Governing Biobanks: Understanding the Interplay between Law and Practice

Governing Biobanks: Understanding the Interplay between Law and Practice

Volumn , Issue , 2012, Pages 1-370

  Kaye, Jane ^a   Gibbons, Susan M C ^b   Heeney, Catherine ^b   Parker, Michael ^b   Smart, Andrew ^c  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c BATH SPA UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85190208402     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Book

References (330)

1. FP Perera and IB Weinstein, ‘Molecular Epidemiology: Recent Advances and Future Directions’ (2000) 21(3) Carcinogenesis 517
2. R Tutton and O Corrigan, ‘Introduction: Public Participation in Genetic Databases’ in R Tutton and O Corrigan (eds), Genetic Databases: Socio-ethical Issues in the Collection and Use of DNA (London, Routledge, 2004).
3. JV McHale, ‘Regulating Genetic Databases: Some Legal and Ethical Issues’ (2004) 12 Medical Law Review 70
4. I Hirtzlin, C Dubreuil, N Préaubert, J Duchier, B Jansen, J Simon, PL de Faria, A Perez-Lezaun, B Visser, GD Williams and A Cambon-Thomsen, ‘An Empirical Survey on Biobanking of Human Genetic Material and Data in Six EU Countries’ (2003) 11 European Journal of Human Genetics 475.
5. D Price, ‘From Cosmos and Damien to Van Veltzen: the Human Tissue Saga Continues’ (2003) 11 Medical Law Review 1
6. C Mannhalter, ‘Collection, Storage and Use of Genetic Data: Issues of Gene Banks’, paper presented at conference on UNESCO Universal Declaration on the Human Genome and Human Rights: present status—future perspectives (June 2003)
7. J Bohannon, ‘UK Researchers Hope for Clarity in Tissue Use’ (2002) 298 Science 1867
8. J Black, ‘Regulation as Facilitation: Negotiating the Genetic Revolution’ in R Brownsword, W Cornish and M Llewellyn (eds), Law and Human Genetics: Regulating a Revolution (Oxford, Hart Publishing, 1998)
9. R Brownsword, ‘Regulating Human Genetics: New Dilemmas for a New Millennium’ (2004) 12 Medical Law Review 14.
10. J Kaye and P Martin, ‘Safeguards for Research Using Large Scale Dna Collections’ (2000) 321 British Medical Journal 1146
11. P Martin and J Kaye, ‘The Use of Large Biological Sample Collections in Genetics Research: Issues for Public Policy’ in P Glasner (ed), Reconfiguring Nature: Issues and Debates in the New Genetics (Aldershot, Ashgate, 2004).
12. H Newiss, ‘Genetic Databanks: How Secure Is Your Information?’ (2001) 1(6) Genetics Law Monitor 1
13. J Strobl, E Cave and T Walley, ‘Data Protection Legislation: Interpretation and Barriers to Research’ (2000) 321 British Medical Journal 890.
14. P Martin, ‘Genetic Governance: The Risks, Oversight and Regulation of Genetic Databases in the UK’ (2001) 20 New Genetics and Society 157.
15. PR Ferguson, ‘Legal and Ethical Aspects of Clinical Trials: the Views of Researchers’ (2003) 11 Medical Law Review 48.
16. Mackenzie, ‘Paradigms of Author/Creator Property Rights in Intellectual Property Law: Ethical Implications for the Acquisition, Access, and Control of Genetic Information’ in AK Thompson and RF Chadwick (eds), Genetic Information: Acquisition, Access, and Control (New York, Kluwer Academic/Plenum Publishers, 1999)
17. M Richards, ‘How Distinctive is Genetic Information?’ (2001) 32 Studies in History and Philosophy of Biological and Biomedical Science 663.
18. BM Knoppers, ‘Genetic Information and the Family: Are We Our Brother’s Keeper?’ (2002) 20(2) Trends in Biotechnology 85
19. D Bell and B Bennett, ‘Genetic Secrets and the Family’ (2001) 9 Medical Law Review 130
20. GT Laurie, ‘Obligations Arising from Genetic Information: Negligence and the Protection of Familial Interests’ (1999) 11(2) Child and Family Law Quarterly 109.
21. L Beecham, ‘BMA Annual Representative Meeting: Debate Needed on Balance Between Patient Confidentiality and Needs of Research’ (2004) 329 British Medical Journal 7457
22. K Korts, S Weldon and ML Guðmundsdóttir, ‘Genetic Databases and Public Attitudes: A Comparison of Iceland, Estonia and the UK’ (2004) 8(1/2) TRAMES 131
23. V Árnason and G Árnason, ‘Informed Democratic Consent? The Case of the Icelandic Database’ (2004) 8(1/2) TRAMES 164
24. G Laurie, Genetic Privacy: A Challenge to Medico-legal Norms (Cambridge, Cambridge University Press, 2002).
25. S Holm, ‘There is Nothing Special About Genetic Information’ in AK Thompson and RF Chadwick (eds), Genetic Information: Acquisition, Access, and Control (London, Kluwer Academic/Plenum Publishers, 1999)
26. LO Gostin and JG Hodge, ‘Genetic Privacy and the Law: An End to Genetics Exceptionalism’ (1999) 40 Jurimetrics 21
27. TH Murray, ‘Genetic Exceptionalism and “Future Diaries”: Is Genetic Information Different from Other Medical Information?’ in MA Rothstein (ed), Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (New Haven, CT, Yale University Press, 1997).
28. BM Knoppers, ‘Of Populations, Genetics and Banks’ (2001) 1 Genetics Law Monitor; Árnason and Árnason, ‘Informed Democratic Consent’ above n 11.
29. HDC Roscam Abbing, ‘Central health Database in Iceland and Patient’s Rights’ (1999) 6 European Journal of Health Law 363
30. JR Gulcher, K Kristjánsson, H Gudbjartsson and K Stefánsson, ‘Protection of Privacy by Third-Party Encryption in Genetic Research in Iceland’ (2000) 8 European Journal of Human Genetics 739.
31. J Kaye, ‘Abandoning Informed Consent: The Case of Genetic Research in Population Collections’ in R Tutton and O Corrigan (eds), Genetic Databases: Socio-ethical Issues in the Collection and Use of DNA (London, Routledge, 2004)
32. T Caulfield, REG Upshur and A Daar, ‘DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model’ (2003) 4(1) BMC Medical Ethics 1
33. E Wright Clayton, KK Steinberg, MJ Khoury, E Thomson, L Andrews, MJ Ellis Kahn, LM Kopelman and JO Weiss, ‘Informed Consent for Genetic Research on Stored Tissue Samples’ (1995) 274(22) Journal of the American Medical Association 1786
34. G Williams and D Schroeder, ‘Human Genetic Banking and the Limits of Informed Consent’ in P Glasner (ed), Reconfiguring Nature: Issues and Debates in the New Genetics (Aldershot, Ashgate, 2004).
35. S Eriksson, ‘Should Results from Genetic Research be Returned to Research Subjects and Their Biological Relatives?’ (2004) 8(1/2) TRAMES 46.
36. AC da Rocha, ‘Ethical Aspects of Human Genetic Databases: Distinctions on the Nature, Provision, and Ownership of Genetic Information’ (2004) 8(1/2) TRAMES 34.
37. RR Sharp and MW Foster, ‘Involving Study Populations in the Review of Genetic Research’ (2000) 28(1) Journal of Law, Medicine and Ethics 41.
38. MA Rothstein, ‘Genetic Secrets: A Policy Framework’ in MA Rothstein (ed), Genetic Secrets: Protecting Privacy and Confi dentiality in the Genetic Era (New Haven, CT, Yale University Press, 1997).
39. BM Knoppers, M Hirtle, S Lormeau, CM Laberge and M Laflamme, ‘Control of DNA Samples and Information’ (1998) 50 Genomics 385.
40. T Caulfield, ‘Regulating the Commercialization of Human Genetics: Can We Address the Big Concerns?’ in AK Thompson and RF Chadwick (eds), Genetic Information: Acquisition, Access, and Control (New York, Kluwer Academic/Plenum Publishers, 1999).
41. HT Greely, ‘Informed Consent and Other Ethical Issues in Human Population Genetics’ (2001) 35 Annual Review of Genetics 785
42. HT Greely, ‘Human Genomics Research: New Challenges for Research Ethics’ (2001) 44(2) Perspectives in Biology and Medicine 221
43. S Wilson, ‘Population Biobanks and Social Justice: Commercial Or Communitarian Models? a Comparative Analysis of Benefit Sharing, Ownership and Access Arrangements’ (2004) 8(1/2) TRAMES 80.
44. JE Wylie and G Mineau, ‘Biomedical Databases: Protecting Privacy and Promoting Research’ (2003) 21 (3) TRENDS in Biotechnology 113.
45. V Árnason et al (eds), Your Genes in a National Bank? Ethical, Legal and Social Concerns (Cambridge, Cambridge University Press, 2008).
46. http://www.genebanc.eu/ (accessed 30 January 2011).
47. http://www.privileged.group.shef.ac.uk/ (accessed 30 January 2011).
48. http://www.tisseu.uni-hannover.de/index.php (accessed 30 January 2011).
49. P Martin and J Kaye, The Use of Biological Sample Collections and Personal Medical Information in Human Genetics Research (London, Wellcome Trust, 1999).
50. J Gerards and H Janssen, ‘Regulation of Genetic and Other Health Information in a Comparative Perspective’ (2006) 13 European Journal of Health Law 339
51. M Majumder, ‘Cyberbanks and Other Virtual Research Repositories’ (2005) 33 Journal of Law Medicine and Ethics 31
52. M Deschenes and C Salle, ‘Accountability in Population Biobanking: Comparative Approaches’ (2005) 33 Journal of Law Medicine and Ethics 40
53. M Rothstein, ‘Expanding Ethical Analysis of Biobanks’ (2005) 33 Journal of Law Medicine and Ethics 89
54. D Winickoff, ‘Partnership in UK Biobank: A Third Way for Genomic Property’ (2005) 33 Journal of Law Medicine and Ethics 440
55. H Gottweis and K Zatloukal, ‘Biobank Governance: Trends and Perspectives’ (2007) 74 Pathobiology 206
56. S Wallace et al, ‘Governance Mechanisms and Population Biobanks: Building a Framework For Trust’ (2008) 6(2) GenEdit 11
57. B Salter and M Jones, ‘Biobanks and Bioethics: The Politics of Legitimation’ (2005) 12 European Public Policy 710
58. SMC Gibbons, ‘Regulating Biobanks: A Twelve-Point Typological Tool’ (2009) 17 Medical Law Review 313
59. J Kaye and M Stranger (ed), Principles and Practice in Biobank Governance (Aldershot, Ashgate, 2009).
60. BM Knoppers, ‘Biobanking: International Norms’ (2005) 33 Journal of Law Medicine and Ethics 7
61. A Cambon-Thomsen, E Rial-Sebbag and BM Knoppers, ‘Trends in Ethical and Legal Frameworks for the Use of Human Biobanks’ (2007) 30 European Respiratory Journal 373
62. LB Andrews, ‘Assessing Values to Set Policies for Consent, Storage, and Use of Tissue and Information in Biobanks’ in K Dierickx and P Borry (eds), New Challenges for Biobanks: Ethics, Law and Governance (Antwerp and Oxford, Intersentia, 2009)
63. DE Winickoff, ‘Biosamples, Genomics, and Human Rights: Context and Content of Iceland’s Biobanks Act’ (2001) 4 Journal of Biolaw and Business 11–17
64. M Anderlik, ‘Commercial Biobanks and Genetic Research: Ethical and Legal Issues’ (2003) 3 American Journal of Pharmacogenomics 203–15
65. T Caulfield, ‘Tissue Banking, Patient Rights, and Confidentiality: Tensions in Law and Policy’ (2004) 23 Medical Law International 39–49
66. G Richardson, ‘The Banking of Embryonic Stem Cells: The Legal and Ethical Framework in the UK’ (2004) 20 Law Human Genome Review 147–60
67. Kaye, ‘Do we Need a Uniform Regulatory System for Biobanks Across Europe?’ (2006) 14 European Journal of Human Genetics 245–46
68. SMC Gibbons et al, ‘Lessons from European Population Genetic Databases: Comparing the Law in Estonia, Iceland, Sweden and the United Kingdom’ (2005) 12(2) European Journal of Health Law 103
69. J Kaye, HH Helgason, A Nõmper et al, ‘Population Genetic Databases: A Comparative Analysis of the Law in Iceland, Sweden, Estonia and the UK’ (2004) 8 TRAMES 15–34.
70. A Kettis-Lindbald et al, ‘Genetic Research and Donation of Tissue Samples to Biobanks. What Do Potential Sample Donors in the Swedish General Public Think?’ (2005) 16 European Journal of Public Health 433
71. M Levitt and S Weldon, ‘A Well Placed Trust?: Public Perceptions of the Governance of DNA Databases’ (2005) 15 Critical Public Health 311
72. 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(2) Critical Public Health 139–49
73. H Busby, ‘Biobanks, bioethics and concepts of donated blood in the UK’, (2006) 28(6) Sociology of Health and Illness 850–65.
74. A Smart et al, ‘Social Inclusivity vs Analytical Acuity? a Qualitative Study of UK Researchers Regarding the Inclusion of Minority Ethnic Groups in Biobanks’ (2008) 9(2) Medical Law International 169–90
75. S Hjörleifsson, R Strand and E Schei, ‘Health as A Genetic Planning Project: Enthusiasm and Second Thoughts Among Biomedical Researchers and Their Research Subjects’ (2005) 3(1) Genomics, Policy and Society 52–65
76. F Milanovic, D Pontille and A Cambon-Thomsen, ‘Biobanking and Data Sharing: A Plurality of Exchange Regimes’ (2007) 23(1) Genomics, Society and Policy 17–30
77. I Hirtzlin et al, ‘An Empirical Survey on Biobanking’, above n 2
78. A Capron, A Mauron and B Elger, ‘Ethical Norms and the International Governance of Genetic Databases and Biobanks: Finding from an International Study’ (2009) 19 Kennedy Institute of Ethics Journal 101.
79. SJ Ceci, ‘Scientists’ Attitudes Toward Data Sharing, (1998) 13 Science Technology and Human Values 45–52
80. S Hilgartner and SI Brandt-Rauf, ‘Data Access, Ownership and Control: Toward Empirical Studies of Access Practices’ (1994) 15 Knowledge 355–72
81. C Hine, ‘Databases as Scientific Instruments and their Role in the Ordering of Scientifi c Work’ (2006) 36 Social Studies of Science 269–98.
82. SL Star and J Griesemer, ‘Institutional Ecology, Translations’ and Boundary Objects: Amateurs and Professionals in Berkeley’s Museum of Vertebrate Zoology, 1907–39’ (1989) 19(3) Social Studies of Science 387–420
83. SL Star, ‘This is Not a Boundary Object: Reflections on the Origins of a Concept’ (2010) 35(5) Science, Technology and Human Values 602–17
84. M Callon, ‘Some Elements of a Sociology of Translation: Domestication of the Scallops and the Fishermen of St Brieuc Bay’ in J Law (ed), Power, Action and Belief; Sociological Review Monograph 32 (London, Routledge and Kegan Paul, 1985)
85. T Gieryn, ‘Policing STS: A Boundary-Work Souvenir from the Smithsonian Exhibition on “Science in American Life” (1996) 21(1) Science, Technology, and Human Values 100–15.
86. N Stephens, P Atkinson and P Glasner, ‘The UK Stem Cell Bank: Securing the Past, Validating the Present, Protecting the Future’ (2008) 17(1) Science as Culture 43–56
87. SP Wainwright, C Williams, M Michael, B Farsides and A Cribb, ‘Ethical Boundary-Work in the Embryonic Stem Cell Laboratory’ (2006) 28(6) Sociology of Health and Illness 732–48
88. G Stoker, ‘Governance as Theory: Five Propositions’ (1998) 50 International Social Science Journal 17
89. J Black, ‘Critical Reflections on Regulation’ (2000) 27 Australian Journal of Legal Philosophy 1, 19.
90. A Mette Kjær, Governance (Oxford, Polity, 2004) 1.
91. R Baldwin and M Cave, Understanding Regulation: Theory, Strategy, and Practice (Oxford, Oxford University Press, 1999) 1–2.
92. R Baldwin, C Scott and C Hood, ‘Introduction’ in R Baldwin, C Scott and C Hood (eds), A Reader on Regulation (Oxford, Oxford University Press, 1998) 1, 3.
93. B Morgan and K Yeung, An Introduction to Law and Regulation (Cambridge, Cambridge University Press, 2007) 4.
94. C Hood, H Rothstein and R Baldwin, The Government of Risk (Oxford, Oxford University Press, 2001) 23.
95. John-Mary Kauzya, Local Governance Capacity Building for Full Range Participation: Concepts, Frameworks, and Experiences in African Countries’ Experiences in African Countries, Background Paper, 4th Global Forum on Reinventing Governance 2002, 2 available at www.unpan.org/DPADM/GlobalForum/4thGlobalForum/tabid/604/Default. aspx#Link_Press (accessed 2 June 2010).
96. EG Guba and YS Lincoln, ‘Competing Paradigms in Qualitative Research’ in NK Denzin and YS Lincoln (eds), Handbook of Qualitative Research (Thousand Oaks, Calif, Sage, 1994) 105–17.
97. S Arthur and J Nazroo, ‘Designing Fieldwork: Strategies and Materials’ in J Ritchie and J Lewis (eds), Qualitative Research Practice. A Guide for Social Science Students and Researchers (London, Sage, 2003) 109–37.
98. J Ritchie, J Lewis and G Elam, ‘Designing and Selecting Samples’ in J Ritchie and J Lewis (eds), Qualitative Research Practice: A Guide for Social Science Students and Researchers. (London, Sage, 2003) 77–108.
99. S Kvale, InterViews (London, Sage 1996).
100. R Gomm, Social Research Methodology. A Critical Introduction (Basingstoke, Palgrave MacMillan, 2004) 189.
101. I Chompalov and W Shrum, ‘Institutional Collaboration in Science: A Typology of Technological Practice’ (1999) 24 Science, Technology, and Human Values 338–72.
102. J Mason, Qualitative Researching (London, Sage, 1996).
103. British Sociological Association, Statement of Ethical Practice (2002), available at .
104. L Hancher and M Moran, ‘Organizing Regulatory Space’ in R Baldwin, C Scott and C Hood, A Reader on Regulation (Oxford, Oxford University Press, 1998) esp 148–72.
105. D Stone, Policy Paradox: The Art of Political Decision-Making (New York and London, Norton, 2002) 285.
106. V Bekker, G Dijkstra, ‘A Edwards and M Fenger, ‘Governance and the Democratic Deficit: Introduction’ in V Bekker, G Dijkstra, A Edwards and M Fenger (eds), Governance and the Democratic Deficit; Assessing the Democratic Legitimacy of Governance Practice (London and New York, Ashgate, 2007) 7.
107. A-M Slaughter, ‘Global Government Networks, Global Information Agencies and Disaggregated Democracies’ (2003) 24 Michigan Journal of Internationl Law 1041–74.
108. C Scott, ‘Accountability in the Regulatory State’ (2000) 27 Journal of Law and Society 38, 41–42.
109. S Kelman, ‘Cost-Benefit Analysis: An Ethical Critique’ (1981) 5(1) Regulation 33
110. A Kronman, ‘Wealth Maximisation as a Normative Principle’ (1980) 9 Journal of Legal Studies 227
111. P Hampton, ‘Reducing Administrative Burdens: Effective Inspection and Enforcement’ Final Report, (London, HM Treasury, March 2005).
112. Better Regulation Task Force, Principles of Good Regulation (revised 2007) available at .
113. BBMRI: www.bbmri.eu.
114. C Macilwain, ‘World Leaders Heap Praise on Human Genome Landmark’ (2000) 405 Nature 983–84.
115. FS Collins, A Patrinos, E Jordan, A Chakravarti, R Gesteland, L ‘Walters and the members of the DOE and NIH planning groups, ‘New Goals for the U.S. Human Genome Project: 1998–2003’ (1998) 282 Science 682–89.
116. International Human Genome Consortium, ‘Initial Sequencing and Analysis of the Human Genome’ (2001) 409 Nature 860–921
117. Human Genome Project: www.ornl.gov/sci/ techresources/Human_Genome/home.shtml.
118. FS Colins, M Morgan and A Patrinos, ‘The Human Genome Project: Lessons from Large- Scale Biology’ (2003) 300 Science 286–90, 286.
119. JD Watson, ‘The Human Genome Project Past, Present, and Future’ (1990) 248 Science 44–49, 45.
120. The Bermuda Principles, First International Strategy Meeting on Human Genome Sequencing (Bermuda, 25–28 February 1996), www.ornl.gov/sci/techresources/Human_ Genome/research/bermuda.shtml#1.
121. E Marshall, ‘Bermuda Rules: Community Spirit, With Teeth’ (2001) 291 Science 1192.
122. Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility (Fort Lauderdale, Wellcome Trust) www.genome.gov/Pages/Research/Wellcome Report0303.pdf.
123. NIH Data Sharing Policy and Implementation Guidance (updated: 5 March 2003) .
124. Genome Canada Data Release and Resource Sharing Policy www.genomecanada.ca/medias/PDF/EN/DataReleaseandResourceSharingPolicy.pdf.
125. Medical Research Council Policy on Data Sharing and Preservation www.mrc.ac.uk/PolicyGuidance/EthicsAndGovernance/DataSharing/PolicyonDataSharingandPreservation/ index.htm#P16_1333.
126. J Sulston and G Ferry, The Common Thread: A Story of Science, Politics, Ethics, and the Human Genome (Washington, DC, Joseph Henry Press, 2002).
127. M Garcia-Sancho, ‘Mapping and Sequencing Information: The Social Context for the Genomics Revolution’ (2007) 31 Endeavour 18–23.
128. J Esparza and T Yamada ‘The Discovery Value of “Big Science”’ (2007) 204 Journal of Experimental Medicine 701–04.
129. CP Lorentz, ED Wieben, A Tefferi, DAH Whiteman and GW Dewald, ‘Primer on Medical Genomics Part I: History of Genetics and Sequencing of the Human Genome’ (2002) 77 Mayo Clinic Proceedings 773–82.
130. www.genome.gov/11006943.
131. P Aldous, ‘Genome Sequencing Falls to $5000’ (2009) New Scientist (6 February).
132. http://genomics.xprize.org/.
133. D Butler, ‘Human Genome at Ten: Science after the Sequence’ (2010) 465 Nature 1000–01, 1001.
134. ER Mardis, ‘A Decade’s Perspective on DNA Sequencing Technology’ (2011) 470 Nature 19–203.
135. LJ Palmer and LR Cardon, ‘Shaking The Tree: Mapping Complex Disease Genes with Linkage Disequilibrium’ (2005) 366 The Lancet 1223–34.
136. R Weinberg, ‘Point: Hypotheses First’ (2010) 464 Nature 678.
137. J Reineke Pohlhaus and RM Cook-Deegan, ‘Genomics Research: World Survey of Public Funding’ (2008) 9 BMC Genomics 472.
138. D Butler, ‘Human Genome at Ten’, above n 29, 1000.
139. N Day, ‘Commentary: How Small is Small?’ (2009) 38 International Journal of Epidemiology 274–75, 274.
140. S O’Rahilly and NJ Wareham, ‘Genetic Variants and Common Diseases: Better Late Than Never’ (2006) 355 New England Journal of Medicine 306–08.
141. PR Burton, Al Hansell, I Fortier et al, ‘Size Matters: Just How Big is BIG?: Quantifying Realistic Sample Size Requirements for Human Genome Epidemiology’ (2009) 38 International Journal of Epidemiology 263–73.
142. AD Hingorani, T Shah, M Kumari, R Sofat, L Smeeth, ‘Science, Medicine, and the Future: Translating Genomics into Improved Healthcare’ (2010) 341 British Medical Journal 1037–42, 1038.
143. www.ncbi.nlm.nih.gov/SNP/.
144. http://hapmap.ncbi.nlm.nih.gov/index.html.en.
145. WTCCC, ‘Genome-wide Association Study of 14,000 Cases of Seven Common Diseases and 3,000 Shared Controls’ (2007) 447 Nature 661–78.
146. http://hapmap.ncbi.nlm.nih.gov/index.html.en.
147. WYS Wang, BJ Barratt, DG Clayton and JA Todd, ‘Genome-wide Association Studies: Theoretical and Practical Concerns’ (2005) 6 Nature Reviews Genetics 109–18
148. KM Channon and H Watkins, ‘Coronary Artery Disease Genetics: Bigger is Better’ (2004) 25 European Heart Journal 900–01.
149. TA Pearson and TA Manolio, ‘How to Interpret a Genome-wide Association Study’ (2008) 299 Journal of the American Medical Association 1335–44.
150. JP Ioannidis, ‘Personalized Genetic Prediction: Too Limited, Too Expensive, Or Too Soon?’ (2009) 150 Annals of Internal Medicine 139–41.
151. AT Hattersley and MI McCarthy, ‘What Makes a Good Genetic Association Study?’ (2005) 366 The Lancet 1315–23.
152. DR Karp et al, ‘Ethical And Practical Issues Associated With Aggregating Databases’ (2008) 5 PLoS Medicine.
153. HapMap Consortium, ‘A Second Generation Human Haplotype Map of over 3.1 Million SNPs’ (2007) 449 Nature 851–61.
154. J Kaiser, ‘A Plan to Capture Human Diversity in 1000 Genomes’ (2008) 319 Science 395.
155. JPA Ioannidis et al, ‘Assessment of Cumulative Evidence on Genetic Associations: Interim Guidelines’ (2007) 37 International Journal of Epidemiology 120–32.
156. R Gibbs, ‘Deeper into the Genome’ (2005) 437 Nature 1233–34.
157. J Little et al, ‘Strenghthening the Reporting of Genetic Association Studies (STREGA): An Extension of the STROBE Statement’ (2009) PLos Medicine e100022.
158. M Pop and SL Salzberg, ‘Bioinformatics Challenges of Sequencing Technology’ (2008) 24 Trends in Genetics 142–49.
159. GAIN Collaborative Research Group, ‘New Models of Collaboration in Genome- Wide Association Studies: The Genetic Association Information Network’ (2007) 39 Nature Genetics 1045–51.
160. Z Lin, AB Owen and RB Altman, ‘Genomic Research and Human Subject Privacy’ (2004) 305 Science 183.
161. N Homer et al, ‘Resolving Individuals Contributing Trace Amounts of DNA to Highly Complex Mixtures Using High-Density SNP Genotyping Microarrays’ (2008) 4 PLoS Genetics e1000167.
162. CA Cassa, B Schmidt, IS Kohane and KD Mandl, ‘My Sister’s Keeper?: Genomic Research and the Identifiability of Siblings’ (2008) 1 BMC Medical Genomics 32.
163. J Gitschier, ‘Inferential Genotyping of Y chromosomes in Latter-Day Saints Founders and Comparison to Utah Samples in the HapMap Project’ (2009) 84 American Journal of Human Genetics 251–58.
164. P Kraft and DJ Hunter, ‘Genetic Risk Prediction: Are We There Yet?’ (2009) 360 The New England Journal of Medicine 1701–03.
165. W Bodmer and C Bonilla, ‘Common and Rare Variants in Multi-Factorial Susceptibility to Common Diseases’ (2008) 40 Nature Genetics 695–701.
166. DB Goldstein, ‘Common Genetic Variation and Human Traits’ (2009) 360 The New England Journal of Medicine 1696–98.
167. JN Hirschhorn, ‘Genomewide Association Studies: Illuminating Biologic Pathways’ (2009) 360 The New England Journal of Medicine 1699–701.
168. J Attia et al, ‘How to Use an Article about Genetic Association B: Are the Results of the Study Valid?’ (2009) 301 Journal of the American Medical Association 191–97.
169. A Hamsten and P Eriksson, ‘Identifying the Susceptibility Genes for Coronary Artery Disease: From Hyperbole through Doubt to Cautious Optimism’ (2008) 263 Journal of Internal Medicine 538–52.
170. JP Zollner and JK Pritchard, ‘Overcoming the Winner’s Curse: Estimating Penetrance Parameters from Case-Control Data’ (2007) 80 American Journal of Human Genetics 605–15.
171. SEARCH Collaborative Group, ‘SLCO1B1 Variants and Statin-Induced Myopathy: a Genomewide Study’ (2008) 359 The New England Journal of Medicine 789–99.
172. RA Hegele, ‘Plasma Lipoproteins: Genetic Influences and Clinical Implications’ (2009) 10 Nature Reviews Genetics 109–21.
173. J Attia et al, ‘How to Use an Article about Genetic Association C’, above n 72.
174. ACJW Janssens and CM van Duijn, ‘Genome-based Prediction of Common Diseases: Advances and Prospects’ (2008) 17 Human Molecular Genetics R166–R172.
175. J Jakobsdottir et al, ‘Interpretation of Genetic Association Studies: Markers with Replicated Highly Significant Odds Ratios May be Poor Classifiers’ (2009) 5 PLoS Genetics e1000337.
176. K Ozake and T Tanaka, ‘Genome-Wide Association Study to Identify SNPS Conferring Risk of Myocardial Infarction and Their Functional Analyses’ (2005) 62 Cellular and Molecular Life Sciences 1804–13.
177. RS Cooper, B Tayo and X Zhu, ‘Genome-wide Association Studies: Implications for Multiethnic Samples’ (2008) 17. Human Molecular Genetics R151–R155.
178. J Kaye, ‘The Regulation of Direct-to-Consumer Genetic Tests’ (2008) 17 Human Molecular Genetics R1–R4.
179. J Reineke Pohlhaus and RM Cook-Deegan, ‘Genomics Research’, above n 33.
180. D Overbye, ‘Human DNA: The Ultimate Spot for Secret Messages (Are Some There Now?)’ (2007) The New York Times.
181. HapMap Project: www.hapmap.org/abouthapmap.html.
182. Genome Project: www.1000genomes.org/page.php.
183. GAIN, http://fnih.org/index.php?option=com_contentandtask=viewandid=338andItem id=454.
184. European Genotyping Archive: www.ebi.ac.uk/ega/page.php.
185. dbGaP: www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/about.html.
186. BBMRI: http://www.bbmri.eu/.
187. P3G Consortium: www.p3gconsortium.org/.
188. J Kaye, C Heeney, N Hawkins, J de Vries, P Boddington, ‘Data Sharing in Genomics: Re-shaping Scientific Practice’ (2009) 10(5) Nature Review Genetics 331–35, 332.
189. A Alonzi and M Pringle, ‘Mental Capacity Act 2005’ (2007) 35 British Medical Journal 335.
190. D Hall, ‘Reflecting on Redfern: What Can We Learn from the Alder Hey story?’ (2001) 84 Archive of Disease in Childhood 455–56
191. M Hunter, ‘Alder Hey Report Condemns Doctors, Management, and Coroner’ (2001) 322 (7281) British Medical Journal 255
192. D Price ‘The Human Tissue Act 2004’ (2005) 68 Modern Law Review 798.
193. J D Neaton et al, ‘Regulatory Impediments Jeopardizing the Conduct of Clinical Trials in Europe Funded by the National Institutes of Health’ (2010) 7 Clinical Trials 705–18
194. J Heam and R Sullivan, ‘The Impact of the “Clinical Trials” Directive on the Cost and Conduct of Non- Commercial Cancer Trials in the UK’ (2007) 43(1) European Journal of Cancer 8–13
195. S Yusuf, ‘Damage to Important Clinical Trials by Over-Regulation’ (2010) 7 Clinical Trials 622.
196. J Hendy et al, ‘Implementing the Nhs Information Technology Programme: Qualitative Study of Progress in Acute Trusts’ (2007) 334 British Medical Journal 1360.
197. J Kaye and SMC Gibbons, ‘Mapping the Regulatory Space for Genetic Databases and Biobanks in England and Wales’ (2008) 9(2) Medical Law International 111
198. SMC Gibbons, ‘Are UK Genetic Databases Governed Adequately? A Comparative Legal Analysis’ (2007) 27(2) Legal Studies 312
199. SMC Gibbons, J Kaye, A Smart, C Heeney and M Parker, ‘Governing Genetic Databases: Challenges Facing Research Regulation and Practice’ (2007) 34(2) Journal of Law and Society 163.
200. R Wong, ‘Assessing the Status of Medical Information in the Light of the UK Data Protection Act 1998’ (2008) 5 Web Journal of Current legal Issues.
201. A Gulland, ‘EU Directive Threatens UK’s “Spectacular” Record in Clinical Trials’ (2009) 338(7696) British Medical Journal 678.
202. JR Griesemer, ‘Institutional Ecology, “Translations” and Boundary Objects: Amateurs and Professionals in Berkeley’s Museum of Vertebrate Zoology, 1907– 39’ (1989) 19(3) Social Studies of Science 387, 393.
203. GC Bowker and SL Star, Sorting Things Out: Classifi cation and its Consequences (Cambridge, MA, MIT Press, 2000)
204. KR Fleischmann, ‘Boundary Objects with Agency: A Method for Studying the Design– Use Interface’ (2006) 22(2) Information Society 77.
205. Gibbons, ‘Are UK Genetic Databases Governed Adequately?’, above n 2, especially 324– 28.
206. D Price, ‘The Human Tissue Act 2004’ (2005) 68 Modern Law Review 798
207. K Liddell and A Hall, ‘Beyond Bristol and Alder Hey: The Future Regulation of Human Tissue’ (2005) 13 Medical Law Review 170.
208. L Hancher and M Moran, ‘Organizing Regulatory Space’ in R Baldwin, C Scott and C Hood, A Reader on Regulation (Oxford, Oxford University Press, 1998) esp 148– 72.
209. B Morgan and K Yeung, An Introduction to Law and Regulation (Cambridge, Cambridge University Press, 2007).
210. I Ayers and J Braithwaite, Responsive Regulation: Transcending the Deregulation Debate (Oxford, Oxford University Press, 1992) ch 3 (tripartite approach).
211. N Luhmann, A Sociological Theory of Law, trans E King and M Albrow (London, Routledge & Kegan Paul, 1985) ch 5
212. C Scott, ‘Analysing Regulatory Space: Fragmented Resources and Institutional Design’ [2001] Public Law 329.
213. ‘Codes of Practice and Other Formal or Informal Documentary Guidance Sources’, pp 64– 66
214. JM Black, ‘Decentring Regulation: Understanding the Role of Regulation and Self- Regulation in a “Post- Regulatory” World’ (2001) 54 Current Legal Problems 103, 109.
215. B Latour, Science in Action: How to Follow Scientists and Engineers Through Society (Cambridge, MA, Harvard University Press, 1987).
216. D Mandelkern, ‘Final Report: Mandelkern Group on Better Regulation’ (Brussels: European Commission, 13 November 2002)
217. B Parry, The Fate of Collections: Exploring the Dynamics of Trade in Bio- Information (New York, Columbia University Press, 2004).
218. V Armstrong et al, ‘Public Perspectives on the Governance of Biomedical Research: A Qualitative Study in a Deliberative Context’ (London, Wellcome Trust, 2007).
219. BM Knoppers, ‘Trends in Ethical and Legal Frameworks for the Use of Human Biobanks’ (2007) 30 European Respiratory Journal 373, especially 374– 75
220. Eriksson, AT Höglund and G Helgesson, ‘Do Ethical Guidelines Give Guidance? A Critical Examination of Eight Ethics Regulations’ (2008) 17 Cambridge Quarterly of Healthcare Ethics 15.
221. A Ogus, Regulation: Legal Form and Economic Theory (Oxford, Hart Publishing, 2004) 57– 58
222. G Wilson, ‘Social Regulation and Explanations of Regulatory Failure’ (1984) 32 Political Studies 203.
223. ‘News— ICO Gains Powers to Fine £500,000 for Data Security Breaches’ (9 April 2010) The British Journal of Healthcare Computing & Information Management, www.bj- hc.co.uk/ archive/news/2010/n1004008.htm (last accessed 19 Sep 2011).
224. S Bridge, ‘Give Me More Power, Information Watchdog to Tell MPs’, The Guardian (4 December 2007).
225. R Thomas and M Walport, ‘Data Sharing Review Report’ (11 July 2008) available .
226. R Ashcroft, AJ Newson and PMW Benn, ‘Reforming Research Ethics Committees’ (2005) 331 British Medical Journal 587.
227. J Saunders, ‘More Guidelines on Ethical Research?’ (2008) 33 Journal of Medical Ethics 683.
228. F Gilardi, J Jordana and D Levi- Faur, ‘Regulation in the Age of Globalization: The Diffusion of Regulatory Agencies Across Europe and Latin America’ in G Hodge (ed), Privatization and Market Development: Global Movements in Public Policy Ideas (Cheltenham, Edward Elgar, 2006) 127
229. A- M Slaughter, A New World Order (Princeton, NJ, Princeton University Press, 2004).
230. C Dyer, ‘Human Tissue Bill is Modifi ed Because of Research Needs’ (2004) 328 British Medical Journal 1518
231. Regulators’ Compliance Code: Statutory Code of Practice for Regulators (17 December 2007).
232. J Kaye and P Martin, ‘Safeguards for Research Using Large Scale DNA Collections’ (2000) 321 British Medical Journal 1146.
233. SMC Gibbons, ‘Regulating Biobanks: A Twelve- point Typological Tool’ (2009) 17(3) Medical Law Review 313– 46.
234. D Chalmers and D Nicol, ‘Human Genetic Research Databases and Biobanks: Towards Uniform Terminology and Australian Best Practice’ (2008) 15 Journal of Law and Medicine 538, 543
235. AV Campbell, ‘The Ethical Challenges of Genetic Databases: Safeguarding Altruism and Trust’ (2007) 18 King’s Law Journal 237
236. B Salter and M Jones, ‘Biobanks and Bioethics: The Politics of Legitimation’ (2005) 12 Journal of European Public Policy 710, 713, 717
237. D Chalmers and D Nicol, ‘Commercialisation of Biotechnology: Public Trust and Research’ (2004) 6 International Journal of Biotechnology 116
238. M Hansson, ‘Building on Relationships of Trust in Biobank Research’ (2005) 31 Journal of Medical Ethics 415.
239. Better Regulation Task Force, Principles of Good Regulation (revised 2007) available at .
240. SMC Gibbons, J Kaye, A Smart, C Heeney and M Parker, ‘Governing Genetic Databases: Challenges Facing Research Regulation and Practice’ (2007) 34 Journal of Law and Society 163–89.
241. I Chompalov and W Shrum, ‘Institutional Collaboration in Science: A Typology of Technological Practice’ (1999) 24 Science, Technology, and Human Values 338–72.
242. JC McKinney, ‘Typification, Typologies and Sociological Theory’ (1969) 48 Social Forces 1–12.
243. H Becker, ‘Constructive Typology in the Social Sciences’ (1940) 5 American Sociological Review 40–55.
244. GC Bowker and SL Star, Sorting Things Out: Classification and its Consequences (Cambridge, MA, MIT Press, 1999) 62.
245. G Deleuze and F Guattari A Thousand Plateaus (Minneapolis, University of Minnesota, 1987).
246. A Hedgecoe and P Martin ‘The Drugs Don’t Work: Expectations and the Shaping of Pharmacogenetics’ (2003) 33 Social Studies of Science 327–64
247. SP Wainwright, C Williams, M Michael, B Farsides and A Cribb ‘From Bench to Bedside? Biomedical Scientists’ Expectations of Stem Cell Science as a Future Therapy for Diabetes’ (2006) 63 Social Science & Medicine 2052–64.
248. AM Mol, The Body Multiple: Ontology in Medical Practice (Durham, NC, Duke University Press 2002).
249. SL Star and JR Griesemer, ‘Institutional Ecology, “Translations” and Boundary Objects: Amateurs and Professionals in Berkeley’s Museum of Vertebrate Zoology, 1907–39’ (1989) 19 Social Studies of Science 387–420.
250. S Hilgartner ‘The Human Genome Project’, in S Jasanoff, GE Markle, JC Petersen and T Pinch (eds), Handbook of Science and Technology Studies (Thousand Oaks, Calif, Sage Publications, 1995) 302–19, 305.
251. M Weber, The Methodology of the Social Sciences, trans and ed EA Shils and HA Finch Free Press 1997 (1903–1917) 88.
252. D Price, ‘The Human Tissue Act 2004’ (2005) 68 Modern Law Review 798
253. K Liddell and A Hall, ‘Beyond Bristol and Alder Hey: The Future Regulation of Human Tissue’ (2005) 13 Medical Law Review 170.
254. S Kerrison and AM Pollock, ‘The Reform of UK Research Ethics Committees: Throwing the Baby Out with the Bath Water?’ (2005) 31 Journal of Medical Ethics 487
255. E Cave and S Holm, ‘New Governance Arrangements for Research Ethics Committees: Is Facilitating Research Achieved at the Cost of Participants’ Interest’ (2002) 28 Journal of Medical Ethics 318
256. SMC Gibbons, ‘Are UK Genetic Databases Governed Adequately? A Comparative Legal Analysis’ (2007) 27(2) Legal Studies 312, 333–38
257. M Weber, The Methodology of the Social Sciences, ed and trans EA Shils and HA Finch (Glencoe, IL, Free Press, 1997 (1903–1917)) 88.
258. N Stephens, P Atkinson and P Glasner, ‘The UK Stem Cell Bank: Securing the Past, Validating the Present, Protecting the Future’ (2008) 17(1) Science as Culture 43.
259. D Dickenson, ‘Should the UK have a National Ethics Committee?’ BioNews 479 (6 October 2008), .
260. SMC Gibbons, ‘Regulating Biobanks: A Twelve-point Typological Tool’ (2009) 17(3) Medical Law Review 313–46.
261. M Weber, The Methodology of the Social Sciences, trans and ed EA Shils and HA Finch Glencoe, IL, Free Press, 1997 (1903–1917) 88.
262. B Latour, Reassembling the Social: An Introduction to Actor Network Theory (Oxford, Oxford University Press, 2005) 11.
263. S Hilgartner and SI Brandt-Rauf ‘Data Access, Ownership, and Control: Toward Empirical Studies of Access Practices’ (1994) 15 Science Communication 355–72.
264. F Milanovic, D Pontille and A Cambon-Thomsen ‘Biobanking and Data Sharing: A Plurality of Exchange Regimes’ (2007) 3(1) Genomics, Society and Policy 17–30.
265. The Wellcome Trust, ‘Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility’ (2003) (accessed 7 March 2011).
266. M Callon ‘Some Elements of a Sociology of Translation: Domestication of the Scallops and the Fishermen of St Brieuc Bay’ in J Law (ed) Power, Action and Belief, Sociological Review Monograph 32 (London, Routledge and Kegan Paul, 1985).
267. T Gieryn, ‘Policing STS: A Boundary-Work Souvenir from the Smithsonian Exhibition on “Science in American Life”’ (1996) 21(1) Science, Technology, & Human Values 100–15.
268. H Nissenbaum, ‘Protecting Privacy in an Information Age: The Problem of Privacy in Public’ (1998) 17 Law and Philosophy 559–96.
269. B Latour, Science in Action. How to Follow Scientists and Engineers Through Society (Cambridge MA, Harvard University Press, 1987).
270. RK Merton, ‘Priorities in Scientifi c Discovery: A Chapter in the Sociology of Science’ (1957) 22 American Sociological Review 635–59
271. S Cole and JR Cole, ‘Scientific Output and Recognition: A Study in the Operation of the Reward System in Science’ (1967) 32 American Sociological Review 377–90.
272. WO Hagstrom, The Scientific Community (New York, Basic Books, 1965).
273. MJ Mahoney, ‘Psychology of the Scientist: An Evaluative Review’ (1979) 9 Social Studies of Science 364.
274. DJ Hess, Science Studies: an advanced introduction (New York, New York University Press, 1997) 56.
275. SL Star and J Griesemer, ‘Institutional Ecology, “Translations” and Boundary Objects: Amateurs and Professionals in Berkeley’s Museum of Vertebrate Zoology, 1907–39’ (1989) 19(3) Social Studies of Science 387–420.
276. SL Star, ‘This is Not a Boundary Object: Refl ections on the Origins of a Concept’ (2010) 35(5) Science, Technology and Human Values 602–17.
277. R Ashcroft, AJ Newson, PMW Benn, ‘Reforming Research Ethics Committees (editorial) (2005) 331 British Medical Journal 587–88.
278. J Kaye and P Martin, ‘Safeguards for Research Using Large Scale DNA Collections’ (2000) 321 British Medical Journal 1146–49.
279. http://www.hta.gov.uk/about_hta/how_we_work.cfm.
280. J Black ‘Constructing and Contesting Legitimacy and Accountability in Polycentric Regulatory Regimes’ (2008) 2 Regulation & Governance 137–64.
281. WG Feero, A Guttmacher and FS Collins, ‘Genomic Medicine: An Updated Primer’ (2010) 362(21) New England Journal of Medicine 2001–11
282. J Witte, ‘Genome-wide Association Studies and Beyond’ (2010) 31 Annual Review of Public Health 9–20.
283. ES Lander et al, ‘Initial Sequencing and Analysis of the Human Genome’ (2001) 409 Nature 806–921
284. FS Collins et al, ‘The Human Genome Project: Lessons from Large Scale Biology’ (2003) 300 Science 286–90.
285. ML Metzker, ‘Sequencing Technologies: The Next Generation’ (2010) 11 Nature Reviews Genetics 31–46.
286. National Human Genome Research Institute at .
287. Decipher at .
288. S Fokstuen et al, ‘Rapid Detection of Genetic Variants in Hypertrophic Cardiomyopathy by Custom Dna Resequencing Array in Clinical Practice’ (2011) Journal of Medical Genetics doi: 10.1136/jmg.2010.083345.
289. YY Teo et al, ‘Genome-wide Comparisons of Variation in Linkage Disequilibrium’ (2009) 19 Genome Research 1849–60.
290. SL Star, ‘This is not a Boundary Object’ (2010) 35 Science Technology Human Values 601.
291. SL Star and JR Griesemer, ‘Institutional Ecology, “Translations” and Boundary Objects: Amateurs and Professionals in Berkeley’s Museum of Vertebrate Zoology, 1907–39’ (1989) 3 Social Studies of Science 387–420
292. AM Mol, The Body Multiple: Ontology in Medical Practice (Durham, NC, Duke University Press, 2002).
293. O O’Neill, ‘Some Limits of Informed Consent’ (2003) 29 Journal of Medical Ethics 4–7.
294. M Sheehan, ‘Can Broad Consent Be Informed Consent?’ (2011) Public Health Ethics doi: 10.1093/phe/phr020.
295. L Brown, M Parker and M Dixon Woods, ‘Whose Interest? British Newspaper Reporting of Use of Medical Records for Research’ (2008) 13 Journal of Health Services Research and Policy 140–45.
296. C Heeney, N Hawkins, J de Vries, P Boddington and J Kaye, ‘Assessing the Privacy Risks of Data Sharing in Genomics’ (2010) 14(1) Public Health Genomics 17–25.
297. M Parker, RE Ashcroft, A Wilkie, A Kent, ‘Ethical Review of Research into Rare Genetic Disorders’ (2004) British Medical Journal 288–89.
298. O Bathe and A McGuire, ‘The Ethical Uses of Existing Samples for Genome Research’ (2009) 11(10) Genetics in Medicine 712–15.
299. Kaye et al, ‘Ethical Implications of the Use of Whole Genome Methods in Medical Research’ (2010) 18 European Journal of Human Genetics 398–403.
300. W Lowrence and FS Collins, ‘Identifiability in Genomic Research’ (2007) 317 Science 600–02.
301. T Caulfield, AL McGuire, M Cho, JA Buchanan et al, ‘Research Ethics Recommendations for Whole-genome Research: Consensus Statement’ (2008) 6(3) PLoS Biology 430–35.
302. GTH Ellison and IR Jones, ‘Social Identities and the “New Genetics”: Scientifi c and Social Consequences’ (2002) 12 Critical Public Health 265–82
303. J Lunshof, R Chadwick, DB Vorhaus and GM Church, ‘From Genetic Privacy to Open Consent’ (2008) 9 Nature Reviews Genetics 406–10.
304. A Cambon-Thomsen, E Rial-Sebbag and B Knoppers, ‘Trends in Ethical and Legal Frameworks for the Use of Human Biobanks’ (2007) 30(2) European Respiratory Journal 373–82
305. AL McGuire and RA Gibbs, ‘No Longer De-identified’ (2006) 312 Science 370–71
306. AL McGuire, T Caulfi eld and M Cho, ‘Research Ethics and the Challenge of Whole-Genome Sequencing’ (2008) 9 Nature Reviews Genetics 152–56.
307. G Haddow, G Laurie, S Cunningham-Burley and KG Hunter, ‘Tackling Community Concerns About Commercialisation and Genetic Research: a Modest Interdisciplinary Proposal’ (2007) 64 Social Science and Medicine 272–82.
308. P Arzberger, P Schroeder, A Beaulieu, G Bowker et al, ‘An International Framework to Promote Access to Data’ (2004) 303 Science 1777–78.
309. R Chadwick and BM Knoppers, ‘Human Genetic Research: Emerging Trends in Ethics’ (2005) 6(1) Nature Reviews Genetics 75–79.
310. G Deleuze and F Guattari, A Thousand Plateaus (Minneapolis, University of Minnesota, 1987).
311. G Deleuze and F Guattari, A Thousand Plateaus (Minneapolis, University of Minnesota, 1987).
312. AM Mol, The Body Multiple: Ontology in Medical Practice (Durham, NC, Duke University Press, 2002).
313. BBMRI:
314. http://www.p3gconsortium.org/
315. C Scott, ‘Analysing Regulatory Space: Fragmented Resources and Institutional Design’ [2001] Public Law 329.
316. M Mayrhofer and B Prainsack, ‘Being a Member of the Club: The Transnational (Self-)Governance of Networks of Biobanks’ (2009) 12(1) International Journal of Risk Assessment and Management 64–81.
317. V Bekker, G Dijkstra, A Edwards and M Fenger, ‘Governance and the Democratic Defi cit: Introduction’ in V Bekker, G Dijkstra, A Edwards and M Fenger (eds), Governance and the Democratic Defi cit: Assessing the Democratic Legitimacy of Governance Practice (London and New York, Ashgate, 2007) 7.
318. SP Wainwright, C Williams, M Michael, B Farsides and A Cribb, ‘Ethical Boundary-Work in the Embryonic Stem Cell Laboratory’ (2006) 28(6) Sociology of Health and Illness 732–48.
319. P Hampton, Final Report, ‘Reducing Administrative Burdens: Effective Inspection and Enforcement’ (HM Treasury, London, March 2005)
320. Better Regulation Task Force, Principles of Good Regulation (revised 2007) available at .
321. House of Lords Constitution Committee, Constitution: Sixth Report 2003–4 Ch 8 paras 132–34 (Parliamentary Copyright: London) .
322. RE Ashcroft, AJ Newson and PMW Benn, ‘Editorial: Reforming Research Ethics Committees’ (2005) 331 BMJ 587–88
323. J Tully, N Ninis, R Booy, R Viner ‘The New System of Review by Multi-Centre Research Ethics Committees: Prospective Study’ (2000) 320 British Medical Journal 1179–82
324. P Glasziou and I Chalmers, ‘Ethics Review Roulette: What Can We Learn?’ (2004) 328 British Medical Journal 121–22.
325. R Souhami, ‘Governance of Research that Uses Identifi able Personal Data’ (2006) 333 British Medical Journal 315–16.
326. Better Regulation Task Force, Principles of Good Regulation (revised 2007) available at .
327. R Baldwin and M Cave, Understanding Regulation: Theory, Strategy, and Practice (Oxford, Oxford University Press, 1999) ch 6.
328. Academy of Medical Sciences, ‘A New Pathway for the Regulation and Governance of Health Research’ (London 2011) http://www.acmedsci.ac.uk/p47prid88.html.
329. L Brown, M Parker and M Dixon Woods, ‘Whose Interest? British Newspaper Reporting of Use of Medical Records for Research’ (2008) 13 Journal of Health Services Research and Policy 140–45.
330. S Hilgartner and SI Brandt-Rauf, ‘Data Access, Ownership, and Control: Toward Empirical Studies of Access Practices (1994) 15 Science Communication 355–72