Pubs & Blogs

open
Elsewhere Online twitter Facebook SLS Blogs YouTube SLS Channel Linked In SLSNavigator SLS on Flickr

Best Ethical Practices for Clinicians and Laboratories in the Provision of Non-Invasive Prenatal Testing

Citation

Publication Date: 
July 31, 2013
Format: 
Journal Article
Bibliography: M.A. Allyse, L.C. Sayres, M. Harvard, J.S. King, H.T. Greely, L. Hudgins, J. Taylor, M.E. Norton, M.K. Cho, D. Magnus & K.E. Ormond, Best Ethical Practices for Clinicians and Laboratories in the Provision of Non-Invasive Prenatal Testing, 33 Prenatal Diagnosis 656 (2013).

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