TY - BOOK PY - 2000 DA - 2000// TI - Declaration of Helsinki: Ethical Principles for Medical Research involving Human Subjects. 5th revision. Edinburgh ID - ref1 ER - TY - STD TI - Directive 2001/20/EC of the European Parliament and of the Council of the 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 the medicinal products for human use In OJ. Volume L 121/34. ; 2000. 4 April 2001 ID - ref2 ER - TY - JOUR AU - Luce, J. M. PY - 2003 DA - 2003// TI - Is the concept of informed consent applicable to clinical research involving critically ill patients? JO - Crit Care Med VL - 31 UR - https://doi.org/10.1097/01.CCM.0000054901.80339.01 DO - 10.1097/01.CCM.0000054901.80339.01 ID - Luce2003 ER - TY - BOOK PY - 1979 DA - 1979// TI - The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research PB - US Government Printing Office CY - Washington, DC ID - ref4 ER - TY - JOUR AU - Etchells, E. AU - Sharpe, G. AU - Burgess, M. M. AU - Singer, P. A. PY - 1996 DA - 1996// TI - Bioethics for clinicians: 2. Disclosure JO - CMAJ VL - 155 ID - Etchells1996 ER - TY - JOUR AU - Etchells, E. AU - Sharpe, G. AU - Elliott, C. AU - Singer, P. A. PY - 1996 DA - 1996// TI - Bioethics for clinicians: 3. Capacity JO - CMAJ VL - 155 ID - Etchells1996 ER - TY - JOUR AU - Etchells, E. AU - Sharpe, G. AU - Dykeman, M. J. AU - Meslin, E. M. AU - Singer, P. A. PY - 1996 DA - 1996// TI - Bioethics for clinicians: 4. Voluntariness JO - CMAJ VL - 155 ID - Etchells1996 ER - TY - JOUR AU - Silverman, H. J. PY - 1996 DA - 1996// TI - Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients JO - Am J Respir Crit Care Med VL - 154 UR - https://doi.org/10.1164/ajrccm.154.3.8810590 DO - 10.1164/ajrccm.154.3.8810590 ID - Silverman1996 ER - TY - JOUR AU - Chenaud, C. AU - Merlani, P. AU - Ricou, B. PY - 2006 DA - 2006// TI - Informed consent for research in ICU obtained before ICU admission JO - Intensive Care Med VL - 32 UR - https://doi.org/10.1007/s00134-005-0059-4 DO - 10.1007/s00134-005-0059-4 ID - Chenaud2006 ER - TY - JOUR AU - Chenaud, C. AU - Merlani, P. G. AU - Roux-Lombard, P. AU - Burger, D. AU - Harbarth, S. AU - Luyasu, S. AU - Graf, J. D. AU - Dayer, J. M. AU - Ricou, B. PY - 2004 DA - 2004// TI - Low apolipoprotein A-I level at intensive care unit admission and systemic inflammatory response syndrome exacerbation JO - Crit Care Med VL - 32 UR - https://doi.org/10.1097/01.CCM.0000114820.47460.0A DO - 10.1097/01.CCM.0000114820.47460.0A ID - Chenaud2004 ER - TY - JOUR AU - Luce, J. M. AU - Cook, D. J. AU - Martin, T. R. AU - Angus, D. C. AU - Boushey, H. A. AU - Curtis, J. R. AU - Heffner, J. E. AU - Lanken, P. N. AU - Levy, M. M. AU - Polite, P. Y. AU - Rocker, G. M. AU - Truog, R. D. PY - 2004 DA - 2004// TI - The Ethical Conduct of Clinical Research Involving Critically Ill Patients in the United States and Canada: Principles and Recommendations JO - Am J Respir Crit Care Med VL - 170 UR - https://doi.org/10.1164/rccm.200406-726ST DO - 10.1164/rccm.200406-726ST ID - Luce2004 ER - TY - JOUR AU - Le Gall, J. R. AU - Lemeshow, S. AU - Saulnier, F. PY - 1993 DA - 1993// TI - A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study JO - JAMA VL - 270 UR - https://doi.org/10.1001/jama.1993.03510240069035 DO - 10.1001/jama.1993.03510240069035 ID - Le Gall1993 ER - TY - JOUR AU - Vincent, J. L. AU - de Mendonca, A. AU - Cantraine, F. AU - Moreno, R. AU - Takala, J. AU - Suter, P. M. AU - Sprung, C. L. AU - Colardyn, F. AU - Blecher, S. PY - 1998 DA - 1998// TI - Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on 'sepsis-related problems' of the European Society of Intensive Care Medicine JO - Crit Care Med VL - 26 UR - https://doi.org/10.1097/00003246-199811000-00016 DO - 10.1097/00003246-199811000-00016 ID - Vincent1998 ER - TY - JOUR AU - Williams, B. F. AU - French, J. K. AU - White, H. D. PY - 2003 DA - 2003// TI - Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study JO - Lancet VL - 361 UR - https://doi.org/10.1016/S0140-6736(03)12773-0 DO - 10.1016/S0140-6736(03)12773-0 ID - Williams2003 ER - TY - JOUR AU - Gammelgaard, A. AU - Mortensen, O. S. AU - Rossel, P. PY - 2004 DA - 2004// TI - Patients' perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial JO - Heart VL - 90 UR - https://doi.org/10.1136/hrt.2003.021931 DO - 10.1136/hrt.2003.021931 ID - Gammelgaard2004 ER - TY - JOUR AU - Yuval, R. AU - Halon, D. A. AU - Merdler, A. AU - Khader, N. AU - Karkabi, B. AU - Uziel, K. AU - Lewis, B. S. PY - 2000 DA - 2000// TI - Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction JO - Arch Intern Med VL - 160 UR - https://doi.org/10.1001/archinte.160.8.1142 DO - 10.1001/archinte.160.8.1142 ID - Yuval2000 ER - TY - JOUR AU - Ciccone, A. AU - Bonito, V. PY - 2001 DA - 2001// TI - Thrombolysis for acute ischemic stroke: the problem of consent JO - Neurol Sci VL - 22 UR - https://doi.org/10.1007/s100720100062 DO - 10.1007/s100720100062 ID - Ciccone2001 ER - TY - JOUR AU - Smithline, H. A. AU - Mader, T. J. AU - Crenshaw, B. J. PY - 1999 DA - 1999// TI - Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research? JO - Acad Emerg Med VL - 6 UR - https://doi.org/10.1111/j.1553-2712.1999.tb01205.x DO - 10.1111/j.1553-2712.1999.tb01205.x ID - Smithline1999 ER - TY - JOUR AU - Taub, H. A. AU - Baker, M. T. AU - Sturr, J. F. PY - 1986 DA - 1986// TI - Informed consent for research. Effects of readability, patient age, and education JO - J Am Geriatr Soc VL - 34 UR - https://doi.org/10.1111/j.1532-5415.1986.tb05766.x DO - 10.1111/j.1532-5415.1986.tb05766.x ID - Taub1986 ER - TY - JOUR AU - Hekkenberg, R. J. AU - Irish, J. C. AU - Rotstein, L. E. AU - Brown, D. H. AU - Gullane, P. J. PY - 1997 DA - 1997// TI - Informed consent in head and neck surgery: how much do patients actually remember? JO - J Otolaryngol VL - 26 ID - Hekkenberg1997 ER - TY - JOUR AU - Emanuel, E. J. AU - Wendler, D. AU - Grady, C. PY - 2000 DA - 2000// TI - What makes clinical research ethical? JO - JAMA VL - 283 UR - https://doi.org/10.1001/jama.283.20.2701 DO - 10.1001/jama.283.20.2701 ID - Emanuel2000 ER - TY - JOUR AU - Flory, J. AU - Emanuel, E. PY - 2004 DA - 2004// TI - Interventions to improve research participants' understanding in informed consent for research: a systematic review JO - JAMA VL - 292 UR - https://doi.org/10.1001/jama.292.13.1593 DO - 10.1001/jama.292.13.1593 ID - Flory2004 ER - TY - JOUR AU - Abramson, N. S. AU - Meisel, A. AU - Safar, P. PY - 1986 DA - 1986// TI - A new approach for resuscitation research on comatose patients JO - JAMA VL - 255 UR - https://doi.org/10.1001/jama.1986.03370180092039 DO - 10.1001/jama.1986.03370180092039 ID - Abramson1986 ER - TY - JOUR AU - Adams, J. G. AU - Wegener, J. PY - 1999 DA - 1999// TI - Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research JO - Ann Emerg Med VL - 33 UR - https://doi.org/10.1016/S0196-0644(99)70398-7 DO - 10.1016/S0196-0644(99)70398-7 ID - Adams1999 ER - TY - JOUR AU - Baren, J. M. AU - Anicetti, J. P. AU - Ledesma, S. AU - Biros, M. H. AU - Mahabee-Gittens, M. AU - Lewis, R. J. PY - 1999 DA - 1999// TI - An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent JO - Acad Emerg Med VL - 6 UR - https://doi.org/10.1111/j.1553-2712.1999.tb00135.x DO - 10.1111/j.1553-2712.1999.tb00135.x ID - Baren1999 ER - TY - JOUR AU - Lemaire, F. AU - Bion, J. AU - Blanco, J. AU - Damas, P. AU - Druml, C. AU - Falke, K. AU - Kesecioglu, J. AU - Larsson, A. AU - Mancebo, J. AU - Matamis, D. PY - 2005 DA - 2005// TI - The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient JO - Intensive Care Med VL - 31 UR - https://doi.org/10.1007/s00134-005-2574-8 DO - 10.1007/s00134-005-2574-8 ID - Lemaire2005 ER - TY - JOUR AU - Cassell, E. J. AU - Leon, A. C. AU - Kaufman, S. G. PY - 2001 DA - 2001// TI - Preliminary evidence of impaired thinking in sick patients JO - Ann Intern Med VL - 134 UR - https://doi.org/10.7326/0003-4819-134-12-200106190-00012 DO - 10.7326/0003-4819-134-12-200106190-00012 ID - Cassell2001 ER - TY - JOUR AU - Cohen, L. M. AU - McCue, J. D. AU - Green, G. M. PY - 1993 DA - 1993// TI - Do clinical and formal assessments of the capacity of patients in the intensive care unit to make decisions agree? JO - Arch Intern Med VL - 153 UR - https://doi.org/10.1001/archinte.1993.00410210109012 DO - 10.1001/archinte.1993.00410210109012 ID - Cohen1993 ER -