Ethical Guideline for Organoid Research

China's Ministry of Science and Technology has issued an ethical guideline for human organoid research, clarifying the basic ethical principles and general and special requirements for human-derived organoid research.

This provides comprehensive guidance for researchers on ethical norms and the code of conduct when carrying out related studies.

The guideline establishes stricter operational standards and ethical boundaries for research with high ethical sensitivity and potential controversy, including the brain organoid and human stem cell-based embryo model.

"Organoids are three-dimensional models constructed in vitro using human stem cells to simulate the structure and partial functions of specific human tissues or organs. They have been widely used in basic research, disease modeling, drug screening and toxicology evaluation," said Peng Yaojin, an expert at the life sciences ethics subcommittee of the National Science and Technology Ethics Committee.

Organoid technology has become a frontier field in international life science and technology competition due to its application prospects in precision medicine and regenerative medicine.

The construction of organoids involves the acquisition of human biological materials and simulation of human tissue and organ functions, which raises ethical concerns. Particularly, highly complex models like brain organoids and reproductive system organoids generate more prominent ethical considerations.

Regarding brain organoid research, the guideline stresses that researchers should pay special attention to the complex neural networks and spontaneous electrical activities that may develop during long-term cultivation of sophisticated brain organoids.

The document highlights the need to monitor potential risks of consciousness development, requiring standardized detection mechanisms to monitor the electrophysiological activity levels and complexity of brain organoids, enabling identification of potential ethical thresholds.

For the integrated stem cell-based embryo model with higher developmental potential that simulates complete embryos and extraembryonic structures, the guideline requires preemptive ethical assessment and risk prevention plans to prevent boundary-crossing in related research.

The guideline also draws on international consensus, prohibiting the implantation of stem cell-derived embryo models into human or non-human animal uteruses, and upholding the red lines of scientific ethics.

Source: Science and Technology Daily