Genetic research and testing in critical care: Surrogates' perspective

Critical Care Medicine

Volumn 34, Issue 4, 2006, Pages 986-994

  Freeman, Bradley D ^a   Kennedy, Carie R ^a   Coopersmith, Craig M ^a   Zehnbauer, Barbara A ^a   Buchman, Timothy G ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical trials; Critical illness; Ethics; Genetics; Proxy decision makers

Indexed keywords

ADULT; CHRONIC DISEASE; CONTROLLED STUDY; DATA ANALYSIS; DIAGNOSTIC TEST; DRUG INDUSTRY; ECONOMIC ASPECT; EMPLOYER; ETHNOLOGY; FEMALE; GENETIC ANALYSIS; GENETIC PROCEDURES; GENETIC TRAIT; GENETICS; GOVERNMENT; HEALTH INSURANCE; HUMAN; INSURANCE; INTENSIVE CARE; MAJOR CLINICAL STUDY; MALE; MEDICAL DECISION MAKING; NON PROFIT ORGANIZATION; PRIORITY JOURNAL; QUESTIONNAIRE; REVIEW; TERTIARY HEALTH CARE; TRUST; UNIVERSITY; URBAN AREA;

EID: 33645826554     PISSN: 00903493     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.CCM.0000206113.47535.2A     Document Type: Article

References (52)

1. Collins FS: Shattuck lecture: medical and societal consequences of the human genome project. N Engl J Med 1999; 342:28-37
2. Bell J: The new genetics in clinical practice. BMJ 1998; 316:618-620
3. Freeman BD, McLeod HL: Challenges of implementing pharmacogenetics in the critical care environment. Nature Rev Drug Discovery 2004; 3:88-93
4. Stuber F, Udalova IA, Book M, et al: -308 Tumor necrosis factor (TNF) polymorphism is not associated with survival in severe sepsis and is unrelated to lipopolysaccharide inducibility of the human TNF promotor. J Inflamm 1996; 46:50
5. Mira JP, Cariou A, Grall F, et al: Association of TNF2, a TNF promotor polymorphism, with septic shock susceptibility and mortality: A multicenter study. JAMA 1999; 282:561-568
6. Tang G, Huang S, Yien H, et al: Tumor necrosis factor gene polymorphism and septic shock in surgical infection. Crit Care Med 2000; 28:2733-2736
7. O'Keefe GE, Hybki DL, Munford RS: The G->A single nucleotide polymorphism at the -308 position in the tumor necrosis factor-[alpha] promoter increases the risk for severe sepsis after trauma. J Trauma 2002; 52:817-826
8. Majetschak M, Obertacke U, Schade FU, et al: Tumor necrosis factor gene polymorphisms, leukocyte function, and sepsis susceptibility in blunt trauma. Clin Diagn Lab Immunol 2002; 9:1205-1211
9. Gordon AC, Cheung L, Aganna E, et al: Lack of association between the -308 TNF promotor polymorphism & outcome from sepsis & septic shock. Intensive Care Med 2002; 28(Suppl 1):S99
10. Nadel S, Newport MJ, Booy R, et al: Variation in the tumor necrosis factor gene promotor region may be associated with death from meningococcal disease. J Infect Dis 1996; 174:878-880
11. Waterer GW, Quasney MW, Cantor RM, et al: Septic shock and respiratory failure in community acquired pneumonia have different TNF polymorphism associations. Am J Respir Crit Care Med 2001; 163:1599-1604
12. Schaaf BM, Boehmke F, Esnashaashari H, et al: Pneumococcal septic shock is associated with the IL-10-1082 gene promotor polymorphism. Am J Respir Crit Care Med 2003; 168:476-480
13. Stuber F, Peterson M, Bokelman F, et al: A genomic polymorphism in the tumor necrosis factor locus influences plasma tumor necrosis factor-alpha concentrations and outcome of patients with severe sepsis. Crit Care Med 1996; 24:381-384
14. Schroder S, Reck M, Hoeft A, et al: Analysis of two leukocyte antigen linked polymorphic heat shock protein 70 genes in patients with severe sepsis. Crit Care Med 1999; 27:1265-1270
15. Fang XM, Schroder S, Hoeft A, et al: Comparison of two polymorphisms of the interleudin-1 gene family: interleukin-1 receptor antagonist polymorphism contributes to susceptibility to severe sepsis. Crit Care Med 1999; 27:1330-1334
16. Hubacek JA, Stuber F, Frolich D, et al: Gene variants of the bactericidal/permeability increasing protein and lipopolysaccharide binding protein in sepsis patients: Gender-specific genetic predisposition to sepsis. Crit Care Med 2001; 29:557-561
17. Gibot S, Cariou A, Drouet L, et al: Association between a genomic polymorphism between the CD14 locus and septic shock susceptibility and mortality rate. Crit Care Med 2002; 30:969-973
18. Ma P, Chen D, Pan J, et al: Genomic polymorphisms within the Interleukin-1 family cytokines influences the outcome of septic patients. Crit Care Med 2002; 30:1046-1050
19. Schluter B, Raufhake C, Erren M, et al: Effect of the interleukin-6 promoter polymorphism (-174 G/C) gene on the incidence and outcome of sepsis. Crit Care Med 2002; 30:32-37
20. Lowe PR, Galley HF, Ashraf AF, et al: Influence of interleukin-10 polymorphisms on interleukin-10 expression and survival in patients with sepsis. Crit Care Med 2003; 31:34-38
21. Haralambous E, Hibberd ML, Hermans PWM, et al: Role of functional plasminogen activator-1 4G/5G promotor polymorphism in susceptibility, severity, and outcome in meningococcal disease in Caucasian children. Crit Care Med 2003; 31:2788-2793
22. Sutherland AM, Walley KR, Russell JA: Polymorphisms in CD14, mannose-binding lectin, and Toll-like receptor-2 are associated with increased prevalence of infection in critically ill adults. Crit Care Med 2005; 33:638-644
23. Inflammation and the Host Response to Injury. www.gluegrant.org (accessed 18 October 2005)
24. Kerlin BA, Yan SB, Isermann BH, et al: Survival advantage associated with heterozygous factor V Leiden mutation in patients with severe sepsis and in mouse endotoxemia. Blood 2003; 102:3085-3092
25. Yan SB, Nelson DR: Effect of factor V Leiden polymorphism in severe sepsis and on treatment with recombinant human activated protein C. Crit Care Med 2004; 32(Suppl):S239-S246
26. Yan SCB, Dhainaut JF: Heterozygous factor V Leiden mutation may provide a survival advantage in patients during severe sepsis. Crit Care Med 2003; 30(Suppl):A47
27. Lord PG, Papoian T: Genomics and drug toxicity. Science 2004; 306:575
28. Roses AD: Pharmacogenetics and drug development: The path to safer and more effective drugs. Nature Rev Gen 2004; 5:645-656
29. Phillips KA, Van Bebber SL: Measuring the value of pharmacogenomics. Nature Rev Drug Discovery 2005; 4:500-510
30. Luce JM: Research ethics and consent in the intensive care unit. Curr Opin Crit Care 2003; 9:540-544
31. Ad Hoc Statement Committee of the American Thoracic Society: The ethical conduct of clinical research involving critically ill patients in the United States and Canada. Am J Respir Crit Care Med 2004; 170:1375-1384
32. Silverman HJ, Luce JM, Lanken PN, et al: Recommendations for informed consent forms for critical care clinical trials. Crit Care Med 2005; 33:867-882
33. Davis N, Pohlman A, Gehlbach B, et al: Improving the process of informed consent in the critically ill. JAMA 2003; 289:1963-1968
34. Rothstein MA, Hornung CA: Public attitudes about pharmacogenomics. In: Rothstein MA (Ed). Pharmacogenomics: Social, Ethical, and Clinical Dimensions. Hoboken, NJ, Wiley-Liss, 2003, pp. 3-27
35. Lapham EV, Kozma C, Weiss JO: Genetic discrimination: Perspectives of consumers. Science 1996; 274:3015-3021
36. Freeman BD, Danner RL, Banks S, et al: Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 2001; 164:190-192
37. Steinbrook R: Trial design and patient safety: The debate continues. N Engl J Med 2003; 349:629
38. Reilly PR: Rethinking risks to human subjects in genetic research. Am J Hum Gen 1998; 63:682-685
39. Clayton EW: Ethical, legal, and social implications of genomic medicine. N Engl J Med 2003; 349:562-569
40. Annas GJ: The limits of state laws to protect genetic information. N Engl J Med 2001; 345:385-388
41. The Ad Hoc Committee on Genetic Testing/ Insurance Issues: Background statement: Genetic testing and insurance. Am J Hum Gen 1995; 56:327-331
42. Mitka M: Genetic discrimination bill. JAMA 2005; 293:1718
43. Falk MJ, Dugan RB, O'Riordan M, et al: Medical geneticists duty to warn at-risk relatives for genetic disease. Am J Hum Gen 2003; 120A:374-380
44. OCR Privacy Brief: Summary of the HIPAA Privacy Rule. Washington, DC, United States Department of Health and Human Services, 2005
45. Offit K, Groeger E, Turner S, et al: The "duty to warn" a patient's family members about hereditary disease risks. JAMA 2004; 292:1469-1473
46. The American Society of Human Genetics Subcommittee on Familial Disclosure: Professional disclosure of familial genetic information. Am J Hum Gen 1998; 62:474-483
47. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001; 358:1772-1777
48. Flory J, Emanuel E: Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA 2004; 292:1593-1601
49. Clayton EW, Steinberg KK, Khoury MJ, et al: Informed consent for genetic research on stored tissue samples. JAMA 1995; 274:1786-1792
50. Winikoff DE, Winickoff RN: The charitable trust as a model for genomic biobanks. N Engl J Med 2003; 349:1180-1184
51. Hakimian R, Korn D: Ownership and use of tissue specimens for research. JAMA 2004; 292:2500-2505
52. Annas GJ: Reforming informed consent to genetic research. JAMA 2001; 286:2326-2328