Best Ethical Practices for Clinicians and Laboratories in the Provision of Noninvasive Prenatal Testing

Overview

Journal Prenat Diagn

Publisher Wiley

Specialty Gynecology & Obstetrics

Date 2013 Apr 25

PMID 23613322

Citations 21

Authors

M A 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

Affiliations

Soon will be listed here.

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.

Citing Articles

Study of Relationship Between Mode of Conception and Non-Specific Psychological Distress in Women Undergoing Noninvasive Prenatal Testing.

Suzumori N, Takeda E, Ebara T, Kumagai K, Sawada Y, Sugiura-Ogasawara M J Reprod Infertil. 2020; 21(3):189-193.

PMID: 32685416 PMC: 7362090.

Noninvasive Prenatal Testing for Trisomies 21, 18, and 13, Sex Chromosome Aneuploidies, and Microdeletions: A Health Technology Assessment.

Ont Health Technol Assess Ser. 2019; 19(4):1-166.

PMID: 30847010 PMC: 6395059.

Perspectives of Pregnant People and Clinicians on Noninvasive Prenatal Testing: A Systematic Review and Qualitative Meta-synthesis.

Vanstone M, Cernat A, Majid U, Trivedi F, De Freitas C Ont Health Technol Assess Ser. 2019; 19(5):1-38.

PMID: 30838086 PMC: 6398533.

Noninvasive Prenatal Whole Genome Sequencing: Pregnant Women's Views and Preferences.

Sullivan H, Bayefsky M, Wakim P, Huddleston K, Biesecker B, Hull S Obstet Gynecol. 2019; 133(3):525-532.

PMID: 30741804 PMC: 6389368. DOI: 10.1097/AOG.0000000000003121.

Knowledge, Attitudes, and Practices of Women Toward Prenatal Genetic Testing.

Abdo N, Ibraheem N, Obeidat N, Graboski-Bauer A, Batieha A, Altamimi N Epigenet Insights. 2019; 11:2516865718813122.

PMID: 30620008 PMC: 6299338. DOI: 10.1177/2516865718813122.

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