Journal of Business Ethics

, Volume 77, Issue 1, pp 17–31 | Cite as

The Ethical Challenges of Direct-to-Consumer Genetic Testing



Genetic testing is currently subject to little oversight, despite the significant ethical issues involved. Repeated recommendations for increased regulation of the genetic testing market have led to little progress in the policy arena. A 2005 Internet search identified 13 websites offering health-related genetic testing for direct purchase by the consumer. Further examination of these sites showed that overall, biotech companies are not providing enough information for consumers to make well-informed decisions; they are not consistently offering genetic counseling services; and some sites even offer tests with little evidence of clinical value. This article aims to raise company and consumer awareness about the ethical concerns surrounding the direct-to-consumer marketing of health-related genetic tests. It also suggests ways that biotech companies can bring their services to the public in an ethically responsible manner, without increased regulatory oversight.


direct-to-consumer marketing direct-to-consumer sales DNA test genetic test Internet marketing ethics 


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  1. American College of Medical Genetics Board of Directors: 2004, ACMG Statement on Direct- to-Consumer Genetic Testing. Genetics in Medicine 6(1):60Google Scholar
  2. Baird P. (2001) Will Genetics be Used Wisely?. ISUMA: Canadian Policy Research Journal 2(1):94–101Google Scholar
  3. Barrett, S. and H. Harriet: 2003, ‘Dubious Genetic Testing’, Available at Accessed August 10, 2005
  4. Becker M. H. (1985) Patient Adherence to Prescribed Therapies. Medical Care 23(5):539–555CrossRefGoogle Scholar
  5. Beckman L. (2004) Are Genetic Self-Tests Dangerous? Assessing the Commercialization of Genetic Testing in Terms of Personal Autonomy. Theoretical Medicine 25:387–398CrossRefGoogle Scholar
  6. Blum K., Sheridan P. J., Wood R. C., Braverman E. R., Chen T. J., Comings D. E. (1995) Dopamine D2 Receptor Gene Variants: Association and Linkage Studies in Impulsive-addictive-compulsive Behaviour. Pharmacogenetics 5:121–141CrossRefGoogle Scholar
  7. Bowen D. J., Battuello K. M., Raats M. (2005) Marketing Genetic Tests: Empowerment or Snake Oil? Health Education and Behavior 32(5):676–685CrossRefGoogle Scholar
  8. Bredart A., Autier P., Riccardo A., Audisio A., Geraghty J. G. (2001) Psychosocial Dimensions of BRCA Testing: An Overshadowed Issue. European Journal of Cancer Care 10(2):96–99CrossRefGoogle Scholar
  9. Burke W., Emery J. (2002). Genetics Education for Primary-care Providers. Nature Review: Genetics 3:561–565CrossRefGoogle Scholar
  10. Chandros S., Prasad K. (2001) Reading Between the Lines: Direct-to-Consumer Advertising of Genetic Testing. Hastings Center Report 31(3):33–35CrossRefGoogle Scholar
  11. Chen W. J., Chen C. H., Huang J., Hsu Y. P., Seow S. V., Chen C.C., Cheng A. T. A. (2001) Genetic Polymorphisms of the Promoter Region of Dopamine D2 Receptor and Dopamine Transporter Genes and Alcoholism Among Four Aboriginal Groups and Han Chinese in Taiwan. Psychiatric Genetics 11:198–195Google Scholar
  12. Collins F. S., McKusick V. (2001) Implications of the Human Genome Project for Medical Science. JAMA 285:540–544CrossRefGoogle Scholar
  13. Crawshaw R., Rogers D.E., Pellegrino E.D., Bulger R.J., Lundberg G.D., Bristow L.R., Cassel C.K., Barondess J.A. (1995) Patient–Physician Covenant. JAMA 273(19):1553CrossRefGoogle Scholar
  14. de Melo-Martin I. (2005) Firing Up the Nature/Nurture Controversy: Bioethics and Genetic Determinism. The Journal of Medical Ethics 31:526–530CrossRefGoogle Scholar
  15. Doc Blum Inc. website: 2005, ‘Imagene: Genetic Testing for the Millennium’, Available at: Accessed: July 16, 2005
  16. Evans J., Skrzynia C., Burke W. (2001) The Complexities of Predictive Genetic Testing. British Medical Journal 322:1052–1056CrossRefGoogle Scholar
  17. GeneTests: 2005, ‘Medical Genetics Information Resource (database online)’, Copyright, University of Washington, Seattle. 1993–2005. Updated weekly. Available at Accessed: August 25, 2005
  18. Genelex website: 2005, ‘Health and DNA’, Copyright, Genelex Corporation, Seattle, Washington. 1995–2001. Available at Accessed July 14, 2005
  19. Goldman D., Urbanek M., Guenther D., Robin R., Long J. C. (1998) A functionally deficient DRD2 variant Is not linked to alcoholism and substance abuse. Alcohol 16:47–52CrossRefGoogle Scholar
  20. Gollust S. E., Hull S. C., Wilfond B. S. (2002) Limitations of Direct-to-Consumer Advertising for Clinical Genetic Testing. JAMA 288(14):1762–1767CrossRefGoogle Scholar
  21. Gollust S. E., Wilfond B. S., Hull S. C. (2003) Direct-to-Consumer Sales of Genetic Services on the Internet. Genetics and Medicine 5(4):332–337CrossRefGoogle Scholar
  22. Hall M. A., Rich S. S. (2000) Laws Restricting Health Insurers’ Use of Genetic Information: Impact on Genetic Discrimination. American Journal of Human Genetics 66:293–307CrossRefGoogle Scholar
  23. Henneman L., Timmermans D. R., van der Wal G. (2004) Public Experiences, Knowledge and Expectations About Medical Genetics and the Use of Genetic Information. Community Genetics 7(1):33–43CrossRefGoogle Scholar
  24. HGC (Human Genetics Commission): 2003, ‘Genes Direct: Ensuring the Effective Oversight of Genetic Tests Supplied Directly to the Public’, (Human Genetics Commission, Department of Health, London). Available at: Accessed: April 14, 2006
  25. Hill E.M., Stoltenberg S.F., Bullard K.H., Li S., Zucker R.A., Burmeister M. (2002) Antisocial Alcoholism and Serotonin-Related Polymorphisms: Association Tests. Psychiatric Genetics 12:143–153CrossRefGoogle Scholar
  26. Hofman K. J., Tambor E. S., Chase G. A., Geller G., Faden R. R., Holtzman N. A. (1993) Physicians’ Knowledge of Genetics and Genetic Tests. Academic Medicine 68:625–632CrossRefGoogle Scholar
  27. Holtzman, N. A. and Watson, M. S. (eds.) 1998, Promoting Safe and Effective Genetic Testing in the United States: Final Report of the Task Force on Genetic Testing (Johns Hopkins University Press, National Institutes of Health, Baltimore MDGoogle Scholar
  28. Holtzman N.A., Marteau T.M. (2000) Will Genetics Revolutionize Medicine? New England Journal of Medicine 343(2):141–144CrossRefGoogle Scholar
  29. Hudson K., Rothenberg K., Andrews L., Kahn M., Collins F. (1995) Genetic Discrimination and Health Insurance: An Urgent Need for Reform. Science 270:391–393CrossRefGoogle Scholar
  30. Hull S. C., Prasad K. (2001) Reading Between the Lines: Direct-to-Consumer Advertising of Genetic Testing in the USA. Reproductive Health Matters 9(18):44–48CrossRefGoogle Scholar
  31. Hunter A., Wright P., Cappelli M., Kasaboski A., Surh L. (1998) Physician Knowledge and Attitudes Towards Molecular Genetic (DNA) Testing of Their Patients. Clinical Genetics 53:447–455CrossRefGoogle Scholar
  32. Javitt G.H., Stanley E., Hudson K. (2004) Direct-to-Consumer Genetic Tests, Government Oversight, and the First Amendment: What the Government Can (and can’t) Do to Protect the Public’s Health. Oklahoma Law Review 57(2):251–302Google Scholar
  33. Jonsen A. R., Durfy S. J., Burke W., Motulsky A. G. (1996) The Advent of the ‘Unpatients’, Nature Medicine 2(6):622–624CrossRefGoogle Scholar
  34. Kolata, G.: 1997, ‘Advent of Testing for Breast Cancer Genes Leads to Fears of Disclosure and Discrimination’, New York Times February 4, C1–C3.Google Scholar
  35. Lloyd F. J., Reyna V. F., Whalen P. (2001) Accuracy and Ambiguity in Counseling Patients About Genetic Risk. Archives of Internal Medicine 161:2411–2413CrossRefGoogle Scholar
  36. Marteau T. M., Lerman C. (2001) Genetic Risk and Behavioural Change. British Medical Journal 322:1056–1059CrossRefGoogle Scholar
  37. McCabe L. L., McCabe E. R. B. (2004) Direct-to-Consumer Genetic Testing: Access and Marketing. Genetics in Medicine 6(1):58–59CrossRefGoogle Scholar
  38. Mesters I., Ausems A., DeVries H. (2005) General Public’s Knowledge, Interest and Information Needs Related to Genetic Cancer: An Exploratory Study. European Journal of Cancer Prevention 14(1):69–75CrossRefGoogle Scholar
  39. NIH SAGCT (Secretary’s Advisory Committee on Genetic Testing) (2000) Enhancing the Oversight of Genetic Tests: Recommendations of the SACGT. NIH, BethesdaGoogle Scholar
  40. Ontario Report to The Provinces and Territories: 2006, ‘Genetics and Gene Patenting: Charting New Territory in Healthcare. January 2002’, Available at: istry_reports/geneticsrep02/report_e.pdf. Accessed: April 14, 2006
  41. Peterson E. A., Milliron K. J., Lewis K. E., Goold S. D., Merajver S. D. (2002) Health Insurance and Discrimination Concerns and BRCA1/2 Testing in a Clinic Population. Cancer Epidemiology Biomarkers and Prevention 11:79–87Google Scholar
  42. Sobel S., Cowan C. B. (2003) Ambiguous Loss and Disenfranchised Grief: The Impact of DNA Predictive Testing on the Family as a System. Family Process 42(1):47–57CrossRefGoogle Scholar
  43. Vineis P., Schulte P., McMichael J. (2001) Misconceptions About the Use of Genetic Tests in Populations. The Lancet 357:709–712CrossRefGoogle Scholar
  44. Welch H. G., Burke W. (1998) Uncertainties in Genetic Testing for Chronic Disease. Journal of the American Medical Association 280:1525–1527CrossRefGoogle Scholar
  45. Williams-Jones B. (2003) Where There’s a Web, There’s a Way: Commercial Genetic Testing and the Internet. Community Genetics 6(1):46–57CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media B.V. 2007

Authors and Affiliations

  1. 1.Institute for Public Health GeneticsUniversity of Washington School of Public Health and Community MedicineSeattleU.S.A.
  2. 2.Department of Medical History and EthicsUniversity of Washington School of MedicineSeattleU.S.A.
  3. 3.Department of Medicine, GastroenterologyUniversity of Washington Medical CenterSeattleU.S.A.

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