메뉴 건너뛰기




Volumn 19, Issue 4, 2011, Pages 382-388

Personal genetics: Regulatory framework in Europe from a service provider's perspective

Author keywords

direct to consumer; genetic testing; genotyping; human genetics commission; personal genetics; regulations

Indexed keywords

ARTICLE; BIOMEDICINE; CONSUMER; COST; EUROPE; EUROPEAN UNION; GENETIC SCREENING; GENETIC SERVICE; GENETICS; GENOTYPE; GOVERNMENT REGULATION; HEALTH CARE PERSONNEL; HEALTH CARE PRACTICE; HEALTH SERVICE; HUMAN; HUMAN GENETICS; HUMAN RIGHTS; LABORATORY TEST; LIFESTYLE; MEDICAL SERVICE; NUTRITION; PERSONAL GENETICS; PRIORITY JOURNAL;

EID: 79952766383     PISSN: 10184813     EISSN: 14765438     Source Type: Journal    
DOI: 10.1038/ejhg.2010.189     Document Type: Article
Times cited : (21)

References (38)
  • 1
    • 84858613809 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • HGC: More Genes Direct http://www.hgc.gov.uk/Client/document.asp?DocId 139&CAtegoryId10, 2007. (accessed 4 September 2010)
    • (2007) HGC: More Genes Direct
  • 2
    • 84858617001 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.phgfoundation.org/news/4562/, (accessed 4 September 2010)
  • 3
    • 84858616997 scopus 로고    scopus 로고
    • accessed 4 September, 2010
    • http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ InVitroDiagnostics/ ucm219582.htm, (accessed 4 September, 2010)
  • 4
    • 84858615160 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.eurogentest.org/cocoon/egtorg/web/index.xhtml, (accessed 4 September 2010)
  • 5
    • 74049131900 scopus 로고    scopus 로고
    • DEBATE genetic risk information for common diseases may indeed be already useful for prevention and early detection
    • Gulcher J, Stefansson K: DEBATE genetic risk information for common diseases may indeed be already useful for prevention and early detection. Eur J Clin Invest 2010; 40: 56-63
    • (2010) Eur J Clin Invest , vol.40 , pp. 56-63
    • Gulcher, J.1    Stefansson, K.2
  • 6
    • 74049101159 scopus 로고    scopus 로고
    • DEBATE personal genomics: Information can be harmful
    • Ransohoff DF, Khoury MJ: DEBATE personal genomics: information can be harmful. Eur J Clin Invest 2010; 40: 64-68
    • (2010) Eur J Clin Invest , vol.40 , pp. 64-68
    • Ransohoff, D.F.1    Khoury, M.J.2
  • 7
    • 69549083158 scopus 로고    scopus 로고
    • Evaluating the utility of personal genomic information
    • Foster MW, Mulvihill JJ, Sharp RR: Evaluating the utility of personal genomic information. Genet Med 2009; 11: 570-574
    • (2009) Genet Med , vol.11 , pp. 570-574
    • Foster, M.W.1    Mulvihill, J.J.2    Sharp, R.R.3
  • 8
    • 84858619743 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.eurogentest.org/news/info/public/unit3/geneCards.xhtml, (accessed 4 September 2010)
  • 9
    • 84858619745 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.ukgtn.nhs.uk/gtn/Information/Services/Gene+Dossiers, (accessed 4 September 2010)
  • 10
    • 84858619744 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.egappreviews.org/about.htm, (accessed 4 September 2010)
  • 11
    • 84858615166 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.ncbi.nlm.nih.gov/gtr/, (accessed 4 September 2010)
  • 12
    • 79952774842 scopus 로고    scopus 로고
    • Direct to consumer genetic testing: Overview of applicable norms and policies
    • Sénécal K, Borry P, Howard HC, Avard D: Direct to consumer genetic testing: overview of applicable norms and policies. GenEdit 2009; 7: 1-14
    • (2009) GenEdit , vol.7 , pp. 1-14
    • Sénécal, K.1    Borry, P.2    Howard, H.C.3    Avard, D.4
  • 13
    • 52949089274 scopus 로고    scopus 로고
    • The current landscape for direct-to-consumer genetic testing: Legal, ethical, and policy issues
    • Hogarth S, Javitt G, Melzer D: The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues. Annu Rev Genomics Hum Genet 2008; 9: 161-182
    • (2008) Annu Rev Genomics Hum Genet , vol.9 , pp. 161-182
    • Hogarth, S.1    Javitt, G.2    Melzer, D.3
  • 14
    • 72449140061 scopus 로고    scopus 로고
    • Legal and ethical concerns in personalized medicine: A European perspective
    • Regniault A, Kupecz A, Gavey M et al: Legal and ethical concerns in personalized medicine: a European perspective. Personalized Medicine 2009; 6: 517-528
    • (2009) Personalized Medicine , vol.6 , pp. 517-528
    • Regniault, A.1    Kupecz, A.2    Gavey, M.3
  • 15
    • 84858623392 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://conventions.coe.int/Treaty/en/Treaties/Html/203.htm, (accessed 4 September 2010)
  • 16
    • 67649217506 scopus 로고    scopus 로고
    • Genetic horoscopes: Is it all in the genes? Points for regulatory control of direct-to-consumer genetic testing
    • Patch C, Sequeiros J, Cornel MC: Genetic horoscopes: is it all in the genes? Points for regulatory control of direct-to-consumer genetic testing. Eur J Hum Genet 2009; 17: 857-859
    • (2009) Eur J Hum Genet , vol.17 , pp. 857-859
    • Patch, C.1    Sequeiros, J.2    Cornel, M.C.3
  • 17
    • 76249096292 scopus 로고    scopus 로고
    • Evaluation of genetic tests for susceptibility to common complex diseases: Why when and how?
    • Wright CF, Kroese M: Evaluation of genetic tests for susceptibility to common complex diseases: why, when and how? Hum Genet 2010; 127: 125-134
    • (2010) Hum Genet , vol.127 , pp. 125-134
    • Wright, C.F.1    Kroese, M.2
  • 18
    • 67649171897 scopus 로고    scopus 로고
    • Personal genomics services whose genomes?
    • Gurwitz D, Bregman-Eschet Y: Personal genomics services: whose genomes? Eur J Hum Genet 2009; 17: 883-889
    • (2009) Eur J Hum Genet , vol.17 , pp. 883-889
    • Gurwitz, D.1    Bregman-Eschet, Y.2
  • 19
    • 84858618817 scopus 로고    scopus 로고
    • accessed 4 September, 2010
    • Direct testing framework - paper HGC08/P16 http://www.hgc.gov.uk/Client/ document.asp?DocId172&CAtegoryId1 ), (accessed 4 September, 2010)
    • Direct Testing Framework - Paper HGC08/P16
  • 20
    • 84858623391 scopus 로고    scopus 로고
    • 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. Oviedo, 4.IV. 1997 accessed 4 September, 2010
    • 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. Oviedo, 4.IV.1997 http://conventions.coe.int/ Treaty/en/Treaties/Html/ 164.htm, (accessed 4 September, 2010)
  • 21
    • 84858623390 scopus 로고    scopus 로고
    • Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Strasbourg, 27.XI. 2008 accessed 4 September, 2010
    • Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Strasbourg, 27.XI.2008 http://conventions. coe.int/Treaty/en/Treaties/Html/203.htm, (accessed 4 September, 2010)
  • 22
    • 84858615163 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • https://www.23andme.com/health/all/, (accessed 4 September 2010)
  • 23
    • 46949101338 scopus 로고    scopus 로고
    • Europe to ban direct-to-consumer genetic tests?
    • DOI 10.1038/nbt0708-736, PII NBT0708736
    • Borry P: Europe to ban direct-to-consumer genetic tests? Nat Biotechnol 2008; 26: 736-737 (Pubitemid 351961437)
    • (2008) Nature Biotechnology , vol.26 , Issue.7 , pp. 736-737
    • Borry, P.1
  • 24
    • 84919955765 scopus 로고    scopus 로고
    • The IVD directive and genetic testing problems and proposals
    • accessed 4 September, 2010
    • Hogarth S, Melzer D: The IVD Directive and Genetic Testing Problems and proposals. A briefing presented to the 20th meeting of Competent Authorities Lisbon, July 2007 http://www.scribd.com/doc/35462727/A-briefing-on-the-IVD- Directiveand- genetic-testing-problems-and-proposals, 2007, (accessed 4 September, 2010)
    • (2007) A Briefing Presented to the 20th Meeting of Competent Authorities Lisbon July 2007
    • Hogarth, S.1    Melzer, D.2
  • 25
    • 84858615164 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://eurlex.europa.eu/LexUriServ/LexUriServ.douriCELEX:31998L0079:EN: HTML, (accessed 4 September 2010)
  • 26
    • 84858623387 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.itas.fzk.de/eng/etag/about-etag.htm, (accessed 4 September 2010)
  • 27
    • 84858615165 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.itas.fzk.de/deu/lit/2008/heua08b.pdf, (accessed 4 September 2010)
  • 28
    • 78549241587 scopus 로고    scopus 로고
    • European Society of Human Genetics: Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes
    • Epub ahead of print 25 August 2010 doi:10.1038/ejhg.2010.129
    • European Society of Human Genetics: Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes. Eur J Hum Genet 2010; Epub ahead of print 25 August 2010 doi:10.1038/ejhg.2010.129
    • (2010) Eur J Hum Genet
  • 29
    • 84858623385 scopus 로고    scopus 로고
    • OECD Guidelines for Quality Assurance in Genetic Testing: Organisation for Economic Co-operation and Development 2007 accessed 4 September, 2010
    • OECD Guidelines for Quality Assurance in Genetic Testing: Organisation for Economic Co-operation and Development, 2007. Available from http://www.oecd.org/dataoecd/ 43/6/38839788.pdf (accessed 4 September, 2010)
  • 30
    • 84858616999 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.hgc.gov.uk/Client/document.aspDocId176&CAtegoryId9, (accessed 4 September 2010)
  • 31
    • 84858615162 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.hgc.gov.uk/Client/Content.asp?ContentId¼816, (accessed 4 September 2010)
  • 33
    • 84858623384 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.eurogentest.org/web/info/public/unit3/regulations.xhtml, (accessed 4 September 2010)
  • 34
    • 84858617002 scopus 로고    scopus 로고
    • accessed 4 September, 2010
    • The full translation can be found at http://www.eurogentest.org/uploads/ 1247230263295/GenDG-German-English.pdf, (accessed 4 September, 2010)
  • 35
    • 84858617003 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.phgfoundation.org/news/4562/, (accessed 4 September 2010)
  • 36
    • 67749092934 scopus 로고    scopus 로고
    • Integrative genomics, personal-genome tests and personalized healthcare: The future is being built today
    • Brand A: Integrative genomics, personal-genome tests and personalized healthcare: the future is being built today. Eur J Hum Genet 2009; 17: 977-978
    • (2009) Eur J Hum Genet , vol.17 , pp. 977-978
    • Brand, A.1
  • 37
    • 84858623386 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • https://www.23andme.com/for/physicians/, (accessed 4 September 2010)
  • 38
    • 84858616998 scopus 로고    scopus 로고
    • accessed 4 September 2010
    • http://www.decodeme.com/service-agreement, (accessed 4 September 2010).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.