New genetic research rules: What impact on collaboration?

New regulatory guidelines on ethical genetic research in fields that require research use of human and animal genetic resources have been released by the Chinese government.

The move comes several years after Chinese scientist He Jiankui was sentenced to three years in prison for breaching ethical guidelines to create the world’s first gene-edited babies, which triggered a global scientific backlash against China’s unethical research practices.

Although some new guidelines were issued, as research ethics rose up the national political agenda following the 2018 He case, the latest draft regulations released by the General Office of the Chinese Communist Party and the State Council, or China’s cabinet, at the end of March are intended to “strengthen the research on relevant laws in key areas such as life sciences, medicine and artificial intelligence” by 2025, the official Xinhua news agency reported.

He, who lost his job as an associate professor at Southern University of Science and Technology, Shenzhen, for his involvement in the genetic modification of three babies using the controversial gene-editing technique known as CRISPR, was released from prison this week and is said to be in contact with members of his research network in China and overseas.

In a rush to avoid China being branded internationally as the ‘wild east’ of genetic research and to restore trust, the country’s National Health Commission released some regulations in 2019 but without detailed implementation guidelines.

In its latest document, described as a draft for consultation, the government has identified genetic data as a national “strategic resource”, with stronger controls over gene banks and other genetic information. The new guidelines also prohibit the export of Chinese genetic materials overseas and bar foreign individuals, organisations and universities from gathering and holding such materials.

The guidelines also push for ethical review and supervision of international collaborative research activities to ensure compliance with the ethics approach “in all of the countries involved”.

Fears of negative effect on research

Guidelines proposed by a World Health Organization (WHO) committee of experts on genome editing released in July 2021 were prompted in large part by the He case. The WHO committee called for stronger controls on human gene editing technologies, including measures to ensure that proper use of gene editing techniques benefits the broader public, particularly people in developing countries.

Some experts say that while the latest guidelines bring China closer to the WHO recommendations, China’s new ‘national security’ emphasis, its controls on exports and use of genetic materials by foreign universities, companies or research organisations could negatively affect international research collaboration with China and subject research projects to obtrusive government scrutiny.

“It’s a big shift since 2018. China really wants to insert its voice or the ‘China story’ in global [research] governance, which I see as a welcome gesture,” said Joy Zhang, reader in sociology at the University of Kent in the United Kingdom and an expert on China’s science policies, adding that it pointed to more openness. “But I would put a question mark on its actual effect.”

“For the past few years all the [Chinese] regulations have been quite simplistic so they just raise the bar to enter this area [of genetic research]. What China has been doing for a very long time [is to say] if we can’t deal with something, we just ban it,” Zhang told University World News.

“Just adding new articles [in regulations] to say what type of research cannot be done will mean its impact will be very limited. My focus will be on enforcement,” she said, adding: “Bear in mind that JK He happened not because China did not have laws, but because of its [lack of] enforcement.”

“So far, what I haven’t seen enough of is China investing in the capacity building in different areas so as to enforce the law that has already been in place,” Zhang said.

The regulation only broadly requires institutions to set up an ethical committee to screen research activities involving humans and animals, following “scientific, independent, just and transparent” principles. It also encourages universities to offer relevant courses that make ethical education an important part of undergraduate and graduate studies.

Chinese authorities are tasked to direct universities, research institutions, medical organisations, social groups and various enterprises to improve their monitoring and early warning mechanisms for ethical risks and follow up developments in emerging areas in science and technology, according to the guidelines.

Zhang and others note that while top tier cities like Beijing, Shanghai and Guangzhou and elite universities have substantially improved the research culture, elsewhere in China it may be lagging.

“In terms of the whole picture in China, there is a lot that needs to be done in terms of awareness-raising, and training even in basics of how an IRB should be set up,” she said referring to the Institutional Review Boards that exist for global research to protect the rights and welfare of human research subjects.

Genetic data as the new oil

China has designated genetic resources as a ‘strategic resource’.

“It means genetic data is the new oil to manage and defend in a geopolitical manner and support its economy,” said Yves Moreau, professor of engineering at KU Leuven, Belgium, and expert in computational biology for genomic medicine.

This will inevitably mean more government oversight and control over research in these fields by companies and universities.

The latest implementation rules do not amount to a complete disregard of important international standards regarding how to manage genetic data, and there were some good elements included, but there were also “important gaps”, Moreau told University World News.

“The largest gap is that there is nothing in the implementation on how the state is allowed to interfere to access this data – a huge [hole] that allows authorities to access just about any data present anywhere in the country.”

“It seems that the state can pretty much do whatever they want with genetic data.”

“Now they make it even clearer, in my mind, that if you share some data with Chinese researchers or Chinese companies, then the data is directly within the reach of the authorities,” he said, noting that “even in Western countries, if authorities want to access some data, it’s very hard to stop them”.

“After seeing those rules, I would strongly discourage anyone from sharing details of genetic information with Chinese researchers or Chinese actors,” Moreau warned.

Export of genetic materials

Overseas organisations and individuals, and institutions established or controlled by foreign stakeholders are not allowed to collect and preserve Chinese human genetic resources inside China or provide Chinese human genetic resources outside the country.

According to the guidelines, only Chinese scientific research institutions, institutions of higher learning, medical institutions and enterprises have the right to collect such human genetic information resources. Overseas institutions are also prohibited from preserving such resources in China or providing China’s human genetic information resources to foreign countries.

Export of genetic materials has been an international issue and not just in China. “It is a discussion that has existed for years. But was overshadowed by these scandals and then COVID,” said Zhang referring to He.

“Originally, it was rooted in a very legitimate concern about biopiracy. In the 1980s and even in the ’90s people could easily smuggle blood samples and tissues outside of China, so there has been a call to regulate human genetic resources for quite a long time,” she said. “But it goes back to the question of how China is going to enforce it, to make it flexible and also to make it practical for international research.”

Moreau noted that according to the guidelines, “if there is an international collaboration, there needs to be a copy of the data, in fact a backup of the data, that is with the Chinese institution.

So, it is going to be hard to avoid the concentration of data, and this will lead to a kind of asymmetry – the flow of data out of China will be slowed down because of the barriers that are being put forward, although they’re not completely unreasonable – but that doesn’t mean it will slow down the flow of data towards China.”

It could also jeopardise international research collaboration if it is too strictly applied.

“If you want to be part of major international collaborations, then, of course, you need to share your data with international partners. But saying that from now on no new data will leave China is also saying that you can forget about major international cooperation,” Moreau said.

“I can understand that there will be a real panic among academic researchers that any form of international collaborations would become impossible. And that would be quite dramatic for the quality of national research in China.”

Nonetheless, Moreau noted, this does not seem to be the intention of the new regulations.

“It is rather positive that in these regulations there are a number of mechanisms that clarify the process by which the data can, under appropriate circumstances, be moved out of the country, and that will give a form of legal certainty to, for example, Chinese researchers to collaborate with foreign partners,” and not be prosecuted or fined.

“Five years ago, it was all the rage for genetics and biotech scientists to collaborate with China, but the pattern of collaboration has certainly decreased,” said Moreau. “The kind of legal certainty that this framework will establish will help limit this decrease or could even push it back to some extent.”

National security scrutiny

Another aspect of the new regulations is the emphasis on security review assessments. China is preparing to conduct a security review on the use of Chinese human genetic information by foreign institutions that may affect China’s public health, national security and public interests.

This security review will be carried out by the Ministry of Science and Technology which is establishing a unified system platform to facilitate declarations by the parties involved, according to the latest document.

Sources told University World News several types of human genetic resources information could trigger a security review if it involves being opened up to or used by institutions overseas, and will need permission from the ministry.

They include human genetic resources information, exome sequencing of populations with more than 500 people, genome sequencing information resources, and “other information that may affect the country’s public health, national security and social public interests”.

In a grey area, this could include overseas institutions which use genetic data from Chinese people not necessarily living in China.

But Moreau was sceptical about China’s centralised IT platform for genetic data to register, catalogue and connect all datasets at the national level, which would require all such data to be handed over. “Scientists outside China note that this is a huge undertaking and a technical challenge to achieve.

“And there could be resistance from scientists who want to have control over their own data,” Moreau noted.

For example, China’s much touted national DNA database does not work as well as it should in terms of accessibility and quality of data although it has been in existence for more than a decade, according to some experts.

“Connecting genetic data across the world is an important goal of the entire scientific community, but usually we do that via authorities that have some degree of independence from the state,” Moreau said, referring to his own research into abuses of DNA databases. “I've seen the level of interference of authorities in a research field like forensic genetics.”