The issue with tissue: why making human biomaterials available for research purposes is still controversial

  • Nils Hoppe
    Affiliations
    Nils Hoppe Dr. iur. LL.B Professor, Centre for Ethics and Law in the Life Sciences, Leibniz Universität Hannover, Germany. Conflicts of interest: The author does not consider that he has financial or personal relationships with other people or organisations that could inappropriately influence the content of this article. In the interests of transparency it is disclosed that he is a member of the scientific advisory boards of two large-scale research projects dealing with human biomaterials (ESPOIR; STEMBANCC), the latter being part-funded and partially carried out by members of EFPIA
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Published:August 08, 2013DOI:https://doi.org/10.1016/j.mpdhp.2013.06.014

      Abstract

      Making human tissue samples, or cells, available for research is not a trivial undertaking. Depending on where these materials come from, their use might be limited. Existing collections of diagnostic archives which are to be made available for a subsequent research use are excellent examples of research resources which give rise to a plethora of ethical and legal problems. Many of these problems are rooted in misperceptions, based on anecdotal accounts of scandals and dishonesty, but are mirrored in jurisprudence and public debate. This paper will outline some aspects of using human tissue for research purposes that have been discussed in international literature and deemed particularly problematic, try to identify the cross-cutting ethical and legal problems and, finally, contrast these with case law. It concludes that the issue is one of control rights, the relinquishing of which can only work in a sustained fashion if there is a sufficient degree of transparency and openness in the research community.

      Keywords

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      References

        • Callaway E.
        Most popular cell in science gets sequenced.
        Nature. 2013; (15 March – available online)https://doi.org/10.1038/nature.2013.12609
      1. See Metz C, Hoppe N. Regulating scandals and scandalous regulation. Eur J Health L; 20: 113–6.

      2. The Royal Liverpool Children's Inquiry Report (The Redfern Report).
        The Stationery Office, London2001 (summary, para. 13)
        • Hoppe N.
        • Denoon A.
        An ethical framework for expanded access to cell-based therapies.
        Regen Med. 2011; 6 (For further brief arguments on this point, see): 273
      3. (I have written extensively on this. See)
        • Hoppe Nils
        Innovative tissue engineering and its regulation.
        (in press)in: Flear Mark Hervey Tamara Murphy Therese Farrell Anne-Maree European law and new health technologies. Oxford University Press, Oxford2013: 109-124
      4. Declaration of Helsinki, Article 24.

        • Sheehan Mark
        Can broad consent be informed consent?.
        Public Health Ethics. 2011; 4: 226-235
      5. Re W [1992] 4 All ER 627 at 633.

      6. As happened in the case of the murder of Swedish foreign minister Anna Lindh in 2003, where a suspect was convicted, partly on the basis of forensic evidence matched against Guthrie cards.

      7. Doodeward v Spence (1908) 6 CLR 406.

      8. R v. Kelly [1998] 3 All ER 741, [1998] EWCA Crim 1578, [1999] QB 621, [1999] 2 WLR 384, (2000) 51 BMLR 142.

      9. R v. Kelly [1998] EWCA Crim 1578, as per Rose LJ.

      10. Moore v The Regents of the University of California 793 P 2d 479 (Cal, 1990).

      11. (Ibid, at p. 481)Case description based on that in Hoppe N. Bioequity – property and the human body. Ashgate Publishing, Farnham2007: 107-110
      12. Greenberg v Miami Children's Hospital Research Institute, Inc. 264 F. Supp. 2d 1064 (S.D. Fla. 2003).

      13. Yearworth et al v North Bristol NHS Trust [2009] EWCA Civ 37, [2010] 1 QB 1, [2009] 3 WLR 118, [2010] QB 1, (2009) 107 BMLR 47, [2009] LS Law Medical 126, [2009] 2 All ER 986.

      14. 09.11.1993, Vi ZR 62/93, BGHZ 124, 52.

      15. As per Lord Judge in §§22, 23 of the Yearworth judgment, op cit.