Ethical and juridical issues of genetic testing: A review of the international regulation

Critical Reviews in Oncology/Hematology

Volumn 69, Issue 2, 2009, Pages 98-107

  Nicolás, Pilar ^a,b  

^a UNIVERSITY OF DEUSTO   (Spain)

^b UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

Author keywords

Biological samples; Confidentiality; Consent; Genetic data; Patient's rights; Right not to know

Indexed keywords

BIOMEDICINE; CONFIDENTIALITY; GENETIC ANALYSIS; GENETIC PROCEDURES; GENETIC SCREENING; GOVERNMENT REGULATION; INFORMED CONSENT; INTERNATIONAL COOPERATION; LEGAL LIABILITY; MEDICAL ETHICS; MEDICOLEGAL ASPECT; PATIENT DECISION MAKING; PATIENT INFORMATION; PATIENT RIGHT; RESEARCH SUBJECT; REVIEW;

CONFIDENTIALITY; GENETIC PRIVACY; GENETIC SCREENING; HUMAN RIGHTS; HUMANS; INSURANCE COVERAGE; INTERNATIONALITY; PREJUDICE;

EID: 58149215909     PISSN: 10408428     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.critrevonc.2008.10.003     Document Type: Review

References (62)

1. See European Commission, Directorate General: Research. Survey on national legislation and activities in the field of genetic testing in EU Member States; 2005.
2. For example and specifically in the area of cancer diagnosis, the National Health and Medical Research Council of Australia has elaborated the document: Familial aspects of cancer: a guide to Clinical Practice, which can be consulted in http://www.accv.org.au. Other interesting reports are:
3. Nuffield Council on Bioethics. Genetic screening: a supplement to the 1993 report (2006), Nuffield Council on Bioethics, London
4. Australia Law Reform Commission. Essentially yours: the protection of human genetic information in Australia (2003), Australia Law Reform Commission, Australia
5. The British society for Human Genetics. Consent and confidentiality in genetic practice. Guidance on genetic testing and sharing genetic information. A report of the Joint Committee on Medical Genetics (2006), The British society for Human Genetics, London
6. o 76, A propos de l'obligation d'information génétique familial en cas de nécessité médical, 2003.
7. Some examples are the following:
8. Recommendation R (92) 3 on genetic testing and screening for health care purposes
9. Recommendation R (94) 11 on screening as a tool of preventive medicine
10. Recommendation R (97) 5 on the Protection of Medical Data
11. Recommendation R (2006) 4 on research on biological materials of human origin.
12. 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 Biomedicine, open to the signature in Oviedo, Spain http://conventions.coe.int/treaty/en/treaties/html/164.htm
13. The countries that have signed the Convention, until September of this same year are 33 out of the 45 members of the Council of Europe: Bosnia and Herzegobina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Moldova, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, the former Yugoslav Republic of Macedonia, Turkey and Ukraine and Montenegro (not member of the Council of Europe).
14. These texts can be found in: http://www.unesco.org.
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19. http://europa.eu.int/comm/research/conferences/2004/genetic/pdf/recommen dations_en.pdf
20. See also. Di Pietro M.L., Giuli A., and Spagnolo A.G. Ethical implications of predictive DNA testing for hereditary breast cancer. European Society for Medical Oncology 15 Suppl. (2004) i65-i70
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27. Harris M., Winship I., and Spriggs M. Controversies and ethical issues in cancer-genetics clinics. The Lancet 6 (2005) 302
28. See American Society of Clinical Oncology Policy statement update: genetic testing for cancer susceptibility, adopted on March 1, 2003, by the American Society of Clinical Oncology. Journal of Clinical Oncology 2003;21(12):2403
29. McAbee G.N., Sherman J., and Davidoff-Feldman B. Physician's duty to warn third parties about the risk of genetic diseases. Official Journal of the American Academy of Pediatrics 102 1 (1998) 140-142
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31. The frequency of non-disclosure is uncertain. In a survey of 800 geneticist, 60% of the 206 respondents had experience of a relative refusing to notify another at risk relative.
32. See. Harris M., Winship I., and Spriggs M. Controversies and ethical issues in cancer-genetics clinics. The Lancet 6 (2005) 303
33. Hansson M. Ethical Management of Hereditary cancer information. vol. 38 (1999), Scandinavian University Press 306-307
34. See. Royal College of Physicians. The British Society for Human Genetics. Consent and Confidentiality in genetic practice. A report of the Join Committee on Medical Genetics (2006), Royal College of Physicians, London p. 12-13
35. Hansson M. Ethical Management of Hereditary cancer information 38 (1999), Scandinavian University Press 306-307
36. National Health and Medical Research Council of Australia has elaborated the document. Familial aspects of cancer: a guide to Clinical Practice, http://www.accv.org.au.
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39. http://www.bioethics.nih.gov/international/declarat/convexpl.htm
40. See. Nys H., et al. Patients' rights, insurance and employment. A survey of regulations in the European Union (2002), European Commission, Brussels
41. http://ec.europa.eu/research/biosociety/pdf/genetic_testing_eur20446.pdf #search=%22herman%20nys%20genetic%20tests%20discrimination%22
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43. Furness P. Consent to using human tissue. British Medical Journal 327 (2003) 759
44. For example:
45. Iceland. Act on Biobanks (2000)
46. Estonia. Human Genes Research Act (2000)
47. Sweden. Biobanks in Medical Care Act (2002)
48. Norway. Act relating to biobanks (2003)
49. United Kingdom. Human Tissue Act (2004)
50. Spain. Law in biomedicine research (2007).
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53. Council of Europe. Steering Committee on Bioethics (CDBI). Proposal for an instrument on the use of archived human biological materials in biomedical research (2002), Council of Europe. Steering Committee on Bioethics (CDBI), Strasbourg
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55. European Society of Human Genetics. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective (2000)
56. European Society of Human Genetics. Data storage and DNA banking for biomedical research: technical, social and ethical issues. Recommendations of the European Society of Human Genetics (2001)
57. National Bioethics Advisory Commission. Research involving human biological materials: ethical issues and policy guidance, vol. I and vol. II (2000), National Bioethics Advisory Commission, Maryland
58. Nationaler Ethikrat (Germany). Opinion: Biobanks for Research (2004)
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62. Organisation for Economic Co-operation Development. Biological resource centres (2001)