Ethical Challenges in Genomic Data Sharing and Patient Privacy in Precision Medicine

Abstract

With precision medicine, the medical field has changed because medical interventions are personalized based on the specific genomic profile. The implementation of this paradigm shift depends on the huge aggregation and distribution of genomic data on worldwide research networks to gain statistical significance and clinical validity. Nevertheless, this model of open science poses a considerable amount of ethical tension in the case of patient privacy due to its collaborative characteristic. The main ethical issues related to genomic data sharing discussed in this paper are the following: First, the technical aspect of the matter that the genetic data is identifiable by nature, and hence the traditional methods of anonymization may not be enough to withstand the current re-identification attacks. Moreover, the drawbacks of the classical informed consent are also examined, with special emphasis on the issue of the tension between the broad consent toward further research and the autonomy of the participant. It is further discussed in terms of issues of data sovereignty and the possibility of worsening the health inequalities of underrepresented populations. This paper proposes a shift in approaches to data governance by assessing existing legal regulations, including GDPR and GINA, as well as considering recent technological privacy protection systems, including differential privacy and federated learning. Finally, it is noted that an effective, clear, and ethically-founded sharing of most protocols is a requirement in terms of keeping the population trustful and providing the sustainable development of precision medicine.