Research involving humans: A time for change?

Journal of Law, Medicine and Ethics

Volumn 32, Issue 4, 2004, Pages 583-595

  Chalmers, Don ^a,b,c  

^a UNIVERSITY OF TASMANIA   (Australia)

^b Gene Technology Ethics Committee

^c Medical Research Council   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

AUSTRALIA; COMMERCIAL PHENOMENA; COMMUNITY CARE; CONFERENCE PAPER; CORRELATION ANALYSIS; DATA BASE; GENETIC ANALYSIS; GENOME ANALYSIS; GOVERNMENT REGULATION; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; INFORMATION PROCESSING; LAW; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL SOCIETY; POLITICS; PRACTICE GUIDELINE; PUBLIC HEALTH; STANDARDIZATION; STATISTICAL SIGNIFICANCE;

EID: 13744261262     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2004.tb01964.x     Document Type: Conference Paper

References (132)

1. See generally Dickens, "Legal Aspects of Human Experimentation, " Eugenics Bulletin 7 (1975): at 11; Dickens, "What is a Medical Experiment?" Canadian Medical Association Journal 113 (1975): at 635.
2. See generally Dickens, "Legal Aspects of Human Experimentation, " Eugenics Bulletin 7 (1975): at 11; Dickens, "What is a Medical Experiment?" Canadian Medical Association Journal 113 (1975): at 635.
3. See generally Dickens, "Research on Human Subjects," in Medical Ethics and Human Rights (London: Commonwealth Medical Association, 1994): at 42; Dickens, Experimentation and the Protection of Human Rights (Geneva: Council for International Organisations of Medical Sciences, 1979): at 200; Dickens, "Human Rights in Medical Experimentation," Israel Yearbook on Human Rights 23, no. 9 (1979).
4. See generally Dickens, "Research on Human Subjects," in Medical Ethics and Human Rights (London: Commonwealth Medical Association, 1994): at 42; Dickens, Experimentation and the Protection of Human Rights (Geneva: Council for International Organisations of Medical Sciences, 1979): at 200; Dickens, "Human Rights in Medical Experimentation," Israel Yearbook on Human Rights 23, no. 9 (1979).
5. See generally Dickens, "Research on Human Subjects," in Medical Ethics and Human Rights (London: Commonwealth Medical Association, 1994): at 42; Dickens, Experimentation and the Protection of Human Rights (Geneva: Council for International Organisations of Medical Sciences, 1979): at 200; Dickens, "Human Rights in Medical Experimentation," Israel Yearbook on Human Rights 23, no. 9 (1979).
6. Dickens, "Coercion and Inducement in Medical Experimentation," in Medicine, Science and the Law: Informed Consent Symposia 1986 (Melbourne: Law Reform Commission of Victoria, 1987): at 48.
7. Dickens, "Legal Approaches to Regulating Human Embryonic Research," in J. M. Nicholas, ed., Moral Priorities in Medical Research: The Second Hannah Conference (Toronto: Hannah Institute for the History of Medicine,1989): at 251.
8. Dickens, "Issues in Preparing Ethical Guidelines for Epidemiological Studies," Law, Medicine & Health Care 19 (1991): at 175.
9. Dickens, "Vulnerable Persons in Biomedical Research: 50 Years After the Nuremberg Code," International Journal of Bioethics 10 (1999): at 13; Dickens, "The Legal Challenge of Health Research Involving Children," Health Law Journal 6 (1989): at 131; Dickens, "Contractual Aspects of Human Medical Experimentation," University of Toronto Law Journal 25 (Autumn 1975): at 406; Dickens, "The Use of Children in Medical Experimentation," Osgoode Hall Law Journal 13 (1975): at 166.
10. Dickens, "Vulnerable Persons in Biomedical Research: 50 Years After the Nuremberg Code," International Journal of Bioethics 10 (1999): at 13; Dickens, "The Legal Challenge of Health Research Involving Children," Health Law Journal 6 (1989): at 131; Dickens, "Contractual Aspects of Human Medical Experimentation," University of Toronto Law Journal 25 (Autumn 1975): at 406; Dickens, "The Use of Children in Medical Experimentation," Osgoode Hall Law Journal 13 (1975): at 166.
11. Dickens, "Vulnerable Persons in Biomedical Research: 50 Years After the Nuremberg Code," International Journal of Bioethics 10 (1999): at 13; Dickens, "The Legal Challenge of Health Research Involving Children," Health Law Journal 6 (1989): at 131; Dickens, "Contractual Aspects of Human Medical Experimentation," University of Toronto Law Journal 25 (Autumn 1975): at 406; Dickens, "The Use of Children in Medical Experimentation," Osgoode Hall Law Journal 13 (1975): at 166.
12. Dickens, "Vulnerable Persons in Biomedical Research: 50 Years After the Nuremberg Code," International Journal of Bioethics 10 (1999): at 13; Dickens, "The Legal Challenge of Health Research Involving Children," Health Law Journal 6 (1989): at 131; Dickens, "Contractual Aspects of Human Medical Experimentation," University of Toronto Law Journal 25 (Autumn 1975): at 406; Dickens, "The Use of Children in Medical Experimentation," Osgoode Hall Law Journal 13 (1975): at 166.
13. Dickens, "Ethics Committees, Organ Transplantation and Public Policy," Law, Medicine & Health Care 300 (1992); Dickens, "Ethics Committees and Transplantation/Implantation Decisions," Transplantation/Implantation Today 3 (1986): at 11.
14. Dickens, "Ethics Committees, Organ Transplantation and Public Policy," Law, Medicine & Health Care 300 (1992); Dickens, "Ethics Committees and Transplantation/Implantation Decisions," Transplantation/Implantation Today 3 (1986): at 11.
15. Dickens, "Codes of Conduct and Ethics Guidelines," ed. by Breslow, in Encyclopaedia of Public Health (New York and Detroit: Macmillan Reference USA, 2002): at 224; Dickens, "Introduction to the Draft Revised Guidelines," in Z. Bankowski and R. J. Levine, eds., Ethics and Research on Human Subjects: International Guidelines (Geneva: Council for International Organisations of Medical Sciences, 1993): at 11.
16. Dickens, "Codes of Conduct and Ethics Guidelines," ed. by Breslow, in Encyclopaedia of Public Health (New York and Detroit: Macmillan Reference USA, 2002): at 224; Dickens, "Introduction to the Draft Revised Guidelines," in Z. Bankowski and R. J. Levine, eds., Ethics and Research on Human Subjects: International Guidelines (Geneva: Council for International Organisations of Medical Sciences, 1993): at 11.
17. Dickens, "Governance Relations in Biomedical Research," The Governance of Health Research Involving Human Subjects (Ottawa: Law Commission of Canada, 2000): 93; Dickens, "The Role and Operation of Ethics Review Committees in Canadian Health Care and Research," in K. Hoshino, ed., The Dignity of Life (Kyoto: Shibunkaku Publishers, 1999):at 67; B. Dickens and R.J. Cook "The FIGO study group on women's sexual and reproductive rights," International Journal of Gynaecology and Obstetrics 67 (1999): at 55; Dickens, "Human Research Beyond the Medical Model: Legal and Ethical Issues," Medicine and Law 16 (1997): at 687.
18. Dickens, "Governance Relations in Biomedical Research," The Governance of Health Research Involving Human Subjects (Ottawa: Law Commission of Canada, 2000): 93; Dickens, "The Role and Operation of Ethics Review Committees in Canadian Health Care and Research," in K. Hoshino, ed., The Dignity of Life (Kyoto: Shibunkaku Publishers, 1999):at 67; B. Dickens and R.J. Cook "The FIGO study group on women's sexual and reproductive rights," International Journal of Gynaecology and Obstetrics 67 (1999): at 55; Dickens, "Human Research Beyond the Medical Model: Legal and Ethical Issues," Medicine and Law 16 (1997): at 687.
19. Dickens, "Governance Relations in Biomedical Research," The Governance of Health Research Involving Human Subjects (Ottawa: Law Commission of Canada, 2000): 93; Dickens, "The Role and Operation of Ethics Review Committees in Canadian Health Care and Research," in K. Hoshino, ed., The Dignity of Life (Kyoto: Shibunkaku Publishers, 1999):at 67; B. Dickens and R.J. Cook "The FIGO study group on women's sexual and reproductive rights," International Journal of Gynaecology and Obstetrics 67 (1999): at 55; Dickens, "Human Research Beyond the Medical Model: Legal and Ethical Issues," Medicine and Law 16 (1997): at 687.
20. Dickens, "Governance Relations in Biomedical Research," The Governance of Health Research Involving Human Subjects (Ottawa: Law Commission of Canada, 2000): 93; Dickens, "The Role and Operation of Ethics Review Committees in Canadian Health Care and Research," in K. Hoshino, ed., The Dignity of Life (Kyoto: Shibunkaku Publishers, 1999):at 67; B. Dickens and R.J. Cook "The FIGO study group on women's sexual and reproductive rights," International Journal of Gynaecology and Obstetrics 67 (1999): at 55; Dickens, "Human Research Beyond the Medical Model: Legal and Ethical Issues," Medicine and Law 16 (1997): at 687.
21. Dickens, "The Challenge of Equivalent Protection," in Ethical and Policy Issues in International research: Clinical Trials in Developing Countries, Volume II (Bethesda, Maryland: National Bioethics Advisory Commission 2001): A1.
22. In the gallery of works by Professor Dickens, there are equally distinguished collections of works devoted to mental health, organ transplantation, reproduction and sexual health law, informed consent, care of the terminally ill and law and genetics.
23. See National Bioethics Advisory Commission Report, Ethical and Policy issues in Research involving Human Participants Vols 1& II at 〈http://www.georgetown.edu/research/nrcbl/nbac/human/ overvol2.html〉 (last visited on Sept. 9, 2004).
24. Australian Law Reform Commission/Australian Health ethics Commission (ALRC/AHEC), "Essentially Yours: The Protection of Human Genetic Information in Australia" Report 96 (2003), Vols 1 & 2 at 〈http://www.austlii.edu.au/au/other/alrc/publications/reports/96/〉 (last visited on Sept. 9, 2004).
25. National Health and Medical Research Council Act 1992, s8. However, these guidelines must be drawn up following a unique two stage public consultation process under s14.
26. Independent Review of the Role and Functioning of Institutional Ethics Committees Australia, Report of the Review of the Role and Functioning of Institutional Ethics, Committees AGPS Canberra (1996) (Chair D Chalmers): 1-104.
27. Australian Health Ethics Committee, National Statement on Ethical Conduct in Research Involving Humans Prepared by the Australian Health Ethics Committee under the relevant provisions of the National Health and Medical Research Council Act 1992 (Cth) and endorsed by the Australian Vice Chancellors' Committee, the Australian Research Council and the Learned Academies in 1999. It is a national research code of practice governing social as well as biomedical research.
28. Ibid see Principles 16.1-16.23 and the section on Human Tissue (Principle 15).
29. Ibid Recommendation 5.2.1.
30. Ibid see Recommendations ibid. Recommendations 5.3.1; 5.4.1; 5.5.4; 5.7-3; 5.8.1 and 5.8.2; 6.1.3; 6.4.1; 6.5; 7.3.1 and 7.3.2.
31. See B. Dickens, "Governance Relations in Biomedical Research," in Law Commission of Canada, The Governance of Health Research Involving Human Subjects, (Ottawa: Law Commission of Canada, 2000): at 93.
32. Ibid Recommendation 9.1.2.
33. Ibid Recommendation 6.2.1.
34. Ibid Recommendation 7.1.1 and 7.1.2.
35. National Statement on Ethical Conduct in Research Involving Humans Chapter 6 - Emergency, Intensive, Neo-natal and Terminal care; and, Impaired Capacity and Unconscious Patients.
36. For example, the Council of Europe, Convention on Biomedicine, the latest version of the Declaration of Helsinki, published by the World Medical Association, the Universal Declaration of the Genome and Human Rights, the Declaration of the Child, were referred to by the AHEC and noted in submissions to the consultation process.
37. For example, the Council of Europe, Convention on Biomedicine, the latest version of the Declaration of Helsinki, published by the World Medical Association, the Universal Declaration of the Genome and Human Rights, the Declaration of the Child, were referred to by the AHEC and noted in submissions to the consultation process.
38. European Committee for Proprietary Medicinal Products/International Conference on Harmonization, Note for guidance on good clinical practice (CPMP/ICH/135/95): annotated with TGA comments (Canberra: Therapeutic Goods Administration, Department of Health and Aged Care, 2000). Available at: 〈www.tga.gov.au/docs/html/ich13595.htm〉 (last visited Sept. 2004).
39. CIOMS and WHO, International Ethical Guidelines for Biomedical Research Involving Human Subjects, (1993): 1-61.
40. U. S. Fed. Reg. Title 45 Part 46.
41. Royal College of Physicians, Guidelines and the Practice of Ethics Committees in Research Involving Humans (London: Royal College of Physicians, 1996).
42. Health Research Council of New Zealand, Ministry of Health Review and the Ethical Review Structure in New Zealand, (New Zealand: New Zealand Government Printer, 1997).
43. Canadian Code of Ethical Conduct in Research Involving Humans. Tri-Council Statement of the Medical Research Council, National Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council of Canada (1997). The National Statement adopted the Canadian term "collectivity," included human genetics and followed the Canadian aim of a single national code, which was achieved in Australia.
44. See D. Chalmers "Research Ethics in Australia" commissioned paper for National Bioethics Advisory Commission, USA at 〈http://www. georgetown.edu/research/nrcbl/nbac/human/overvol2.pdf〉.
45. See National Statement, supra note 16, Principles 1.1, 1.2, 1.3 and 1.4 in particular.
46. See National Statement, supra note 16 Principle 2.2 at p15.
47. See National Statement, supra note 16, Principle 2.48 at p.21.
48. See D. Chalmers and P. Pettit, "Towards a Consensual Culture in the Ethical Review of Research," Medical Journal of Australia 168 (for the AHEC) (1998): 79-82.
49. SS 35 and 36 National Health and Medical Research Council Act 1992 (Cth).
50. Ibid SS 11-14
51. See National Statement, supra note 16.
52. See National Statement, supra note 16, Principles 1.1-1.21 and 2.1-2.48. On Human Genetics see Principles 16.1-16.23, and on Human Tissue Principles 15.1-15.8.
53. See National Statement, supra note 16, Principles 1.1-1.21 and 2.1-2.48. On Human Genetics see Principles 16.1-16.23, and on Human Tissue Principles 15.1-15.8.
54. See National Statement, supra note 16, Principles 1.1-1.21 and 2.1-2.48. On Human Genetics see Principles 16.1-16.23, and on Human Tissue Principles 15.1-15.8.
55. The concern about the regulatory gap over private institutions was a major concern raised with the Andrews' Report discussed in Section 3 of this article.
56. The 2003 AHEC Annual Training Workshop held in Canberra drew an attendance of some 500 delegates who were mainly HREC members. A startling admission was made by many that they were unfamiliar with the contents of the National Statement.
57. National Bioethics Advisory Commission Report Ethical and Policy issues in Research involving Human Participants Vol. 1 (Bethesda, Maryland 2001): 1-139.
58. Ibid at Rec. 2.2 at 28
59. See D. Chalmers and P. Pettit, supra note 36.
60. See P. Drahos "Intellectual Property Law and Basic Science: Extinguishing Prometheus?" Law in Context 10 (1992): at 56. See also R. Merton, The Sociology of Science (Chicago: University of Chicago Press, 1973).
61. See P. Drahos "Intellectual Property Law and Basic Science: Extinguishing Prometheus?" Law in Context 10 (1992): at 56. See also R. Merton, The Sociology of Science (Chicago: University of Chicago Press, 1973).
62. T. Sakaiya, Knowledge-Value Revolution (New York: Kodansha American, 1992).
63. See web site at 〈www.genomecanada.ca〉 (Last visited Sept. 10, 2004).
64. Commonwealth of Australia, Australian Biotechnology: A National Strategy (Canberra Australia: AGPS, 2000).
65. D. Nicol, M. Otlowski and D. Chalmers, "Consent, Commercialisation and Benefit Sharing," Journal of Law and Medicine 9 (2001): 80-94, at 80.
66. M. Heller and R. Eisenberg, "Can Patents Deter Innovation? The Anti-Commons in Bio-Medical Research," Science 280 (1998): 698-701, at 698.
67. D. Nicol and J. Nielsen, An Empirical Analysis of Issues Facing the Australian Industry (Tasmania: Centre for Law and Genetics, 2003): 1-276 at 36-38, 218-222; see also, I. Rabino, "How Human Geneticists in U.S. View Commercialization of the Human Genome Project," Nature Genetics, 29 (2001) 15-16, at 15.
68. D. Nicol and J. Nielsen, An Empirical Analysis of Issues Facing the Australian Industry (Tasmania: Centre for Law and Genetics, 2003): 1-276 at 36-38, 218-222; see also, I. Rabino, "How Human Geneticists in U.S. View Commercialization of the Human Genome Project," Nature Genetics, 29 (2001) 15-16, at 15.
69. See generally D. Chalmers and D. Nicol, "Commercialisation of Biotechnology: Public Trust and Research," International Journal of Biotechnology 6 (2004): 116-133, at 116.
70. D. Nicol, M. Otlowski and D. Chalmers, supra note 50.
71. These include: UK Medical Research Council, Human Tissue and Biological Samples for Use in Research. Interim Operational and Ethical Guidelines Issues by the Medical Research Council (1999); Canadian Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans (1998); U.S.A. "Federal Policy for the Protection of Human Subjects" (45 CFR 46) and National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (1999).
72. These include: UK Medical Research Council, Human Tissue and Biological Samples for Use in Research. Interim Operational and Ethical Guidelines Issues by the Medical Research Council (1999); Canadian Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans (1998); U.S.A. "Federal Policy for the Protection of Human Subjects" (45 CFR 46) and National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (1999).
73. These include: UK Medical Research Council, Human Tissue and Biological Samples for Use in Research. Interim Operational and Ethical Guidelines Issues by the Medical Research Council (1999); Canadian Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans (1998); U.S.A. "Federal Policy for the Protection of Human Subjects" (45 CFR 46) and National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (1999).
74. For example, HUGO Statement on the Principled Conduct of Genetics Research (1996); HUGO Ethics Committee, Statement on DNA Sampling: Control and Access (1998); HUGO Ethics Committee Statement on Benefit Sharing (2000); HUGO Statement on Patenting of DNA Sequences (2000).
75. For example, HUGO Statement on the Principled Conduct of Genetics Research (1996); HUGO Ethics Committee, Statement on DNA Sampling: Control and Access (1998); HUGO Ethics Committee Statement on Benefit Sharing (2000); HUGO Statement on Patenting of DNA Sequences (2000).
76. For example, HUGO Statement on the Principled Conduct of Genetics Research (1996); HUGO Ethics Committee, Statement on DNA Sampling: Control and Access (1998); HUGO Ethics Committee Statement on Benefit Sharing (2000); HUGO Statement on Patenting of DNA Sequences (2000).
77. For example, HUGO Statement on the Principled Conduct of Genetics Research (1996); HUGO Ethics Committee, Statement on DNA Sampling: Control and Access (1998); HUGO Ethics Committee Statement on Benefit Sharing (2000); HUGO Statement on Patenting of DNA Sequences (2000).
78. See National Statement, supra note 16, Principle 2.2.1.
79. See National Statement, supra note 16, Principle 2.2.1.
80. See National Statement, supra note 16, Principle 12.6.
81. See National Statement, supra note 16, Principle 12.5.
82. For example, the ARC Blood Service HREC requires disclosure of commercialization intentions as a condition of release of samples for research. These samples are almost invariably released in deidentified form.
83. The author is Chair of the National Australian Red Cross Blood Service Ethics Committee, which requires disclosure and has not received adverse comments from researchers nor reports of participant withdrawals.
84. United Kingdom Parliament, House of Lords Select Committee on Science and Technology 2000 Third Report: Science and Society, at 〈http://www. publications.parliament.uk/pa/ld199900/ldselect/ldsctech/38/3801.htm〉.
85. See D. Chalmers and D. Nicol, "Commercialisation of Biotechnology: Public Trust and Research," International Journal of Biotechnology 6 (2004): 116-133, at 116.
86. Ibid 50, paragraphs 13-14.
87. US Department of Health and Human Services, "Financial Relationships and Interests in Research Involving Human Subjects," Bulletin of Medical Ethics 198 (2004): 9-11, at 9.
88. See B. Dickens, supra note 9, op cit.
89. B. Dickens, "Vulnerable Persons in Biomedical Research: 50 Years after the Nuremberg Code," International Journal of Bioethics 10 (1999): at 13.
90. D. Rothman Strangers at the Bedside (New York: Basic Books, 1991).
91. See Privacy (Private Sector) Amendment Act 2001 (Cth).
92. This ruling applies equally to all other committees of the NHMRC, Tobacco Industry Australia v. National Health and Medical Research Council (1996): 142 ALR 1 per Finn J.
93. SS 55-61 NHMRC Act 1992 (Cth). In fact, there have been few complaints and mainly about review of decisions on grants by the Research Committee.
94. For example, the Council of Europe Convention on Biomedicine, the latest version of the Declaration of Helsinki, published by the World Medical Association, the Universal Declaration of the Genome and Human Rights, the Declaration of the Child, were referred to by the AHEC and noted in submissions to the consultation process.
95. For example, the Council of Europe Convention on Biomedicine, the latest version of the Declaration of Helsinki, published by the World Medical Association, the Universal Declaration of the Genome and Human Rights, the Declaration of the Child, were referred to by the AHEC and noted in submissions to the consultation process.
96. Promulgated by the General Conference of UNESCO at its 29th Session (November 11, 1997).
97. Gene Technology Act 2000(Cth).
98. Research involving Human Embryos Act 2002(Cth).
99. Established under state and territory Animal Welfare Acts.
100. P. Young, "Welcome to the Genome Era," Australian Biotechnology News (July 4 2003): 8-8, at 8.
101. Science: Special Issue 291 (2001):1177-1207; and Nature: Special Issue 409 (2001): 745-964.
102. Science: Special Issue 291 (2001):1177-1207; and Nature: Special Issue 409 (2001): 745-964.
103. The term "junk DNA" was coined in an early article by R. Nowak, "Mining Treasures from 'Junk DNA,'" Science 263 (1994): 608-610, at 608.
104. G. Berjano, M. Pheasant, I. Makunin, S. Stephen, W.J. Kent, J.S. Mattick, and D. Haussler, "Ultraconserved Elements in the Human Genome," Science Express (Published on line May 6 2004) at 〈http://www.sciencemag. org/sciencexpress/recent.shtml〉 (visited 10 Sept. 2004).
105. A bio-marker is a physiological response or a laboratory test that occurs in association with a pathological process that has possible diagnostic and/or prognostic utility.
106. With acknowledgement to Dr Tracey Edinburg of Eli Lilly Australia Pty Ltd for this information.
107. See National Statement, supra note 16, Principle 16.12-16.14. In these cases the HREC must take account of the nature of existing consents, the justification presented by the researcher for the waiver, proposals for privacy and the relationship of the project to an existing project.
108. ALRC/AHEC, supra note 13, 15-1 to 15-3.
109. R. Magnusson, "The Use of Human Tissue Samples in Medical Research: Legal Issues for Human Research Ethics Committees," Journal of Law and Medicine 7 (2000): 390-403, at 390.
110. For example, this is the method adopted by the Australia Red Cross Blood Service.
111. National Statement on Ethical Conduct in Research Involving Humans, supra note 16, Principles 15.1-15.9 on Human Tissue (1999).
112. For a very good consideration of these issues see B. Knoppers, "Banking of Human Materials, Intellectual Property Rights and Ownership Issues: Emerging Trends in the Literature and International Policy Positions," Parts I and II Law and Human Genome Review 5-6 (1996-1997): at 87 and 63 respectively.
113. See Privacy (Private Sector) Amendment Act 2001(Cth).
114. AHEC Scientific, Ethical and regulatory Considerations Relevant to Cloning of Human Beings Report to the Commonwealth Minister for Health and Aged Care 16 December 1998 (Chair D. Chalmers); D. Chalmers and D. Nicol, "Embryonic Stem Cell Research: Ethical and Economic Values (Part 1)" Law and the Human Genome Review 18 (2003): 43-53, at 43.
115. AHEC Scientific, Ethical and regulatory Considerations Relevant to Cloning of Human Beings Report to the Commonwealth Minister for Health and Aged Care 16 December 1998 (Chair D. Chalmers); D. Chalmers and D. Nicol, "Embryonic Stem Cell Research: Ethical and Economic Values (Part 1)" Law and the Human Genome Review 18 (2003): 43-53, at 43.
116. See D. Nicol D. Chalmers and B. Gogarty, "Regulating Biomedical Advances: Embryonic stem cell technology," Macquarie Law Journal 2 (2002): 31-59; D. Chalmers and D. Nicol Embryonic Stem Cell Research: Ethical and Economic Values (Part 1) Law and the Human Genome Review 18 (2003): 43-53, at 43; (Part II) in Law and the Human Genome Review 19 (2003): 91-108, at 91.
117. See D. Nicol D. Chalmers and B. Gogarty, "Regulating Biomedical Advances: Embryonic stem cell technology," Macquarie Law Journal 2 (2002): 31-59; D. Chalmers and D. Nicol Embryonic Stem Cell Research: Ethical and Economic Values (Part 1) Law and the Human Genome Review 18 (2003): 43-53, at 43; (Part II) in Law and the Human Genome Review 19 (2003): 91-108, at 91.
118. See D. Nicol D. Chalmers and B. Gogarty, "Regulating Biomedical Advances: Embryonic stem cell technology," Macquarie Law Journal 2 (2002): 31-59; D. Chalmers and D. Nicol Embryonic Stem Cell Research: Ethical and Economic Values (Part 1) Law and the Human Genome Review 18 (2003): 43-53, at 43; (Part II) in Law and the Human Genome Review 19 (2003): 91-108, at 91.
119. See House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: Scientific, Ethical and Legal Aspects of Human Cloning and the Stem Cell Research 2001 (Andrews' Report), August 2001, Recommendation 15, at 235. This particular recommendation was not based on any survey or public consultation but based on the few submissions received, on stem cell research.
120. Commonwealth of Australia, House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research, AGPS (2001). See D. Nicol D. Chalmers and B. Gogarty, "Regulating Biomedical Advances: Embryonic Stem Cell Technology," Macquarie Law Journal 2 (2002): 31-59.
121. Commonwealth of Australia, House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research, AGPS (2001). See D. Nicol D. Chalmers and B. Gogarty, "Regulating Biomedical Advances: Embryonic Stem Cell Technology," Macquarie Law Journal 2 (2002): 31-59.
122. Ibid at paragraph 12.80.
123. Andrews' Report, supra note 93, at paragraphs 9.47 and 9.49.
124. Head of the United States National Human Genome Research Institute and Chair of the Human Genome Project and its successor the International Haplotype Mapping Project.
125. News release during the XIX International Congress of Genetics Melbourne (July 5-9, 2003).
126. ALRC/AHEC, supra note 13.
127. Ibid, Rec 5-1.
128. Ibid, Rec 7-1.
129. See Commonwealth Privacy Act 1988 (Cth) and Privacy Amendment (Private Sector) Act 2000 (Cth).
130. The Report Rec 8-1.
131. Ibid, Rec 15-1.
132. National Statement, supra note 16, at 2.