Setting a dangerous precedent? Ethical issues in human genetic database research

Medical Law International

Volumn 8, Issue 2, 2007, Pages 105-137

  Takala, Tuija ^a,b  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b UNIVERSITY OF HELSINKI   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

GENETIC ANALYSIS; GENETIC DATABASE; HEALTH CARE SYSTEM; HUMAN; INFORMED CONSENT; MEDICAL DECISION MAKING; MEDICAL INFORMATION; MEDICAL RESEARCH; PROFESSIONAL STANDARD; RESEARCH ETHICS; REVIEW; RISK ASSESSMENT; WELLBEING;

EID: 33947500069     PISSN: 09685332     EISSN: None     Source Type: Journal    
DOI: 10.1177/096853320700800201     Document Type: Review

References (124)

1. Estonian Genome Foundation (http://www.genomics.ee), deCODE Genetics Inc (http://www.decode.com), Karolinska Institutet Biobank (http://ki.se/ki/jsp/ polopoly.jsp?d=866&a=1306&1=en), and UK Biobank (http://www.ukbiobank. ac.uk), respectively.
2. See e.g. The Scientist, 'Estonia genome project lives on', 28 April 2004. http://www.the-scientist.com/news/20040428/03.
3. See e.g. Daily Telegraph, 'Interview with Sir Alec Jeffreys', 6 September 2004. http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2004/09/06/ nba06.xml. He criticises the UK biobank mainly.
4. Kuusi, Osmo, Geenitieto Kuuluu Kaikille [Genetic Information for All] (Helsinki: Edita, 2004).
5. Häyry, Matti and Takala, Tuija 'American principles, European values, and the mezzanine rules of ethical genetic data banking' in V. Árnason, G. Árnason, R. Chadwick and M. Häyry (eds), The Ethics and Governance of Human Genetic Databases (Cambridge: Cambridge University Press, forthcoming).
6. Cf. Harris, John, 'Scientific research is a moral duty', Journal of Medical Ethics 31 (2005): 242-248.
7. Sometimes therapeutic research is called 'medical research combined with medical care'. See e.g. World Medical Association, Declaration of Helsinki, 2004. http://www.wma.net/e/policy/b3.htm.
8. With the possible exception of Estonia where participants have been promised 'gene cards'. No-one is quite sure what these 'gene cards' would be and how they would be used, although there has been some talk about making use of the card for 'personalised medicines'. Many Estonians expressed an interest of receiving such a card. See, Sutrop, Margit and Kadri, Simm, 'The Estonian healthcare system and the genetic database project: From limited resources to big hopes', Cambridge Quarterly of Healthcare Ethics 13 (2004): 254-262.
9. See e.g. The Scientist on 28 April 2004. http://www.the-scientist. com/news/20040428/03.
10. A very successful Finnish company (mobile phones, networks and accessories).
11. Kent, Alastair, 'Consent and confidentiality in genetics: Who's information is it anyway?' Journal of Medical Ethics 29 (2003): 16-18.;
12. Harris, John and Keywood, Kirsty, 'Ignorance, information and autonomy', Theoretical Medicine and Bioethics 22 (2001): 415-436.
13. Not all think that the prevention of such births is a good thing. See e.g, Vehmas, Simo, 'Parental responsibility and the morality of selective abortion', Ethical Theory and Moral Practice 5 (2002): 463-484.
14. Note though that the distinction between health-related and other genetically shaped features is blurred. On the complexity of defining health and illness, see e.g. Nordenfelt, Lennart, On the Nature of Health: An Action-Theoretic Approach (Dordrect: Kluwer Academic Publishers, 1995).
15. Savulescu, Julian, 'Procreative beneficence: Why we should select the best children', Bioethics 15 (2001): 413-426.
16. There are problems to this view as it is often difficult to draw the line and further, it does not necessarily follow that all treatments are 'good' and all enhancements somehow 'evil'. See e.g. Buchanan, Allen, Brock, Dan W., Daniels, Norman & Wikler, Daniel, From Change to Choice. Genetics and Justice (Cambridge: Cambridge University Press, 2000), esp. chapters 4-5.
17. There are many problems in using the argument from naturalness. See e.g. Takala, Tuija, 'The (im)morality of (un)naturalness'. Cambridge Quarterly of Healthcare Ethics 13 (2004): 15-19.
18. It should be noted though that within the scientific community there is some discussion as to whether the current hypothesis on genes and disease is indeed the right one. See e.g. Smith, Desmond J. and Lusis, Aldons J., 'The allelic structure of common disease', Human Molecular Genetics 11 (2002): 2455-2461.
19. The Estonian Human Genes Research Act (2000) states that gene donors have the right to personally (and free of charge) access their genetic data and they have the right to counseling upon accessing their data (§11, [2&4]).
20. Takala, Tuija, 'Justice for all? The Scandinavian approach' in Rosamond Rhodes, Margaret R. Battin and Anita Silvers (eds), Medicine and Social Justice: Essays on the Distribution of Health Care. Oxford: Oxford University Press, 2002, 183-190.
21. Of course, negative results could mean that no unnecessary check-ups are needed.
22. Karlsen, J.R., de Faria P.L. and Solbakk, J.H., 'To know the value of everything - a critical commentary on B Björkman and S O Hansson's "Bodily rights and property rights"'. Journal of Medical Ethics 32 (2006): 215-219.
23. Andrews, Lori B., 'Harnessing the benefits of biobanks', Journal of Law, Medicine and Ethics 33 (2005): 22-30.
24. The word 'discrimination' tends to be taken as a normative concept. It is, however, possible to make a distinction between 'acceptable' discrimination and 'unfair' discrimination. For analysis, see Halldenius, Lena, 'Dissecting discrimination', Cambridge Quarterly of Healthcare Ethics 14 (2005): 455-463.
25. Nuffield Council on Bioethics, Pharmacogenetics: Ethical Issues, 2003. http://www.nuffieldbioethics.org/go/ourwork/pharmacogenetics/ publication_314.html;
26. Netzer, Christian and Biller-Andorno, Nikola, 'Pharmacogenetic testing, informed consent and the problem of secondary information', Bioethics 18 (2004): 344-360;
27. Smart, Andrew; Martin, Paul and Parker, Michael, 'Tailored medicine: Whom will it fit? The ethics of patient and disease stratification', Bioethics 18 (2004): 321-343.
28. There were some earlier ones guidelines, but these were not international. Brody, Baruch A., 'A historical introduction to the requirement of obtaining informed consent from research participants' in Len Doyal and Jeffrey S Tobias (eds), Informed Consent in Medical Research (London: BMJ Books, 2001), 7-14.
29. Note though that the Nuremberg code mentions effects to person in addition to his health, which could be interpreted to include non-physical effects too. Nuremberg Code, Principle One. http://ohsr.od.nih.gov/ guidelines/nuremberg.html.
30. Some even say that consent procedures are there to 'protect the doctors against charges of assault'. O'Brien, J and Chantler, C., 'Confidentiality and the Duties of Care', Journal of Medical Ethics 29 (2003): 39.
31. For a very inclusive list see CIOMS (Council for International Organizations of Medical Sciences) International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002. http://www.cioms.ch/ frame_guidelines_nov_2002.htm.
32. Declaration of Helsinki, 2004, § 21.
33. See also, CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002.
34. This will be especially controversial if traits of character become issues to be looked at: 'Not suitable for working with children.'
35. See e.g. Burgess, Michael, M., 'Beyond consent: ethical and social issues in genetic testing', Nature Reviews: Genetics 2 (2001): 149, for a brief but comprehensive overview and further references.
36. Also, Launis, Veikko, 'The use of genetic test information in insurance: The argument from indistinguishability reconsidered', Science and Engineering Ethics 6 (2000): 299-310, for issues in insurance.
37. Kent 2003:16, supra note 12.
38. The 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: Convention on Human Rights and Biomedicine, 1997 (article 11) prohibits all discrimination on the grounds of a person's heritage. It remains to be seen whether this will change some of the existing insurance policies or whether the change will be towards including genetic information from genetic tests.
39. Takala, Tuija, 'Genetic knowledge and our conception of ourselves as persons' in D.C. Thomasma, D.N. Weisstub and C. Hervé (eds), Personhood and Health Care. Dordrecht: Kluwer Academic Publishers, 2001, 91-97.
40. Burgess 2001: 148-149, supra note 32.
41. For more analysis see Takala, Tuija, 'Genetic ignorance and reasonable paternalism', Theoretical Medicine and Bioethics 22 (2001): 485-491;
42. Takala, Tuija, 'The right to genetic ignorance confirmed'. Bioethics 13 (1999): 288-293.
43. Some could perhaps argue that once in possession of such information, the person has the duty to pass it on to those to whom it could be useful. (However, there are complications to this because of the problems in knowing for sure whether the information would be a benefit - rather than a harm - to the person in question.) Nevertheless, even if such a duty existed once the person has acquired the information, it is questionable whether the person should be duty bound to seek that information - i.e. to be put in an awkward situation.
44. See Janger, Edward J., 'Genetic information, privacy and insolvency', Journal of Law, Medicine & Ethics 33 (2005): 79-88. Janger discusses the worrying prospect of a biobank going bankrupt.
45. See e.g. Medical Research Council, Human Tissue and Biological Samples for use in Medical Research. Operational and Ethical Guidelines (London: MRC, 2001). http://www.mrc.ac.uk/pdf-tissue_guide_fin.pdf;
46. Eriksson, Stefan, 'Should results from genetic research be returned to research subjects and their biological relatives?' Trames: Journal of the Humanities and Social Sciences 8 no 1/2 (2004): 46-62.
47. Due to factual constraints, like time and money, this is unlikely to become a duty, making the contacts random.
48. Large life insurance policies and critical illness insurance policies are in some countries exempted. E.g. in the UK the insurance companies can use predictive genetic information for life insurance over £500,000 and for critical illness insurance over £300,000. Concordant and Moratorium on Genetics and Insurance (Published 14 March 2005) http://www.dh.gov.uk/ assetRoot/04/10/60/50/04106050.pdf.
49. With the Icelandic database there is the additional problem that there is no explicit consent in the first place. In Iceland you can opt-out from the database, but if you do not, you are included (Act on Health Sector Database 139/1998, Article 8).
50. Such change of policies is taking place around the world regarding sperm donors. When the practice first started everyone considered the anonymity of donors to be self-evident while now children born with donated sperm are widely believed to have a right to know their biological father. See e.g. BBC News, 'Call to end sperm donor anonymity', 14 May 2002, http://news.bbc.co. uk/1/hi/health/1986683.stm.
51. The Human Genes Research Act (Estonia, 2000) currently allows a doctor of a gene donor to access her patient's records even without her consent in urgent cases, where the donor is unable to give consent, no legal representative is available and when this is in the donor's interests and according to her presumed intentions (§24[2][7]).
52. United Nations Educational, Scientific and Cultural Organisation (UNESCO), Universal Declaration on the Human Genome and Human Rights, 1997. http://portal.unesco.org/en/ev.php-URL_ID=13177&URL_DO= DO_TOPIC&URL_SECTION=201.html
53. Human Genome Organisation, Statement on human genomic databases, 2002. http://www.hugo-international.org/Statement_on_Human_Genomic_Databases.htm.
54. With some well-known exceptions where groups of human beings have been seen as sub-human and, therefore, not though of as being protected by their humanity.
55. Andrews 2005, supra note 23.
56. For example, the Estonian Human Genes Research Act 2000 grants a non-transferable ownership of the samples in the Estonian Biobank to the Chief Processor (§15), and a recent US case Washington University v Catalona (4:03CV1065SNL) judged that neither the donors or the researcher own the samples, but the University where the research was carried out does.
57. Using the language of property was suggested e.g. in the 2003 WHO report on genetic databases. World Health Organisation, Genetic Databases: Assessing the Benefits and the Impact on Human Rights and Patient Rights, 2003. http://www.law.ed.ac.uk/ahrb/publications/online/whofinalreport.pdf.
58. For a more thorough analysis with similar premises see, Erin, Charles, 'Who own Mo? Using historical entitlement theory to decide the ownership of human derived cell lines' in A. Dyson and J. Harris (eds), Ethics and Biotechnology (London, Routledge, 1994, 157-178). Note though that Dr. Erin's contribution deals with the profits to be made from genetic material, while my primary interest is in who has the right to make decisions.
59. Locke, John, Second Treatise on Government (1960), chapter V;
60. See also Copleston, Frederick, A History of Philosophy volume 5 (Cornwall: Burns & Oates, 1999), 129-131.
61. I am not expecting this analogy to hold if stretched to its limits. Intellectual property rights are not directly applicable to biological entities.
62. There are some exceptions, but I will not discuss them here. For more details see, Kaye, Jane; Helgason, Hordur Helgi: Nõmper, Ants; Sild, Tarmo and Wendel, Lotta, 'Population genetic databases: A comparative analysis of the law in Iceland, Sweden, Estonia and the UK', Trames: Journal of the Humanities and Social Sciences 8 no 1/2 (2004): 15-33.
63. Then again, I suppose, that it could also be argued that since God also owns all the natural environment and humans can make it their property by mixing their labour with it, the same would apply to scientists mixing their labour with genetic raw-material.
64. UNESCO, Universal Declaration on the Human Genome and Human Rights, 1997.
65. Kent 2003:17, supra note 12.
66. For an analysis on many of these issues concluding that perhaps we should not rely on individual consent too much, see Chadwick, Ruth, 'Informed consent and genetic research' in Len Doyal and Jeffrey S Tobias (eds), Informed Consent in Medical Research (London: BMJ Books, 2001), 203-210.
67. For instance, it is believed that about 10% of children are not their father's biological offspring. See e.g. Baker, Robert, Sex in the Future: The Reproductive Revolution and How it Will Change Us? (New York: Arcade Publishing, 2001.)
68. For a more thorough discussion on the different notions, see Takala, Tuija, 'Concepts of "person" and "liberty" and their implications to our fading notions of autonomy', Journal of Medical Ethics, forthcoming.
69. See e.g. O'Neill, Onora, Autonomy and Trust in Bioethics. Cambridge: Cambridge University Press, 2001;
70. Takala, Tuija and Häyry, Matti, 'Genetic ignorance, moral obligations and social duties', Journal of Medicine and Philosophy 25 (2000): 107-113.
71. Mill, John Stuart, On Liberty (1859),
72. reprinted in On Liberty and The Subjection of Women (Ware, Hertfordshire: Wordsworth Classics of World Literature, 1996), 13.
73. Schneewind, J.B., The Invention of Autonomy: A History of Modern Moral Philosophy (Cambridge: Cambridge University Press, 1998), esp. chapters 22-23.
74. See e.g. Harris and Keywood 2001: 415-436, supra note 12; Rhodes, Rosamond, 'Genetic links, family ties, and social bonds: Rights and responsibilities in the face of genetic knowledge', Journal of Medicine and Philosophy 23 (1998): 10-30.
75. These could be seen as instances of public health policies, which have traditionally been considered interventions where the common good takes precedence over individual choice. See e.g. O'Neil, Onora, 'Some limits of informed consent'. Journal of Medical Ethics 29 (2003): 4-7. However, it is debatable whether genetic databanks should be seen as public health measures.
76. See also Lipwoth, W., Ankeny, R. and Kerridge, I., 'Consent in crises: the need to reconseptualize consent to tissue banking research', Internal Medicine Journal 36 (2006): 124-128.
77. On genetic databanks and minority concerns, see Häyry, Matti and Takala, Tuija, 'Bioethical analysis of the results: How well do laws and regulations address people's concerns?' in V. Árnason, G. Árnason, R. Chadwick and M. Häyry (eds), The Ethics and Governance of Human Genetic Databases (Cambridge: Cambridge University Press, forthcoming).
78. See Greely, Henry T. 'Informed consent and other ethical issues in human population genetics', Annual Review of Genetics 35 (2001): 792-793.
79. Compare e.g. Furness, P.N. and Nicholson, M.L., 'Obtaining explicit consent for the use of archival tissue samples: practical issues', Journal of Medical Ethics 30 (2004): 561-564;
80. and Houston, H., Pill, R., Fay, J. and Evans HM., 'Public attitudes towards the use of primary care patient record data in medical research without consent: a qualitative study', Journal of Medical Ethics 30 (2004): 104(6): online.
81. For an overview of studies see Korts, Küllikki; Weldon, Sue and Guomundsdóttir, Margrét Lilja, 'Genetic databases and public attitudes: A comparison of Iceland, Estonia and the UK', Trames: Journal of the Humanities and Social Sciences 8 no 1/2 (2004): 131-149.
82. Goldworth, Amnon, 'Informed consent in the genetic age', Cambridge Quarterly of Healthcare Ehics 8 (1999): 393-400.
83. Holm, Søren, 'There is nothing special about genetic information' in Alison K. Thompson and Ruth Chadwick (eds), Genetic Information, Acquisition, Access and Control (New York: Kluwer Academic/Plenum Publishers, 1997, 97-103);
84. O'Neill, Onora, 'Informed consent and genetic information', Studies in the History and Philosophy of Biological and Biomedical Sciences 32 no 4 (2001): 696-699.
85. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979. http://ohsr.od.nih.gov/guidelines/belmont.html;
86. CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002;
87. Nuremberg Code; United Nations Educational, Scientific and Cultural Organisation (UNESCO), Universal Draft Declaration on Bioethics and Human Rights, 2005. SHS/EST/05/CONF.24/3REV. Paris, France, 24 June 2005;
88. UNESCO, Universal Declaration on the Human Genome and Human Rights, 1997;
89. Declaration of Helsinki, 2004.
90. For overviews see e.g. Meslin, Eric M., 'A perspective from USA and Canada' in Len Doyal and Jeffrey S Tobias (eds), Informed Consent in Medical Research (London: BMJ Books, 2001), 148-155;
91. Nicholson, Richard, 'The European perspective' in Len Doyal and Jeffrey S Tobias (eds), Informed Consent in Medical Research (London: BMJ Books, 2001), 155-165;
92. Bauer, Keith; Taub, Sara and Parsi, Kayhan, 'Ethical issues in tissue banking: A brief review of existing organizational policies', Theoretical Medicine and Bioethics 25 (2004): 113-142.
93. For a more general discussion on the diminishing role of consent in biomedical practice see Kottow, M., 'The battering of informed consent', Journal of Medical Ethics 30 (2004): 565-569.
94. See e.g. Dyer, Clare, 'Human Tissue Bill is modified because of research needs', British Medical Journal 328 (2004): 1518.
95. Caulfield, Timothy; Upshur, Ross EG and Daar, Abdallah, 'DNA databanks and consent: A suggested policy option involving authorization model', BMC Medical Ethics 4 no 1 (2003): online, http://www.biomedcentral.com/ 1472-6939/4/1.
96. See e.g. O'Brien and Chantler 2003: 38, supra note 28; Kent 2003: 17, supra note 12.
97. Those holding this view say things like: 'not letting the ghosts of Nuremberg or the shadow of Nuremberg to confuse us'. See e.g. Deutsch, Erwin, 'The Nuremberg code: The proceedings in the medical case, the ten principles of Nuremberg and the lasting effect of the Nuremberg Code' in Ulrich Trohler and Stella Reiter-Theil (eds), Ethics Codes in Medicine: Foundations and Achievements of Codification Since 1947 (Aldershot: Ashgate, 1998), 75.
98. Habermas, Jürgen, The Future of Human Nature (Polity Press/Blackwell Publishing, 2003), 28.
99. Harris 2005, supra note 7.
100. I owe this point to Christopher Nobbs.
101. Skene, Loane, 'Genetic data banks: A justifiable intrusion on privacy' in Regulating the New Frontiers: Legal Issues in Biotechnology. University of Tasmania: Centre for Law and Genetics Symposium 2001 (Paper no 4.): 92-99;
102. Árnason, Vilhjálmur, 'Coding and consent: Moral challenges of the database project in Iceland', Bioethics 18 (2004): 27-49.
103. Echo (anon), 'The public must decide whether genetic screening is ethical', Journal of Medical Ethics 30 (2004): 62.
104. Peto, Julian; Fletcher, Olivia and Gilham, Clare, 'Data protection, informed consent, and research: Medical research suffers from pointless obstacles', British Medical Journal 328 (2004): 1030.
105. Declaration of Helsinki, 2004, § 5.
106. See also, 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: Convention on Human Rights and Biomedicine, 1997, § 2.;
107. United Nations Educational, Scientific and Cultural Organisation's (UNESCO), Universal Draft Declaration on Bioethics and Human Rights, 2005. SHS/EST/05/CONF.24/3REV. Paris, France. 24 June 2005.
108. For the arguments, see e.g. Turnberg, L., 'Common sense and common consent in communicable disease surveillance', Journal of Medical Ethics 13 (2003): 27-29.
109. From, say, taxation to quarantining people with serious communicable diseases. While some of the analogy arguments can be interesting, I will not go into those here. Further, it is perhaps worth noting that the justifiability of these practices can be questioned too. About taxation, see e.g. Nozick, Robert, Anarchy, State and Utopia (Oxford: Blackwell, 1974).
110. as for the ethics of quarantining, see e.g. Singer, Peter, A., Benatar, Salomon R., Bernstein, Mark, Dickens, Bernard M., MacRae, Susan K., Upshur, Ross E.G., Wright, Linda and Shaul Rhandi Zlotnik, 'Ethics and SARS: Lessons from Toronto', British Medical Journal 327 (2003): 1342-1344.
111. This is an issue that has come up in empirical studies on people who have refused to participate. See e.g. Haimes, Erika and Whong-Barr, Michael, 'Key issues in genetic epidemiology: Lessons from a UK based epidemiological study', Trames: Journal of the Humanities and Social Sciences 8 no 1/2 (2004): 150-163.
112. Cf. Árnason 2004: 43, supra note 82; Caulfield et al 2003, supra note 76.
113. Yet another option is not to ask for consent in the first place, but to work on 'implied consent'. This was the strategy used in Iceland. Basically the idea is to make everyone aware that a biobank is being created and then offer the option to opt-out, and in the absence of this, to assume that the person has consented - 'has implied her consent by not opting out'. See Hansson, Sven Ove, 'The ethics of biobanks'. Cambridge Quarterly of Healthcare Ethics 13 (2004): 320-322;
114. Greely, Henry T., 'Human genomics research - new challenges for ethical research', Perspectives in Biology and Medicine 44 (2001): 224-225; Greely 2001: 788-789, supra note 68.
115. For analysis on broad consent, see Kaye, Jane, 'Broad consent - the only option for population genetic databases?' in G. Árnason, S. Nordal and V. Árnason (eds), Blood and Data: Ethical, Legal and Social Aspects of Human Genetic Database. (Reykjavik: University of Iceland Press, 2004), 103-109.
116. See e.g. Caulfield et al 2003, supra note 76.
117. CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002, guideline 4: Individual Informed Consent;
118. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 1979. However, in guidelines currently being developed in Europe there are some problems both in defining and regulating research on anonymous and anonymised materials.
119. See, Trouet, C., 'New European guidelines for the use of stored human biological materials in biomedical research', Journal of Medical Ethics 30 (2004): 99(3): online.
120. Benatar, David and Benatar, Solomon R., 'Informed consent and research' in participants' in Len Doyal and Jeffrey S Tobias (eds), Informed Consent in Medical Research (London: BMJ Books, 2001), 137-138.
121. Jones, D.G. and Galvin K.A., 'Stored human tissue: an ethical perspective on the fate of anonymous, archival material', Journal of Medical Ethics 29 (2003): 343(5): online. (On page 5/9 of the printout.)
122. Kent 2003: 17, supra note 12.
123. As noted by Professor Leena Palotie (Scientific Council of the European Research Council) at a Seminar on Bioinformatics, Helsinki, May 2005. Also, Richards, M.P.M., Ponder, M., Phroah, P, Everest, S. and Mackay J., 'Issues of consent and feedback in a genetic epidemiological study of women with breast cancer', Journal of Medical Ethics 29 (2003): 95; Greely 2001: 226, supra note 90.
124. Richards et al 2003: 95-96, supra note 96.