Dr Yingyi Luo1
1University Of Melbourne, Australia
Biography:
Dr Yingyi Luo is a research fellow at the University of Melbourne Law School, specializing in health law and human rights. Her work focuses on the legal and ethical challenges of pediatric genomic research, particularly informed consent and data protection.
Abstract:
Informed consent is a fundamental principle in genomic research, requiring participants to fully understand and voluntarily agree to their involvement. However, in pediatric genomic research, this principle encounters significant challenges due to minors’ evolving autonomy and the complexities of genomic data protection. This paper aims to examine these challenges within the Australian context, focusing on the proposed broad consent framework under the Australian Privacy Law Reform Initiative and the current "sufficient maturity" standard used by the National Health and Medical Research Council. Through a detailed legal analysis, this paper finds that these frameworks emphasize general data protection but inadequately address the unique needs of pediatric genomic data governance. A central concern is the lack of clear guidelines detailing the process, responsibility, and criteria for reassessing the competency of child participants as they become “mature minors”, particularly in longitudinal genomic studies where initial consent is parental. There is a risk that the effectiveness of these consent frameworks depends heavily on the actions and subjective judgment of data controllers, which may lead to variability in how consent is obtained and managed. To conclude, this paper advocates for the development of more explicit legal and ethical frameworks that support a dynamic and continuous consent process, aiming to practically seek fresh informed consent from children once they are deemed mature enough to consent independently. It explores the potential of AI and dynamic consent mechanisms to address the challenges of obtaining and managing informed consent in pediatric genomic research.