Published online by Cambridge University Press: 16 August 2011
The ongoing legal and bioethics debates on consent requirements for collecting, storing, and utilizing human biological material for purposes of basic and applied research—that is, genomic research biobanking—have already managed to pass through three ostensibly dissimilar stages
1. Galcher, JR, Steffanson, K.The Icelandic Healthcare Database and informed consent. New England Journal of Medicine 2000;24(324):1827–30.CrossRefGoogle Scholar
2. Knoppers, BM, Laberge, C.DNA sampling and informed consent. Canadian Medical Association Journal 1989;140(9):1023–8Google ScholarPubMed; Beskow, LM, Burke, W, Mertz, JF, Barr, PA, Terry, S, Penchaszadeh, VB, et al. . Informed consent for population-based research involving genetics. Journal of the American Medical Association 2001;286(18):2315–21CrossRefGoogle ScholarPubMed; Mertz, JF, McGee, GE, Sankar, P.“Iceland Inc.”?: On the ethics of commercial population genomics. Social Science & Medicine 2003;58(6):1201–9.CrossRefGoogle Scholar
3. Hansson, MG, Dillner, J, Bartram, CR, Carlson, JA, Helgesson, G.Should donors be allowed to give broad consent to future biobank research? Lancet Oncology 2006;7(3):266–9CrossRefGoogle ScholarPubMed; Hansson, MG.Ethics and biobanks. British Journal of Cancer 2009;100:8–12.CrossRefGoogle ScholarPubMed
4. Lunshof, JE, Chadwick, R, Vorhaus, DB, Church, GM.From genetic privacy to open consent. Nature Reviews Genetics 2008 May;9(5):406–11.CrossRefGoogle ScholarPubMed
5. Canguilhem, G.A Vital Rationalist: Selected Writings from Georges Canguilhem. Goldhammer, A , translator. New York: Zone Books; 1994.Google Scholar
6. U.S Department of Health and Human Services, NIH, International Consortium Announces the 1000 Genomes Project, available at: http://www.genome.gov/26524516.
7. Sachidanandam, RD, Weissman, S, Schmidt, J, Kakol, L, Stein, G, Marth, S, et al. . A map of human genome sequence variation containing 1.42 million single nucleotide polymorphisms. Nature 2001; 409(6822): 928–33CrossRefGoogle ScholarPubMed; Venter, JC, Adams, MD, Myers, EW, Li, PW, Mural, RJ, Sutton, GG, et al. . The sequence of the human genome. Science 2001;291(5507):1304–51.CrossRefGoogle ScholarPubMed
8. Levy, S, Sutton, G, Feuk, L, Halpern, AL, Walenz, BP, Axelrod, N, et al. . The diploid genome sequence of an individual human. PLoS Biology 2007;5(10):e254.CrossRefGoogle ScholarPubMed
9. Mayrhofer, MT, Prainsack, B.Being a member of the club: The transnational (self-)governance of networks of biobanks. International Journal of Risk Assessment and Management 2009;12(1):64–81.CrossRefGoogle Scholar
10. Karlsen, JR, Solbakk, JH, Strand, R. In the ruins of Babel: Should biobank regulations be harmonised? In: Solbakk, JH, Holm, S, and Hoffman, B, eds. The Ethics of Research Biobanks. Dordrecht: Springer Verlag: 2009:331–43.CrossRefGoogle Scholar
11. Karlsen, JR, Strand, R. Annexation of life: The biopolitics of industrial biology. In: Solbakk, JH, Holm, S, and Hoffman, B, eds. The Ethics of Research Biobanks. Dordrecht: Springer Verlag; 2009:315–29.CrossRefGoogle Scholar
12. Althingi. Act on Biobanks. Iceland No 110/2000; Riksdagen. The Swedish Act on Biobanks. Sweden SF 2002:297; Stortinget. Act Relating to Biobanks. Norway No. 12 21.2 2003.
13. Stortinget. Act Relating to Biobanks. Norway No. 12 21.2 2003, §1.
14. The Norwegian Research Council . Gode biobanker—Bedre helse (Good biobanks—Better health). Oslo: The Norwegian Research Council; 2008.Google Scholar
15. Norges offentlige utredninger. NOU 2001:19 Biobanker. Norway.
19. UNESCO. Universal Declaration on Bioethics and Human Rights. 2005, Article 3.2. For this, see also Council of Europe. Convention on Human Rights and Biomedicine, §2.
21. Árnason, V.Coding and consent: Moral challenges of the database project in Iceland. Bioethics 2004;18(1):41CrossRefGoogle ScholarPubMed; Hofmann, B.Broadening consent—and diluting ethics? Journal of Medical Ethics 2009;35:125–9.CrossRefGoogle ScholarPubMed
24. McGuire, AL, Gibbs, RA.No longer de-identified. Science 2006;312:370–1CrossRefGoogle ScholarPubMed; Lowrance, WW, Collins, FS.Identifiability in genomic research. Science 2007;317:600–2CrossRefGoogle ScholarPubMed; See note 4, Lunshof et al. 2008.
31. Porter, R.The Greatest Benefit to Mankind: A Medical History of Humanity from Antiquity to the Present. London: HarperCollins; 1999.Google Scholar
32. Rosen, R.Life Itself: A Comprehensive Inquiry into the Nature, Origin, and Fabrication of Life. New York: Columbia University Press; 1991.Google Scholar
33. Holm, S, Takala, T.High hopes and automatic escalators. Journal of Medical Ethics 2007;33(1):1–4.CrossRefGoogle ScholarPubMed
34. Beecher, H.Ethics and clinical research. New England Journal of Medicine 1966;274(24):1354–60.CrossRefGoogle ScholarPubMed
35. See note 11, Karlsen, Strand 2009; Norges offentlige utredninger . NOU 2001:19 Biobanker. Norway.Google Scholar
36. Holm, S.Who should control the use of human embryonic stem cell lines—A defence of the donors’ ability to control. Journal of Bioethical Inquiry 2006;3(1–2):55–68CrossRefGoogle Scholar; Solbakk, JH.Stem cell research and the ethics of transparency. Regenerative Medicine 2006;1(6):831–5.CrossRefGoogle ScholarPubMed
37. Karlsen, JR, Strand, R. The ethical topography of research biobanking. In: Gunning, J, Holm, S, Kenway, I, eds. Ethics Law and Society, Volume IV. Farnham: Ashgate; 2009:127–47.Google Scholar
38. Wittgenstein, L.Philosophical Investigations. Anscombe, GEM , translator. Oxford: Blackwell; 1997:19:8.Google Scholar
39. Pirsig, RM.Zen and the Art of Motorcycle Maintenance. London: Vintage, 1989.Google Scholar