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.
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.
Authors: Klaske D Lichtenbelt; Behrooz Z Alizadeh; Peter G Scheffer; Philip Stoutenbeek; Peter C J I Schielen; Lieve C M L Page-Christiaens; G Heleen Schuring-Blom Journal: Prenat Diagn Date: 2011-06-21 Impact factor: 3.050
Authors: Matthijs van den Berg; Danielle R M Timmermans; Leo P ten Kate; John M G van Vugt; Gerrit van der Wal Journal: Patient Educ Couns Date: 2005-10-20
Authors: Timothy Caulfield; Amy L McGuire; Mildred Cho; Janet A Buchanan; Michael M Burgess; Ursula Danilczyk; Christina M Diaz; Kelly Fryer-Edwards; Shane K Green; Marc A Hodosh; Eric T Juengst; Jane Kaye; Laurence Kedes; Bartha Maria Knoppers; Trudo Lemmens; Eric M Meslin; Juli Murphy; Robert L Nussbaum; Margaret Otlowski; Daryl Pullman; Peter N Ray; Jeremy Sugarman; Michael Timmons Journal: PLoS Biol Date: 2008-03-25 Impact factor: 8.029