Sharing, shared responsibility and shared governance-The new challenges and solutions of precision medicine ethics

As a new medical concept and medical model, precision medicine cannot develop without the collection, storage and sharing of medical clinical data and biomedical big data. These data include personal information such as personal genetic information, electronic medical records, living environment and clinical data. However, information sharing in the context of big data faces many ethical challenges: (1) The issue of ownership of biomedical data, that is, once the biological information (including behavioral information) originally belonging to individuals is mined; (2) the exposure of personal privacy and group privacy and the resulting discrimination and injustice; (3) the reconstruction of the subject of informed consent and the unclear purpose; (4) data conversion for the distribution of benefits after the value, etc. Precision medicine is a scientific and technological activity that benefits both individuals and humankind in general. The development of precision medicine must resolve the contradiction between data sharing and privacy protection. The key to solving this problem is to establish a biomedical big data management mechanism of sharing, joint responsibility, and joint governance, so as to lead the development of precision medicine in the direction of rigorous regulation, scientific order, effective implementation, and proper supervision. On the one hand, it is necessary to strengthen the sense of responsibility and ethics of scientific researchers; on the other hand, it is necessary to strengthen the supervision and governance responsibilities of institutions. On the basis of ensuring the security of personal data, the public is encouraged to donate and contribute personal biomedical data in the spirit of solidarity, benevolence, and mutual aid. To this end, this paper puts forward the following principles: First, respect independent decision-making and encourage data sharing. It must be clear that individuals are the subjects of rights to their biomedical data. At the same time, the public is encouraged to actively participate in precision medicine cohort studies and actively share personal data. Second, protect privacy and balance risks and benefits. While ensuring the sharing of biomedical data, no one shall infringe on personal privacy and endanger the safety of individuals and related groups. To this end, it is necessary to develop and construct privacy and security protection information technology and policies, laws and regulations corresponding to precision medicine from multiple dimensions such as technology, ethics, policy and law. Third, to strengthen shared responsibility and strengthen institutional governance, it is necessary to strengthen moral education and ethical training for practitioners involved in biomedical data, not only to make relevant personnel familiar with and master relevant national laws and regulations, but also to strengthen the privacy protection responsibility of relevant personnel. Those who intentionally leak or even maliciously sell and transfer other people's biomedical data should be held accountable legally and administratively.