Including ELSI research questions in newborn screening pilot studies

for the Bioethics and Legal Workgroup of the Newborn Screening Translational Research Network

Research output: Contribution to journalArticle

Abstract

Background: The evidence review processes for adding new conditions to state newborn screening (NBS) panels rely on data from pilot studies aimed at assessing the potential benefits and harms of screening. However, the consideration of ethical, legal, and social implications (ELSI) of screening within this research has been limited. This paper outlines important ELSI issues related to newborn screening policy and practices as a resource to help researchers integrate ELSI into NBS pilot studies. Approach: Members of the Bioethics and Legal Workgroup for the Newborn Screening Translational Research Network facilitated a series of professional and public discussions aimed at engaging NBS stakeholders to identify important existing and emerging ELSI challenges accompanying NBS. Results: Through these engagement activities, we identified a set of key ELSI questions related to (1) the types of results parents may receive through newborn screening and (2) the initiation and implementation of NBS for a condition within the NBS system. Conclusion: Integrating ELSI questions into pilot studies will help NBS programs to better understand the potential impact of screening for a new condition on newborns and families, and make crucial policy decisions aimed at maximized benefits and mitigating the potential negative medical or social implications of screening.

Original languageEnglish (US)
Pages (from-to)525-533
Number of pages9
JournalGenetics in Medicine
Volume21
Issue number3
DOIs
StatePublished - Mar 1 2019

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Newborn Infant
Research
Bioethics
Translational Medical Research
Parents
Research Personnel

Keywords

  • ELSI
  • Ethics
  • Newborn screening
  • Pilot studies
  • Research

Cite this

for the Bioethics and Legal Workgroup of the Newborn Screening Translational Research Network (2019). Including ELSI research questions in newborn screening pilot studies. Genetics in Medicine, 21(3), 525-533. https://doi.org/10.1038/s41436-018-0101-x

Including ELSI research questions in newborn screening pilot studies. / for the Bioethics and Legal Workgroup of the Newborn Screening Translational Research Network.

In: Genetics in Medicine, Vol. 21, No. 3, 01.03.2019, p. 525-533.

Research output: Contribution to journalArticle

for the Bioethics and Legal Workgroup of the Newborn Screening Translational Research Network 2019, 'Including ELSI research questions in newborn screening pilot studies', Genetics in Medicine, vol. 21, no. 3, pp. 525-533. https://doi.org/10.1038/s41436-018-0101-x
for the Bioethics and Legal Workgroup of the Newborn Screening Translational Research Network. Including ELSI research questions in newborn screening pilot studies. Genetics in Medicine. 2019 Mar 1;21(3):525-533. https://doi.org/10.1038/s41436-018-0101-x
for the Bioethics and Legal Workgroup of the Newborn Screening Translational Research Network. / Including ELSI research questions in newborn screening pilot studies. In: Genetics in Medicine. 2019 ; Vol. 21, No. 3. pp. 525-533.
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