EU in adults incapable of giving consent?
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Visser H. Non therapeutic research in the EU in adults incapable of giving consent? Lancet 2001; 357:818-819.
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(2001)
Lancet
, vol.357
, pp. 818-819
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Visser, H.1
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18
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18744409613
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The European Union Directive on Clinical Research: Present status of implementation in EU member states' legislations with regard to the incompetent patient
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Lemaire F, Bion J, Blanco J, et al. 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 2005; 31:476-479.
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(2005)
Intensive Care Med
, vol.31
, pp. 476-479
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Lemaire, F.1
Bion, J.2
Blanco, J.3
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19
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33645839880
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Liddell K, Chamberlain D, Menon DK, et al. The European Clinical Trials Directive revisited: The VISEAR recommendations. Resuscitation 2006; 69:9-16. This is a systematic and documented analysis of the hurdles Directive 2001/20/CE imposes now to academic research.
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Liddell K, Chamberlain D, Menon DK, et al. The European Clinical Trials Directive revisited: The VISEAR recommendations. Resuscitation 2006; 69:9-16. This is a systematic and documented analysis of the hurdles Directive 2001/20/CE imposes now to academic research.
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20
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1342289565
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Informed consent for randomised controlled trials in critically ill patients: The case of septic shock
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Annane D, Outin H, Fisch C, Bellissant E. Informed consent for randomised controlled trials in critically ill patients: the case of septic shock. Intensive Care Med 2004; 30:321-324.
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(2004)
Intensive Care Med
, vol.30
, pp. 321-324
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Annane, D.1
Outin, H.2
Fisch, C.3
Bellissant, E.4
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21
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21244476405
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Ethical considerations on consent procedures for emergency research in severe and moderate traumatic brain injury
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Kompanje E, Maas A, Hilhorst M, et al. Ethical considerations on consent procedures for emergency research in severe and moderate traumatic brain injury. Acta Neurochir 2005; 147:633-639.
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(2005)
Acta Neurochir
, vol.147
, pp. 633-639
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Kompanje, E.1
Maas, A.2
Hilhorst, M.3
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22
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8644255839
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Research in emergency situations: With or without relatives consent
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Crash Trial Management Group
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Crash Trial Management Group. Research in emergency situations: with or without relatives consent. Emerg Med J 2004; 21:703.
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(2004)
Emerg Med J
, vol.21
, pp. 703
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23
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23444461703
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Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): A randomised controlled trial
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Harvey S, Harrison DA, Singer M, et al. Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Lancet 2005; 366:472-477.
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(2005)
Lancet
, vol.366
, pp. 472-477
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Harvey, S.1
Harrison, D.A.2
Singer, M.3
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24
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33750223042
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Informed consent in clinical trials in critical care: Experience from the PAC-Man Study
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This study showed that deferred or surrogate consent is workable in emergency setting and that patients themselves, if and once they recover, agree on what was done on their behalf
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Harvey S, Elbourne D, Ashcroft J, et al. Informed consent in clinical trials in critical care: experience from the PAC-Man Study. Intensive Care Med 2006; 32:2020-2025. This study showed that deferred or surrogate consent is workable in emergency setting and that patients themselves, if and once they recover, agree on what was done on their behalf.
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(2006)
Intensive Care Med
, vol.32
, pp. 2020-2025
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Harvey, S.1
Elbourne, D.2
Ashcroft, J.3
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25
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26944451326
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Consent in emergency research: New regulations
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Coats TJ, Shakur H. Consent in emergency research: new regulations. Emerg Med J 2005; 22:683-685.
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(2005)
Emerg Med J
, vol.22
, pp. 683-685
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Coats, T.J.1
Shakur, H.2
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27
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33847255259
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Clinical research in Italy in adult patients unable to consent: After implementation of the European Union's Directive 2001/20/CE
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Nov 30 [Epub ahead of print, This describes the current situation in Italy
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Wiedermann C, Almici M, Mangione S, et al. Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE. Intensive Care Med 2006; Nov 30 [Epub ahead of print]. This describes the current situation in Italy.
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(2006)
Intensive Care Med
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Wiedermann, C.1
Almici, M.2
Mangione, S.3
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28
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33750219045
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Changes in the Dutch law on medical research
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This describes an improvement of the situation in The Netherlands and the efficacy of specialists lobbying
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van der Voort P, van Dijk Y, Kesecioglu J. Changes in the Dutch law on medical research. Intensive Care Med 2006; 32:1906-1907. This describes an improvement of the situation in The Netherlands and the efficacy of specialists lobbying.
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(2006)
Intensive Care Med
, vol.32
, pp. 1906-1907
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van der Voort, P.1
van Dijk, Y.2
Kesecioglu, J.3
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29
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0041365228
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California's new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity
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Luce J. California's new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity. Intensive Care Med 2003; 29:1024-1025.
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(2003)
Intensive Care Med
, vol.29
, pp. 1024-1025
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Luce, J.1
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