Present situation and trend of ethical governance in life sciences

Countries around the world have strengthened their governance systems and reached ethical consensus

Subversive new achievements and new technologies in the field of life science, while bringing human progress, will trigger people's thinking and discussion on potential ethical and security risks that may occur, thus promoting the continuous progress and improvement of ethical governance in the field of life science in the international community.

Figure 1 Ethical hotspots in the field of life sciences and related regulatory measures in some countries and regions

When new technological risks emerge, countries have formulated their own ethical laws and regulations in the field of life sciences based on their own legal systems, historical traditions and religious beliefs. Especially for new technologies that may directly change species, such as stem cells and gene editing, countries around the world have adopted a variety of measures to regulate and prevent related ethical issues, focusing on the management of scientific research involving human embryos, technology application, operational norms, as well as the management, commercialization and import and export of medical products containing genetic modification or synthetic components.

In 1946, the "Nuremberg Code" was born at the Nuremberg military Tribunal in Germany, which clarified 10 standards for doctors to conduct human trials, opening up the standardization of human trials. The UK Human Fertilisation and Embryology Act (1990, amended in 2008) was the world's first regulatory act relating to human embryos. Its revised version allows human and animal "cell fusion" to innovate "hybrid embryo" experiments, which will promote subsequent research and development of stem cell technology. The German Embryo Protection Act (issued in 1991, amended in 2012) strictly prohibits human embryonic stem cell research and cloning; The German Reproductive Medicine Law (Draft) (published in 2000) again emphasizes that the cultivation of embryonic stem cells is not allowed in Germany. Since 2014, Japan has implemented the "Regenerative Medical Safety Assurance Law", which classifies clinical research and treatment using induced pluripotent stem cells and embryonic stem cells as the "first class" with the highest risk and needs to be reviewed by a special committee.

In addition to laws and regulations at the national level, major international organizations have issued various guidelines or management frameworks to help the scientific community reach consensus and self-govern through practical guidance. For example, the Declaration of Helsinki adopted by the International Medical Congress in 1964 stipulated that in human medical research, the consideration of the health of the subjects should take precedence over the interest in scientific research, which laid the foundation for the ethical code of clinical research. In 2016, the Council for International Organizations of Medical Sciences (CIOMS) developed a revised version of the International Code of Ethics for Health-related Research Involving Humans, which aims to guide health research from the perspectives of ethics, medical product development and safety to promote public health; The International Society for Stem Cell Research (ISSCR) released updated Guidelines for Stem Cell Research and Clinical Translation in May 2021, which combines the latest research advances and clinical ethics in the fields of stem cell-based embryonic models, human embryo research, chimera, organoids and gene editing. Some practical suggestions were put forward for scientific supervision of clinical transformation of stem cells. On July 12, 2021, an expert committee of the World Health Organization (WHO) issued the "Governance Framework for Human Genome Editing" and "Human Genome Editing Recommendations", which for the first time put forward global recommendations on human gene editing as a public health tool and demonstrated its safety, effectiveness and ethical issues.

In addition, the international community has also maintained attention to emergencies in the field of life sciences and actively responded to possible risks. The Joint Statement on COVID-19: Ethical Considerations from a Global Perspective issued by UNESCO's International BioEthics Committee (IBC) and the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) shows that the COVID-19 pandemic is a global pandemic that calls for a global bioethical reflection and response.

2 Current situation of ethical governance in the field of life sciences in China

The research on ethical issues in the field of life science has been paid more and more attention

A number of national and local funds and programs support research on ethical issues, policy and regulation in the life sciences

Since 2006, the National Social Science Foundation has funded more than 60 projects related to ethical issues, regulations and standards research in the field of life sciences, including 5 major projects and 1 key project. The National Key research and Development Program and other science and technology funding projects have set supporting topics to support ethics-related soft science research, such as the 2017 precision medicine research project "Precision medical ethics, policy and regulatory framework research" and the 2018 synthetic biology special project "Synthetic Biology Ethics, policy and regulatory framework research".