Mapping the regulatory space for genetic databases and biobanks in England and wales

Medical Law International

Volumn 9, Issue 2, 2008, Pages 111-130

  Kaye, Jane ^a   Gibbons, Susan M C ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; GENE MAPPING; GENETIC DATABASE; LEGAL ASPECT; LITERATURE; MEDICAL RESEARCH; METHODOLOGY; RESEARCH ETHICS; SOCIAL ASPECT; UNITED KINGDOM;

EID: 47049123276     PISSN: 09685332     EISSN: None     Source Type: Journal    
DOI: 10.1177/096853320800900202     Document Type: Article

References (61)

1. Wellcome Trust Biomedical Ethics programme, award ref: 076070/Z/04/Z (2005-2008); http://www.ggd.org.uk (last accessed 11.02.08).
2. For convenience, 'England' and 'English' will be used to denote England and Wales.
3. For detailed discussion, see: S.M.C. Gibbons, 'Are UK Genetic Databases Governed Adequately? A Comparative Legal Analysis' (2007) 27(2) LS 312;
4. S.M.C. Gibbons et al., 'Governing Genetic Databases: Challenges Facing Research Regulation and Practice' (2007) 34(2) JLS 163.
5. L. Hancher and M. Moran, 'Organizing Regulatory Space' in R. Baldwin, C. Scott and C. Hood, A Reader on Regulation (Oxford: OUP, 1998), especially 148-172.
6. See generally: Hancher and Moran, above n4; C. Scott, 'Analysing Regulatory Space: Fragmented Resources and Institutional Design' [2001] PL 329. These papers provide the foundation for the overview presented and used in this paper.
7. See, eg, Hancher and Moran, above n4 (domestic and European-level economic regulation under advanced capitalism); Scott, above n5 (UK telecommunications sector; EU regulations).
8. Scott, above n5, 331.
9. Ibid, 336. Scott's four-fold list adapts Hood's 'NATO scheme' of four basic resources possessed by government: nodality (the property of being centrally positioned within a domain); authority (ie, legal or official authority); treasure (moneys and other fungible resources); and organisation (eg, land, buildings, materials, skilled people and so forth directly possessed by or available to government that physically enable it to act directly).
10. See C. Hood and H. Margetts, The Tools of Government in the Digital Age (updated edn) (London: Palgrave Macmillan, 2007).
11. J.M. Black, 'Decentring Regulation: Understanding the Role of Regulation and Self-Regulation in a "Post-Regulatory" World' (2001) 54 CLP 103, 109.
12. Our qualitative sociological research (conducted by Dr Catherine Heeney) seeks to uncover (inter alia) the perspectives, priorities, awareness and concerns of researchers and genetic database operators regarding current governance.
13. Examples include negligence, battery, consent, capacity, the duty of confidence, human rights (notably privacy), property rights and intellectual property.
14. Bolitho v City and Hackney Health Authority [1998] AC 232 (HL);
15. AB v Leeds Teaching Hospital NHS Trust [2004] EWHC 644 (QB), [2004] 2 FLR 365.
16. Especially Sched I, art 8 (right to respect for private and home life).
17. Eg, the Data Protection (Processing of Sensitive Personal Data) Order 2000 (SI 2000/417), especially art 9, which permits the processing of sensitive personal data (including health data) for research purposes in certain circumstances.
18. Eg, the statutory Codes of Practice issued by the Human Tissue Authority under the HTAct, discussed below.
19. OJ L281, 23/11/1995, pp 31-50.
20. OJ L102, 07/04/2004, pp 48-58. Two technical annexes (Commission Directives 2006/17/EC and 2006/86/EC) provide detailed rules.
21. OJ L121, 01/05/2001 pp 34-44.
22. OJ L77, 27/03/1996, pp 20-28.
23. These sections repealed and replaced ss 60-61 of the Health and Social Care Act 2001.
24. SI 2004/1031. These Regulations implemented the EU Clinical Trials Directive (above n18).
25. Feedback is addressed in guidelines issued by the Medical Research Council. But these do not apply to researchers funded by other bodies.
26. B.S. Elger and A.L. Caplan, 'Consent and Anonymization in Research Involving Biobanks' (2006) 7 EMBO Reports 661, 662;
27. F.W. Hondius, 'Protecting Medical and Genetic Data' (1997) 4 EJHL 361, 384.
28. Inter alia, non-binding but authoritative Recommendations cover research on human biological materials, medical research, human tissue banks, and protection of research and medical data.
29. Key documents include Declarations addressing human rights and the human genome, human genetic data, and bioethics and human rights, plus numerous reports.
30. Relevant Statements cover benefit-sharing, the principled conduct of genetics research, and human genomic databases.
31. Including the Westminster Parliament, European Parliament and European Commission.
32. Under the Medical Act 1983 (as amended), the GMC registers doctors to practise medicine in the UK. Many genetic database professionals and researchers are registered medical practitioners. Historically, the GMC's powers included setting and advising on standards of professional conduct, performance and medical ethics, and taking disciplinary actions. However, comprehensive reforms reducing its role and sanctioning powers are underway.
33. Sched 1.
34. HTAct, s 45.
35. HTAct, s 16(2)(e)(ii).
36. The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, SI 2006/1260. 'Qualifying research' means research ethically approved in accordance with the Regulations.
37. HTAct ss l(7)-(9) and ibid;
38. HTAct, s 45 and Sched 4, para 6.
39. http://www.hta.gov.uk/about_hta/how_we_work.cfm (last accessed 11.02.08).
40. A. Ogus, Regulation: Legal Form and Economic Theory (Oxford: Hart, 2004) 57-58;
41. G. Wilson, 'Social Regulation and Explanations of Regulatory Failure' (1984) 32 Pol Stud 203.
42. ICO, 'A Strategy for Data Protection Regulatory Action' (version 1.1, November 2005).
43. See, eg, S. Bridge, 'Give Me More Power, Information Watchdog to tell MPs' The Guardian, 4 December 2007.
44. See National Research Ethics Service, 'Governance Arrangements for NHS Research Ethics Committees' (GAfREC) (July 2001). For more detailed discussion, see Gibbons, above n3, 333-338.
45. Above n21.
46. NRES, 'Standard Operating Procedures for Research Ethics Committees in the United Kingdom ('SOPs')' (version 3.4, September 2007).
47. R. Ashcroft, A.J. Newson and P.M.W. Benn, 'Reforming Research Ethics Committees' (2005) 331 BMJ 587.
48. J. Saunders, 'More Guidelines on Ethical Research?' (2008) 33 JME 683.
49. Notably, the Royal Colleges of Physicians, Pathologists, General Practitioners, and Medicine.
50. The NHS also lays down many guidelines for research practice that enshrine and inculcate professional culture.
51. See text to n33 above.
52. D. Price, 'The Human Tissue Act 2004' (2005) 68 MLR 798, 800;
53. C. Dyer, 'Human Tissue Bill is Modified Because of Research Needs' (2004) 328 BMJ 1518.
54. HC Deb vol 416 col 986, 15 January 2004 (Ms Rosie Winterton).
55. HC Deb vol 423 cols 88-89, 28 June 2004 (Ms Winterton).
56. J. Kaye and P. Martin, 'Safeguards for Research Using Large Scale DNA Collections' (2000) 321 BMJ 1146.
57. http://www.mrc.ac.uk/PolicyGuidance/EthicsAndGovernance/ RegulatorySupportCentre/index.htm (last accessed 11.02.08).
58. The Office for Strategic Coordination of Health Research (OSCHR), a central coordinating body for health research, now oversees budgetary decisions and research strategies of the National Institute for Health Research, MRC and Department of Health. This could have implications for the MRC's independence in terms of its funding policies, research strategy and decision-making.
59. UK Biobank Ethics and Governance Framework (version 3.0, October 2007).
60. I. Ayers and J. Braithwaite, Responsive Regulation: Transcending the Deregulation Debate (Oxford: OUP, 1992) ch 3.
61. Legislative and Regulatory Reform Act 2006, ss 2 and 21.