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Accountability, Governance and Biobanks: The Ethics and Governance Committee as Guardian or as Toothless Tiger?

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Abstract

The huge potential of biobanks/genetic databases for the research community has been recognised across jurisdictions in both publicly funded and commercial sectors. But although there is tremendous potential there are likewise potential difficulties. The long-term storage of personal health information and samples poses major challenges. This is an area is fraught with ethical and legal uncertainties. Biobanks raise many questions of the control of rights, of consent, of privacy and confidentiality and of property in human material. It is thus unsurprising then that there has been a lively debate as to how biobanks should operate, the boundaries of participation and what governance structure, if any they should adopt, a debate which has been engaged in across the academic community and by funders and researchers alike. This paper asks despite the good intentions can ad hoc ethics and ethics and governance committees long term provide an effective solution to the legal and regulatory challenges arising from biobanks.

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Notes

  1. http://www.alspac.bristol.ac.uk.

  2. See for background Slowther et al. [37].

  3. Directive 2001/20/EC on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use implemented into UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031.

  4. Sections “The rise and rise of ethics committees” and “Ethics committees biobanks and the question of “teeth”” Human Tissue Act 2004.

  5. Mental Capacity Act s 32(8), (9).

  6. Currently Professor Roger Brownsword, Emeritus Professor of Law at the University of Sheffield.

  7. No 552/1999, issued under the Act on the Rights of Patients, No 74/1997.

  8. HL Deb vol 664 col 370 22 July 2004. See also Dr Ladyman, HC Standing Committee G col 51 27 Jan 2004.

  9. See, e.g., the discussion in Pretty v UK (2002) FLR 45.

  10. Widows and Mullen provide an instructive discussion of what constitutes genetic information.

  11. X v. Y (1988) 2 All ER 648; W v Egdell (1990) 1 All ER 835; GMC, Confidentiality (GMC, 2009)Z v Finland (1998) 25 EHRR 371; MS v Sweden (1999) 28 EHRR 313; Campbell v Mirror Group Newspapers (2004) 2 All ER 995.

  12. R v Rothery (1976) RTR 550.

  13. R v Welsh (1974) RTR 478.

  14. (1974) RTR 478.

  15. Rv Luff, The Times, 13 December, 160, R v Herbert, The Times, 22 December 1960.

  16. (1999) QB 621.

  17. Doodeward v Spence (1908) 6 CLR 406. Dobson v North Tyneside HA (1997) 1 WLR 596 (CA),

  18. See Yearworth v North Bristol NHS Trust (2009) EWCA Civ 37, Quigley [36], Tutton [38].

  19. This is an issue which has recently exercised UK Biobank.

  20. http://www.acmedsci.ac.uk/p47prid80.html.

  21. See Kaye in relation to the question of biobanks across Europe.

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Authors and Affiliations

  1. Birmingham Law School, University of Birmingham, Birmingham, UK

    Jean V. McHale

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  1. Jean V. McHale
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Correspondence to Jean V. McHale.

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The author was previously a member of UK Biobank Interim Ethics and Governance Advisory Group and is a member of the Home Office/Imperial College Airwave Project Ethical Advisory Group. It must be emphasized that all opinions here expressed are solely the personal views of the author.

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McHale, J.V. Accountability, Governance and Biobanks: The Ethics and Governance Committee as Guardian or as Toothless Tiger?. Health Care Anal 19, 231–246 (2011). https://doi.org/10.1007/s10728-011-0195-7

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