TY - JOUR
T1 - Including ELSI research questions in newborn screening pilot studies
AU - Goldenberg, Aaron J.
AU - Lloyd-Puryear, Michele
AU - Brosco, Jeffrey P.
AU - Therrell, Bradford
AU - Bush, Lynn
AU - Berry, Susan
AU - Brower, Amy
AU - Bonhomme, Natasha
AU - Bowdish, Bruce
AU - Chrysler, Denise
AU - Clarke, Angus
AU - Crawford, Thomas
AU - Goldman, Edward
AU - Hiner, Sally
AU - Howell, R. Rodney
AU - Orren, David
AU - Wilfond, Benjamin S.
AU - Watson, Michael
N1 - Publisher Copyright:
© 2018, American College of Medical Genetics and Genomics.
PY - 2019/3/1
Y1 - 2019/3/1
N2 - 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.
AB - 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.
KW - ELSI
KW - Ethics
KW - Newborn screening
KW - Pilot studies
KW - Research
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U2 - 10.1038/s41436-018-0101-x
DO - 10.1038/s41436-018-0101-x
M3 - Article
C2 - 30100612
AN - SCOPUS:85052504198
SN - 1098-3600
VL - 21
SP - 525
EP - 533
JO - Genetics in Medicine
JF - Genetics in Medicine
IS - 3
ER -