Consenting in population genomics as an open communication process

Studies in Ethics, Law, and Technology

Volumn 3, Issue 1, 2009, Pages

  Mascalzoni, Deborah ^a   Hicks, Andrew ^a   Pramstaller, Peter P ^a  

^a EURAC   (Italy)

Author keywords

Informed consent; Population genomics policy; Public engagement; Public trust

Indexed keywords

EID: 68149103125     PISSN: None     EISSN: 19416008     Source Type: Journal    
DOI: 10.2202/1941-6008.1085     Document Type: Article

References (53)

1. Angius, A., P. M. Melis, L. Morelli, E. Petretto, G. Casu, G. B. Maestrale, C. Fraumene, D. Bebbere, P. Forabosco, and M. Pirastu. 2001. Archival, demographic and genetic studies define a sardinian sub-isolate as a suitable model for mapping complex traits. Hum Genet 109, (2) (Aug): 198-209.
2. Arnason, V. 2004. "Coding and consent: Moral challenges of the database project in iceland". Bioethics vol. 18, : 1:27-49.
3. Arnason, V., and S. Hjorleifsson. 2007. Geneticization and bioethics: Advancing debate and research. Med Health Care Philos 10, (4) (Dec): 417-31.
4. Artizzu, F. 2007. The informed consent aftermath of the genetic revolution. an italian example of implementation. Med Health Care Philos (Jul 19).
5. Caulfield, T. SSRN-biobanks and blanket consent: The proper place of the public good and public perception rationales. 2007 [cited 6/18/2008 2008]. Available from http://papers.ssrn.com/sol3/papers.cfm?abstract-id=1119208 (accessed 6/18/2008).
6. Caulfield, T., A. L. McGuire, M. Cho, J. A. Buchanan, M. M. Burgess, U. Danilczyk, C. M. Diaz, et al. 2008. Research ethics recommendations for whole-genome research: Consensus statement. PLoS Biology 6, (3) (Mar 25): e73.
7. CIOMS. 2006. CIOMS guidelines "Special ethical considerations for epidemiological research" response from the medical research council and the wellcome trust 15 december 2006. 4.
8. - . 2002. International ethical guidelines for biomedical research involving human subjects.
9. da Rocha, A. C., and J. A. Seoane. 2008. Alternative consent models for biobanks: The new spanish law on biomedical research. Bioethics 22, (8) (Sep): 440-7.
10. Elger, B. S., and A. L. Caplan. 2006. Consent and anonymization in research involving biobanks: Differing terms and norms present serious barriers to an international framework. EMBO Rep 7, (7) (Jul): 661-6.
11. Europe, Council of. 1997. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on human rights and biomedicineCouncil, EU.
12. Foster, M. W., and R. R. Sharp. 2006. Ethical issues in medical-sequencing research: Implications of genotype-phenotype studies for individuals and populations. Hum Mol Genet 15 Spec No 1, (Apr 15): R45-9.
13. Funtowicz S., Ravetz. 1993. Science for the post-normal age. Futures 25, : 735-55.
14. Gulcher, J. R., and K. Stefansson. 1999. Ethics of population genomics research. Nature 400, (6742) (Jul 22): 307-8.
15. Helgesson, Gert. 2005. The right to withdraw consent to research on biobank samples. Med Health Care Philos(8): 315-321.
16. Helgesson, G., J. Dillner, J. Carlson, C. R. Bartram, and M. G. Hansson. 2007.
17. Ethical framework for previously collected biobank samples. Nature Biotechnology 25, (9) (Sep): 973-6.
18. Hoedemaekers, R., and W. Dekkers. 2002. The ontological status of human DNA: Is it not first and foremost a biological "file self"? Theoretical Medicine and Bioethics 23, (4-5): 377-95.
19. Jasanoff, S. 2005. In the democracies of DNA: Ontological uncertainty and political order in three states. New Genet Soc 24, (2): 139-55.
20. Johnsson, L., M. G. Hansson, S. Eriksson, and G. Helgesson. 2008. Opt-out from biobanks better respects patients' autonomy. BMJ (Clinical Research Ed.) 337, (Sep 10): a1580.
21. Jorde, L. B., W. S. Watkins, J. Kere, D. Nyman, and A. W. Eriksson. 2000. Gene mapping in isolated populations: New roles for old friends? Human Heredity 50, (1) (Jan-Feb): 57-65.
22. Knoppers, B. M. 2005. Biobanking: International norms. J Law Med Ethics 33, (1) (Spring): 7-14.
23. Kohane, I. S., K. D. Mandl, P. L. Taylor, I. A. Holm, D. J. Nigrin, and L. M.
24. Kunkel. 2007. Medicine. reestablishing the researcher-patient compact. Science (New York, N.Y.) 316, (5826) (May 11): 836-7.
25. Laurie, G. 2008. The european association of health law: Addressing unmet needs in policy, practice and research. European Journal of Health Law 15, (3) (Sep): 251-9.
26. - . 2008. Evidence of support for biobanking practices. BMJ (Clinical Research Ed.) 337, (Jul 10): a337.
27. Liberty. 2002. Inside information. balancing interests in the use of personal genetic data, liberty, response to human genetics commission's "Whose hands on your genes?". Liberty, .
28. Lowrance, W. W., and F. S. Collins. 2007. Ethics. identifiability in genomic research. Science (New York, N.Y.) 317, (5838) (Aug 3): 600-2.
29. Lunshof, J. E., R. Chadwick, D. B. Vorhaus, and G. M. Church. 2008. From genetic privacy to open consent. Nature Reviews.Genetics 9, (5) (May): 406-11.
30. M.C.Gibbons S., Kaye J., Smart A., Heeney C.,Parker M. 2007. Governing genetic databases: Challenges facing research regulation and practice. Journal of Law and Society 34, (2): 163-89.
31. Malin, B. 2006. Re-identification of familial database records. AMIA ...Annual Symposium Proceedings / AMIA Symposium.AMIA Symposium: 524-8.
32. Mascalzoni, D., A. Hicks, P. Pramstaller, and M. Wjst. 2008. Informed consent in the genomics era. PLoS Medicine 5, (9) (Sep 16): e192.
33. Maschke, K. J. 2006. Alternative consent approaches for biobank research. The Lancet Oncology 7, (3) (Mar): 193-4.
34. MC Gibbons S., Kaye J. 2007. Governing genetic databases: Collection, storage and use. KLJ 18, : 201-8.
35. Milanovich F. , Pontille D.,Cambon-Thomsen A. 2007. Biobanking and data sharing: A plurality of exchange regimes. Genomics, Society and Policy 3, (1): 17-30.
36. Nils Homer et al. PLoS genetics: Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. [cited 11/17/2008 2008]. Available from http://www.plosgenetics. org/article/info:doi/10.1371/journal.pgen.1000167 (accessed 11/17/2008).
37. Peltonen L, Palotie A,Lange K, and . 2000. Use of population isolates for mapping complex traits. .Nat. Rev. Genet: 1: 182-90.
38. Petersen, A. 2007. Biobanks "engagements": Engendering trust or engineering consent? Genomics, Society and Policy 3, (1): 31-43.
39. Prainsack, B., J. Reardon, R. Hindmarsh, H. Gottweis, U. Naue, and J. E. Lunshof. 2008. Personal genomes: Misdirected precaution. Nature 456, (7218) (Nov 6): 34-5.
40. Rose, H. 2003. An ethical dilemma. Nature 425, (6954) (Sep 11): 123-4.
41. - . 2000. The commodification of bioinformation: The icelandic health sector database. London: Wellcome Trust.
42. S. Funtowicz, J. Ravetz. 1993. Science for the post-normal age. Futures 25, : 735-55.
43. Santosuosso. 2000. "Il diritto alla disobbedienza genetica: Il caso dell'Islanda" in C. M. mazzoni , etica della ricerca biologica. Firenze,: Olschki.
44. Shifman, S., and A. Darvasi. 2001. The value of isolated populations. Nature Genetics 28, (4) (Aug): 309-10.
45. Taylor, P. 2008. Personal genomes: When consent gets in the way. Nature 456, (7218) (Nov 6): 32-3.
46. UNESCO. 2003. International declaration on human genetic data. UNESCO, .
47. Upshur, R. E., J. V. Lavery, and P. O. Tindana. 2007. Taking tissue seriously means taking communities seriously. BMC Medical Ethics 8, (Oct 26): 11.
48. Weill, C. 2003. Can consultation of both, experts and the public help developing public policy? Science and Public Policy 30, (3): 199-203.
49. Wellcome, Trust. 2004, April. Briefing note. Wellcome Trust, Medical Research Council, .
50. Wendler, D. 2006. One-time general consent for research on biological samples: Is it compatible with the health insurance portability and accountability act? Archives of Internal Medicine 166, (14) (Jul 24): 1449-52.
51. Winickoff, D. 2000. The icelandic healthcare database. N Engl J Med 343, (23) (Dec 7): 1734; author reply 1735.
52. Winickoff, D. E. 2001. Biosamples, genomics, and human rights: Context and content of iceland's biobanks act. J Biolaw Bus 4, (2): 11-7.
53. Winickoff, D. E., and R. N. Winickoff. 2003. The charitable trust as a model for genomic biobanks. N Engl J Med 349, (12) (Sep 18): 1180-4.