title: Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Center for Biomedical Ethics, Stanford University, Stanford, CA, USA. megand@stanford.edu
authors.forename: M A
authors.initials: MA
authors.lastname: Allyse
authors.forename: L C
authors.initials: LC
authors.lastname: Sayres
authors.forename: M
authors.initials: M
authors.lastname: Havard
authors.forename: J S
authors.initials: JS
authors.lastname: King
authors.forename: H T
authors.initials: HT
authors.lastname: Greely
authors.forename: L
authors.initials: L
authors.lastname: Hudgins
authors.forename: J
authors.initials: J
authors.lastname: Taylor
authors.forename: M E
authors.initials: ME
authors.lastname: Norton
authors.forename: M K
authors.initials: MK
authors.lastname: Cho
authors.forename: D
authors.initials: D
authors.lastname: Magnus
authors.forename: K E
authors.initials: KE
authors.lastname: Ormond
mesh_terms: D004247:DNA / Q000097:blood; D005260:Female; D005333:Fetus / Q000737:chemistry / Q000166:cytology; D005820:Genetic Testing / Q000941:ethics* / Q000379:methods; D006282:Health Personnel / Q000941:ethics; D006801:Humans; D007258:Informed Consent; D007753:Laboratories / Q000941:ethics; D009316:National Institutes of Health (U.S.); D017410:Practice Guidelines as Topic; D011247:Pregnancy; D011296:Prenatal Diagnosis / Q000941:ethics* / Q000379:methods; D014481:United States
chemical_list: D004247:DNA