Abstract:

With the rapid development of digital and intelligent technologies such as genomics, precision medicine, and medical artificial intelligence, medical research increasingly exhibits new features: the other-regarding nature of individual data, the indeterminacy of research purposes, the proactive character of research participation, and etc. They pose a profound challenge to the traditional paradigm of subject protection, which is grounded in the principle of respect for autonomy and centered on the institution of informed consent. Introducing the principle of solidarity offers a fresh perspective for resolving this predicament. This principle emphasizes the interdependence of human health, the foundational role of social responsibility, and the relational nature of autonomy, thereby expanding the ethical considerations of medical research in the dimension of public health. Driven by the principle of solidarity, the subject of medical research shifts from subject to participant, the relationships in medical research expand from a dyadic structure to a multi-stakeholder network, and the focus of informed consent moves from fully informed disclosure to shared responsibility. These three transformations together propel a paradigm shift in medical research ethics from subject protection to participant solidarity.

Key words: solidarity, autonomy, informed consent, research ethics, medical ethics