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Erschienen in: Intensive Care Medicine 11/2006

01.11.2006 | Review

Ethics and research in critical care

verfasst von: Henry J. Silverman, Francois Lemaire

Erschienen in: Intensive Care Medicine | Ausgabe 11/2006

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Abstract

Background

The past few years have witnessed several controversies regarding the ethics of conducting research involving critically ill patients, and such research is ethically challenging.

Discussion

Research ethics is a changing field, one that is influenced by empirical data, contemporary events, and new ideas regarding aspects of clinical trial design and protection of human subjects. We describe recent thoughts regarding several aspects of research ethics in the critical care context.

Conclusion

The ability of the research community to conduct research ethically and to maintain public trust would benefit from heightened awareness to the principles and requirements that govern such research.
Literatur
1.
Zurück zum Zitat National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. U.S. Government Printing Office, Washington National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. U.S. Government Printing Office, Washington
2.
Zurück zum Zitat Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283:2701–2711PubMedCrossRef Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283:2701–2711PubMedCrossRef
3.
Zurück zum Zitat Anonymous (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. Off J Eur Communities L121:33–44 Anonymous (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. Off J Eur Communities L121:33–44
4.
Zurück zum Zitat London AJ, Kadane JB (2002) Placebos that harm: sham surgery controls in clinical trials. Stat Methods Med Res 11:413–427PubMedCrossRef London AJ, Kadane JB (2002) Placebos that harm: sham surgery controls in clinical trials. Stat Methods Med Res 11:413–427PubMedCrossRef
5.
Zurück zum Zitat Freedman B (1987) Equipoise and the ethics of clinical research. N Engl J Med 317:141–145PubMedCrossRef Freedman B (1987) Equipoise and the ethics of clinical research. N Engl J Med 317:141–145PubMedCrossRef
6.
Zurück zum Zitat Dreyfuss D (2005) Is it better to consent to an RCT or to care? Intensive Care Med 31:345–355PubMedCrossRef Dreyfuss D (2005) Is it better to consent to an RCT or to care? Intensive Care Med 31:345–355PubMedCrossRef
7.
Zurück zum Zitat Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892PubMedCrossRef Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892PubMedCrossRef
8.
Zurück zum Zitat Mann H, Djulbegovic B (2003) Choosing a control intervention for a randomised clinical trial. BMC Med Res Methodol 3:7PubMedCrossRef Mann H, Djulbegovic B (2003) Choosing a control intervention for a randomised clinical trial. BMC Med Res Methodol 3:7PubMedCrossRef
9.
Zurück zum Zitat Silverman HJ, Miller FG (2004) Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment. Crit Care Med 32:852–857PubMedCrossRef Silverman HJ, Miller FG (2004) Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment. Crit Care Med 32:852–857PubMedCrossRef
10.
Zurück zum Zitat Miller FG, Silverman HJ (2004) The ethical relevance of the standard of care in the design of clinical trials. Am J Respir Crit Care Med 169:562–564PubMedCrossRef Miller FG, Silverman HJ (2004) The ethical relevance of the standard of care in the design of clinical trials. Am J Respir Crit Care Med 169:562–564PubMedCrossRef
11.
Zurück zum Zitat Parshuram CS, Kavanagh BP (2004) Positive clinical trials. Understand the control group before implementing the result. Am J Respir Crit Care Med 170:223–226PubMedCrossRef Parshuram CS, Kavanagh BP (2004) Positive clinical trials. Understand the control group before implementing the result. Am J Respir Crit Care Med 170:223–226PubMedCrossRef
12.
Zurück zum Zitat Gutierrez G, Palizas F, Doglio G, Wainsztein N, Gallesio A, Pacin J, Dubin A, Schiavi E, Jorge M, Pusajo J ea (1992) Gastric intramucosal pH as a therapeutic index of tissue oxygenation in critically ill patients. Lancet 339:195–199PubMedCrossRef Gutierrez G, Palizas F, Doglio G, Wainsztein N, Gallesio A, Pacin J, Dubin A, Schiavi E, Jorge M, Pusajo J ea (1992) Gastric intramucosal pH as a therapeutic index of tissue oxygenation in critically ill patients. Lancet 339:195–199PubMedCrossRef
13.
Zurück zum Zitat Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M, Canadian Critical Care Clinical Trials Group (2003) A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med 348:5–14PubMedCrossRef Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M, Canadian Critical Care Clinical Trials Group (2003) A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med 348:5–14PubMedCrossRef
14.
Zurück zum Zitat Richard C, Warszawski J, Anguel N, Deye N, Combes A, Barnoud D, Boulain T, Lefort Y, Fartoukh M, Baud F, Boyer A, Brocahrd L, Teboul JL, for the French Pulmonary Artery Catheter Study Group (2003) Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome. A randomized controlled trial. JAMA 290:2713–2720PubMedCrossRef Richard C, Warszawski J, Anguel N, Deye N, Combes A, Barnoud D, Boulain T, Lefort Y, Fartoukh M, Baud F, Boyer A, Brocahrd L, Teboul JL, for the French Pulmonary Artery Catheter Study Group (2003) Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome. A randomized controlled trial. JAMA 290:2713–2720PubMedCrossRef
15.
Zurück zum Zitat Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourme D, Brampton W, Williams D, Young DR, Rowan K, PAC-Man Study collaboration (2005) Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomized controlled trial. Lancet 366:472–477PubMedCrossRef Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourme D, Brampton W, Williams D, Young DR, Rowan K, PAC-Man Study collaboration (2005) Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomized controlled trial. Lancet 366:472–477PubMedCrossRef
16.
Zurück zum Zitat SAFE Study Investigators (2004) A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 350:2247–2256CrossRef SAFE Study Investigators (2004) A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 350:2247–2256CrossRef
17.
Zurück zum Zitat Krishnan JA, Moore D, Roveson C, Rand CS, Fessler HE (2004) A prospective, controlled trial of a protocol-based strategy to discontinue mechanical ventilation. Am J Respir Crit Care Med 169:673–678PubMedCrossRef Krishnan JA, Moore D, Roveson C, Rand CS, Fessler HE (2004) A prospective, controlled trial of a protocol-based strategy to discontinue mechanical ventilation. Am J Respir Crit Care Med 169:673–678PubMedCrossRef
18.
Zurück zum Zitat Randolph AG, Wjypij D, Venkataraman ST, Hanson JH, Gedeit rG, Meert KL, Luckett PM, Forbes P, Lilley M, Thompson J (2002) Effect of mechanical ventilator weaning protocols on respiratory outcomes in infants and children: a randomized controlled trial. JAMA 288:2561–2568PubMedCrossRef Randolph AG, Wjypij D, Venkataraman ST, Hanson JH, Gedeit rG, Meert KL, Luckett PM, Forbes P, Lilley M, Thompson J (2002) Effect of mechanical ventilator weaning protocols on respiratory outcomes in infants and children: a randomized controlled trial. JAMA 288:2561–2568PubMedCrossRef
19.
Zurück zum Zitat Ely EW, Baker AM, Duagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF (1996) Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med 335:1864–1869PubMedCrossRef Ely EW, Baker AM, Duagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF (1996) Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med 335:1864–1869PubMedCrossRef
20.
Zurück zum Zitat Anonymous (2004) The ethical conduct of clinical research involving critically ill patients in the United States and Canada. Am J Respir Crit Care Med 170:1375–1384CrossRef Anonymous (2004) The ethical conduct of clinical research involving critically ill patients in the United States and Canada. Am J Respir Crit Care Med 170:1375–1384CrossRef
21.
Zurück zum Zitat NICE-SUGAR Study Investigators (2005) A multi-centre, open label, randomised controlled trial of two target ranges for glycaemic control in intensive care unit (ICU) patients. Availlable at: http://controlled-trialscom/isrctn/trial/ISRCTN0498275/0/04968275html, accessed 5 February 2006 NICE-SUGAR Study Investigators (2005) A multi-centre, open label, randomised controlled trial of two target ranges for glycaemic control in intensive care unit (ICU) patients. Availlable at: http://​controlled-trialscom/​isrctn/​trial/​ISRCTN0498275/​0/​04968275html, accessed 5 February 2006
22.
Zurück zum Zitat Acute Respiratory Distress Syndrome Network (2000) Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 342:1301–1308CrossRef Acute Respiratory Distress Syndrome Network (2000) Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 342:1301–1308CrossRef
23.
Zurück zum Zitat Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Fihlo G, Kariralla RA, Deheinzeline D, Munoz C, Oliveria R (1998) Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med 338:347–354PubMedCrossRef Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Fihlo G, Kariralla RA, Deheinzeline D, Munoz C, Oliveria R (1998) Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med 338:347–354PubMedCrossRef
24.
Zurück zum Zitat Van Den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R (2001) Intensive insulin therapy in critically ill patients. N Engl J Med 345:1359–1367PubMedCrossRef Van Den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R (2001) Intensive insulin therapy in critically ill patients. N Engl J Med 345:1359–1367PubMedCrossRef
25.
Zurück zum Zitat Eichacker PQ, Gerstenberger EP, Banks SM, Cui X, Natanson C (2002) Meta-analysis of acute lung injury and acute respiratory distress syndrome trials testing low tidal volumes. Am J Respir Crit Care Med 166:1510–1514PubMedCrossRef Eichacker PQ, Gerstenberger EP, Banks SM, Cui X, Natanson C (2002) Meta-analysis of acute lung injury and acute respiratory distress syndrome trials testing low tidal volumes. Am J Respir Crit Care Med 166:1510–1514PubMedCrossRef
26.
Zurück zum Zitat Bellomo R (2005) Glycemic control in the intensive care unit: why we should wait for NICE-SUGAR. Mayo Clin Proc 80:1546–1548PubMedCrossRef Bellomo R (2005) Glycemic control in the intensive care unit: why we should wait for NICE-SUGAR. Mayo Clin Proc 80:1546–1548PubMedCrossRef
27.
Zurück zum Zitat Parshuram C, Kavanagh B (1983) Meta-analysis of tidal volumes in ARDS. Am J Respir Crit Care Med 167:798 Parshuram C, Kavanagh B (1983) Meta-analysis of tidal volumes in ARDS. Am J Respir Crit Care Med 167:798
28.
Zurück zum Zitat Weijer C (2000) The ethical analysis of risk. J Law Med Ethics 28:344–361PubMed Weijer C (2000) The ethical analysis of risk. J Law Med Ethics 28:344–361PubMed
29.
Zurück zum Zitat McRae AD, Weijer C (2002) Lessons from everyday lives: a moral justification for acute care research. Crit Care Med 30:1146–1151PubMedCrossRef McRae AD, Weijer C (2002) Lessons from everyday lives: a moral justification for acute care research. Crit Care Med 30:1146–1151PubMedCrossRef
30.
Zurück zum Zitat National Bioethics Advisory Commission (2001) Ethical and policy issues in research involving human participants. U.S. Government Printing Office, Rockville National Bioethics Advisory Commission (2001) Ethical and policy issues in research involving human participants. U.S. Government Printing Office, Rockville
31.
Zurück zum Zitat Freeman BD, Danner RL, Banks SM, Natanson C (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192PubMed Freeman BD, Danner RL, Banks SM, Natanson C (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192PubMed
32.
Zurück zum Zitat Lemaire F, Brun-Buisson C (2000) Are institutional review boards effective in safe-guarding patients in intensive care units? Curr Opin Anaesthesiol 13:195–200PubMedCrossRef Lemaire F, Brun-Buisson C (2000) Are institutional review boards effective in safe-guarding patients in intensive care units? Curr Opin Anaesthesiol 13:195–200PubMedCrossRef
33.
Zurück zum Zitat Karlawish JHT (2003) Research involving cognitively impaired adults. N Engl J Med 348:1289–1392CrossRef Karlawish JHT (2003) Research involving cognitively impaired adults. N Engl J Med 348:1289–1392CrossRef
34.
Zurück zum Zitat National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) Research involving children: report and recommendations. U.S. Department of Health, Education and Welfare, Washington National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) Research involving children: report and recommendations. U.S. Department of Health, Education and Welfare, Washington
35.
Zurück zum Zitat National Bioethics Advisory Commission (1998) Research involving persons with mental disorders that may affect decisionmaking capacity. U.S. Government Printing Office, Rockville National Bioethics Advisory Commission (1998) Research involving persons with mental disorders that may affect decisionmaking capacity. U.S. Government Printing Office, Rockville
36.
Zurück zum Zitat World Medical Association (2000) World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. HIV Clin Trials 2001:92–95 World Medical Association (2000) World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. HIV Clin Trials 2001:92–95
37.
Zurück zum Zitat Morin K, Rakatansky H, Riddick FA et al. (2002) Managing conflicts of interest in the conduct of clinical trials. JAMA 287:78–84PubMedCrossRef Morin K, Rakatansky H, Riddick FA et al. (2002) Managing conflicts of interest in the conduct of clinical trials. JAMA 287:78–84PubMedCrossRef
38.
Zurück zum Zitat University of California Office of the President Office of Research (2002) Guidance on surrogate consent for research. Available at: http://www.llnl.gov/HumanSubjects/pdfs/surrogate.pdf; accessed 22 September 2003 University of California Office of the President Office of Research (2002) Guidance on surrogate consent for research. Available at: http://​www.​llnl.​gov/​HumanSubjects/​pdfs/​surrogate.​pdf; accessed 22 September 2003
39.
Zurück zum Zitat Saks ER (1999) Competency to decide on treatment and research. The MacArthur capacity instruments. In: National Bioethics Advisory Commission (ed) Research involving persons with mental disorders that may affect decisionmaking capacity,vol II. Commissioned papers. National Bioethics Advisory Commission, Rockville Saks ER (1999) Competency to decide on treatment and research. The MacArthur capacity instruments. In: National Bioethics Advisory Commission (ed) Research involving persons with mental disorders that may affect decisionmaking capacity,vol II. Commissioned papers. National Bioethics Advisory Commission, Rockville
40.
Zurück zum Zitat Silverman HJ, Luce JM, Schwartz J (2004) Protecting subjects with decisional impairment in research. The need for a multifaceted approach. Am J Respir Crit Care Med 169:10–14PubMedCrossRef Silverman HJ, Luce JM, Schwartz J (2004) Protecting subjects with decisional impairment in research. The need for a multifaceted approach. Am J Respir Crit Care Med 169:10–14PubMedCrossRef
41.
Zurück zum Zitat Keyserlingk EW, Kogan GK, Gauthier S (1995) Proposed guidelines for the participation of persons with dementia as research subjects. Perspect Biol Med 38:319–361PubMed Keyserlingk EW, Kogan GK, Gauthier S (1995) Proposed guidelines for the participation of persons with dementia as research subjects. Perspect Biol Med 38:319–361PubMed
42.
Zurück zum Zitat Lidz WW, Appelbaum PS (2002) The therapeutic misconception. Problems and solutions. Med Care 40:V55–V63PubMedCrossRef Lidz WW, Appelbaum PS (2002) The therapeutic misconception. Problems and solutions. Med Care 40:V55–V63PubMedCrossRef
43.
Zurück zum Zitat Dresser R (2002) The ubiquity and utility of the therapeutic misconception. Soc Philos Policy Foundation 19:271–294CrossRef Dresser R (2002) The ubiquity and utility of the therapeutic misconception. Soc Philos Policy Foundation 19:271–294CrossRef
44.
Zurück zum Zitat Silverman HJ (1996) Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients. Am J Respir Crit Care Med 154:582–586PubMed Silverman HJ (1996) Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients. Am J Respir Crit Care Med 154:582–586PubMed
45.
Zurück zum Zitat International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1997) Consolidated guideline on good clinical practice in the conduct of clinical trials on medicinal products for human use. Int Dig Health Legis 48:231–234 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1997) Consolidated guideline on good clinical practice in the conduct of clinical trials on medicinal products for human use. Int Dig Health Legis 48:231–234
46.
Zurück zum Zitat Silverman HJ, Hull SC, Sugarman J (2001) Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med 29:235–241PubMedCrossRef Silverman HJ, Hull SC, Sugarman J (2001) Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med 29:235–241PubMedCrossRef
47.
Zurück zum Zitat Advisory Committee on Human Radiation Experiments (1995) Final report. U.S. Government Printing Office, Washington Advisory Committee on Human Radiation Experiments (1995) Final report. U.S. Government Printing Office, Washington
48.
Zurück zum Zitat Silverman HJ, Luce JM, Lanken PN, Morris AH, Harabin AL, Oldmixon CF, Thompson BT, Bernard GR, for the NHLBI Acute Respiratory Distress Syndrome Clinical Trials Network (2005) Recommendations for informed consent forms for critical care clinical trials. Crit Care Med 33:867–882PubMedCrossRef Silverman HJ, Luce JM, Lanken PN, Morris AH, Harabin AL, Oldmixon CF, Thompson BT, Bernard GR, for the NHLBI Acute Respiratory Distress Syndrome Clinical Trials Network (2005) Recommendations for informed consent forms for critical care clinical trials. Crit Care Med 33:867–882PubMedCrossRef
49.
Zurück zum Zitat Estey A, Wilkin G, Dossetor J (1994) Are research subjects able to retain the information they are given during the consent process. Health Law Rev 3:37–41 Estey A, Wilkin G, Dossetor J (1994) Are research subjects able to retain the information they are given during the consent process. Health Law Rev 3:37–41
50.
Zurück zum Zitat Williams FF, French JK, White HD, for the HERO-2 consent substudy investigators (2003) Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study. Lancet 361:918–922PubMedCrossRef Williams FF, French JK, White HD, for the HERO-2 consent substudy investigators (2003) Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study. Lancet 361:918–922PubMedCrossRef
51.
Zurück zum Zitat Schaeffer MH, Krantz DS, Wichman A, Masur H, Reed E, Vinicky JK (1996) The impact of disease severity on the informed consent process in clinical research. Am J Med 100:261–268PubMedCrossRef Schaeffer MH, Krantz DS, Wichman A, Masur H, Reed E, Vinicky JK (1996) The impact of disease severity on the informed consent process in clinical research. Am J Med 100:261–268PubMedCrossRef
52.
Zurück zum Zitat Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W (1987) False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 17:20–24PubMed Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W (1987) False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 17:20–24PubMed
53.
Zurück zum Zitat Miller FG, Rosenstein DL (2003) The therapeutic orientation to clinical trials. N Engl J Med 348:1383–1386PubMedCrossRef Miller FG, Rosenstein DL (2003) The therapeutic orientation to clinical trials. N Engl J Med 348:1383–1386PubMedCrossRef
54.
Zurück zum Zitat Lemaire F (2004) Patient care versus research: does clinical research provide individual benefit to patients enrolled in trials. Curr Opin Crit Care 10:565–569PubMedCrossRef Lemaire F (2004) Patient care versus research: does clinical research provide individual benefit to patients enrolled in trials. Curr Opin Crit Care 10:565–569PubMedCrossRef
55.
Zurück zum Zitat Appelbaum PS (2002) Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception. Am J Bioethics 2:22–23CrossRef Appelbaum PS (2002) Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception. Am J Bioethics 2:22–23CrossRef
56.
Zurück zum Zitat Clemens JD, Frederik FP, van Loon L, Rao M, Sack DA, Ahmed F, Chakraborty J, Khan MR, Yunus M, Harris JR, Svennerholm AM et al. (1992) Nonparticipation as a determinant of adverse health outcomes in a field trial of oral cholera vaccines. Am J Epidemiol 135:865–874PubMed Clemens JD, Frederik FP, van Loon L, Rao M, Sack DA, Ahmed F, Chakraborty J, Khan MR, Yunus M, Harris JR, Svennerholm AM et al. (1992) Nonparticipation as a determinant of adverse health outcomes in a field trial of oral cholera vaccines. Am J Epidemiol 135:865–874PubMed
57.
Zurück zum Zitat Peppercorn JM, Weeks JC, Cook EF, Joffe S (2004) Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 363:263–270PubMedCrossRef Peppercorn JM, Weeks JC, Cook EF, Joffe S (2004) Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 363:263–270PubMedCrossRef
58.
Zurück zum Zitat Hawkins JS, Emanuel EJ (2005) Clarifying confusions about coercion. Hastings Cent Rep 35:16–19PubMed Hawkins JS, Emanuel EJ (2005) Clarifying confusions about coercion. Hastings Cent Rep 35:16–19PubMed
59.
Zurück zum Zitat Anonymous (2005) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing of importation of such products. Official J Eur Union L91:13–19 Anonymous (2005) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing of importation of such products. Official J Eur Union L91:13–19
60.
Zurück zum Zitat Sulmasy DP, Terry PB, Weisman CS, Miller DJ, Stallings RY, Vettese MA, Haller KB (1998) The accuracy of substituted judgments in patients with terminal diagnoses. Ann Intern Med 128:621–629PubMed Sulmasy DP, Terry PB, Weisman CS, Miller DJ, Stallings RY, Vettese MA, Haller KB (1998) The accuracy of substituted judgments in patients with terminal diagnoses. Ann Intern Med 128:621–629PubMed
61.
Zurück zum Zitat Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119:603–612PubMedCrossRef Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119:603–612PubMedCrossRef
62.
Zurück zum Zitat Jones C, Skirrow P, Griffiths R, Humphris G, Ingleby S, Eddleston J, Waldmann C, Gager M (2004) Post-traumatic stress disorder-related symptoms in relatives of patients following intensive care. Intensive Care Med 30:456–460PubMedCrossRef Jones C, Skirrow P, Griffiths R, Humphris G, Ingleby S, Eddleston J, Waldmann C, Gager M (2004) Post-traumatic stress disorder-related symptoms in relatives of patients following intensive care. Intensive Care Med 30:456–460PubMedCrossRef
63.
Zurück zum Zitat Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, LeGall JR, Dhainaut JF, Schlemmer B, French FAMIRFA Group (2001) Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med 29:1893–1897PubMedCrossRef Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, LeGall JR, Dhainaut JF, Schlemmer B, French FAMIRFA Group (2001) Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med 29:1893–1897PubMedCrossRef
64.
Zurück zum Zitat United States Department of Health and Human Services (1996) Protection of human subjects: informed consent and waiver of informed consent requirements in certain emergency research. Final rules, 61. Fed Register 51500–51533 United States Department of Health and Human Services (1996) Protection of human subjects: informed consent and waiver of informed consent requirements in certain emergency research. Final rules, 61. Fed Register 51500–51533
65.
Zurück zum Zitat Nichol G, Huszti E, Rokosh J, Dumbrell A, McGowan J, Becker L (2004) Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research? Resuscitation 62:3–23PubMedCrossRef Nichol G, Huszti E, Rokosh J, Dumbrell A, McGowan J, Becker L (2004) Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research? Resuscitation 62:3–23PubMedCrossRef
66.
Zurück zum Zitat Hiller KM, Haukoos JS, Heard K, Tashkin JS, Paradis NA (2005) Impact of the final rule on the rate of clinical cardiac arrest research in the United States. Acad Emerg Med 12:1091–1098PubMedCrossRef Hiller KM, Haukoos JS, Heard K, Tashkin JS, Paradis NA (2005) Impact of the final rule on the rate of clinical cardiac arrest research in the United States. Acad Emerg Med 12:1091–1098PubMedCrossRef
67.
Zurück zum Zitat Lemaire F (2002) European Society of Intensive Care Medicine statement. Intensive Care Med 28:1218–1219PubMedCrossRef Lemaire F (2002) European Society of Intensive Care Medicine statement. Intensive Care Med 28:1218–1219PubMedCrossRef
68.
69.
Zurück zum Zitat Morse MA, Califf RM, Sugarman J (2001) Monitoring and ensuring safety during clinical research. JAMA 285:1201–1205PubMedCrossRef Morse MA, Califf RM, Sugarman J (2001) Monitoring and ensuring safety during clinical research. JAMA 285:1201–1205PubMedCrossRef
Metadaten
Titel
Ethics and research in critical care
verfasst von
Henry J. Silverman
Francois Lemaire
Publikationsdatum
01.11.2006
Verlag
Springer-Verlag
Erschienen in
Intensive Care Medicine / Ausgabe 11/2006
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-006-0305-4

Weitere Artikel der Ausgabe 11/2006

Intensive Care Medicine 11/2006 Zur Ausgabe

Delir bei kritisch Kranken – Antipsychotika versus Placebo

16.05.2024 Delir Nachrichten

Um die Langzeitfolgen eines Delirs bei kritisch Kranken zu mildern, wird vielerorts auf eine Akuttherapie mit Antipsychotika gesetzt. Eine US-amerikanische Forschungsgruppe äußert jetzt erhebliche Vorbehalte gegen dieses Vorgehen. Denn es gibt neue Daten zum Langzeiteffekt von Haloperidol bzw. Ziprasidon versus Placebo.

Eingreifen von Umstehenden rettet vor Erstickungstod

15.05.2024 Fremdkörperaspiration Nachrichten

Wer sich an einem Essensrest verschluckt und um Luft ringt, benötigt vor allem rasche Hilfe. Dass Umstehende nur in jedem zweiten Erstickungsnotfall bereit waren, diese zu leisten, ist das ernüchternde Ergebnis einer Beobachtungsstudie aus Japan. Doch es gibt auch eine gute Nachricht.

Darf man die Behandlung eines Neonazis ablehnen?

08.05.2024 Gesellschaft Nachrichten

In einer Leseranfrage in der Zeitschrift Journal of the American Academy of Dermatology möchte ein anonymer Dermatologe bzw. eine anonyme Dermatologin wissen, ob er oder sie einen Patienten behandeln muss, der eine rassistische Tätowierung trägt.

Ein Drittel der jungen Ärztinnen und Ärzte erwägt abzuwandern

07.05.2024 Klinik aktuell Nachrichten

Extreme Arbeitsverdichtung und kaum Supervision: Dr. Andrea Martini, Sprecherin des Bündnisses Junge Ärztinnen und Ärzte (BJÄ) über den Frust des ärztlichen Nachwuchses und die Vorteile des Rucksack-Modells.

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