메뉴 건너뛰기




Volumn , Issue , 2009, Pages 85-102

Risk-Based Regulation of Direct-to-Consumer Nutrigenetic Tests

Author keywords

[No Author keywords available]

Indexed keywords


EID: 78649983824     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-374125-7.00005-9     Document Type: Chapter
Times cited : (1)

References (35)
  • 1
    • 0842327454 scopus 로고    scopus 로고
    • American College of Medical Genetics, ACMG Statement on Direct-to-Consumer Genetic Testing.Genet Med 6:60.
    • American College of Medical Genetics (2004). ACMG Statement on Direct-to-Consumer Genetic Testing. Genet Med 6:60.
    • (2004)
  • 2
    • 84882490036 scopus 로고    scopus 로고
    • American College of Medical Genetics, ACMG Statement on Direct-to-Consumer Genetic Testing. Online:
    • American College of Medical Genetics (2008). ACMG Statement on Direct-to-Consumer Genetic Testing. Online: . http://www.acmg.net/.
    • (2008)
  • 3
    • 84882508097 scopus 로고    scopus 로고
    • American Medical Association, News Release: AMA adopts new policies at Annual Meeting. Online:(New policies adopted include recommendations on DTC advertising and provision of genetic testing.)
    • American Medical Association (2008). News Release: AMA adopts new policies at Annual Meeting. Online: . (New policies adopted include recommendations on DTC advertising and provision of genetic testing.) . http://www.ama-assn.org/ama/pub/category/18690.html.
    • (2008)
  • 4
    • 35348957507 scopus 로고    scopus 로고
    • American Society of Human Genetics, Statement on Direct-to-Consumer Genetic Testing in the United States.
    • American Society of Human Genetics (2007). Statement on Direct-to-Consumer Genetic Testing in the United States. Am J Hum Genet 81:635.
    • (2007) Am J Hum Genet , vol.81 , pp. 635
  • 5
    • 84882549918 scopus 로고    scopus 로고
    • Presentation to July 8, 2008 meeting of the Secretary's Advisory Committee on Genetics, Health and Society. Online:
    • Avey, L. (2008). Presentation to July 8, 2008 meeting of the Secretary's Advisory Committee on Genetics, Health and Society. Online: . http://www4.od.nih.gov/oba/SACGHS/meetings/2008Jul/Avey.pdf.
    • (2008)
    • Avey, L.1
  • 6
    • 0034770853 scopus 로고    scopus 로고
    • Categorizing genetic tests to identify their ethical, legal and social implications
    • Burke W., Pinsky L.E., Press N.A. Categorizing genetic tests to identify their ethical, legal and social implications. Am J Med Genet (Semin Med Genet) 2001, 106:233-240.
    • (2001) Am J Med Genet (Semin Med Genet) , vol.106 , pp. 233-240
    • Burke, W.1    Pinsky, L.E.2    Press, N.A.3
  • 7
    • 84882489346 scopus 로고    scopus 로고
    • Council of Europe, Additional protocol to the convention on human rights and biomedicine, concerning genetic testing for health purposes. Online:
    • Council of Europe (2008). Additional protocol to the convention on human rights and biomedicine, concerning genetic testing for health purposes. Online: . http://conventions.coe.int/Treaty/EN/Treaties/Html/TestGen.htm.
    • (2008)
  • 8
    • 36549024431 scopus 로고    scopus 로고
    • Editorial, Risky business.
    • Editorial (2007). Risky business. Nature Genetics 39: 1415.
    • (2007) Nature Genetics , vol.39 , pp. 1415
  • 9
    • 0017022073 scopus 로고
    • Do-it-yourself pregnancy tests: The tip of the iceberg?
    • Entwistle P.A. Do-it-yourself pregnancy tests: The tip of the iceberg?. Am J Publ Hlth 1976, 66:1108-1109.
    • (1976) Am J Publ Hlth , vol.66 , pp. 1108-1109
    • Entwistle, P.A.1
  • 10
    • 0029439809 scopus 로고
    • Home HIV testing and conflicts with state HIV testing regulations
    • Fabbri W.O. Home HIV testing and conflicts with state HIV testing regulations. Am J Law Med 1995, 21:419-444.
    • (1995) Am J Law Med , vol.21 , pp. 419-444
    • Fabbri, W.O.1
  • 11
    • 84882492348 scopus 로고    scopus 로고
    • Federal Trade Commission, At-home genetic tests: a healthy dose of skepticism may be the best prescription. Online:
    • Federal Trade Commission (2006). At-home genetic tests: a healthy dose of skepticism may be the best prescription. Online: . http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.shtm.
    • (2006)
  • 12
    • 84882559996 scopus 로고    scopus 로고
    • Federal Trade Commission, Press release: 'Operation Cure.all' targets Internet health fraud (24 June 1999). Online:
    • Federal Trade Commission (1999). Press release: 'Operation Cure.all' targets Internet health fraud (24 June 1999). Online: . http://www.ftc.gov/opa/1999/06/opcureall.shtm.
    • (1999)
  • 13
    • 84882491579 scopus 로고    scopus 로고
    • Food and Drug Administration, Donor screening assays for infectious agents and HIV diagnostic assays. Website updated March 18, 2008. Online:
    • Food and Drug Administration (2008). Donor screening assays for infectious agents and HIV diagnostic assays. Website updated March 18, 2008. Online: . http://www.fda.gov/Cber/products/testkits.htm.
    • (2008)
  • 14
    • 41149180025 scopus 로고    scopus 로고
    • The evaluation of diagnostic laboratory tests and complex biomarkers
    • summary of a diagnostic summit. Joint report of the Public Health Genomics Foundation and the Royal College of Pathologists. Online:
    • Furness, P., Zimmern, R., Wright, C. and Adams, M. (2008). The evaluation of diagnostic laboratory tests and complex biomarkers: summary of a diagnostic summit. Joint report of the Public Health Genomics Foundation and the Royal College of Pathologists. Online: . http://www.phgfoundation.org/file/3998/.
    • (2008)
    • Furness, P.1    Zimmern, R.2    Wright, C.3    Adams, M.4
  • 15
    • 84882553273 scopus 로고    scopus 로고
    • Genetics and Public Policy Center, News release: comparison of state laws for direct-to-consumer testing (6 July 2007), available online: Genetics and Public Policy Center, See also Genetics and Public Policy Center (2007). Survey of direct-to-consumer testing statutes and regulations. Washington, D.C. Online:
    • Genetics and Public Policy Center (2007). News release: comparison of state laws for direct-to-consumer testing (6 July 2007), available online: Genetics and Public Policy Center . See also Genetics and Public Policy Center (2007). Survey of direct-to-consumer testing statutes and regulations. Washington, D.C. Online: . http://www.dnapolicy.org/resources/DTCStateLawChart.pdf.
    • (2007)
  • 16
    • 41449113701 scopus 로고    scopus 로고
    • Evaluating online direct-to-consumer marketing of genetic tests: Informed choices or buyers beware?
    • Geransar R., Einsiedel E. Evaluating online direct-to-consumer marketing of genetic tests: Informed choices or buyers beware?. Genet Test 2008, 12(1):13-23.
    • (2008) Genet Test , vol.12 , Issue.1 , pp. 13-23
    • Geransar, R.1    Einsiedel, E.2
  • 17
    • 34548015480 scopus 로고    scopus 로고
    • Awareness and use of direct-to-consumer nutrigenomic tests, United States, 2006
    • Goddard K.A.B., et al. Awareness and use of direct-to-consumer nutrigenomic tests, United States, 2006. Genet Med 2007, 9:510-517.
    • (2007) Genet Med , vol.9 , pp. 510-517
    • Goddard, K.A.B.1
  • 18
    • 84882469458 scopus 로고    scopus 로고
    • Government Accountability Office, Nutrigenetic testing: tests purchased from four web sites mislead consumers. Online:
    • Government Accountability Office (2006). Nutrigenetic testing: tests purchased from four web sites mislead consumers. Online: . http://www.gao.gov/new.items/d06977t.pdf.
    • (2006)
  • 19
    • 38149036642 scopus 로고    scopus 로고
    • A systematic review of perceived risks, psychological and behavioral impacts of genetic testing
    • Heshka J.T., et al. A systematic review of perceived risks, psychological and behavioral impacts of genetic testing. Genet Med 2008, 10:19-32.
    • (2008) Genet Med , vol.10 , pp. 19-32
    • Heshka, J.T.1
  • 20
    • 84882550216 scopus 로고    scopus 로고
    • The regulation of commercial genetic testing services in the UK: a briefing for the Human Genetics Commission. Online:
    • Hogarth, S., Melzer, D. and Zimmern, R. (2005). The regulation of commercial genetic testing services in the UK: a briefing for the Human Genetics Commission. Online: . http://www.phpc.cam.ac.uk/epg/dtc.pdf.
    • (2005)
    • Hogarth, S.1    Melzer, D.2    Zimmern, R.3
  • 21
    • 84882476650 scopus 로고    scopus 로고
    • Human Genetics Commission, Genes direct: ensuring the effective oversight of genetic tests supplied directly to the public. Online:
    • Human Genetics Commission (2003). Genes direct: ensuring the effective oversight of genetic tests supplied directly to the public. Online: . http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicati onsPolicyAndGuidance/DH_4084423.
    • (2003)
  • 22
    • 84882476293 scopus 로고    scopus 로고
    • Human Genetics Commission, More genes direct: a report on new developments in the availability, marketing and regulation of genetic tests supplied directly to the public. Online:
    • Human Genetics Commission (2007). More genes direct: a report on new developments in the availability, marketing and regulation of genetic tests supplied directly to the public. Online: . http://www.hgc.gov.uk/UploadDocs/DocPub/Document/More%2520Genes%2520Dire ct.pdf.
    • (2007)
  • 23
    • 41149120561 scopus 로고    scopus 로고
    • A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions
    • Janssens A.C.J.W., et al. A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions. Am J Hum Genet 2008, 82:593-599.
    • (2008) Am J Hum Genet , vol.82 , pp. 593-599
    • Janssens, A.C.J.W.1
  • 24
    • 63449087310 scopus 로고    scopus 로고
    • Evidence and evaluation: building public trust in genetic tests for common diseases
    • Research report of the Public Health Genomics Foundation and the Peninsula Medical School. Available online:
    • Melzer, D., Hogarth, S., Liddell, K., Ling, T., Sanderson, S. and Zimmern, R. (2008). Evidence and evaluation: building public trust in genetic tests for common diseases. Research report of the Public Health Genomics Foundation and the Peninsula Medical School. Available online: . http://www.phgfoundation.org/file/4003/.
    • (2008)
    • Melzer, D.1    Hogarth, S.2    Liddell, K.3    Ling, T.4    Sanderson, S.5    Zimmern, R.6
  • 25
    • 44449167597 scopus 로고    scopus 로고
    • 'Breaking the news' in Genetic Testing for Everyone
    • Pearson H. 'Breaking the news' in Genetic Testing for Everyone. Nature 2008, 453:570.
    • (2008) Nature , vol.453 , pp. 570
    • Pearson, H.1
  • 26
    • 84882460553 scopus 로고    scopus 로고
    • Scientists urge more regulation of DIY kits for health checks. The Guardian 11 March 2008. Online:
    • Randerson, J. (2008). Scientists urge more regulation of DIY kits for health checks. The Guardian 11 March 2008. Online: . http://www.guardian.co.uk/society/2008/mar/11/health.medicalresearch.
    • (2008)
    • Randerson, J.1
  • 27
    • 57149092088 scopus 로고    scopus 로고
    • Regulating nutrigenetic tests: an international comparative analysis
    • Ries N.M. Regulating nutrigenetic tests: an international comparative analysis. Hlth Law Rev 2008, 16:9-20.
    • (2008) Hlth Law Rev , vol.16 , pp. 9-20
    • Ries, N.M.1
  • 28
    • 0029171403 scopus 로고
    • HIV home testing and the FDA: the case for regulatory restraint, Hastings L.J
    • Salbu, S.R. (1994). HIV home testing and the FDA: the case for regulatory restraint. 46 Hastings L.J. 403-457.
    • (1994) , vol.46 , pp. 403-457
    • Salbu, S.R.1
  • 29
    • 38949166076 scopus 로고    scopus 로고
    • Regulators weigh risks of consumer genetic tests
    • Schmidt C. Regulators weigh risks of consumer genetic tests. Nat Biotechnol 2008, 26:145.
    • (2008) Nat Biotechnol , vol.26 , pp. 145
    • Schmidt, C.1
  • 30
    • 77955630483 scopus 로고    scopus 로고
    • Secretary's Advisory Committee on Genetics, Health and Society
    • US system of oversight of genetic testing: a response to the charge of the Secretary of Health and Human Services. Online:
    • Secretary's Advisory Committee on Genetics, Health and Society (2008). US system of oversight of genetic testing: a response to the charge of the Secretary of Health and Human Services. Online: . http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf.
    • (2008)
  • 31
    • 77955630483 scopus 로고    scopus 로고
    • Secretary's Advisory Committee on Genetics, Health and Society
    • US system of oversight of genetic testing: a response to the charge of the secretary of HHS draft report of the Secretary's Advisory Committee on Genetics, Health, and Society. Department of Health and Human Services. Draft report made available for public comment between November 5 and December 21, 2007.
    • Secretary's Advisory Committee on Genetics, Health and Society (2007). US system of oversight of genetic testing: a response to the charge of the secretary of HHS draft report of the Secretary's Advisory Committee on Genetics, Health, and Society. Department of Health and Human Services. Draft report made available for public comment between November 5 and December 21, 2007.
    • (2007)
  • 32
    • 84882555430 scopus 로고    scopus 로고
    • Secretary's Advisory Committee on Genetic Testing
    • Enhancing the oversight of genetic testing: recommendations of the SACGT. Online:
    • Secretary's Advisory Committee on Genetic Testing (2000). Enhancing the oversight of genetic testing: recommendations of the SACGT. Online: . http://www4.od.nih.gov/oba/sacgt/reports/oversight_report.pdf.
    • (2000)
  • 33
    • 84882561022 scopus 로고    scopus 로고
    • Secretary's Advisory Committee on Genetic Testing
    • Development of a classification methodology for genetic tests: conclusions and recommendations of the secretary's advisory committee on genetic testing. Online:
    • Secretary's Advisory Committee on Genetic Testing (2001). Development of a classification methodology for genetic tests: conclusions and recommendations of the secretary's advisory committee on genetic testing. Online: . http://www4.od.nih.gov/oba/sacgt/reports/Addendum_final.pdf.
    • (2001)
  • 34
    • 46249129322 scopus 로고    scopus 로고
    • Gene-testing firms face legal battle
    • Wadman M. Gene-testing firms face legal battle. Nature 2008, 453:1148-1149.
    • (2008) Nature , vol.453 , pp. 1148-1149
    • Wadman, M.1
  • 35
    • 33749173434 scopus 로고    scopus 로고
    • Rapid HIV testing at home: does it solve a problem or create one?
    • Walensky R.P., Paltiel A.D. Rapid HIV testing at home: does it solve a problem or create one?. Ann Intern Med 2006, 145:459-462.
    • (2006) Ann Intern Med , vol.145 , pp. 459-462
    • Walensky, R.P.1    Paltiel, A.D.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.