Biobanking: International norms

Journal of Law, Medicine and Ethics

Volumn 33, Issue 1, 2005, Pages 7-14

  Knoppers, Bartha Maria ^a  

^a UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

AB INITIO CALCULATION; BIOINFORMATICS; BIOMEDICINE; CLINICAL GENETICS; COMMERCIAL PHENOMENA; CONFERENCE PAPER; DNA DETERMINATION; GENETIC DATABASE; GENETIC RISK; HEALTH CARE FACILITY; HUMAN; HUMAN GENOME PROJECT; MEDICAL CARE; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; PHARMACOGENETICS; PRACTICE GUIDELINE; PROTEOMICS; SOCIAL ASPECT; WORLD HEALTH ORGANIZATION;

EID: 17844408413     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2005.tb00205.x     Document Type: Conference Paper

References (76)

1. J. C. Fletcher and D. Wertz, eds., Ethics and Human Genetics: A Cross-Cultural Perspective (New York: Springer-Verlag, 1989); J. C. Fletcher and D. Wertz, eds., Genetics and Ethics in Global Perspective (The Hague: Kluwer Academic Publishers, 2004).
2. J. C. Fletcher and D. Wertz, eds., Ethics and Human Genetics: A Cross-Cultural Perspective (New York: Springer-Verlag, 1989); J. C. Fletcher and D. Wertz, eds., Genetics and Ethics in Global Perspective (The Hague: Kluwer Academic Publishers, 2004).
3. B. M. Knoppers, ed., Human DNA: Law and Policy (The Hague: Kluwer Law International, 1997); B. M. Knoppers, ed., Populations and Genetics: Legal and Socio-Ethical Perspectives (Leiden: Martinus Nijhoff, 2003).
4. B. M. Knoppers, ed., Human DNA: Law and Policy (The Hague: Kluwer Law International, 1997); B. M. Knoppers, ed., Populations and Genetics: Legal and Socio-Ethical Perspectives (Leiden: Martinus Nijhoff, 2003).
5. United Nations Educational, Scientific and Cultural Organization (International Bioethics Committee), Universal Declaration on the Human Genome and Human Rights, Paris, November 11, 1997, Official site of the UNESCO, at 〈http://www.unesco.org/shs/human_rights/hrbc.htm〉 (last visited January 13, 2005).
6. United Nations - Ad Hoc Committee on an International Convention against the Reproductive Cloning of Human Beings, Report of the Ad Hoc Committee on an International Convention against the Reproductive Cloning of Human Beings, New York, March 8, 2002, at 〈http://www.un.org/law/cloning/〉 (last visited January 13, 2005); Council of Europe (CE), ETS No. 168, Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings, Paris, 1998 at 〈http://conventions.coe.int/treaty/en/ Treaties/Html/168.htm〉 (last visited January 13, 2005).
7. United Nations - Ad Hoc Committee on an International Convention against the Reproductive Cloning of Human Beings, Report of the Ad Hoc Committee on an International Convention against the Reproductive Cloning of Human Beings, New York, March 8, 2002, at 〈http://www.un.org/law/cloning/〉 (last visited January 13, 2005); Council of Europe (CE), ETS No. 168, Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings, Paris, 1998 at 〈http://conventions.coe.int/treaty/en/ Treaties/Html/168.htm〉 (last visited January 13, 2005).
8. World Trade Organization, DOHA WTO Ministerial Declaration, WT/MIN(01)/DEC/1, Fourth Session, at 〈http://www.wto.org/english/thewto_e/ minist_e/min01_e/mindecl_e.pdf〉 (last visited January 13, 2005).
9. C. Sallée, Existing Human Genetic Research Databases: Context (Consent Mechanisms and Communication Strategies), paper presented at the OECD Meeting, Tokyo, Japan, February 26-27, 2004.
10. B. M. Knoppers and M. Saginur, "Towards a Common Language for Biobanking" (in preparation).
11. Human Genome Organization (1998), Statement on DNA Sampling: Control and Access (February 1998): 6: 1; Genome Digest 8, at 〈http://www.gene.ucl.ac. uk/hugo/sampling.html〉 (last visited February 28, 2005).
12. Human Genome Organization (1998), Statement on DNA Sampling: Control and Access (February 1998): 6: 1; Genome Digest 8, at 〈http://www.gene.ucl.ac. uk/hugo/sampling.html〉 (last visited February 28, 2005).
13. World Health Organization (European Partnership on Patients' Rights and Citizens' Empowerment) (2003), Genetic Databases - Assessing the Benefits and the Impact on Human Rights and Patient Rights, Geneva, 2003, at 〈http://www.law.ed.ac.uk/ahrb/publications/online/whofinalreport.rtf〉 (last visited January 13, 2005), (Sect. 4.4).
14. World Health Organization (1998), Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services, Report of a WHO Meeting on Ethical Issues in Medical Genetics, Geneva, December 15 and 16, 1997, Official site of the World Health Organization, at 〈http://whqlibdoc.who. int/hq/1998/WHO_HGN_GL_ETH_98.1.pdf〉 (last visited January 13, 2004), (guideline 10).
15. World Health Organization, supra note 9.
16. World Health Organization, supra note 9 (rec. 10).
17. Human Genome Organization, supra note 8.
18. Council for International Organizations of Medical Sciences (2002), International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, November 2002, Official site of the CIOMS, at 〈http://www.cioms.ch/frame_guidelines_nov_2002.htm〉 (last visited January 13, 2004), (guideline 4).
19. United Nations Educational, Scientific and Cultural Organization (2003), International Declaration on Human Genetic Data, Geneva, October 16, 2003, Official site of UNESCO, at 〈http://portal.unesco.org/shs/en/file_download. php/6016a4bea4c293a23e913de638045ea9Declaration_en.pdf〉 (last visited January 13, 2004), (arts. 16 and 17).
20. Human Genome Organization, supra note 8 (rec. 2).
21. Council for International Organizations, supra note 14 (guideline 4).
22. Council for International Organizations, supra note 14 (commentary on guideline 4).
23. Nations Educational, Scientific and Cultural Organization, supra note 15 (art. 16).
24. Council for International Organizations, supra note 14 (commentary on guideline 4).
25. Council for International Organizations, supra note 14 (commentary on guideline 4); See also, e.g. for genetic databases, supra note 12 (rec. 6).
26. Nations Educational, Scientific and Cultural Organization, supra note 15 (arts. 16 and 17).
27. Human Genome Organization, supra note 8.
28. V. Arnason, "Coding and Consent: Moral Challenges of the Database Project in Iceland," Bioethics 18 (2004): 27-49.
29. World Health Organization, supra note 10 (Tab. 10, guideline 10).
30. World Health Organization, supra note 9.
31. World Health Organization, supra note 9 (rec. 14).
32. Human Genome Organization (2002), Statement on Human Genomic Databases, London, December 2002, Official site of HUGO, at 〈http://www.hugo- international.org/hugo/HEC_Dec02.html〉 (last visited January 13, 2005), (rec. 4).
33. Consortium on Pharmacogenetics (2002), Pharmacogenetics: Ethical and Regulatory Issues in Research and Clinical Practice, April 2002, at 〈http://www.firstgenetic.net/latest_news/article_16.pdf〉 (last visited January 13, 2005), (Research B).
34. United Nations Educational, Scientific and Cultural Organization, supra note 15 (article 14 [e]).
35. World Health Organization, supra note 9 (Sect. 4.2 and rec. 7).
36. Consortium on Pharmacogenetics, supra note 29 (Research F).
37. World Health Organization, supra note 9 (4.2).
38. Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, Oviedo, April 4, 1997, Int. Dig. Health Leg. 48, 99, Official site of the Council of Europe, at 〈http://conventions.coe.int/treaty/en/treaties/ html/164.htm〉 (last visited January 13, 2005).
39. European Society of Human Genetics, Data Storage and DNA Banking for Biomedical Research: Technical, Social and Ethical Issues, Birmingham, November 2001, official site of the ESHG, at 〈http://www.eshg.org/ESHGDNAbankingrec. pdf〉 (last visited January 14, 2005).
40. Council of Europe (Steering Committee on Bioethics), Proposal for an Instrument on the Use of Archived Human Biological Materials in Biomedical Research, Strasbourg, October 17, 2002, at 〈http://www.coe.int/T/E/ Legal_affairs/Legal_co-operation/Bioethics/Activities/Biomedical_research/ CDBI-INF (2002)5E.pdf〉 (last visited January 14, 2005).
41. European Society of Human Genetics, supra note 35 (rec. 9).
42. European Society of Human Genetics, supra note 35 (rec. 14).
43. European Society of Human Genetics, supra note 35 (rec. 12).
44. Council of Europe, supra note 36 (art. 14).
45. Council of Europe, supra note 36 (art. 16).
46. Council of Europe, supra note 36 (art. 15.1).
47. Council of Europe, supra note 36 (art. 9).
48. European Society of Human Genetics, supra note 35 (rec. 10-11).
49. European Society of Human Genetics, supra note 35 (rec. 3).
50. European Society of Human Genetics, supra note 35 (rec. 8).
51. European Society of Human Genetics, supra note 35 (rec. 15).
52. See e.g. Nations Educational, Scientific and Cultural Organization, supra note 15 (4[a]); See e.g. Council of Europe, supra note 34 (art. 21).
53. See e.g. United Nations Educational, Scientific and Cultural Organization, supra note 3 (art. 1); Human Genome Organization (1996), Statement on the Principled Conduct of Genetic Research (May 1996) 3: 2 Genome Digest 2, available at 〈http://www.gene.ucl.ac.uk/hugo/conduct.htm〉 (last visited January 14, 2005).
54. Human Genome Organization, supra note 28.
55. European Parliament (1998), Directive 98/44/EC of the European Parliament and of the Council of 6 July 1999 on the Legal Protection of Biotechnological Inventions (July 30, 1998) L 213 Official Journal of the European Communities p.13, Official site of the European Union, at 〈http://europa.eu.int/eur- lex/pri/en/oj/dat/1998/l_213/l_21319980730en00130021.pdf〉 (last visited January 14, 2005).
56. Convention on Biological Diversity, Rio de Janeiro, June 5, 1992, at 〈www.biodiv.org〉 (last visited January 14, 2005).
57. Human Genome Organization, Statement on Benefit-Sharing, Vancouver, April 9, 2003, at 〈http://www.gene.ucl.ac.uk/hugo/benefit.html〉 (last visited January 14, 2005); Human Genome Organization, supra note 28.
58. United Nations Educational, Scientific and Cultural Organization, supra note 15.
59. World Health Organization, supra note 9.
60. Convention on Biological Diversity, supra note 52.
61. United Nations Educational, Scientific and Cultural Organization, supra note 15 (art. 19).
62. United Nations Educational, Scientific and Cultural Organization, supra note 15 (art. 19).
63. United Nations Educational, Scientific and Cultural Organization, supra note 49.
64. Human Genome Organization, supra note 28.
65. World Health Organization, supra note 9.
66. World Health Organization, supra note 9 (rec. 19).
67. See e.g. European Society of Human Genetics (Public and Professional Policy Committee), Population Genetic Screening Programs: Technical, Social and Ethical Issues, Recommendations of the European Society of Human Genetics, July 2000, Official site of the European Society of Human Genetics, at 〈http://www.eshg.org/ESHGscreeningrec.pdf〉 (last visited January 14, 2005).
68. European Society of Human Genetics, supra note 35.
69. European Society of Human Genetics, supra note 35 (art. 27).
70. Council of Europe, supra note 34.
71. Council of Europe, supra note 34 (art. 21).
72. Council of Europe, supra note 36.
73. Council of Europe, supra note 36 (article 14).
74. Council of Europe (Parliamentary Assembly), Recommendation 1512 (2001), Protection of the Human Genome by the Council of Europe, 2001, Official site of the European Council, at 〈http://assembly.coe.int/Documents/AdoptedText/ ta01/erec1512.htm〉 (last visited January 14, 2005), (vi).
75. L. Sheremata and B. M. Knoppers, "Beyond the Rhetoric: Population Genetics and Benefit Sharing," Health Law Journal 11 (2003): 89-117.
76. European Patent Office, Press Release, 'Myriad/Breast Cancer' Patent Revoked after Public Hearing (May 18, 2004). Online: 〈http://www.european- patent-office.org/news/pressrel/2004_ 05_18_e.htm〉 (last visited January 14, 2005).