Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing

Megan Allyse, L. C. Sayres, M. Havard, J. S. King, H. T. Greely, L. Hudgins, J. Taylor, M. E. Norton, M. K. Cho, D. Magnus, K. E. Ormond

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

Objective: The goal of this study is to provide an ethical framework for clinicians and companies providing noninvasive prenatal testing using cell-free fetal DNA or whole fetal cells. Method: In collaboration with a National Institutes of Health-supported research ethics consultation committee together with feedback from an interdisciplinary group of clinicians, members of industry, legal experts, and genetic counselors, we developed a set of best practices for the provision of noninvasive prenatal genetic testing. Results: Principal recommendations include the amendment of current informed consent procedures to include attention to the noninvasive nature of new testing and the potential for a broader range of results earlier in the pregnancy. We strongly recommend that tests should only be provided through licensed medical providers and not directly to consumers. Conclusion: Prenatal tests, including new methods using cell-free fetal DNA, are not currently regulated by government agencies, and limited professional guidance is available. In the absence of regulation, companies and clinicians should cooperate to adopt responsible best ethical practices in the provision of these tests.

Original languageEnglish (US)
Pages (from-to)656-661
Number of pages6
JournalPrenatal Diagnosis
Volume33
Issue number7
DOIs
StatePublished - Jul 1 2013
Externally publishedYes

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Practice Guidelines
Ethics Consultation
Government Agencies
Research Ethics Committees
DNA
National Institutes of Health (U.S.)
Genetic Testing
Informed Consent
Industry
Pregnancy

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Genetics(clinical)

Cite this

Allyse, M., Sayres, L. C., Havard, M., King, J. S., Greely, H. T., Hudgins, L., ... Ormond, K. E. (2013). Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing. Prenatal Diagnosis, 33(7), 656-661. https://doi.org/10.1002/pd.4144

Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing. / Allyse, Megan; Sayres, L. C.; Havard, M.; King, J. S.; Greely, H. T.; Hudgins, L.; Taylor, J.; Norton, M. E.; Cho, M. K.; Magnus, D.; Ormond, K. E.

In: Prenatal Diagnosis, Vol. 33, No. 7, 01.07.2013, p. 656-661.

Research output: Contribution to journalArticle

Allyse, M, Sayres, LC, Havard, M, King, JS, Greely, HT, Hudgins, L, Taylor, J, Norton, ME, Cho, MK, Magnus, D & Ormond, KE 2013, 'Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing', Prenatal Diagnosis, vol. 33, no. 7, pp. 656-661. https://doi.org/10.1002/pd.4144
Allyse, Megan ; Sayres, L. C. ; Havard, M. ; King, J. S. ; Greely, H. T. ; Hudgins, L. ; Taylor, J. ; Norton, M. E. ; Cho, M. K. ; Magnus, D. ; Ormond, K. E. / Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing. In: Prenatal Diagnosis. 2013 ; Vol. 33, No. 7. pp. 656-661.
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