When news broke in November 2018 that the first gene-edited human babies had been born in an experiment conducted by Jiankiu He, an associate professor at Southern University of Science and Technology (SUStech) in Shenzhen, the initial reaction from Chinese authorities was  positive. Indeed, the People’s Daily—official newspaper of China’s Communist Party—used the words “milestone achievement” to describe the twin girls’ birth.

Jiankiu He had used the gene-editing technique known as CRISPR-Cas9 in an attempt to replicate a mutation in the CCR5 gene known to offer immunity to the HIV virus. This mutation—known as CCR5Δ32—occurs naturally among about 10 percent of the Northern European population, but rarely in China. He said that he had conducted the work because he’d wanted to give the resulting babies immunity against HIV, and that he thought his work would be met with praise. Instead, as soon as news of his work was revealed—by MIT’s Technology Review, in late November 2018 (Regalado 2018)—negative feedback started rolling in, particularly at the Second International Summit on Human Genome Editing, in Hong Kong, which coincidentally took place a few days after the publication of the MIT article, and where He presented his research (He Q&A 2018). Scientists described He’s work as ethically irresponsible, saying that among other things, the use of CRISPR-Cas9 for human reproduction has not been proven safe.

The experiment was also medically unnecessary: The prevention of HIV transmission from parents to new-born babies can be safely achieved with existing standard methods, such as sperm-washing and C-section delivery. He also broke many rules of ethical conduct for research, most notably by providing misleading information to his subjects. He showed complete disregard for the well-being of his subjects and their babies, creating embryos without sufficient prior experimentation under controlled oversight or scientific peer review.

Following the public and scientific backlash after the babies’ birth, the response of the Chinese authorities to the experiment became more negative. In December 2018, Jiankiu He was placed under house arrest, his experiment terminated, his data and remaining genetically edited embryos seized (Regalado 2019). SUStech fired him in January 2019, and an investigation launched by regional authorities concluded that he violated Chinese law ‘in pursuit of fame and gain.’ He and two of his team members, Renli Zhang and Jinzhou Qin—both of whom had actually injected the embryos—were tried for violating Chinese law by practicing medicine without a license; violating rules that prevent HIV-positive individuals in China from receiving fertility treatment; and forging ethics approval forms as well as blood tests, among other things. Their sentences were made public in December 2019: Three years in prison and a fine of $430,000 for He, two-years’ prison with a $143,000 fine for Zhang, and a suspended sentence of 18 months in prison with a $71,000 fine for Qin. The trial was held behind closed doors, and little has come to light publicly of the investigation and the evidence presented during the trial. All of which leaves a key question unanswered: Did Jiankiu He carry out the clinical stage of his project with government and university approval?

Who funded Jiankiu He’s research?

Soon after the announcement of the birth of genetically edited twins in October 2018 (a third baby was later born, to a different mother, in 2019), the institutions that publicly supported Jiankiu He’s research denounced his work. SUStech issued a statement to the effect that the university was not aware of He’s experiment, which they said he conducted off-campus (Cohen 2019). Similarly, authorities at the Shenzen HarMoniCare Women and Children’s Hospital, which was responsible for issuing the ethics approval for the clinical trial, claimed that they did not participate in the clinical part of his research and that the signatures on the ethics approval forms had been forged.

Nevertheless, looking at the sources of funding for He’s research can help weed out what university and government authorities knew, or at least should have known, about the project. Publicly available data in English and Chinese language sources indicate that He’s work was in large part supported with public funding. So, it would seem inconceivable that his university and Chinese authorities at the local and national level were unaware of the work. However, He also amassed a war chest of funds from the generous research grants he received for other work from Chinese regional and national authorities and his business ventures, which could have allowed him to carry out the clinical phase of his experiment under the radar, without informing university and government authorities.

To delve further into who funded He’s work, we examine below the funding sources of He’s basic research at the laboratory stage and those that most likely supported the  clinical stage of his  experiment. We then analyze the role that scientific culture in China has played in the CRISPR babies controversy, by emphasizing three key features of this culture—government prioritization of a biotechnology boom (dingceng sheji)the over-emphasis on being first, or “quick success” (jigong jinli), and the weaknesses in federal and provincial oversight of biotech research and development (tian gao, huangdi yuan).

Funding of He’s basic research

There seems no doubt that the basic research laboratory stage of He’s experiment was almost entirely financed with public funds provided by He’s university, the region of Shenzhen, and the Chinese government.

This first stage, which consisted of laboratory experiments on mice and monkey embryos, started in June 2016.

A key source of funding was SUStech, the university that hired Jiankiu He in 2012, offering him a brand new laboratory and a position as associate professor. During that period, Jiankiu He hired staff, and used the facilities and equipment made available by SUStech to carry out the first stage of the experiment: Evaluate the safety of germline editing by studying the likelihood of off-target effects (when CRISPR makes edits at the wrong site) and mosaicism (when some cells are edited while others are not).

Then in November 2016, the team started translating their protocols to non-viable human embryos, injecting about 300 non-viable human embryos with the CRISPR system (Begley 2018). SUStech probably had the funds to support He’s research entirely: The provincial government of Guangdong invested significant sums of money to create the university in 2011 —one year before Jiankui He arrived—with the aim of becoming a world-class research university, as indicated by its promotional literature (Study in China 2018) and reports from institutions such as the Times Higher Education’s World University Rankings (Times Higher Education 2020). But He also had access to two other sources of funding, which might have been used to supplement the university’s funding.

Jiankiu He’s recruitment by SUStech was made under the Shenzhen region’s Peacock Program, set up in 2011 to attract foreign and Chinese talents from overseas by offering state-of-the-art labs, generous research funding, and salaries. The program offers a sizeable tax-free signing bonus as well as start-up funds to its awardees, along with free housing, rent subsidies, and jobs for spouses. To receive the award, applicants must submit a written proposal and present it to a board created by the Shenzhen government. Under this program, Jiankiu He was recruited as a “C level” talent, which in 2012 came with a grant of 800,000RMB, (or $127,000 in US dollar at the 2012 exchange rate). Because the proposal had to be presented in front of a regional board, regional authorities most certainly knew about at least the basic research laboratory stage of He’s project.

In January 2017, Jiankiu He received another sizeable source of funding, as the recipient of the Chinese government-sponsored initiative called the Thousand Talents Plan, which aims to recruit Chinese and foreign scientists and entrepreneurs to work on projects deemed important for China. The program is managed by a dedicated office within the Central Committee of China’s Communist Party, while implementing and coordinating the program is overseen by the Central Talent Coordination Group, composed of representatives from various central government bodies, including the Academies of Sciences, and Engineering, the Ministries of Education, Foreign Affairs, Industry and Information Technology, Science and Technology, and Human Resources and Social Security, and National Development and Reform Commission.

The Thousand Talents Plan provides its awardees a start-up bonus on top of their salaries from their host university of 1 million RMB ($151,000), along with the option to apply for a research fund of 3–to-5 million RMB, as well as other perks such as education and housing subsidies, meal allowances, relocation compensation, and jobs for spouses (Jia 2018).

Jiankiu He was recruited under a sub-program of the Thousand Talents Plan devoted to those younger than 40 years old. This program provides a so-called ‘living subsidy’ of 500,000RMB (about $76,000 at the 2017 exchange rate) and a research subsidy of between 1-to-3 million RMB (about $150,000 to $500,000) for three years. This is a substantial budget that would have allowed He to supplement whatever budget was provided by SUStech and the Peacock program for his research.

In addition to the research grants received from regional and national authorities, He also received public and private funding to launch several biotech companies, which would have offered him additional private funds to support his project. In 2012, soon after arriving at SUStech, He founded Direct Genomics, with a $6 million start-up fund from the city of Shenzhen (Cohen 2019). Another influx of over $40 million came from private investors in 2016 (Coleman 2019). The company produces single-molecule DNA sequencers for diagnostics tests based on a technology originally developed by his former mentor at Stanford University, Stephen Quake. Jiankiu He simplified Quake’s original process and developed a sequencer, called GenoCare Analyzer, that aims to provide Chinese hospitals with a quick sequencing alternative for diagnostic purposes at the low cost of about $100. The sequencers eventually reached the Chinese market in 2017. This was not a small feat: GenoCare Analyzer was only the second Chinese-made sequencer on the domestic market after the larger biotech company Beijing Genomic Institutes launched its own sequencer in 2015. As a measure of He’s rising fame, a Chinese television program called “Extraordinary Guangdong: He Jiankui—The New Top Shot in The Gene World”  featured He and his sequencer in September 2017 (Qiu 2019).

In 2016, He also created Vienomics Biotech, with about $12 million from private investors (He, Zhang and Moon 2018A). The company offers cancer screening via gene sequencing. In 2016, Vienomics Biotech received 10 million RMB (about $1.5 million) from an angel investor, and in 2017 another 20 million RMB (about $3 million) in funding from a Chinese venture company (Wang 2019). It is also worth noting that another company created by He in 2016, Shinzen Nanke Biotechnology, with a capital of about $10 million, was in part owned by Shenzhen South Science and Technology Asset Management LTD, a company owned by SUStech.

In total, between 2012 and 2018, He created or held managing positions in nine companies, in fields that included DNA sequencing, cancer screening, software development, the export and import of technology, and consulting, among other things (He, Zhang, and Moon , 2018B).  He’s wife, Zeng Yan, and his father also hold stakes and managing positions in several of these companies (Tianyancha). Profit data is not publicly available, so it is difficult to ascertain the total net worth of He’s companies. But in January 2018, Jiankiu He was reportedly cited on a government website as saying that Direct Genomics was worth 1.5 billion RMB (over $200 million). One source estimated He’s companies’ total worth to half a billion dollars (Nie 2018). If those figures are reliable, Jiankiu He would have had more than enough funds to cover the cost of his entire project, clinical stage included.

Funding of He’s clinical stage research

The clinical stage of Jiankiu He’s experiment started in March 2017, about a year after the laboratory stage commenced and lasted until November 2018, when news broke of the genome- edited twins’ birth. In early March, the ethics review of his project was granted by the HarMoniCare Women and Children’s Hospital in Shenzhen, and that same month, He teamed up with an HIV advocacy group based in Beijing to start recruiting subjects—couples with an HIV-positive male and a healthy female (Cohen 2019, Marchine 2018). Eight couples were eventually enrolled in the project, but one dropped out before the start of the clinical study due to concerns about the risks of the experiment, leaving seven couples in the study. The editing of the viable embryos was to take place during IVF treatment, which would be covered entirely by the study, at a price tag of about $42,000 per couple (Kleiderman 2019). The study would also offer health insurance to the couples as well as long-term health follow-up for the babies, until the age of 18—and longer if they permitted it.

Jiankiu He claims that he took a leave from his university position to start the clinical trial, and that he used personal funds to pay for IVF treatment for his subjects. IVF treatment alone would have cost a total of about $300,000 for the seven couples. It is not clear how many of the seven couples did receive full IVF treatment. What is clear however, is that only two couples were implanted with edited embryos, each resulting in a pregnancy (He 2018). One couple gave birth to twin girls in October 2018, and the other couple gave birth to a baby sometime in Summer 2019. Jiankiu He stated that the implantation of any more edited embryos was terminated after the backlash from the announcement of the twin girls’ birth in November 2018. Even if only two IVF treatments were completed, the cost for Jiankiu He would have amounted to about $85,000—a substantial sum. However, considering the previously mentioned start-up bonuses he received from the Peacock and Thousand Talents program, and the profits he seems to have made through his companies, it seems entirely feasible that he could have covered the cost of the clinical stage on his own.

He’s rising fame in China as an up-and-coming entrepreneur, his ability to attract investors in his business ventures (including his university), and his business successes all might have prompted university and Chinese authorities to apply less scrutiny on his activities. In turn, He might have felt emboldened to take risky decisions. Jiankiu He seems to have rushed the experiment, completing it in a little over two years, with little care for ethical and scientific principles. He’s slides from the Hong Kong meeting, and a review by a team of experts of his unpublished manuscript about the experiment, both indicate that he did not even perform the most basic quality control steps required to confirm that the edits he made to the CCR5 gene did confer resistance to HIV before insemination. Nor is there any evidence that he attempted to confirm that the edits he made had any effect at all (Regalado 2019). He’s carelessness, however, does not let SUStech and government authorities off the hook. Their responsibility, even if indirect, lies in the effects of the scientific environment they have been promoting for the past decade on research in China.

Jiankui He’s gene editing experiment did not occur in a vacuum. It is important to note that there was a larger social, cultural, and economic backdrop that enabled its birth.

The following sections will examine three issues: the Chinese funding landscape for biotechnology; a culture that prizes scientific so-called “firsts”; and gaps in regulatory oversight in the biotech arena. All three of these overlapping issues created the world in which Jiankui’s experiment was realized. By looking at each of them in detail, we can see beyond the popular, yet simplistic, rhetoric of Jiankui He as a rogue scientist to blame solely for this controversy, and instead focus on the more important individual factors that allowed it to happen. Hopefully, this understanding can provide insight into the elements driving unethical genome-editing experiments, and allow us to see points where we can intervene to stop or lessen future harm.

The Chinese funding landscape for biotechnology—dingceng sheji

Over the past several decades, the Chinese government has gradually moved away from a centrally planned economy to a more market-oriented one. But government still plays a large role in China. The country still operates from a top-down approach, often referred to as dingceng sheji (top-level design), in its economic planning, with the development of successive “Plans” that influence not only decision-making and allocation of resources on a national level, but also on a local and provincial level in China. Based on these Plans, executive branches of the Chinese government decide what research projects are funded. In recent years, China has devoted significant resources and efforts to becoming a global science and technology powerhouse (Xie, Zhang, and Lai 2014)—and the development of its biotechnology sector has been a crucial pillar in China’s ambitions for science and technology ambitions. As it happens, the year 2012—when Jiankui He came back to China from his scientific training in the United States—was a moment of heavy Chinese government investment in the life sciences and biotechnology.

In March 2011, China released its 12^th Five-Year Plan (for the period 2011-2015), which heavily emphasized science and technology, with a prominent focus on what were deemed the seven “Strategic Emerging Industries”—one of which was biotechnology. Priority areas included: building databases of gene resources for pharmaceuticals, important plants and animals, and industrial microbial bacteria; constructing R&D and industrialization bases for biopharmaceuticals and biomedical engineering products; and developing bio-manufacturing application platforms. The central government’s goal was to nearly double the size of these seven industries in China’s economy between 2010 and 2020, to nearly 15 percent of China’s Gross Domestic Product by 2020.

In addition, in May 2015, the Chinese government issued its “Made in China 2025” strategic plan to increase the competitiveness of Chinese industries, reduce China’s reliance on foreign technology, and boost the development of high-tech fields. The plan included the pharmaceutical sectors as a focal point for development.

When the plan came to an end, the Chinese government doubled-down. Its 13^thFive-Year Plan  singled out the biotech industry as a “Strategic Emerging Industry,” particularly in the areas of genomics, personalized medicine, and gene and cell banks. The country also launched its China Precision Medicine Initiative, a 15-year project with $9.2 billion in funding that aimed to make China a global leader in this area. The effort focused on early cancer diagnosis and, subsequently, gene editing, gene therapy and cell therapy (Wien 2018). Around the same time, the Ministry of Science and Technology released its Biotechnology Development Plan, which called for China to lead instead of follow in biomedical technology. In addition to investing in biotechnology to modernize its industrial base, the Chinese government sees this support as a way to address key health needs (particularly the high morbidity from non-communicable diseases) of its population and to strengthen its healthcare system. China sees investment, particularly in genomics, as a way to create more targeted and preventative medicines for its population.

To implement these and other policies, the Chinese government has supported the biotechnology industry through a variety of research and development funding programs, specific ministry investments, development of research parks, and recruitment of overseas talent. For example, in 2016, China’s National Natural Science Fund (NNSF) approved more applications for health sciences (17.1 percent) and life sciences-related (15.3 percent) projects than any of the other six program scientific departments, indicating the importance of this research.

In 2015, the NNSF awarded more than 23 million RMB ($3.5 million) to at least 42 CRISPR projects, more than double the previous year. In 2017, the NNSF doubled again, funding more than 90 CRISPR projects. Overall, from 2013 to 2017, this one Chinese federal government agency had funded more than 270 projects. And that is just one government agency; others funding CRISPR research include the National Basic Research Program and the Ministry of Science and Technology

Over the years, these investments and developments have led to a rapid rise in China’s global rankings in the biotech sector: China rose from the ninth-largest biomedical sector in the world in 2006 to the third-largest in 2010.

This is the key timeframe when Jiankui He returned back to China.

And Shenzhen, in particular, is known as China’s leading innovation hub. This city was selected by the Chinese edition of Forbes with the highest innovation capabilities in mainland China for five consecutive years since 2011 (Kwan 2016). The Shenzhen government aims to bring in more than 10,000 high tech companies by 2020. Since 2007 Shenzhen has been the location for the headquarters of BGI, China’s largest genome sequencing company; several other biotechnology and other high tech companies also set up shop in Shenzhen over the past decade because of the city’s designation as a special economic zone and special financial inducements offered by the local government. Of 111 biotechnology research parks in China, 93 are located in the Gangzhou region, where Shenzhen is located.

As biologist Robin Lovel-Badge of the United Kingdom’s Crick Institute noted: “Money is plentiful to certain Chinese researchers, possibly more so than to their competitors, especially if it means gaining an edge” (Ball 2018). One can understand how Jiankui He was lured back to China by its biotech boom. A number of national, provincial, and local policies and programs supported Jiankui He’s work; and his revenue from his biotech industry holdings also provided additional outside funds to further his research ambitions. Shenzhen, in particular, provided incentives for universities and companies like his.

Scientific culture in China—Jigong jinli: An emphasis on “short-term gain”

As part of its global science and technology ambitions, the Chinese government handsomely rewards scientists who publish in top tier journals and achieve international scientific recognition. One 2016 study by researchers at Wuhan University, Nanjing University of Science and Technology, and Canada’s McGill University found that on average a paper in Nature or Science could earn the scientist a bonus of almost $44,000 in 2016; the highest bonus was $165,000 for a single paper, up to 20 times a typical university professor’s annual salary (Quan, Chen and Shu 2018). Other incentives for publishing in top tier journals include housing benefits and other perks.

Many have argued that the intense pressure in China to produce notable scientific achievements, its scientific rewards system, and the metrics used for evaluation, can lead to severe negative consequences—including a focus on quick, high-impact results, rather than longer term research; incentives for personal advancement rather than scientific progress (Cyranoski 2017), as well as scientific misconduct (Zuo 2018). The 2016 Wuhan University study also found evidence of plagiarism, ghostwritten papers, reviewers being paid to write favorable peer reviews, and other dishonest attempts to get scientific papers published. A survey run by Tsinghua University noted that roughly one-third of more than 6,000 surveyed across six top Chinese institutions admitted to plagiarism, falsification, or fabrication. Other surveys have found similar results (Yi, Nemery, Dierickx 2019). The problems of scientific fraud have been well-documented by Shimin Fang (under the pen name of Fang Zhouzi), a freelance science writer devoted to discovering and exposing instances of fraud, and other scientific misconduct in China.

According to Zeng Guoping, one of the Wuhan University’s survey researchers, these practices are due to the culture of jigong jinli—a Chinese phrase that means seeking quick success and short-term gain (Qiu 2010). Chinese researchers have also noted how scientists are often rewarded with funding due to personal or professional connections with bureaucrats rather than for the scientific merit of a project—especially in the awarding of large research projects, a practice known as guanxi. Some observers would argue that all of these practices are driven by China’s intense drive to be a scientific super power, as revealed by a statement by China’s president, Xi Jinping: “[S]elf-determination in innovation is the unavoidable path … to becoming the world’s … leading player in technology.” These observers would argue that the result has been a research culture that pressures scientists to succeed and permits ethical corner-cutting, such as plagiarism, in order to achieve recognition and rewards (Henry 2017). This does not mean that all Chinese scientists are guilty of misconduct, but that fertile ground has been established for certain scientists to do fraudulent or dangerous research.

Others argue that incentives are not the problem, but instead point to China’s lack of rigorous quality control, oversight, or disciplinary measures for misconduct. According to this argument, the problem lies in how scientists are evaluated to receive funding and promotion, and who does the evaluating—causing Chinese scientists to be rewarded by bureaucrats for productivity, citation scores, and the number of publications, rather than an assessment of the quality of the research (Qiu 2010). 

Jiankui He fits perfectly within this rewards system. As noted earlier, he was a recipient of the Thousand Talents and Peacock Programs. In 2018, He was also nominated for the China Youth Science and Technology Award of the Central Government and the Chinese Association of Science and Technology—although once the gene-editing controversy broke, he was dropped from consideration of this award.

Although China has since passed new reforms to address scientific misconduct, these disciplinary mechanisms were not in place during the time when Jiankui He was most active in his genome-editing research. Engineering Professor Yu Hailiang at Central South University in Changsha argues that efforts to change the culture of science in China will be key to reducing misconduct. Along these same lines, Jiang Wenlai, a Chinese Academy of Agricultural Sciences member, says: “It is not just the problem of the author, it is a societal problem. Just punishing the author will not eradicate the problem.” (Cyranowski 2017)

All of these issues lead to the final problem: weaknesses in oversight.

Scientific culture in China—Tian gao, huangdi yuan: Weaknesses in federal and provincial oversight

These are just a few examples of many problems with medical and biotech developments in China. Reports indicate that implementation, oversight, and enforcement of central government policies and standards for experiments, clinical trials, and pharmaceutical production at the provincial government and local levels can often be lax or weak (Hancock and Xueqiao  2018).

The massive increases in research and spending in science have not been accompanied by parallel growth in regulatory oversight to prevent misconduct. Moreover, the career progressions of local officials are tied to meeting the goals of the national five-year plans. According to professor Willy Shih of Harvard Business School: “Meeting targets for a city, region or province, for example, is the path to advancement for officials in the [Communist] Party. Those who do a superlative job get chosen for prime leadership positions. Those who fail to meet those targets get sidetracked. So the motivation is really quite powerful.”

This can create a situation where Chinese scientists and entrepreneurs (and those who oversee them) can rush innovations to market, without proper safety or ethical considerations.

Problems also plague ethics review boards in hospital and other clinical settings; even when ethics boards exist, there are often conflicts of interest, few enforcement mechanisms for violations, and few guidance or instructions for investigators (Cheng 2018). As a result, Hu Qingli, one of China’s leading medical bioethicists, states that the local ethics review process for medical experimentation is often reduced to a formality, a mere rubber stamp.

In addition, several Chinese cultural traditions discourage whistle‐blowing—due to loyalty to  personal relationships, an emphasis on avoiding damage to reputations or ‘saving face,’ the tendency to tolerate rather than confront misbehavior, and deference to authority (Titus, Wells, and Rhoades 2008). Consequently, the Chinese proverb tian gao, huangdi yuan— “heaven is high and the emperor is far away”—is apt in describing how even though there may be regulations on the books, oversight at the local level is often lax or non-existent in practice. The lax ethical and regulatory environment has led many to consider China the “Wild East” in biomedical research (Tatlow 2015).

What have we learned?

He Jiankiu and the CRISPR babies controversy seem to fit perfectly into the scientific culture created by Chinese authorities over the past ten years, which offers large sums of money to support new projects and prizes scientific firsts. The gaps in regulatory oversight in the biotech arena, and the inability of government authorities to enforce the rules they issue provide scientists and entrepreneurs much greater freedom than the legendary surveillance system deployed in China would suggest.

Therefore, it is conceivable that Jiankiu He did conduct the clinical part of his project without direct knowledge from university, regional and national authorities. It is also possible that Jiankiu He’s sentencing resulted from the fact that he failed in his experiment and brought shame to China’s bureaucrats and scientific establishment.

If Jiankui He had succeeded with an experiment that would have passed Western scientific review (and a Nature or Science paper to boot), Chinese authorities might have been less inclined to punish him, and actually might have further rewarded him—in spite of severe ethical lapses in the experiment.

The Jiankui He case illustrates the importance of monitoring biotech developments in China and whether the Chinese government will work harder to combat scientific misconduct and create more robust ethical norms and practices in science in its quest to become a global scientific leader.

Disclosure Statement

No potential conflict of interest was reported by the author.

Funding

No specific funding.

Acknowledgments

We would like to thank George Mason University graduate students Yizhe Wang, Cathleen Chang, and Shannon Marnien for their research support.

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