The ethical and legal problems connected with the activity of biobanks

Jakub Pawlikowski, Jarosław Sak, Krzysztof Marczewski

Abstract


The paper presents the most significant ethical and legal problems connected with biobanks in the world. The issues brought up most frequently in this context are informed consent, commercialization, property rights and granting gene patents, the risk of discrimination, and a patient’s right to known and not to know. At the end the situation of Polish biobanks is analyzed with reference to European standards.

Full Text:

PDF (In Polish)


References


  1. M. Almeida, Spanish DNA Bank, „Translational medicine and public health policy: lessons from biobanks, Ethical, Legal, Social Issues (ELSI)” – Brocher Foundation Workshop, Geneva, 5-7 December 2007.
  2. B.A. Armson, Umbilical cord blood banking: implications for perinatal care providers, „Journal of Obstetrics and Gynaecology Canada” 27(3) 2005, s. 263-90.
  3. S. Bogdanovic, B. Langlands, Pharmacogenomics players, BioFrontiers Management Report, Financial Times, London 1999.
  4. T. Brzeziński, Etyka lekarska, PZWL, Warszawa 2002.
  5. Data storage and DNA banking for biomedical research: technical, social and ethical issues. Recommendations of the European Society of Human Genetics, „European Journal of Human Genetics”, 11 (2003), Suppl. 2, s. S8-S10.
  6. T. Caulfield, R.E.G. Upshur, A. Daar, DNA databanks and consent: A suggested policy option involving an authorization model, „BMC Medical Ethics” (4:1) 2003.
  7. O.P. Corrigan, B. Williams-Jones, Pharmacogenetics: the bioethical problem of DNA investment banking, „Studies in History and Philosophy of Biological and Biomedical Sciences” 37 (2006), s. 550-565.
  8. Council for International Organizations of Medical Sciences, International ethical guidelines for biomedical research involving human subjects, CIOMS, Geneva 2002.
  9. C. Dawson, Public Perceptions of the Collection of Human Biological Samples, The Wellcome Trust 2000.
  10. C. Deschênes, G. Cardinal, B.M. Knoppers, K. Glass, Human genetic research, DNA banking and consent: A question of „form”?, „Clinical Genetics” 59 (2001), s. 221-239.
  11. http://www.firstgenetic.com/products_icf.html Grzymkowska [2006] – M. Grzymkowska, Europejski system ochrony prawa człowieka wobec rozwoju biomedycyny [rozprawa doktorska], Uniwersytet Jagielloński, Kraków 2006.
  12. D.C. Hertz, J.H. Fanos, P.R. Reill, Genetic testing for children and adolescents: who decides?, „JAMA” (272) 1994, s. 875-881.
  13. D.F. Horrobin, Innovation in the pharmaceutical industry, „Journal of the Royal Society of Medicine” 93(7) 2000, s. 341-345.
  14. International Bioethics Committee of UNESCO, Draft Report on Collection, Treatment, Storage and Use of Genetic Data, 2001.
  15. International Bioethics Committee of UNESCO, Human genetic data: Preliminary study by the IBC on its collection, processing, storage and use. Paris: UNESCO. http://portal.unesco.org/shs/en/file_download.php/82e7c58d69d425a6fd9f1001 71e3c072Rapfinal_gendata_en.pdf
  16. F. Kauffman, A. Cambon-Thomsen, Tracing biological collections: Between books and clinical trials, „JAMA” (299) 2008, s. 2316-2318.
  17. H.T. Lynch, O. Watson, S. Tinley, Y. Kirnarsky i in., An update on DNA-Based BRCA1/BRCA2 genetic Counseling in Hereditary breast cancer, „Cancer Genetics and Cytogenetics” (109) 1999, s. 91-98.
  18. M.G. Hansson, Combining efficiency and concerns about integrity when using human biobanks, „Studies in History and Philosophy of Biological and Biomedi- cal Sciences” (37) 2006, s. 520-532.
  19. E. McNally, A. Combon-Thomsen, 25 rekomendacji dotyczących etycznych, prawnych i społecznych implikacji badań genetycznych, Bruksela 2004.
  20. J.F. Merz, Psychosocial risks of storing and using human tissue in research, „Risk: Health, Safety & Environment” (8) 1997, s. 235-248.
  21. K.J. Moise, Co powiedzieć pacjentom o przechowywaniu komórek macierzystych z krwi pępowinowej, „Ginekologia po dyplomie” 2007 tom 9 , nr 1(47), s. 70-76.
  22. M.J. Molnar, P. Bencsik, Establishing a Neurological-Psychiatric Biobank: Banking, informatics, ethics, „Cellular Immunology”( 244:2) 2006, s. 101-104.
  23. M.R. Mueller, Science versus care: Physicians, nurses and the dilemma of clinical research, w: M.A. Elston (red.), The sociology of medical science and technology, Blackwell, Oxford 1997, s. 57-78.
  24. D. Shicle, The consent problem within DNA biobanks, „Studies in History and Philosophy of Biological and Biomedical Sciences” (37) 2006, s. 503-519.
  25. M.J. Siemińska, Społeczne wymiary dyskursu nad badaniami genetycznymi w medycynie, w: W. Piątkowski, B. Płonka-Syroka (red.), Socjologia i antropologia medycyny w działaniu, Arboretum, Wrocław 2008, s. 41-53.
  26. S. Sobel, D.B. Cowan, Impact of genetic testing for Huntington disease on the family as a system, „American Journal of Medical Genetics”, (62) 2000, s. 121-127.
  27. B. Stagmary, K. Asplund, Informed consent for genetic research on blood stored for more than a decade: A population based study, „BMJ” (325) 2002, s. 634-635.
  28. A. Surbone, Ethical implications of genetic testing for breast cancer susceptibility, „Critical Reviews in Oncology/Hematology” (40) 2001, s. 149-157.
  29. UK Human Genetics Commission, Public atti- tudes to human genetic information: People’s Panel Quantitative Study conducted for the Human Genetics Commission, Human Genetics Commission, London 2001. http://www.hgc.gov.uk/UploadDocs/DocPub/Document/morigeneticattitudes.pdf
  30. M. Watson, V. Duvivier, M. Wade Walsh, S. Ashley i in., Family history of breast cancer: what do woman understand and recall about their genetic risk? „Journal of Medical Genetics” (35) 1998, s. 731-738.
  31. D. Wendler, E. Emanuel, The debate over research on stored biological samples: what do sources think? „Archives of Internal Medicine” (162) 2002, s. 1457-1462.
  32. Proposed international guidelines on ethical issues in med- ical genetics and genetic services. Report of a WHO Meeting on Ethical Issues in Medical Genetics, Geneva 15-16 December 1997, WHO, Geneva 1998. http://www.who.int/genomics/publications/en/ethicalguidelines1998.pdf

DOI:

http://dx.doi.org/10.13153/diam.19.2009.335

Article links:

Default URL: http://www.diametros.iphils.uj.edu.pl/index.php/diametros/article/view/335
Polish abstract URL: http://www.diametros.iphils.uj.edu.pl/index.php/diametros/article/view/335/pl
English abstract URL: http://www.diametros.iphils.uj.edu.pl/index.php/diametros/article/view/335/en

Share:






All works are licensed under a Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) License.