China has released a trial guideline on the review of science and technology ethics to ensure both high-quality development and high-level security in sci-tech innovation.
The guideline was jointly released by the ministries of science and technology, industry and information technology, and education, the National Health Commission and other departments with the aim of tackling problems such as unclear responsibilities, nonstandard procedures and imperfect mechanisms for ethical reviews in the sci-tech sector.
Activities involving human research participants, human biological samples and personal information data, as well as those related to experimental animals, must face ethical reviews, according to the guideline.
It delineated a major range of reviews with focusing on activities that may pose ethical risks and challenges in areas such as life and health, ecological environment, public order and sustainable development.
The guideline also stipulated entities responsible for managing sci-tech ethics review in higher education, research, medical and health institutions and enterprises.
A review committee is required to be established in institutions engaging in life sciences, medicine and artificial intelligence activities if the research subjects are "ethically sensitive".
The committee must conduct follow-up ethical reviews of the approved sci-tech activities and make decisions to suspend or terminate such activities if necessary, the guideline said, adding that the interval between follow-up reviews must not exceed 12 months.
The guideline specified a range of activities that need to undergo a "second ethics review", targeting those activities that may pose "relatively high" ethical risks.
The list, which will be dynamically adjusted, has been released by the Ministry of Science and Technology. It covers basic research that alter the genetic material or genetic laws of human reproductive cells and fertilized eggs, and the development of algorithm models, applications and systems with the ability to "mobilize public opinion and guide social consciousness".
Zhai Xiaomei, a member of the National Science and Technology Ethics Committee, said the guideline provides a comprehensive and universally applicable bench mark for ethical review in different sci-tech activities.
It will help overcome problems previously encountered in ethical review work such as coordination difficulties and the lack of unified evaluation criteria, she said.
Zhai said that many emerging technological research and development projects currently have significant social value and are in line with the public interest, but they also pose certain risks. "For example, in research involving the use of data and biological samples, there are risks related to protecting the privacy of sample providers and ensuring biosecurity."
She said that sci-tech activities are closely related to people's lives, and people are increasingly concerned about the misuse of scientific achievements. "Ethical review plays a key role in regulating and curbing such risks."
Public awareness of ethical risks increased after Chinese researcher He Jiankui claimed in 2018 that he had created the world's first gene-edited baby immune to HIV.
In 2019, He was sentenced to three years in prison and fined 3 million yuan ($412,000) for illegal practices including forging ethical approval documents and practicing medicine without a license.
Last year, the central government released a set of guidelines to strengthen ethics governance in science and technology, given the rapid progress of China's sci-tech innovation and the growing challenges in the field.
