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

Authors


  • Funding sources: This work was supported by the NIH grants P50 HG003389 (Center for Integrating Ethics and Genetic Research) and 1 U54 RR024374-01A1 (Stanford Center for Clinical and Translational Education and Research).
  • Conflicts of interest: Mary Norton is a principal investigator on clinical trial NCT0145167, sponsored by Ariosa Diagnostics.

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. © 2013 John Wiley & Sons, Ltd.

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