This study aims to develop a standardized informed consent system for whole-genome sequencing (WGS)-based newborn screening (NBS) in Korea through a policy design approach grounded in the domestic legal and policy context. We conducted an integrated literature review of international norms, domestic legal frameworks, guidelines, and major overseas WGS-based NBS programs using a common analytical framework. To develop a consent model feasible in the Korean context, we also analyzed stakeholder evidence from parent interviews and a clinician survey focused on consentrelated issues. The findings indicate that the current Korean legal and institutional framework does not adequately address long-term storage, reanalysis, recontact, and the transfer of decision-making authority as the child matures. Based on these findings, we propose a Korean informed consent model consisting of a staged consent pathway spanning antenatal, postnatal, and adulthood-related decision points; tiered consent options for the return of results; and safeguards against disadvantage or discrimination related to participation, non-participation, or withdrawal. The study further suggests that implementation will require broader legal and procedural clarification across the relevant regulatory framework, along with the continued development of education and counseling strategies.

Informed consent for whole-genome sequencing (WGS)-based newborn screening presents distinctive ethical and legal challenges, particularly in balancing parental consent given on behalf of the child with the progressive realization of children’s rights. This study examines the issues discussed in the literature and proposes consent frameworks that are responsive to evolving clinical and societal contexts. A systematic literature review was conducted in accordance with PRISMA 2020 guidelines, analyzing 19 empirical, normative, and legal studies. The synthesis identified persistent tensions between safeguarding parental autonomy and ensuring the child’s future selfdetermination, alongside challenges in determining the scope, timing, and format of genomic information disclosure. International models increasingly adopt dynamic consent processes, such as staged consent or re-consent upon reaching legal capacity. These approaches illustrate the feasibility of aligning clinical utility, public health objectives, and rights-based ethics within largescale genomic programs. Based on its findings, this study recommends the implementation of staged consent mechanisms, transparent disclosure protocols, and procedural safeguards tailored to domestic legal and political frameworks. Such evolving consent practices are expected to support the development of ethically robust and socially sustainable governance for WGS-based newborn screening.