Medical research: Future directions in the genome era

Routledge Handbook of Medical Law and Ethics

Volumn , Issue , 2014, Pages 303-318

  Chalmers, Don ^a  

^a UNIVERSITY OF TASMANIA   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84953291733     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (80)

1. Annas, G. J. and Grodin, M. A. (eds) (1992) The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. Oxford: Oxford University Press.
2. Australian Health and Ministers Advisory Council (2006) 'A Streamlined National Approach to Scientific and Ethics Review of Multi-Centre Health and Medical Research in Australia: Issues and Options,' viewed 12 September 2013 at: https://www.nhmrc.gov.au/_files_nhmrc/file/health_ethics/hrecs/A_ streamlined_national_approach_to%20scientific_and_ethics_reviewvof%20multi-centre_health_and_ medical_research_in_Australia.pdf.
3. Australian National University (2013) 'Centre for Deliberative Democracy and Global Governance,' viewed 17 September 2013 at: http://deliberativedemocracy.anu.edu.au.
4. Baker, R. (1995) 'The historical context of the American Medical Association's 1847 Code of Ethics,' in R. Baker (ed.), The Codification of Medical Morality, Vol. 2. Dordrecht: Kluwer Academic, pp. 1-6.
5. Beecher, H. K. (1966) 'Ethics and clinical research,' New England Journal of Medicine, 274 (24): 1354-60.
6. Beecher, H. K. (1968) 'Ethical problems created by the hopelessly unconscious patient,' New England Journal of Medicine, 278 (26): 1425-30.
7. Brodsky, J. (1987) 'Aesthetics and language,' in Nobel Lectures: From the Literature Laureates, 1986-2005. Melbourne: Melbourne University Press, pp. 266-80.
8. Brownsword, R. (2013) 'Regulating biobanks: another triple bottom line,' in G. Pascuzzi, U. Izzo and M. Macilotti (eds), Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property, and the Role of Technology. Berlin: Springer-Verlag.
9. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (2010) Tri-Council Policy Statement: Ethical Conductfor Research Involving Humans, viewed 28 October 2013 at: http://www.ethics.gc.ca/pdf/ engZtcps2ZTCPS_2_FINAL_Web.pdf.
10. Chalmers, D. (2001a) 'Research ethics in Australia,' in National Bioethics Advisory Commission, Report on Ethical and Policy Issues in Research Involving Human Participants, vol. II. Bethesda, MD: NBAC.
11. Chalmers, D. (2001b) 'Are research ethics committees working in the best interests of participants in an increasingly globalised research environment?,' Journal of Internal Medicine, 269: 392-5.
12. Chalmers, D. (2004) 'Research involving humans: a time for change?,' Journal of Law, Medicine and Ethics, 32 (4): 583-495.
13. Chalmers, D. (2006) 'International medical research regulation: from ethics to law,' in S. McLean (ed.), First Do No Harm. Farnham: Ashgate, pp. 81-100.
14. Chalmers, D. (2011) 'Are research ethics committees working in the best interests of participants in an increasingly globalised research environment?,' Journal of Internal Medicine, 269: 392-5.
15. Chalmers, D. and Nicol, D. (2004) 'Commercialisation of biotechnology: public trust and research,' International Journal of Biotechnology, 6 (2/3): 116-33.
16. Chalmers, D. and Nicol, D. (2008) 'Human genetic research databases and biobanks-towards uniform terminology and Australian best practice,' Journal of Law and Medicine, 15 (4): 538-54.
17. Chalmers, D. and Pettit, P. (1989) 'Towards a consensual culture in the ethical review of research,' Medical Journal of Australia, 168: 79-82.
18. Chalmers, D., Nicol, D., Otlowski, M. and Critchley, C. (2013) 'Personalised medicine in the genome era,' Journal of Law and Medicine, 20 (3): 577-94.
19. Chima, S. (2006) 'Regulation of biomedical research in Africa,' British Medical Journal, 332: 848-51.
20. Council of International Organizations of Medical Sciences (CIOMS) and the World Health Organization (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects, viewed 17 September 2013 at: http://www.cioms.ch/publications/layout_guide2002.pdf.
21. Collins, F. (2010) The Language of Life: DNA and the Revolution in Personalized Medicine. Sydney: HarperCollins. Commonwealth of Australia (1996) 'Report of the Review of the Role and Functions of Institutional Ethics Committees,' viewed 15 September 2013 at: http://www.nhmrc.gov.au/_files_nhmrc/publica-tions/attachments/e34.pdf.
22. Council of International Organizations of Medical Sciences (CIOMS) (2008) International Ethical Guidelines for Epidemiological Studies, viewed 17 September 2013 at: http://www.ufrgs.br/bioetica/cioms2008.pdf.
23. Dawson, J. and Peart, N. (2003) 'Research ethics committees,' in J. Dawson and N. Peart (eds), The Law of Research: A Guide. Otago: University of Otago Press, pp. 47-60.
24. Dutton, G. (2005) 'NIH's new ethics regulations,' Genetic Engineering and Biotechnology, 25 (5), viewed 17 September 2013 at: http://www.genengnews.com/gen-articles/nih-s-new-ethics-regulations/933/.
25. Easton, D. F. et al. (2007) 'Genome-wide association study identifies novel breast cancer susceptibility loci,' Nature, 447: 1087-93.
26. European Commission (2013) 'Medicinal Products for Human Use: Clinical Trials-Major Developments,' viewed 18 September 2013 at: http://ec.europa.eu/health/human-use/clinical-trials/developments/.
27. Foster, M. W. and Sharp, R. R. (2007) 'Share and share alike: deciding how to distribute the scientific and social benefits of genomic data,' Nature Review Genetics, 8 (8): 633-9.
28. Furrow, B., Greaney, T., Johnson, S., Jost, T. andSchwartz, R. (2000) Health Law: Cases, Materials and Problems, 2nd edn. St Paul, MN: West.
29. Gibbons, S. and Kaye, J. (2007) 'Governing genetic databases: collection, storage and use', King's LawJournal, 18: 201-8.
30. Global Alliance for Genomic Health (2014) 'Global Alliance for Genomic Health,' viewed 7 March 2014 at: http://genomicsandhealth.org/.
31. Gottweis, H. and Petersen, A. (2008) Biobanks: Governance in Comparative Perspective. Oxford: Routledge.
32. Greenbaum, D., Sboner, A., Mu, X. J. and Gerstein, M. (2011) 'Genomics and privacy: implications of the new reality of closed data for the field,' PLoS Computational Biology, 7 (12).
33. Hansson, M. (2006) 'Should donors be allowed to give broad consent to future biobank research?,' Lancet Oncology, 7: 266-9.
34. Harris, S. H. (1994) Factories of Death: Japanese Biological Warfare 1932-45 and the American Cover-Up. Oxford: Routledge.
35. House of Lords Select Committee on Science and Technology (2000) 'Third Report: Science and Society,' viewed 17 September 2013 at: http://www.publications.parliament.uk/pa/ld199900/ldselect/ ldsctech/38/3802.htm.
36. Hudson, T. (2010) 'International network of cancer genome projects,' Nature, 464: 993-8.
37. Human Genome Organization (HUGO) Ethical, Legal and Social Issues Committee (1996) Statement on the Principled Conduct of Genetics Research, viewed 17 September 2013 at: http://www1.umn.edu/ humanrts/instree/geneticsresearch.html.
38. Human Genome Organization (HUGO) Ethics Committee (1998) Statement on DNA Sampling: Control and Access, viewed 17 September 2013 at: http://hugo-international.org/img/dna_1998.pdf.
39. Human Genome Organization (HUGO) Ethics Committee (2000) Statement on Benefit-Sharing, viewed 18 September 2013 at: http://hugo-international.org/img/benefit_sharing_2000.pdf.
40. Human Genome Organization (HUGO) Intellectual Property Committee (2000) Statement on Patenting of DNA Sequences in Particular Response to the European Biotechnology Directive, viewed 18 September 2013 at: http://www.hugo-international.org/img/ip_dna_2000.pdf.
41. Human Genome Project Consortium and Celera Genomics (2001a) Science: Special Issue, 291: 1145-344.
42. Human Genome Project Consortium and Celera Genomics (2001b) Nature: Special Issue, 409: 745-964.
43. Joly, Y., Dove, E. S., Knoppers, B. M., Bobrow, M. and Chalmers, D. (2012) 'Data sharing in the post-genomic world: the experience of the International Cancer Genome Consortium (ICGC) Data Access Compliance Office (DACO),' PLoS Computational Biology, 8 (7): e1002549.
44. Katz, J. (1993) 'Human experimentation and human rights,' Saint Louis University Law Journal, 38: 7-54.
45. Kaye, J. (2011) 'From single biobanks to international networks: developing e-governance', Human Genetics, 130: 377-82.
46. Kaye, J. and Stranger, M. (2009) Principles and Practice in Biobank Governance. Farnham: Ashgate.
47. Kirby, A. (2003) 'Nanotech may spark fierce ethical row,' BBC News, 14 February, viewed 19 September 2013 at: http://news.bbc.co.uk/2/hi/science/nature/2758191.stm.
48. Knoppers, B. M. (ed.) (2007) Genomics and Public Health. Leiden: Martinus Nijhoff
49. Leake, C. (1927) Percival's Medical Ethics. Baltimore, MD: Williams & Wilkinson.
50. Leblanc, R. and Gillies, J. (2005) Inside the Boardroom: How Boards Really Work and the Coming Revolution in Corporate Governance. Ontario: John Wiley & Son.
51. Levine, R. (1986) Ethics and Regulation of Clinical Research. Munich: Urban & Schwarzenberg.
52. Llewellyn, J., Downie, J. and Holmes, R. (2003) 'Protecting health research subjects: a jurisdictional analysis', Health Law Journal, special edn, pp. 207-42.
53. McLean, S. (2004) 'Regulating research and experimentation: a view from the UK,' Journal of Law, Medicine and Ethics, 32: 604-12.
54. Mascalzoni, D., Hicks, A., Pramstaller, P. and Wjst, M. (2008) 'Informed consent in the genomics era', PLoS Medicine, 5 (9): e192.
55. Medicines for Malaria Venture (2013) 'Our History', viewed 17 September 2013 at: http://www.mmv.org/ about-us/our-history.
56. Mendelson, D. (1998) 'The medical duty of confidentiality in the Hippocratic tradition and Jewish medical ethics,' Journal of Law and Medicine, 5 (227): 227-38.
57. National Bioethics Advisory Commission (NBAC) (2001a) Report on Ethical and Policy Issues in Research Involving Human Participants, vol. I. Bethesda, MD: NBAC.
58. National Bioethics Advisory Commission (NBAC) (2001b) Report on Ethical and Policy Issues in Research Involving Human Participants, vol. II. Bethesda, MD: NBAC.
59. National Cancer Institute (2013) 'The Cancer Genome Atlas,' viewed 17 September 2013 at: http://can-cergenome.nih.gov/.
60. Nie, J. B., Guo, N., Selden, M. and Kleinman, A. (2010) Japan's Wartime Medical Atrocities: Comparative Inquiries in Science, History, and Ethics. Oxford: Routledge.
61. Novartis Global (2011) 'The Novartis Malaria Initiative: Lessons from a Dramatic Decade,' 22 April, viewed 17 September 2013 at: http://www.novartis.com/newsroom/feature-stories/2011/04/malaria-initiative-1.shtml.
62. Organisation for Economic Cooperation and Development (OECD) (2009) 'Guidelines on Human Biobanks and Genetic Research Databases,' viewed 10 October 2013 at: http://www.oecd.org/sti/ biotech/guidelinesforhumanbiobanksandgeneticresearchdatabaseshbgrds.htm.
63. Pace Mason, J., McCall Smith, R. and Laurie, G. (2010) Law and Medical Ethics, 8th edn. Oxford: Oxford University Press, p. 572.
64. Pascuzzi, G., Izzo, U. and Macilotti, M. (eds) (2013) Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property, and the Role of Technology. Berlin: Springer-Verlag.
65. Pogge, T. (2002) World Poverty and Human Rights: Cosmopolitan Responsibilities and Reforms. New York: John Wiley & Sons.
66. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1983) Deciding to Forego Life Sustaining Treatment: The Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, viewed 5 September 2013 at: https://bioethicsarchive.georgetown. edu/pcbe/reports/past_commissions/deciding_to_forego_tx.pdf.
67. Rahman, F. (1997) Health and Medicine in the Islamic Tradition: Change and Identity. Chicago: Kazi Publications.
68. Reiser, S. J. (1995) 'Creating a medical profession in the United States: The first Code of Ethics of the American Medical Association,' in R. Baker (ed.), The Codification of Medical Morality, vol. 2. Dordrecht: Kluwer Academic.
69. Royal College of Physicians (2007) 'Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants,' 4th edn, viewed 17 September 2013 at: http://www.rcplondon.ac.uk/sites/ default/files/documents/guidelines-practice-ethicscommittees-medical-research.pdf.
70. Sakaiya, T. (1991) The Knowledge-Value Revolution, Or, A History of the Future. Tokyo: Kodansha America.
71. Sugarman, J. (2005) 'Should the Gold Rule? Assessing "equivalent protections" for research participants cross international borders,' Hastings Center Report, 35 (5): 12-15.
72. Sulston, J. and Ferry, G. (2003) The Common Thread. London: Corgi Books.
73. Taylor, P. (2008) 'Personal genomes: when consent gets in the way,' Nature, 456: 32-3.
74. UK Academy of Medical Sciences (2010a) 'A New Pathway for the Regulation and Governance of Health Research,' viewed 16 September 2013 at: http://www.acmedsci.ac.uk/index.php?pid=99andpuid=209.
75. UK Academy of Medical Sciences (2010b) 'Reaping the Rewards: A Vision for UK Medical Science,' viewed 17 September 2013 at: http://www.acmedsci.ac.uk/p99puid172.html.
76. UK Academy of Medical Sciences (2010c) 'Biomedical Research: A Platform for Increasing Health and Wealth in the UK,' viewed 17 September 2013 at: http://www.acmedsci.ac.uk/policy/policy-projects/ biomedical-research-a-platform-for-increasing-health-and-wealth-in-the-uk/.
77. UK Biobank (2013) 'Ethics,' viewed 19 September 2013 at: http://www.ukbiobank.ac.uk/ethics/.
78. UK Department of Health (2011) 'Governance Arrangements for Research Ethics Committees: A Harmonised Edition,' viewed 11 September 2013 at: https://www.gov.uk/government/uploads/ system/uploads/attachment_data/file/213753/dh_133993.pdf.
79. Universitat Jena (1981) Islamic Code of Medical Ethics, viewed 11 September 2013 at: http://www.rewi.uni-jena.de/rewimedia/Downloads/LS_Ruffert/Ethical+Codes/Islamic+Code+of+Medical+Ethics.pdf
80. World Health Organization (2011) Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: WHO Press.