Ethical reflections on pharmacogenetics and DNA banking in a cohort of HIV-infected patients

Pharmacogenetics

Volumn 12, Issue 9, 2002, Pages 667-675

  De Montgolfier, Sandrine ^a   Moutel, Grégoire ^a   Duchange, Nathalie ^a   Theodorou, Ioannis ^b   Hervé, Christian ^a   Leport, Catherine ^c   Raffi, F ^d   Chenc G ^d   Salamon, R ^d   Moatti, J P ^d   Pierret, ^d   Brun Vezinet F ^d   Fleury, H ^d   Peytavin, G ^d   Garraffo, R ^d   Costagliola, D ^d   Dellamonica, P ^d   Katlama, C ^d   Meyer, L ^d   Morin, M ^d   Sicard, D ^d   Sobel, A ^d   Ballereau, F ^d   Bach, M A ^d   Bourdillon, F ^d   Choutet, P ^d   Delfraissy, J F ^d   Dormont, J ^d   Souteyrand, Y ^d   Vilde J L ^d   Dupon, M ^d   Le Moing, V ^d   Marchou, B ^d   May, T ^d   Morlat, P ^d   Waldner Combernoux, A ^d   Thuret, F ^d   Dreyfus Netter, F ^d   Grillot Courvalin, C ^d   Alfaro, C ^d   Boucherit, S ^d   Cailleton, V ^d   Charlois, C ^d   Droz, C ^d   Duran, S ^d   Ecobichon, J L ^d   Egouy, C ^d   Journot, V ^d   Lassalle, R ^d   Latour, L ^d   Lewden, C ^d   Masquelier, B ^d   Nouioua, W ^d   Palmer, G ^d   Petit, C ^d   Preau M ^d   Roloff, S ^d   Saves M ^d   Spire, B ^d   Winum, R ^d   Schmit, ^d   Chennebault, ^d   Faller, ^d   Estavoyer, ^d   Laurent, ^d   Vuitton, ^d   Beylot, ^d   Lacut, ^d   Le Bras, ^d   Ragnaud, ^d   Granier, ^d   Garre ^d   Bazin, ^d   Veyssier, ^d   Devidas, ^d   Sobel, ^d   Portier, ^d   Perronne, ^d   Lagarde, ^d   Ceccaldi, ^d   Peyramond, ^d   Allard, ^d   Reynes, ^d   Canton, ^d   Cassuto, ^d   Dellamonica, ^d   Arsac, ^d   Bricaire, ^d   Caulin, ^d   Frottier, ^d   Herson, ^d   Imbert, ^d   Malkin, ^d   Rozenbaum, ^d   Sicard, ^d   Vachon, ^d   Vilde ^d   Becq Giraudon, ^d   Remy ^d   more..

^a Faculte de Medecine Necker   (France)

^b PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^c Faculté Xavier Bichat   (France)

^d NONE

Author keywords

DNA banking; Ethics; HIV; Pharmacogenetics

Indexed keywords

DNA;

ACCURACY; ARTICLE; COHORT ANALYSIS; CONFIDENTIALITY; DECISION MAKING; EVALUATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMED CONSENT; MEDICAL ETHICS; PATIENT INFORMATION; PHARMACOGENETICS; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; STORAGE;

BIOLOGICAL SPECIMEN BANKS; COHORT STUDIES; CONFIDENTIALITY; DATABASES, FACTUAL; DNA; ETHICS, MEDICAL; GENETIC PRIVACY; GENETIC RESEARCH; GENETIC SCREENING; HIV INFECTIONS; HUMANS; INFORMED CONSENT; PHARMACOGENETICS;

HUMAN IMMUNODEFICIENCY VIRUS;

EID: 12244306200     PISSN: 0960314X     EISSN: None     Source Type: Journal    
DOI: 10.1097/00008571-200212000-00001     Document Type: Article

References (33)

1. Dean M, Carrington M, Winkler C, Huttley GA, Smith MW, Allikmets R, et al. Genetic restriction of HIV-1 infection and progression to AIDS by a deletion allele of the CKR5 structural gene. Hemophilia Growth and Development Study, Multicenter AIDS Cohort Study, Multicenter Hemophilia Cohort Study, San Francisco City Cohort, ALIVE Study (published erratum appears in Science 1996 274: 1069). Science 1996; 273:1856-1862.
2. Meyer L, Magierowska M, Hubert JB, Rouzioux C, Deveau C, Sanson F, et al. Early protective effect of CCR-5 delta 32 heterozygosity on HIV-1 disease progression: Relationship with viral load. The SEROCO Study Group. AIDS 1997; 11:F73-78.
3. Spear BB. Viewpoint - Pharmacogenomics: Today, tomorrow and beyond. Drug Benefit Trends 1999; 11:53-54.
4. Emilien G, Ponchon M, Caldas C, Isacson O, Maloteaux JM. Impact of genomics on drug discovery and clinical medicine. Q J Med 2000; 93:391-423.
5. Brockmoller J, Kirchheiner J, Meisel C, Roots I. Pharmacogenetic diagnosis of cytochrome P450 polymorphisms in clinical development and in drug treatment. Pharmacogenomics 2000, 1:125-151.
6. Wolf CR, Smith G, Smith RL. Science, medicine, and the future: Pharmacogenetics. BMJ 2000; 320:987-990.
7. Le Moing V, Chene G, Masquelier B, Sicard D, Brun-Vezinet F, Reynes J, Raffi F. Definition of virologic response and the type of assay used for quantification of viral load may influence the proportion of responders to antiretroviral therapy. APROCO study group. J Acquir Immune Defic Syndr 2000; 24:82-83.
8. Saves M, Raffi F, Clevenbergh P, Marchou B, Waldner-Combernoux A, Morlat P, et al. Hepatitis B or hepatitis C virus infection is a risk factor for severe hepatic cytolysis after initiation of a protease inhibitor-containing antiretroviral regimen in human immunodeficiency virus-infected patients. The APROCO Study Group. Antimicrob Agents Chemother 2000; 44:3451-3455.
9. Duran S, Spire B, Raffi F, Walter V, Bouhour D, Journot V, Cailleton V, et al. Self-reported symptoms following initiation of a protease inhibitor-containing regimen: Association with adherence to HAART in HIV-infected patients. HIV Clin Trials 2001; 2:38-45.
10. Lewden C, Raffi F, Cuzin L, Cailleton V, Vilde JL, Chene G, et al. Factors associated with mortality in human immunodeficiency virus type 1-infected adults initiating protease inhibitor-containing therapy: Role of education level and of early transaminase level elevation (APROCO-ANRS EP11 Study). J Infect Dis 2002; 186:710-714.
11. Le Moing V, Chene G, Carrieri MP, Besnier JM, Masquelier B, Salomon R, et al. Clinical, biologic and behavioral predictors of early immunologic and virologic response in HIV-infected patients initiating protease inhibitors. J Acquir Immune Defic Syndr 2001; 27:372-376.
12. Reilly PR. Rethinking risks to human subjects in genetic research. Am J Hum 1998; 63:682-685.
13. Eurogapp Project 1999-2000. Genetic Information and Testing in Insurance and Employment: Technical, Social and Ethical Issues. European Society of Human Genetics.
14. Nebert DW. Pharmacogenetics and pharmacogenomics: Why is this relevant to the clinical geneticist? Clin Genet 1999; 56:247-258.
15. Bailey DS, Bondar A, Furness LM. Pharmacogenomics - It's not just pharmacogenetics. Curr Opin Biotechnol 1998; 9:595-601.
16. WHO. Organization, Legislation and Patients' Rights. Genetic Database: Assessing the Benefits and the Impact on Human and Patient Rights. September 2001.
17. Robertson JA. Consent and privacy in pharmacogenetic testing. Nat Genet 2001; 28:207-209.
18. Weir RF, Horton JR. DNA banking and informed consent. Part 1 & 2. IRB 1995; 17:1-8.
19. Wolf M, Gaillard M, Hervé C. [Informed consent: What is the question? Correlation between practice and theory.] Presse Med 1997; 26:7-10. French.
20. Moutel G, de Montgolfier S, Meningaud JP, Hervé C. Bio-libraries and DNA storage: Assessment of patient perception of information. Medicine Law 2001; 20:193-204.
21. World Health Organization, Helsinki Declaration, adopted at the 52nd General Assembly, Edinburgh, October 2000 (http://www.wma.net/f/policy/17-c_f.html).
22. France. Ministère des Affaires Sociales, de la Santé et de la Ville. Law no. 88-1138 of the 20 December 1988 relative to the protection of human subjects undergoing biomedical research and Law no. 94-630 of the 25th July 1994, relative to the protection of human subjects undergoing biomedical research. JO lois et décrets 1994, 26 juill. 1994; 10747-10749.
23. National Bioethics Advisory Commission (NBAC). Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. USA, Maryland. August 1999. (http://bioethics.georgetown.edu/nbac/pubs.html).
24. Clarke A, English V, Harris H and Wells F. Report on ethical considerations. Int J Pharm Med 2001; 15:89-94.
25. Annas GJ. Privacy rules for DNA databanks. Protecting coded 'future diaries'. JAMA 1993; 270:2346-2350.
26. Troy ES. The Genetic Privacy Act: An analysis of privacy and research concerns. J Law Med Ethics 1997; 25:256-272.
27. Issa AM. Ethical considerations in clinical pharmacogenomics research. Trends Pharmacol Sci 2000; 21:247-249.
28. France. Ministère des Affaires Sociales, de la Santé et de la Ville. Law no. 2002-303 of the 4 March 2002 relative to patients' rights and to the quality of the health system. JO no. 54, 5 mars 2002; 4118.
29. Kaplan JC, Junien C. Genomics and medicine: An anticipation. From Boolean Mendelian genetics to multifactorial molecular medicine. C R Acad Sci III 2000; 323:1167-1174.
30. Knoppers BM. Genetic information and the family: Are we our brother's keeper? Trends Biotechnol 2002; 20:85-86.
31. Longuet P, Barthier S, Beuscart C, Leport C, Vilde JL. Medical confidentiality and HIV infection. Lancet 1993; 341:1350.
32. Deschênes M, Cardinal G, Knoppers BM, Glass KC. Human genetic research, DNA banking and consent: A question of 'form'? Clin Genet 2001; 59:221-239.
33. Rothstein MA, Epps PG. Ethical and legal implications of pharmacogenomics. Nat Rev Genet 2001; 2:228-231.