eases were outweighed by the potential benefit to the future health of the
child and the child’s parent of discovering an incidental finding for which
intervention might be possible.
108 Thus, the ACMG recommended the reporting of incidental findings “not be limited by the age of the person being
sequenced.”
109
C. Storage, Ownership, and Use
Another crucial consideration will be the issue of storage, ownership, and
use of the samples and increased amount of genetic data gained from
WGS.
110 The storage and use of residual blood spots are of prevailing de-
bate and litigation, and the use of WGS will add an advanced dimension to
the controversy, especially considering the increased amount of personal
information that will be contained in the results. Policymakers would need
to examine such issues as whether the state should retain genetic data gen-
erated from WGS for use in future research, and if so, whether an opt-in or
opt-out approach for parents to decide if their newborn’s data could be uti-
lized for future research would be most appropriate.
111 Further considera-
tions include who shall gain ownership over the samples and resulting data
(possibly the state itself); the type and number of entities that will be grant-
ed access to the data for research purposes; how long the data should be
maintained; and who should maintain oversight of the data.112
D. Privacy
Privacy of health information is of preeminent concern. Genetic infor-
mation has the potential for abuse, and information about a newborn’s
health could negatively follow the child throughout their lifetime.113 This
concern for the protection of the privacy of genetic information has been
reviewed and studied extensively.114 While privacy should be an issue to be
taken into thorough consideration in the development of a WGS approach
to newborn screening, the authors would like to focus on one aspect of the
108. Robert Green et al., ACMG recommendations for reporting of incidental findings
in clinical exome and genome sequencing,
15 GENETICS MED. 565, 568 (2013).
109. Id. The ethical and legal issues pertaining to the return of results from newborn
screenings are included in one of the aforementioned NIH funded grant projects.
110. See Jeffrey R. Botkin et al., Retention and Research Use of Residual Newborn
Screening Bloodspots, 131 PEDIATRICS 120, 122-25 (2013); John A. Robertson, The $1000
Genome: Ethical and Legal Issues in Whole Genome Sequencing of Individuals, 3 AM. J.
BIOETHICS W35, W37 (2003).
111. Id.
112. Id.
113. See, e.g., Yuval E. Landau et al., supra note 102, at 18.
114. See, e.g., Gostin & Hodge, Jr., supra note 98; PRESIDENTIAL COMM. FOR THE
STUDY OFBIOETHICALISSUES,PRIVACY ANDPROGRESS INWHOLE GENOMESEQUENCING
(2012), available at
http://bioethics.gov/sites/default/files/PrivacyProgress508_1.pdf.
