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Non-Invasive Prenatal Screening: Navigating the Relevant Legal Norms

Published:April 28, 2020DOI:https://doi.org/10.1016/j.jogc.2020.03.020

      Abstract

      The implementation of non-invasive prenatal screening (NIPS) in Canada will be affected by legal norms. The law can shape physician behaviour, help to crystallize standards of care, influence utilization patterns, and reflect and reinforce patient expectations.
      In Canada, failure to inform a patient about NIPS, or misinterpretation of NIPS results, could result in a successful "wrongful birth" claim if the patient subsequently gives birth to a child with a condition that had been detectable. Given that research shows that physicians’ decisions are influenced by concerns about liability, malpractice law seems likely to encourage increased recommendation and use of NIPS.
      Physicians’ fiduciary and negligence-based disclosure standards require they consider both objective factors as well as a specific patient's subjective and reasonable beliefs, fears, desires, and expectations. Thus, physicians likely must address dominant public discourses and controversies relevant to NIPS. Given the existence of spin, hype, and misinformation about NIPS, there is an increasing need for a robust consent process and, when appropriate, genetic counselling.
      In sum, the law will define and bound the acceptable behaviour of physicians recommending or administering NIPS, and nudge the technology's implementation forward. Physicians and policymakers should be aware of the potential impact of these legal norms on both utilization and public expectations.

      Résumé

      La mise en œuvre du dépistage prénatal non invasif (DPNI) au Canada dépendra des normes juridiques. La loi peut façonner le comportement du médecin, contribuer à fixer les normes de soins, influencer les habitudes d'utilisation en plus de refléter et de renforcer les attentes des patientes.
      Au Canada, le fait de ne pas informer une patiente au sujet du DPNI et la mauvaise interprétation des résultats de DPNI peuvent aboutir à un gain de cause pour « naissance préjudiciable » si la patiente donne naissance à un enfant dont l'affection aurait été détectable. Comme les recherches montrent que les préoccupations en matière de responsabilité influencent les décisions des médecins, les lois en matière de faute professionnelle risquent de faire augmenter la recommandation et l'utilisation du DPNI.
      Les normes relatives à l'obligation fiduciaire et au devoir de diligence des médecins exigent qu'ils tiennent compte des facteurs objectifs en plus des croyances, peurs, souhaits et attentes subjectives et raisonnables de la patiente. Ainsi, les médecins doivent vraisemblablement composer avec les discours et controverses du public en ce qui concerne les DPNI. Compte tenu des retombées, de la publicité et de la désinformation à propos des DPNI, il est de plus en plus nécessaire d’établir un protocole solide sur le consentement et, le cas échéant, sur les consultations génétiques.
      En résumé, les lois viendront définir et encadrer le comportement acceptable des médecins qui recommandent ou réalisent les DPNI, en plus de faire progresser la mise en œuvre de la technologie. Les médecins et les responsables de l’élaboration des politiques doivent avoir conscience des conséquences potentielles de ces normes juridiques tant sur l'utilisation des DPNI que sur les attentes du public en la matière.

      Keywords

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