Advertisement

Trading in Cold Blood?

Trustworthiness in Face of Commercialized Biobank Infrastructures
  • Klaus Hoeyer
Conference paper
First Online:
  • 649 Downloads
Part of the Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim book series (IMGB, volume 33)

Abstract

In this chapter I discuss trustworthiness as a quality of biobanks constructed and regulated in ways that make them serve the expectations donors have. Beginning with a short review of empirical studies of donor expectations and attitudes, I show that their concerns tend to revolve around issues of 1) personal control, 2) harmful uses of medical knowledge and 3) social fairness, in particular whether research is shaped by creed rather than medical need. I then rehearse the regulatory tendencies addressing these three issues, and identify an overall trend towards commercialization in particular in the areas of property law and research management. Then, the potential effects of this commercialization on the research agenda and research results are assessed based on available empirical studies. In conclusion, I point to the gap between donor expectations and the thrust of regulatory efforts. I argue that it is important that ethicists begin to address the wider innovation system surrounding biobanks if they wish that biobanks do not only preserve, but also deserve, the trust of the donating public.

Keywords

Research Agenda Embryonic Stem Cell Line European Patent Office Industry Sponsorship hESC Research 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
This is a preview of subscription content, log in to check access.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Literatur

  1. Anderlik MR (2003) Commercial Biobanks and Genetic Research: Ethical and Legal Issues. Am J Pharmacogenomics 3: 203-215Google Scholar
  2. Andrews LB (2002) Genes and Patent Policy: Rethinking intellectual property rights. Nat Rev Genet 3: 803-808Google Scholar
  3. Azoulay P, Ding W, Stuart T (2006) The impact of academic patenting on the rate, quality, and direction of (public) research. National Bureau of Economic Research, CambridgeGoogle Scholar
  4. Barnes DE, Bero LA (1998) Why Review Articles on the Health Effects of Passive Smoking Reach Different Conclusions. JAMA 279: 1566-1570Google Scholar
  5. Barr M (2006) ’I’m not Really Read up on Genetics’: Biobanks and the Social Context of Informed Consent. BioSocieties 1: 251-262Google Scholar
  6. Bekelman JE, Li Y, Gross GP (2003) Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review. JAMA 289: 454-465Google Scholar
  7. Bhandari M, Busse JW, Jackowski D et al (2004) Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. Can Med Assoc J 170: 477-480Google Scholar
  8. Bister MD, Felt U, Strassing M, Wagner U (forthcoming) Refusing the information paradigm: Informed consent, medical research, and patient participation. HealthGoogle Scholar
  9. Boettiger S, Bennett AB (2006) Bayh-Dole: if we knew then what we know now. Nat Biotechnol 24: 320-323Google Scholar
  10. Borrás S (2003) The Innovation Policy of the European Union: From Government to Governance. Edward Elgar, CheltenhamGoogle Scholar
  11. Bouchard RA, Lemmens T (2008) Privatizing biomedical research – a ‘third way’. Nat Biotechnol 26: 31-36Google Scholar
  12. Busby H (2007) Biobanks, bioethics and concepts of donated blood in the UK. In: de Vries R, Turner L, Orfali K, Bosk CL (eds) The View From Here. Bioethics and the Social Sciences pp 179-193. Blackwell Publishing, OxfordGoogle Scholar
  13. Busby H (2006) Consent, trust and ethics: reflections on the findings of an interview based study with people donating blood for genetic research for research within NHS. Clin Ethics 1: 211-215Google Scholar
  14. Busby H (2004) Blood donation for genetic research: what can we learn from donors’ narratives? In: Tutton R, Corrigan O (eds) Genetic Databases: Socio-ethical issues in the collection and use of DNA (p. 39-56). Routledge, LondonGoogle Scholar
  15. Busby H, Martin P (2006) Biobanks, National Identity and Imagined Communities: The Case of UK Biobank. Sci Cult 15: 237-251Google Scholar
  16. Cambon-Thomsen A (2004) The social and ethical issues of post-genomic human biobanks. Nat Rev Genet 5: 6-13Google Scholar
  17. Caulfield T (2007) Profit and the Production of the Knowledge: The Impact of Industry on Representations of Research Results. Harv Health Policy Rev 8: 51-60Google Scholar
  18. Caulfield T, Einsiedel E, Merz JF, Nicol D (2006) Trust, patents and public perceptions: the governance of controversial biotechnology research. Nat Bio-technol 24: 1352-1354Google Scholar
  19. Clayton EW (2005) Informed Consent and Biobanks. J Law Med Ethics 33: 15-21Google Scholar
  20. Commission of the European Communities (2005) Report From the Commission to the Council and the European Parliament. Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering. COM (2005) 312. Brussels, The European ParliamentGoogle Scholar
  21. Contopoulos-Ioannidis D, Ntzani E, Ioannidis J (2003) Translation of higly promosing basic science research into clinical applications. Am J Med 114: 477-484Google Scholar
  22. Cousins G, McGee H, Ring L et al (2005) Public Perceptions of Biomedical Research. A survey of the general population in Ireland. Health Research Board, DublinGoogle Scholar
  23. Cragg Ross Dawson (2000) Public Perceptions of the Collection of Human Bio-logical Samples. The Wellcome Trust and Medical Research Council, LondonGoogle Scholar
  24. Daemmrich AA (2004) Pharmacopolitics. Drug Regulation in the United States and Germany. The University of North Carolina Press, Chapel Hill/LondonGoogle Scholar
  25. Ducournau P (2007) The viewpoint of DNA donors on the consent procedure. New Genet Soc 26: 105-116Google Scholar
  26. Earnscliffe Research & Communications (2000) Public Opinion Research Into Biotechnology Issues Third Wave. The Biotechnology Assistant Deputy Minister Coordinating Committee / Government of Canada, OttawaGoogle Scholar
  27. Egilman DS (2005) Suppression Bias at the Journal of Occupation and Environmental Medicine. Int J Occup Environ Health 11: 202-204Google Scholar
  28. Fernandes M, Miska D (2004) Beyond Bayh-Dole and the Lambert Review: an Initial Product Development and Transactional Model for the Interface between Universities and Business. Biotechnol Genet Eng Rev 21: 249-276Google Scholar
  29. Fleising U, Smart A (1993) The Development of Property Rights in Biotechnology. Cult Med Psychiatry 17: 43-57Google Scholar
  30. Foray D (2004) The patent system and the dynamics of innovation in Europe. Sci Public Policy 31: 449-456Google Scholar
  31. Forsknings- og Innovationsstyrelsen (2006) Kommercialisering af Forskningsresultater. Statistik 2005. Forsknings- og Innovationsstyrelsen, CopenhagenGoogle Scholar
  32. Friedman L, Richter ED (2005) Conflicts of Interest and Scientific Integrity. Int J Occup Environ Health 11: 205-206Google Scholar
  33. Gold ER (1996) Body parts. Property rights and the ownership of human biological materials. Georgetown University Press, Washington DCGoogle Scholar
  34. Gold ER, Caulfield TA (2002) The Moral Tollbooth: A Method that Makes Use of the Patent System to Address Ethical Concerns in Biotechnology. Lancet 359: 2268-2270Google Scholar
  35. Goldman,B. (2007) HER2 testing: The patent “genee” is out of the bottle. Can Med Assoc J 176: 1443-1444Google Scholar
  36. Gudmundsdóttir ML, Nordal S (2007) Iceland. In M.Häyry, R.Chadwick, V.Árnason, & G.Árnason (Eds.), The Ethics and Governance of Human Genetic Databases (pp. 53-57). Cambridge: Cambridge University PressGoogle Scholar
  37. Haddow G, Laurie G, Cunningham-Burley S et al (2007) Tackling community concerns about commercialisation and genetic research: A modest interdisciplinary proposal. Soc Sci Med 64: 272-282Google Scholar
  38. Haimes E, Whong-Barr M (2004) Levels and styles of participation in genetic databases: a case study of the North Cumbria Community Genetics Project. In: Tutton R, Corrigan O (eds) Genetic Databases: Socio-ethical issues in the collection and use of DNA (p. 57-77). Routledge, LondonGoogle Scholar
  39. Heller MA, Eisenberg RS (1998) Can patents deter innovation? The anticommons in biomedical research. Science 280: 698-701Google Scholar
  40. Herder M (2006) Proliferating Patent Problems with Human Embryonic Stem Cell Research? J Bioeth Inq 3: 69-79Google Scholar
  41. Hoeyer K (2003) “Science is Really Needed – That’s All I Know”. Informed Consent and the Non-Verbal Practices of Collecting Blood for Genetic Research in Sweden. New Genet Soc 22: 229-244Google Scholar
  42. Hoeyer K (2004) Ambiguous gifts. Public anxiety, informed consent and commercial genetic biobank research. In: Tutton R, Corrigan O (eds) Genetic Databases: Socio-ethical issues in the collection and use of DNA (p 97-116). Routledge, LondonGoogle Scholar
  43. Hoeyer K (2006) The power of ethics: a case study from Sweden on the social life of moral concerns in policy processes. Sociol Health Illn 28: 785-801Google Scholar
  44. Hoeyer K, Olofsson BO, Mörndal T, Lynöe N (2004) Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research. Scand J Public Health 32: 224-229Google Scholar
  45. Hopkins MM, Mahdi S, Thomas SM, Patel P (2006) The Patenting of Human DNA: Global Trends in Public and Private Sector Activity (the PATGEN Project). University of Sussex, SPRUGoogle Scholar
  46. HUGO Ethics Committee. (2002) Statement on Human Genetic Databases. http://www.hugointernational. org/Statement_on_Human_Genomic_Databases.htmGoogle Scholar
  47. Jack A, Womack C (2003) Why surgical patients do not donate tissue for commercial research: review of records. BMJ 327: 262Google Scholar
  48. Joly Y, Wahnon F, Knoppers BM (2007) Impact of the Commercialization of Biotechnology Research on the Communication of Research Results: North American Perspective. Harv Health Policy Rev 8: 71-84Google Scholar
  49. Jørgensen AW, Hilden J, Gøtzsche PC (2006) Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. BMJ 333: 782-785Google Scholar
  50. Kettis-Lindblad Å, Ring L, Viberth E, Hansson MG (2007) Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: A population-based study. Scand J Public Health 35: 148-156Google Scholar
  51. Kettis-Lindblad Å, Ring L, Viberth E, Hansson MG (2006) Genetic research and donation of tissue samples to biobanks. What do potential sample donors in the Swedish general public think? Eur J Public Health 16: 433-440Google Scholar
  52. Kortum S, Lerner J (1999) What is behind the recent surge in patenting? Res Policy 28: 1-22Google Scholar
  53. de Laet M (2000) Patents, travel, space: ethnographic encounters with objects in transit. Environ Plan D 18: 149-168Google Scholar
  54. Le Grand J (2003) Motivation, Agency, and Public Policy: Of Knights and Knaves, Pawns and Queens. Oxford University Press, New YorkGoogle Scholar
  55. Levitt M, Weldon S (2005) A Well Placed Trust?: Public Perceptions of the Governance of DNA Databases. Crit Public Health 15, 311-321Google Scholar
  56. Lewis G (2004) Tissue collection and the pharmaceutical industry: investigating corporate biobanks. In: Tutton R, Corrigan O (eds) Genetic Databases. Socio-ethical issues in the collection and use of DNA (p. 181-202). Routledge, LondonGoogle Scholar
  57. Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326: 1167-1170Google Scholar
  58. Malone T, Catalano PJ, O’Dwyer PJ, Giantonio B (2002) High Rate of Consent to Bank Biologic Samples for Future Research: The Eastern Cooperative Oncology Group Experience. J Natl Cancer Inst 94: 769-771Google Scholar
  59. Mamo L, Fishman JR (2001) Potency in All the Right Places: Viagra as a Technology of the Gendered Body. Body Soc 7: 13-35Google Scholar
  60. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B (2003) Evidence b(i)ased medicine – selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 326: 1171-1173Google Scholar
  61. Merz JF (1997) Psychosocial Risks of Storing and Using Human Tissues in Research. Risk Health Saf Environ 8: 235-248Google Scholar
  62. Moses H, Dorsey ER, Matheson DHM, Their SO (2005) Financial Anatomy of Biomedical Research. JAMA 294: 1333-1342Google Scholar
  63. Murray F (2007) The Stem-Cell Market – Patents and the Pursuit of Scientific Progress. N Engl J Med 356: 2341-2343Google Scholar
  64. National Institute of Health [NIH] (2007) Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of Clinical Trials.gov: Registration. Notice number NOT-OD-08-014Google Scholar
  65. Nilstun T, Hermerén G (2006) Human tissue samples and ethics – attitudes of the general public in Sweden to biobank research. Med Health Care Philos 9: 81-86Google Scholar
  66. Nordic Council of Ministers (2006) Assisted Reproduction in the Nordic Countries: A comparative study of policies and regulation. Nordic Committee on Bioethics, CopenhagenGoogle Scholar
  67. Oudshoorn N, Pinch T (2003) Introduction: How Users and Non-Users Matter. In: Oudshoorn N, Pinch T (eds) How Users Matter – The Co-Construction of Users and Technologies pp 1-25. MIT Press, New BaskervilleGoogle Scholar
  68. Pearce N (2008) Corporate influences on epidemiology. Int J Epidemiol 37: 46-53Google Scholar
  69. Pentz RD, Billot L, Wendler D (2006) Research on Stored Biological Samples: Views of African American and White American Cancer Patients. Am J Med Genet 140A: 733-739Google Scholar
  70. Pentz RD, Young LN, Amos CJ et al (1999) Informed Consent for Tissue Research. JAMA 282: 1625Google Scholar
  71. Petersen A (2005) Securing Our Genetic Health: Engendering Trust in UK Bio-bank. Sociol Health Illn 27: 271-292Google Scholar
  72. Petryna A (2007) Clinical Trials Offshored: On Private Sector Science and Public Health. Bio-Societies 2: 21-40Google Scholar
  73. Plomer A (2006) Stem Cell Patents: European Patent Law and Ethics Report. University of Nottingham, NottinghamGoogle Scholar
  74. Rodriguez V (2007) Merton and Ziman’s modes of science: the case of biological and similar material transfer agreements. Sci Public Policy 34: 355-363Google Scholar
  75. Schneider I (2005) “Taming the future with patents - frames and rhetoric in policy processes”. Paper for ECPR (European Consortium for Political Research) conference, section 13: Theory and Praxis of Policy Analysis, September 8-10, 2005Google Scholar
  76. Seglen PO (1997) Why the impact factor of journals should not be used for evaluating research. BMJ 314: 497Google Scholar
  77. Shickle D (2006) The consent problem within DNA biobanks. Stud Hist Philos Biol Biomed Sci 37: 503-519Google Scholar
  78. Skolbekken J-A, Ursin LØ, Solberg B, Christensen E, Ytterhus B (2005) Not Worth the Paper it’s Written on? Informed Consent and Biobank Research in a Norwegian Context. Crit Public Health 15: 335-347Google Scholar
  79. Stegmayr B, Asplund K (2002) Informed consent for genetic research on blood stored for more than a decade: a population based study. BMJ 325: 634-635Google Scholar
  80. Stelfox HT, Chua G, O’Rourke K, Detsky AS (1998) Conflict of Interest in the Debate over Calcium-channel Antagonists. N Engl J Med 338: 101-106Google Scholar
  81. Sutrop M (2007) Trust. In: Häyry M, Chadwick R, Árnason V, Árnason G (eds) The Ethics and Governance of Human Genetic Databases (p. 190-198). Cambridge University Press, CambridgeGoogle Scholar
  82. Svendsen MN (2007) Mellem reproduktiv og regenerativ medicin. Donation som handlerum i fertilitetsklinikken. In: Koch L, Hoeyer K (eds) Håbets teknologi. Samfundsvidenskabelige perspektiver på stamcelleforskning i Danmark (p. 176-200). Munksgaard, CopenhagenGoogle Scholar
  83. Thomson JA, Itskovitz-Eldor J, Shapiro SS, et al (1998) Embryonic Stem Cell Lines Derived from Human Blastocysts. Science 282: 1145-1147Google Scholar
  84. UN News Centre. (2005) General Assembly Approves Decleration Banning All Form of Cloning. UN News Center, New YorkGoogle Scholar
  85. Weber M (1947) Science as a Vocation. In: Gerth HH, Mills CW (eds) From Max Weber: Essays in Sociology (p. 129-156). Oxford University Press, New YorkGoogle Scholar
  86. Webster A, Packer K (1996a) Intellectual Property and the Wider Innovation System. In: Webster A, Packer K (eds) Innovation and the Intellectual Property System pp 1-19. Kluwer Law International, LondonGoogle Scholar
  87. Webster A, Packer K (1996b) Patens and Technology Transfer in Public Sector Research: The Tension Between Policy and Practice. In Kirkland J (ed) Barriers to International Technology Transfer (p. 43-64). Kluwer Academic Publishers, LondonGoogle Scholar
  88. Weldon S (2007) United Kingdom. In: Häyry M, Chadwick R, Árnason V, Árnason G (eds) The Ethics and Governance of Human Genetic Databases (p 66-72). Cambridge University Press, CambridgeGoogle Scholar
  89. Welsh R, Glenna L (2006) Considering the Role of the University in Conducting Research on Agri-biotechnologies. Soc Stud Sci 36: 929-942Google Scholar
  90. Wendler D (2006) One time general consent for research on biological samples. BMJ 332: 544-547Google Scholar
  91. Wendler D, Emanuel E (2002) The Debate over Research on Stored Biological Samples: What Do Sources Think? Arch Intern Med 162: 1457-1462Google Scholar
  92. Winickoff DE, Winickoff RN (2003) The Charitable Trust as a Model for Genomic Biobanks. N Engl J Med 349: 1180-1184Google Scholar
  93. Womack C, Jack A (2003) Family attitudes to research using samples taken at coroner’s postmortem examinations: review of records. BMJ 327: 781-782Google Scholar
  94. Womack C, Pope J, Jack A, Semple C (2006) Cadaveric Tissue Retrieval Service for Research: One-year Review and Options for the Future. Cell and Tissue Banking 7: 211-214Google Scholar
  95. Wright S (1994) Molecular Politics. Developing American and British Regulatory Policy for Genetic Engineering 1972-1982. University of Chicago Press, ChicagoGoogle Scholar
  96. Zika E, Papatryfon I, Wolf O, Gómez-Barbero M, Stein AJ, Bock A-K (2007) Consequences, Opportunities and Challenges of Modern Biotechnology for Europe. Spain, European Commision, Institute of Prospective Technological StudiesGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Klaus Hoeyer
    • 1
  1. 1.University of CopenhagenCopenhagenDenmark

Personalised recommendations

Cite paper

Buy options