Best ethical practices for clinicians and laboratories in the provision of non-invasive prenatal testing.

Allyse MA, Sayres LC, Havard M, King JS, Greely HT, Hudgins L, Taylor J, Norton ME, Cho MK, Magnus D, Ormond KE.

Source

Center for Biomedical Ethics, Stanford University, Stanford, CA, USA. megand@stanford.edu.

Abstract

OBJECTIVE:

To provide an ethical framework for clinicians and companies providing non-invasive prenatal testing using cell-free fetal DNA or whole fetal cells.

METHOD:

In collaboration with an NIH-supported research ethics consultation committee, together with feedback from an inter-disciplinary group of clinicians, members of industry, legal experts and genetic counselors we developed a set of best practices for the provision of non-invasive prenatal genetic testing.

RESULTS:

Principal recommendations include the amendment of current informed consent procedures to include attention to the non-invasive 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 direct-to-consumer.

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. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.