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

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.

Human-subjects research: The ethics squad

“…In 2011, for example, a start-up company approached the centre for guidance on the sale and promotion of a prenatal genetic test that involves analysing fetal DNA circulating in maternal blood (see Nature 478, 440; 2011). The consultation led to an academic paper that called for amendments to informedconsent procedures and restrictions on the sale of direct-to-consumer tests 4 . "Many of our consults end up that way, " says Mildred Cho, associate director of the Stanford centre.…”

Non-Invasive Prenatal Testing: Review of Ethical, Legal and Social Implications

“…While the invasiveness and risk of miscarriage associated with current diagnostic testing prevent the expansion of its uptake for a wider range of conditions, NIPT's capacity to offer genetic information in a safe and easy manner is anticipated to lower the threshold of testing, i.e., to encourage women to consider prenatal testing as appropriate for less severe conditions and even for non-medical reasons [34,50,51]. It is thus argued that in the future, expanding the scope of NIPT could generate large amounts of information regarding late onset diseases (e.g., Huntington's), predispositions to severe and common diseases (e.g., breast cancer and diabetes), minor abnormalities [52][53][54], and ISSN 1923-2799 6 / 14 even non-medical information (e.g., paternity) and physical traits (e.g., eye colour).…”

“…Consequently, potential benefits for women and families were over-estimated. Moreover, direct-to-consumer (DTC) commercial offer of NIPT is considered by several authors to be a potential threat to an ethical implementation of this test [7,49,50]. Health professionals do not recommend this type of marketing for NIPT, arguing that women and couples may not have access to suitable information, counselling and support to guide their decision-making [25,50].…”

“…The rapid technological advancement and future expansion in scope of the conditions that NIPT can detect may further complicate matters. If NIPT is introduced into a public healthcare system, questions will arise regarding which conditions should be covered, for whom, who should make these decisions and how [50,79].…”

Moral Responsibility in the Context of Prenatal Testing: What can be Expected?

“…Meanwhile, notions of community, common good, public interest, responsibility, and duties to others are given little attention [6]; and recent bioethics literature on prenatal testing and reproductive autonomy is no exception. While numerous authors have explored the ethical aspects of the newest prenatal testing technology (cellfree fetal DNA testing), emphasis seems to be most often placed on those ethical dimensions that pertain to the individual, such as the need for thorough counselling about risks and benefits, informed consent, social or medical pressure on individuals to test, as well as equity in access and regulation issues pertaining to direct-to-consumer use [1,[7][8][9][10][11][12]. Except from proponents of the disability rights critique, social concerns such as the above-mentioned ones have seemingly been given less attention.…”