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Otlowski, Margaret; Nicol, Dianne; Stranger, Mark --- "Biobanks Information Paper" [2010] JlLawInfoSci 5; (2010) 20(1) Journal of Law, Information and Science 97

[†] This Biobanks Information Paper was originally published by the National Health and Medical Research Council. It is reproduced here in substantially the same form. Minor changes have been made to accommodate publication in the Journal of Law, Information and Science.

[*] Professor, Dean and Head of School, Faculty of Law and Deputy Director, Centre for Law and Genetics, University of Tasmania, Private Bag 89, Hobart Tas 7001, Australia.

[**] Professor, Faculty of Law and Deputy Director, Centre for Law and Genetics, University of Tasmania, Private Bag 89, Hobart Tas 7001, Australia. Part of this work was completed while Professor Nicol was a visiting research fellow at RegNet, Australian National University.

[***] Senior Research Fellow and Executive Director of the Centre for Law and Genetics, University of Tasmania.

[1] H Hirtzlin et al, ‘An empirical survey on biobanking of human genetic material and data in six EU countries’ (2003) 11 European Journal of Human Genetics 475.

[2] A Campbell, ‘The ethical challenges of genetic databases: Safeguarding altruism and trust’ (2007) 18 King's Law Journal 227.

[3] National Health and Medical Research Council, National Statement on Ethical Conduct in Human Research (NHMRC, 2007) (‘National Statement’).

[4] Australian Law Reform Commission and Australian Health Ethics Committee (ALRC/AHEC), Essentially Yours, the Protection of Human Genetic Information in Australia, Report No 96 (2003) (‘ALRC/AHEC Report’).

[5] Ibid, 471, [18.8].

[6] Ibid, 472, [18.12]–[18.13].

[7] Secretary’s Advisory Committee on Genetics, Health and Society, Policy Issues Associated with Undertaking a New Large U.S. Population Cohort Study of Genes, Environment and Disease (Department of Health and Human Services, 2007) (‘US Cohort Study Report’).

[8] US Cohort Study Report, ibid, citing M Austin, S Harding, and C McElroy, ‘Genebanks: a comparison of eight proposed international genetic databases’ (2003) 6 Community Genetics 37, 37.

[9] Organisation for Economic Co-operation and Development (OECD), Guidelines for Human Biobanks and Genetic Research Databases (2009) <www.oecd.org/sti/biotechnology/hbgrd> (‘OECD Guidelines’).

[10] OECD, Creation and Governance of Human Genetic Research Databases (OECD Publishing, 2006) 9 (‘OECD Report’).

[11] National Cancer Institute, National Institutes of Health, Best Practices for Biospecimen Resources (2007) US Department of Health and Human Services, 3

<http://www.allirelandnci.org/pdf/NCI_Best_Practices_060507.pdf> . (‘NCI Best Practices’).

[12] US Cohort Study Report, above n 7, 16.

[13] OECD Guidelines, above n 9, 1.

[14] Further information on the 1000 Genomes Project is available at:

<http://www.1000 genomes.org/page.php?page=home> .

[15] National Statement, above n 3, [3.2.1].

[16] NHMRC, Guidelines for Genetic Registers and Associated Genetic Material (NHMRC 1999) [1.2(c)].

[17] See generally P3G Observatory, <http://www.p3gobservatory.org> .

[18] Further information on ABN activities is available at: <http://www.abrn.net/> .

[19] International Society for Biological and Environmental Repositories (ISBER), Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Human Biological Materials for Research (ISBER, 2nd ed, 2007) (‘ISBER Best Practices’).

[20] NCI Best Practices, above n 11.

[21] Information on OnCore UK policies and procedures is available at <http://www.oncoreuk.org/pages/about_sops.html> .

[22] OECD Report, above n 10, 68.

[23] Ibid, 72.

[24] OECD Guidelines, above n 9, Principle 2.D.

[25] Ibid, Best Practice 2.5.

[26] US Cohort Study Report, above n 7, 51.

[27] OECD Report, above n 10, 72.

[28] K G Hunter and G T Laurie, ‘Involving publics in biobank governance: Moving beyond existing approaches’ in H Widdows and C Mullen (eds), The Governance of Genetic Information (Cambridge University Press, 2009).

[29] J H Barker, ‘Common-pool resources and population genomics in Iceland, Estonia, and Tonga’ (2003) 6 Medicine, Health Care and Philosophy 133; J Tansey and M Burgess, ‘The foundations, applications and ethical dimensions of biobanks’ (2004) (DEG Electronic Working Papers Series No. DEG 005, W Maurice Young Centre for Applied Ethics, University of British Columbia, 2004) <www.ethics.ubc.ca>; J Duce, ‘Tonga gene pool rights acquired’ BBC News (online), 22 November 2000

<http://news.bbc.co.uk/2/hi/asia-pacific/1035686.stm> .

[30] Barker, above n 29; Tansey and Burgess, above n 29.

[31] UK Biobank Coordinating Centre, UK Biobank: Protocol for a large-scale prospective epidemiological resource (21 November 2006) <http://www.ukbiobank.ac.uk/docs/UKBProtocolfinal.pdf> .

[32] OECD Report, above n 10, 10, 58.

[33] Ibid, 10.

[34] US Cohort Study Report, above n 7, 21.

[35] Ibid, 16.

[36] OECD Report, above n 10, 58.

[37] Ibid, 55.

[38] UK Biobank, Ethics and Governance Framework (2006), 4 <http://www.ukbiobank.ac.uk/ethics/egf.php> .

[39] National Statement, above n 3, Chapter 1.1–1.3, 1.4.

[40] NCI Best Practices, above n 11, 3, Best Practice B.1.1.2.

[41] US Cohort Study Report, above n 7, 21.

[42] OECD Guidelines, above n 9, Principle 4.C.

[43] Ibid, Principle 4.A.

[44] Ibid.

[45] UK Biobank, above n 38, 4.

[46] National Statement, above n 3, [1.10].

[47] OECD Guidelines, above n 9, Best Practice 5.3.

[48] United Nations Educational, Scientific and Cultural Organization (UNESCO), International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39; Convention on Human Rights and Biomedicine, opened for signature 4 April 1997, CETS 164 (entered into force 1 December 1999) Article 11.

[49] OECD Guidelines, above n 9, Principle 4.C.

[50] Canadian Institute of Health Research, CIHR Guidelines for Health Research Involving Aboriginal People (Canadian Institute of Health Research, 2007); see also National Statement, above n 3, Chapter 4.7.

[51] European Group on Ethics in Science and New Technologies (EGE), Ethical Aspects of Human Tissue Banking, (Opinion of the European Group on Ethics in Science and New Technologies to the European Commission No 11, 21 July 1998) 7 (‘European Group Opinion, Tissue Banking’).

[52] National Statement, above n 3 [3.4.8].

[53] Ibid, [3.4.9].

[54] European Group on Ethics Opinion, Tissue Banking, above n 51, 9.

[55] OECD Guidelines, above n 9, Principles 10.A, 10.B.

[56] Ibid, Principle 2.C.

[57] Ibid, Best Practice 2.4.

[58] OECD Report, above n 10, 59.

[59] Ibid, 59–60.

[60] Ibid.

[61] NCI Best Practices, above n 11, Best Practice B.1.

[62] ISBER Best Practices, above n 19, Section B: Records Management.

[63] Ibid, Section C: Facilities.

[64] Ibid, Section D: Storage Equipment and Environments.

[65] OECD Report, above n 10, 111.

[66] ISBER Best Practices, above n 19, Section A, Part 3: Staffing.

[67] Ibid, Section G: Training.

[68] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 15 – Accuracy, reliability, quality and security.

[69] OECD Guidelines, above n 9, Best Practice 2.3.

[70] Australian Law Reform Commission (ALRC), For Your Information: Privacy Law and Practice (ALRC Report 108, 2008) <http://www.alrc.gov.au/inquiries/title/alrc108/index.html> .

[71] UNESCO, Universal Declaration on Bioethics and Human Rights, Gen Conf, 33d Sess (19 October 2005).

[72] UNESCO, Universal Declaration on the Human Genome and Human Rights, 29th Sess, 29 C/Res 16 (1997), endorsed by the UN General Assembly in GA Res 152, UN GAOR, 53rd Sess, UN Doc A/53/625/Add.2 (1998).

[73] OECD Report, above n 10, 61.

[74] Convention on Biological Diversity (opened for signature 5 June 1992) 1760 UNTS 142 (entered into force 29 December 1993).

[75] OECD Report, above n 10, 61.

[76] Ibid.

[77] Ibid.

[78] R Gertz, ‘An analysis of the Icelandic Supreme Court judgement on the Health Sector Database Act’ 2004(1) Script-ed 241.

[79] Both Statements can be found at RMGA Network for Applied Genetic Medicine (Réseau de Médecine Génétique Appliquée), (2007) <http://www.rmga.qc.ca/fr/programs_and_forms> .

[80] OECD Report, above n 10, 117.

[81] Ibid.

[82] For example, Nationaler Ethikrat, Biobanks for Research Opinion (2004) (‘German Biobank Opinion’) 55–56.

[83] OECD Report, above n 10, 117.

[84] Ibid.

[85] UK Biobank, above n 38, 18.

[86] The Nuremberg Code, (Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, 1949) 189–182.

[87] Declaration of Helsinki, World Medical Association, 18th Assembly (June 1964), reprinted in (1964) 8 World Medical Journal 281.

[88] UNESCO, International Bioethics Committee, Report of the International Bioethics Committee of UNESCO on Consent (2008) <http://unesdoc.unesco.org/images/0017/001781/178124e.pdf> .

[89] C Porteri and P Borry, ‘A proposal for a model of informed consent for the collection, storage and use of biological materials for research purposes’ (2008) 71(1) Patient Education and Counselling 136.

[90] National Statement, above n 3, Chapter 2.2.

[91] Ibid, [2.2.6].

[92] Ibid, [2.2.5].

[93] ISBER Best Practices, above n 19, 47.

[94] OECD Report, above n 10, 89.

[95] NCI Best Practices, above n 11, 16.

[96] M Rothstein, ‘Expanding the ethical analysis of biobanks’ (2005) 33(1) Journal of Law and Medicine 89, 91.

[97] T Caulfield, R Brown and E Meslin, ‘Challenging a well established consent norm? One time consent for biobank research’ (2007) 4 Journal of International Biotechnology Law 74; T Caulfield, ‘Biobanks and blanket consent: The proper place of the public good and public perception rationales’ (2007) 18 Kings Law Journal 209.

[98] M Otlowski, ‘Developing an appropriate consent model for biobanks: In defence of ‘broad’ consent’ in J Kaye and M Stranger (eds) Principles and Practice of Biobank Governance (Ashgate, 2009).

[99] National Statement, above n 3, [2.2.15].

[100] Human Genome Organisation (HUGO), HUGO Ethics Committee Statement on Human Genomic Databases (2002) <http://www.hugo-international.org/img/genomic_2002.pdf> (‘HUGO Statement on Human Genomic Databases’).

[101] OECD Guidelines, above n 9, Best Practice 4.6, Annotation 29.

[102] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39.

[103] WHO, Genetic Databases: Assessing the Benefits and the Impact on Human and Patient Rights (World Health Organization, 2003).

[104] National Statement, above n 3, [2.2.16].

[105] NCI Best Practices, above n 11, 16.

[106] OECD Report, above n 10, 91.

[107] National Statement, above n 3, [2.2.6].

[108] Ibid, [3.2.9]–[3.2.12].

[109] Ibid, [3.4.5]–[3.4.7].

[110] Ibid, [3.5.8].

[111] OECD Guidelines, above n 9, Best Practice 4.3.

[112] Ibid, Best Practice 4.11.

[113] Ibid, Best Practice 4.1.

[114] National Statement, above n 3, [3.2.9(a)]; OECD Guidelines, above n 9, Best Practice 4.4.

[115] OECD Guidelines, above n 9, Annotation 35; UK Biobank, above n 38, 5.

[116] National Statement, above n 3, [2.2.14].

[117] OECD Guidelines, above n 9, Best Practice 4.5.

[118] Ibid, Best Practice 4.7.

[119] See for example, UK Biobank, above n 38, 9; see also the P3G generic information pamphlet <http://www.p3gobservatory.org/> .

[120] National Statement, above n 3, [3.5.8(d)].

[121] OECD Guidelines, above n 9, Principle 4D; UK Biobank, above n 38, 5.

[122] National Statement, above n 3, [3.2.9(a)]; note also [3.4] with regard to human tissue samples.

[123] Ibid, [3.5.8(a)].

[124] OECD Guidelines, above n 9, Best Practice 4.4; note also National Statement, above n 3, [3.5.7], [3.5.12(e)].

[125] National Statement, above n 3, [3.5.8(c)]; OECD Guidelines, above n 9, Annotation 35.

[126] OECD Guidelines, above n 9, Best Practice 5.1.

[127] OECD Report, above n 10, 90.

[128] National Statement, above n 3, [3.5.8(e)].

[129] OECD Guidelines, above n 9, Principles 4H and 4I; NCI Best Practices, above n 11, 18.

[130] OECD Guidelines, above n 9, Annotation 34.

[131] HUGO, Statement on Human Genomic Databases, above n 100, Recommendation 4d; note also UK Biobank, above n 38, 5.

[132] OECD Guidelines, above n 9, Annotation 35.

[133] Ibid.

[134] Ibid, Annotation 27.

[135] Ibid, Annotation 35.

[136] Ibid, 4H and Annotation 35.

[137] National Statement, above n 3, [2.2.1(g)]; Ibid, Principle 4G; OECD Report, above n 10, 91.

[138] OECD Guidelines, above n 9, Annotation 44; UK Biobank, above n 38, 5.

[139] D Mascalzoni, A Hicks, P Pramstaller and M Wjst, ‘Informed consent in the genomics era’ 2008 5(9) PLoS Medicine 192, doi:10.1371/journal.pmed.0050192.

[140] UK Biobank, above n 38, 5.

[141] National Statement, above n 3, [3.2.11].

[142] National Statement, above n 3, [3.2.12].

[143] Ibid, [2.2.20].

[144] UNESCO, Universal Declaration on the Human Genome and Human Rights, 29th Sess, 29 C/Res 16 (1997), Article 9; OECD Guidelines, above n 9, Principle 4G, Best Practice 4.13.

[145] Declaration of Helsinki, World Medical Association, 18th Assembly (June 1964), reprinted in (1964) 8 World Medical Journal 281.

[146] OECD Guidelines, above n 9, Annotation 43.

[147] ISBER Best Practices, above n 19, 48.

[148] UK Biobank, above n 38, 9; note also OECD Guidelines, above n 9, Annotation 42.

[149] OECD Guidelines, above n 9, Annotation 57.

[150] UK Biobank, above n 38, 8–9.

[151] OECD Guidelines, above n 9, Annotation 44.

[152] Ibid.

[153] UK Biobank, above n 38, 10.

[154] Ibid.

[155] Ibid.

[156] see Gertz, above n 78; and R Gertz, ‘Is it “me” or “we”? Genetic relations and the meaning of “personal data” under the Data Protection Directive’ 2004 11 European Journal of Health Law 231.

[157] OECD Guidelines, above n 9, Best Practice 4.5.

[158] Ibid, Annotation 33.

[159] Ibid, Best Practice 3.1.

[160] OECD Report, above n 10, 93.

[161] OECD Guidelines, above n 9, Principle 4.C.

[162] Above n 3, see Chapter 4.2: Children and Young People.

[163] D Chalmers, ‘Genetic Research and Biobanks’ in Dillner (ed), Methods in Biobanking (Humana Press, forthcoming 2010).

[164] National Statement, above n 3, [4.2.7]–[4.2.9].

[165] OECD Guidelines, Best Practice 4.7.

[166] OECD Guidelines, above n 9, Glossary.

[167] OECD Report, above n 10, 93.

[168] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 8c.

[169] OECD Guidelines, above n 9, Best Practice 4.8.

[170] NCI Best Practices, above n 11, 20, Best Practices C.2.2.11.

[171] Gillick v West Norfolk and Wisbech Area Health Authority [1985] UKHL 7; (1985) 3 All ER 402.

[172] Medical Research Council, Human Tissue and Biological Samples for use in Research: Operational and Ethical Guidelines (2001) 26, <http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002420> .

[173] Julie Samuël, Nola M Ries, David Malkin and Bartha Maria Knoppers, ‘Biobanks and Longitudinal Studies: Where are the Children?’ (2008) 6 GenEditorial 1, 7.

[174] OECD Report, above n 10, 94.

[175] See, <http://www.bristol.ac.uk/alspac> .

[176] See, <http://www.canadianchildstudy.ca/> .

[177] See, <http://www.nationalchildrensstudy.gov/pages/default.aspx> .

[178] See, <http://www.genepi.org.au/waghp> .

[179] National Statement, above n 3, [4.3]–[4.5].

[180] Chalmers, above n 163, 17.

[181] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 8b.

[182] OECD Guidelines, above n 9, Principle 4.C.

[183] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 8c.

[184] OECD Guidelines, above n 9, Best Practice 5.3

[185] National Statement, above n 3, [1.10], [3.4.1(g)], Chapters 4.7, 4.8.

[186] Ibid, [3.5.11].

[187] See also, OECD Guidelines, above n 9, Annotation 29.

[188] See also, European Society of Human Genetics, ‘Data storage and DNA banking for biomedical research: technical, social and ethical issues’ (2003) 11(Suppl 2) European Journal of Human Genetics S8.

[189] National Statement, above n 3, [3.5.11].

[190] Ibid, [2.2.5(b)].

[191] OECD Report, above n 10, 94–95.

[192] Chalmers, above n 163, 35.

[193] OECD Guidelines, above n 9, Annotation 33.

[194] National Statement, above n 3, [2.3.5]–[2.3.6].

[195] National Statement, above n 3, [2.3.6].

[196] Chalmers, above n 163, 37.

[197] European Society of Human Genetics, above n 188, S9.

[198] National Statement, above n 3, [3.5.5].

[199] Academy of Medical Sciences, Personal Data for Public Good (2006) <http://www.acmedsci.ac.uk/p99puid62.html> .

[200] N Zeps, B J Iacopetta, L Schofield, J M George and J Goldblatt, ‘Waiver of individual patient consent in research: When do potential benefits to the community outweigh private rights?’ (2007) 83(2) Medical Journal of Australia 88.

[201] National Statement, above n 3, [15.8].

[202] National Statement, above n 3, Chapter 3.2, on Databanks.

[203] Ibid, [3.5.8(a)].

[204] Ibid, [3.2.9].

[205] Ibid, [3.2.10].

[206] OECD Guidelines, above n 9, Principles, 6A, 6B.

[207] ALRC/AHEC Report, above n 4, [8.19].

[208] European Commission, Article 29 Working Party, Opinion Nº 4/2007 on the Concept of Personal Data, WP 136, 20 June 2007, 15.

[209] National Statement, above n 3, Chapter 3.2.

[210] Ibid, [3.2.7].

[211] ALRC/AHEC, above n 4, recommendation 16-1.

[212] National Statement, above n 3, [3.2.2].

[213] Ibid, [3.4.1].

[214] See the National Pathology Accreditation Advisory Council, Requirements for the Retention of Laboratory Records and Diagnostic Material (Australian Government Department of Health and Ageing, 2007).

[215] See National Health and Medical Research Council and the Australian Research Council, Australian Code for the Responsible Conduct of Research, (2007).

[216] OECD Guidelines, above n 9, Principle 6.D; see also NCI Best Practices, above n 11, 2.

[217] OECD Guidelines, above n 9, Best Practice 2.8.

[218] NCI Best Practices, above n 11, 4–5.

[219] Ibid, 9–10.

[220] NCI Best Practices, 16.

[221] Opened for signature 19 December 1966, 999 UNTS 171 (entered into force 23 March 1976).

[222] OECD, Directorate for Science, Technology and Industry, OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data (1980) <http://www.oecd.org> .

[223] ALRC/AHEC, above n 4.

[224] National Statement, above n 3, [3.5.6].

[225] NCI Best Practices, above n 11, 20.

[226] Commonwealth Attorney General's Department, Australian Law Reform Commission and Australian Health Ethics Committee Report, Essentially Yours: The Protection of Human Genetic Information in Australia: Government Response to Recommendations, (Commonwealth of Australia 2005).

[227] Privacy Act 1988 (Cth) s 6.

[228] Ibid.

[229] ALRC, For Your Information: Privacy Law and Practice, ALRC Report No 108 (2008).

[230] Australian Government, Australian Government First Stage Response to the Australian Law Reform Commission Report 108, For Your Information: Australian Privacy Law and Practice (October 2009) <http://www.dpmc.gov.au/privacy/alrc_docs/stage1_aus_govt_response.pdf> .

[231] National Statement, above n 3, [2.2.6(f)], [3.5.8].

[232] Ibid, [3.2.5].

[233] Ibid, [3.5.7].

[234] Ibid, [3.5.13].

[235] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 14; HUGO Statement on Human Genomic Databases, above n 100, Recommendation 4c.

[236] See OECD Guidelines, above n 9, Principle 6.B.

[237] OECD Guidelines, above n 9, Best Practice 6.5.

[238] See Ibid; UK Biobank, above n 38, 10–12; ISBER Best Practices, above n 19, 48.

[239] NCI Best Practice, above n 11, B3.

[240] OECD Report, above n 10, 111.

[241] Ibid.

[242] National Institutes of Health (NIH), Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (2008) 9, Principle III,

<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html> (‘NIH GWAS Policy’).

[243] OECD Report, above n 10, 112.

[244] Ibid, 113.

[245] Ibid, 113.

[246] NCI Best Practices, above n 11, Best Practice B.5.

[247] Chalmers, above n 163, 31.

[248] See also OECD Report, above n 10, 96.

[249] J Murphy, J Scott, G Geller, L LeRoy and K Hudson, ‘Public perceptions for return of results from large-cohort genetic research’ (2008) 8 American Journal of Bioethics 36.

[250] See OECD Guidelines, above n 9, Best Practice 4.9; note also the obligations on researchers identified in the National Statement, above n 3, Chapter 3.5: Human Genetics, which is outlined in the next section.

[251] National Statement, above n 3, [3.2.6].

[252] Ibid, [3.4.6].

[253] Ibid, [3.5.8(g)].

[254] Ibid, [3.5.8(h)].

[255] See also OECD Guidelines, above n 9, Annotation 46.

[256] S B Haga and L M Beskow, ‘Ethical, legal and social implications of biobanks for genetics research’ (2008) 60 Advances in Genetics 505, 528–529.

[257] D Shalowitz and F Miller, ‘Disclosing individual results of clinical research: Implications of respect for participants’ (2005) 294 Journal of the American Medical Association 737, 737.

[258] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 13.

[259] OECD Guidelines, above n 9, Annotation 46.

[260] UK Biobank, above n 38, 7.

[261] C Johnstone and J Kaye, ‘Does the UK Biobank have a legal obligation to feedback individual findings to participants?’ (2004) 12 Medical Law Review 239, 239.

[262] National Statement, above n 3, [3.5.2(a)(i)].

[263] UK Biobank, above n 38, 7.

[264] Haga and Beskow, above n 250, 535.

[265] See, <http://www.kconfab.org/Index.shtml> .

[266] National Statement, above n 3, [3.5.6].

[267] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 7.

[268] OECD Guidelines, above n 3, Best Practice 1.4.

[269] ISBER Best Practices, above n 19, 48.

[270] See OECD Guidelines, above n 9, Annotation 10.

[271] Ibid, Annotation 53.

[272] National Statement, above n 3, [3.5.12(e)].

[273] See also ISBER Best Practices, above n 19, 48.

[274] OECD Guidelines, above n 9, Annotation 53.

[275] National Statement, above n 3, [3.4.1].

[276] ALRC/AHEC Report, above n 4, Recommendation 18-1.

[277] OECD Report, above n 10, 105.

[278] OECD Guidelines, above n 9, Principle 3.A.

[279] Ibid, Principle 3.C.

[280] Ibid, Principle 3.D.

[281] H Gottweis and A Petersen, Biobanks: Governance in Comparative Perspective (Routledge, 2008) 4.

[282] Ibid, 6.

[283] Ibid, 7.

[284] Ibid, 12.

[285] Chalmers, above n 163.

[286] C Lyall, T Papaioannou and J Smith, ‘The challenges of policy-making for the new life sciences’ in C Lyall, T Papaioannou and J Smith (eds), The Limits to Governance: The Challenge of Policy-Making for the New Life Sciences (Ashgate, 2009) 1–16.

[287] Bioethics Advisory Committee, Singapore, Report: Human Tissue Research (November 2002) 31–32 <http://www.bioethics-singapore.org/uploadhtml/54126%20PMHuman%20Tissue%20Report.html> (‘Singapore Report’).

[288] Ibid, 32.

[289] Ibid.

[290] German Biobank Opinion, above n 82, 64.

[291] OECD Report, above n 10, 14.

[292] Ibid, 105.

[293] Ibid.

[294] Human Tissue Act 2004 (UK) s 16.

[295] Human Tissue Act 2004 (UK) s 17.

[296] Human Tissue Act 2004 (UK) ss 13, 14; Schedule 1.

[297] Available at:

http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm>.

[298] ALRC/AHEC Report, above n 4, 402.

[299] Ibid, 490.

[300] Ibid, 491.

[301] Ibid.

[302] Singapore Report, above n 287, 17–18.

[303] Ibid, 18.

[304] Ibid.

[305] German Biobank Opinion, above n 82, 62–63.

[306] Ibid, 63.

[307] Ibid.

[308] Singapore Report, above n 287, 17.

[309] Ibid, 18.

[310] European Group on Ethics in Science and New Technologies (EGE), Ethical Aspects of Human Tissue Banking (Opinion of the European Group on Ethics in Science and New Technologies to the European Commission No 11, 21 July 1998).

[311] Ibid, Recommendation 2.8.

[312] German Biobank Opinion, above n 82, 26.

[313] OECD Report, above n 10, 105.

[314] Ibid.

[315] Ibid, 106.

[316] See above n 79.

[317] OECD Report, above n 10, 106.

[318] German Biobank Opinion, above n 82, 26.

[319] UK Biobank, above n 38, 3.

[320] G Laurie, A Bruce and C Lyall, ‘The roles of values and interests in the governance of the life sciences: Learning lessons from the “Ethics+” approach of UK Biobank’ in C Lyall, T Papaioannou and J Smith J (eds), The Limits to Governance: The Challenge of Policy-Making for the New Life Sciences (Ashgate, 2009) 51.

[321] Further information about the activities of the Ethics and Governance Council is available at, <http://www.egcukbiobank.org.uk/> .

[322] OECD Report, above n 10, 109.

[323] K Bédard, S Wallace, S Lazor and B M Knoppers, ‘Potential conflicts in governance mechanisms used in population biobanks’ in J Kaye and M Stranger (eds), Principles and Practice in Biobank Governance (Ashgate 2009).

[324] OECD Report, above n 10, 107.

[325] German Biobank Opinion, above n 82, 63.

[326] OECD Report, above n 10, 14.

[327] German Biobank Opinion, above n 82, 63–64.

[328] UK Biobank, above n 38, 15–16.

[329] National Statement, above n 3, [3.2.5].

[330] Ibid, [3.2.6].

[331] Ibid, [3.2.8].

[332] UK Biobank, above n 38, 12.

[333] Irish Law Reform Commission, The Establishment of a DNA Database, Report No 78 (2004) Chapter 4.

[334] NCI Best Practices, above n 11, Best Practice C.1.

[335] ALRC/AHEC Report, above n 4, 493.

[336] Ibid, 493–494.

[337] National Statement, above n 3, [3.2.7].

[338] German Biobank Opinion, above n 82, 64.

[339] OECD Report, above n 10, 109.

[340] UK Biobank, above n 38, 3.

[341] Ibid, 14.

[342] D E Winickoff and R N Winickoff, ‘The charitable trust as a model for genomic biobanks’ (2003) 349 The New England Journal of Medicine 1180, 1180.

[343] Ibid, 1181.

[344] D E Winickoff, ‘Partnership in U.K. Biobank: A third way for genomic property?’ (2007) 35(3) Journal of Law, Medicine and Ethics 440, 452–453.

[345] Hunter and Laurie, above n 28.

[346] German Biobank Opinion, above n 82, 75.

[347] OECD Report, above n 10, 113.

[348] Ibid, 114.

[349] OECD Guidelines, above n 9, Principles 7.A and 7.B.

[350] NCI Best Practices, above n 11, Best Practice C.4.

[351] See OECD Report, above n 10, 113.

[352] UNESCO, Universal Declaration on the Human Genome and Human Rights, 29th Sess, 29 C/Res 16 (1997), Article 18.

[353] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 18.

[354] HUGO, Statement on Human Genomic Databases, above n 100, Recommendation 1.

[355] Ibid, Recommendation 3.

[356] Ibid, Recommendation 6.

[357] OECD, Principles and Guidelines for Access to Research Data from Public Funding (OECD, 2007) 11,

<http://www.oecd.org/dataoecd/9/61/38500813.pdf> .

[358] Ibid, 15–16.

[359] International Council for Science (ICSU), Scientific Data and Information: Report of the CSPR Assessment Panel (December 2004) 10, [33] <http://www.icsu.org/2_resourcecentre/RESOURCE_list_base.php4?rub=9> (‘ICSU Report’).

[360] Prime Minister’s Science, Engineering and Innovation Council (PMSEIC), From Data to Wisdom: Pathways to Successful Data Management for Australian Science (Working Group on Data for Science Report to PMSEIC, 2006) Recommendation 6.

[361] National Institutes of Health (NIH), Statement on Sharing Research Data (2003) <http://grants.nih.gov/grants/policy/data_ sharing/> .

[362] ICSU Report, above n 359, 10.

[363] HUGO, Summary of Principles Agreed at the First International Strategy Meeting on Human Genome Sequencing (1996): <http://www.ornl.gov/sci/techresources/Human_Genome/research/bermuda.shtml#> .

[364] See International HapMap Consortium, ‘Integrating ethics and science in the International HapMap Project’ (2004) 5 Nature Reviews Genetics 467.

[365] See 1000 Genomes Project, above n 14.

[366] NIH GWAS Policy, above n 242, 12–13, Principle V.

[367] Ibid, 13, Principle V.

[368] Toronto International Data Release Workshop Authors, ‘Prepublication data sharing’ (2009) 461 Nature 168.

[369] J Kaye, C Heeney, N Hawkins , J de Vries and P Boddington, ‘Data sharing in genomics – re-shaping scientific practice’ (2009) 10 Nature Reviews Genetics 331.

[370] As explained in the NIH, Background Fact Sheet on GWAS Policy Update (2008) <http://grants.nih.gov/grants/gwas/> .

[371] See US Cohort Study Report, above n 7, 29; OECD Guidelines, above n 9, Principle 7.E.

[372] OECD Report, above n 10, 114.

[373] Ibid.

[374] Ibid, 114–115.

[375] UK Biobank, above n 38, 12.

[376] National Statement, above n 3, [3.2.7].

[377] E Eiseman, G Bloom, J Brower, N Clancy and S S Olmsted, Case Studies of Existing Human Tissue Repositories: “Best Practices” for a Biospecimen Resource for the Genomic and Proteomic Era (Commissioned by the National Cancer Institute National Dialogue on Cancer, Rand Corporation, 2003).

[378] Ibid, 143–144.

[379] German Biobank Opinion, above n 82, 76.

[380] German Biobank Opinion, above n 82, 76.

[381] OECD Report, above n 10, 115.

[382] OECD Guidelines, above n 9, Best Practice 7.6.

[383] UK Biobank, above n 38, 7.

[384] Ibid, 14.

[385] Eiseman et al, above n 377.

[386] See, for example, National Statement, above n 3, [3.4.10].

[387] NHMRC, Ethics and the Exchange, Sale of and Profit from Products Derived from Human Tissue: An Issues Paper (NHMRC, 2009) (‘Human Tissue Products Issues Paper’).

[388] Ibid, 34.

[389] Ibid, 21.

[390] Ibid, 35.

[391] Ibid, 37–38.

[392] OECD Report, above n 10, 127.

[393] US Cohort Study Report, above n 7, 29.

[394] Ibid, 29.

[395] OECD Report, above n 10, 127.

[396] UK Biobank, above n 38, 13.

[397] Human Tissue Products Issues Paper, above n 387, 69.

[398] OECD Guidelines, above n 9, Principle 7.F.

[399] UK Biobank, above n 38, 13.

[400] Human Tissue Products Issues Paper, above n 387, 28–29, footnote omitted.

[401] Ibid, 38.

[402] Ibid, 16.

[403] 51 Cal. 3d 120 (Cal. 1990)

[404] 264 F.Supp. 2d 1064 (Fla. 2003).

[405] 437 F.Supp. 2d 985 (Miss. 2006).

[406] R Rao, ‘Genes and spleens: property, contract, or privacy rights in the human body’ (2007) 35(3) Journal of Law, Medicine and Ethics 371.

[407] ALRC/AHEC Report, above n 4, 527.

[408] Ibid, 532–535.

[409] Ibid, Recommendation 20-1.

[410] Human Tissue Products Issues Paper, above n 387, 15.

[411] OECD Guidelines, above n 9, Principle 9.C.

[412] UK Biobank, above n 38, 12.

[413] European Parliament, Directive 96/9/EC of the European Parliament and the Council of 11 March 1996 on the legal protection of databases [1996] <http://europa.eu/legislation_summaries/internal_market/businesses/intellectual_property/l26028_en.htm> .

[414] OECD Report, above n 10, 124.

[415] Ibid.

[416] Ibid, 125.

[417] UK Biobank, above n 38, 18.

[418] Human Tissue Products Issues Paper, above n 387, 56.

[419] Ibid, 57.

[420] OECD Report, above n 10, 126.

[421] UK Biobank’s, above n 38, 18.

[422] Human Tissue Products Issues Paper, above n 387, 38.

[423] OECD Report, above n 10, 123.

[424] US Cohort Study Report, above n 7, 42.

[425] OECD Report, above n 10, 123.

[426] UNESCO, International Declaration on Human Genetic Data, 32 C/Res 22 (2003) 39, Article 19a.

[427] Ibid, Article 19(a)(i).

[428] Ibid, Article 19(a)(ii)–(vii).

[429] HUGO Ethics Committee, Statement on Benefit Sharing (9 April 2000) <http://www.hugo-international.org/comm_hugoethicscommittee.php> .

[430] Ibid.

[431] OECD Guidelines, above n 9, Principles 9.C and 9.D.

[432] Ibid, Best Practices 9.1 and 9.2.

[433] Newfoundland and Labrador Department of Health and Community Services, Policy Implications of Commercial Genetic Research in Newfoundland and Labrador (2003).

[434] See, for example, B M Knoppers and L Sheremeta, ‘Beyond the rhetoric: Population genetics and benefit-sharing’ (2003) 11 Health Law Journal 89.

[435] A Webster, B Brown , C Douglas, G Lewis, J Kaye, R Tutton and N Williams, Public Attitudes to Third Party Access and Benefit Sharing: Their Application to UK Biobank (Final Report to the UK Biobank Ethics and Governance Council, York, Science and Technology Studies, University of York, 2008)

<http://www.egcukbiobank.org.uk/meetingsandreports/index.html> .

[436] G Haddow, G Laurie, S Cunningham-Burley and KG Hunter, ‘Tackling community concerns about commercialization and genetic research: A modest interdisciplinary proposal’ (2007) 64 Social Sciences and Medicine 272; G Haddow, S Cunningham-Burley, A Bruce, and S Parry, Generation Scotland: Consulting publics and specialists at an early stage in a genetic database’s development (2008) 18 Critical Public Health 139.

[437] D Nicol and C Critchley, ‘What benefit sharing arrangements do people want from biobanks? A survey of public opinion in Australia’ in J Kaye and M Stranger (eds), Principles and Practice of Biobank Governance (Ashgate, 2009).

[438] OECD Report, above n 10, 127.

[439] RMGA Network of Applied Genetic Medicine 2000, 2003, above n 79; OECD Report, above n 10, 128.

[440] UK Biobank, above n 38, 17, Part III.C.1.

[441] International HapMap Consortium, above n 364.

[442] See, for example, National Statement, above n 3, [2.2.10].

[443] OECD Report, above n 10, 128.

[444] Australasian Biospecimen Network, Biorepository Guidelines (2007) 6 <http://www.abrn.net/pdf/ABN_SOPs_Review_Mar07_final.pdf> .

[445] OECD Report, above n 10, 128.

[446] Canadian Institute of Health Research, CIHR Guidelines for Health Research Involving Aboriginal People (Canadian Institute of Health Research, 2007) 23, Article 9.

[447] Human Tissue Products Issues Paper, above n 387, 49.

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