Ethics reviews need upgrade, experts say
Advocates push for system to approve scientific research before work begins
Poor ethics education, weak regulatory capabilities and a lack of consensus in the scientific community are undermining the effectiveness of the nation’s oversight of scientific research, according to experts.
Even though the authorities are paying “unprecedented attention” to the issue and making strides, ethical problems continue to vex the sector, they said.
Strengthening ethics education and awareness; making regulatory bodies that oversee ethics more professional, transparent and legally binding; and establishing multi-tier ethics review mechanisms are the keys to preventing future scientists from overstepping ethical boundaries, they said.
In late January, the Ministry of Science and Technology and Ministry of Finance issued a joint document urging scientists and research institutes to enhance ethics oversight and regulation, and establish regulatory committees to ensure ethical practices in their research activities.
The document is the latest testimony to China’s growing effort to encourage responsible research practices. In the past three months, various government officials and entities, from Premier Li Keqiang to Guangdong’s provincial government, have stressed the importance of curtailing unethical practices in scientific research.
The National Natural Science Foundation of China, the country’s main financial contributor to basic scientific research, issued new rules in December calling on sponsored institutes and projects to optimize their supervision to prevent both ethics and security risks in fields such as information technology and biotech.
The foundation said it will withdraw its support for three to five years from those who have seriously violated its rules or failed to carry out their duties in accordance with laws and regulations.
Lagging guidelines
Zhai Xiaomei, executive director of the Chinese Academy of Medical Sciences’ research center for bioethics, said China’s academic research on bioethics began in the early 1980s, but its ethics guidelines and regulations relating to biomedical research involving humans are behind those found in developed countries such as the United States and the United Kingdom.
A key reason for the lax oversight is a lack of ethics review boards, both in number and capability, Zhai said.
According to a survey of 324 institutions around the country by the China Association for Science and Technology last year, 87.5 percent of medical and health institutions have ethics regulatory bodies, such as an ethics review board.
But for universities the figure was 17.6 percent, the survey found, while at research institutes it was 5.4 percent and at companies just 1 percent. Moreover, many ethics review boards are staffed by scholars who are not professionally trained in bioethics, so “they may not be competent to review risky scientific research or clinical experiments,” Zhai said.
He Jiankui is the latest example of insufficient ethics regulation. His controversial experiment to create the world’s first gene-edited babies sparked global outrage. Ethics inspection papers from a hospital in Shenzhen, Guangdong province, were forged, according to preliminary investigation results published by local authorities last month.
“An effective ethics regulation should be able to nip unethical experiments in the bud, and it should also have some teeth that can hold serious violators accountable,” Zhai said.
However, research ethics is a complex and poorly understood subject that is sometimes overlooked, she said, “Hence ethical training for scientists, officials and the public is essential.”
In the association’s survey last year, nearly 90 percent of the 12,332 scientists surveyed said they believe unethical practices are deeply harmful. Yet less than a quarter said they would always take research ethics into consideration when designing their experiments.
Only 5 percent of respondents said they knew much about ethics guidelines unrelated to academic honesty, which primarily deals with truthfulness and integrity in their work — meaning that Chinese scientists have poor knowledge of other areas of scientific ethics, such as bioethics, animal rights and environmental impacts.
“Most of our scientists do their research in good faith, but they need to have the necessary theoretical knowledge and regulatory mechanisms to guide them through uncharted ethical territory,” Zhai said.
Li Zhenzhen, a science ethics expert and a researcher at the Chinese Academy of Sciences’ Institute of Science and Development, said China needs ethics agencies whose regulatory capability can keep up with the rapid growth of the country’s scientific development.
China is estimated to have spent around 1.95 trillion yuan ($290 billion), or 2.15 percent of its GDP, on research and development last year, according to the Ministry of Science and Technology. The country also boasted around 4.18 million research personnel last year, the most in the world, it said.
“Legal and ethical regulations can’t keep up with the rapid progress China is making in some scientific fields,” Li said, adding that genetics, biosciences and artificial intelligence are examples of high-tech fields that sorely need stronger ethics oversight.
Li said insufficient oversight will tarnish China’s image in the eyes of the global scientific community, create misunderstandings and mistrust between Chinese and foreign scientists and fuel the stereotype that China’s frequent breakthroughs in biosciences are the result of a system in which ethics rules are not holding it back.
“These notions are very detrimental to China’s scientific development and international cooperation, especially when many cutting-edge sciences now require global collaboration to advance,” she said, adding that enhancing ethical oversight will likely be a hot topic at the upcoming two sessions, the annual meetings of China’s top legislative and advisory bodies in early March.
Proposed solution
One solution, Li said, is to establish a multi-tier ethics review system that covers regulatory bodies at different levels — from institutions to the national level — that can grant approvals appropriately based on the ethical risks of the experiment.
“If such a system were in place, He Jiankui’s experiment would not have happened in the first place, because it would have required the highest ethical approval from national authorities, which is near impossible given the nature of his work,” Li said.
“Local hospitals, such as the one where He forged his ethics approval, do not and should not have the power to greenlight experiments that are as risky and unpredictable as gene-editing of human embryos.”
Zhai also supports the idea of a multi-tier ethics review system, but said the proposal has been debated in the scientific community for some time and no consensus has been reached.
“China is paying unprecedented attention to enhancing ethical oversight in science, and I’m sure it will improve in the future,” she said. “But how fast it can improve ultimately depends on the critical will of the decision-makers.”
Huang Yu, deputy director of the medical genetics department at Peking University, said China should optimize its ethics regulations at its own pace and not be pressured to fully adopt Western ethical norms, which may not always be suitable for China.
“Ethics supervision should be and is very prevalent in our current research,” he said. “However, an ethics review can be a very timeconsuming and expensive process, and these costs typically fall onto the research teams, who have limited budgets and heavy workloads.”
Huang said scientists will likely support ethics oversight if China can improve its ethics evaluation services, such as institutions having a dedicated budget to pay for ethics review expenses. Streamlining administration and paperwork, as well as creating clear, practical and transparent ethics guidelines would also be beneficial, he added.
“The ideal ethics oversight should serve scientific endeavors while protecting the interests of all parties involved,” Huang said.