Bioethics Forum Essay
Is Chinese Bioethics Ready to Move Forward from the CRISPR Baby Scandal?
The Third International Summit on Human Genome Editing is being held in London this week. Chinese biophysicist He Jiankui’s illegal experimentation with heritable human genome editing, announced at the Second International Summit in Hong Kong four years ago, will haunt some of the discussions. To what extent has the Chinese bioethics community addressed gaps exposed by the CRISPR Baby scandal and prepared to prevent similar future scenarios?
The newly published updated version of China’s Measures for the Ethical Review of Life Science and Medical Research Involving Humans,as well as our reflections on the first public bioethical discussion of Chinese academics with He, recently gave a mixture of optimism and concern. While China has made substantial improvements in its national ethics review regulation, vulnerabilities remain. More importantly, we argue that, in addition to legislative updates, encouraging a culture where Chinese academics feel comfortable having open and frank conversations on challenging questions is critical for the improvement and delivery of ethical oversight.
Three ethical governance gaps exploited by He
If He’s CRISPR Baby experiment proved anything, it was his deftness in exploiting vulnerabilities in the system of research governance. At the time, He was an academic at the Southern University of Science and Technology funded by the Shenzhen Science and Technology Innovation Commission, and his research involved at least two hospitals in China. He succeeded in bypassing four separate institutions, described in an article in the leading news outlet The Paper.
Enforcement has always been a challenge in China’s research governance. He Jiankui exploited at least three system vulnerabilities that the China’s bioethics community has long campaigned for regulatory attention to. First, He’s case demonstrated the danger of China’s widening regulatory gap between a national push for academics to engage with the industry and private ventures and a chronic negligence of building corresponding ethical and governing infrastructures for them. Second, He’s successful evasion of administrative supervision reminded us of the fragmented nature of China’s science governance. In the absence of a transparent regulatory culture, Chinese institutions often have little idea of what one another is doing (or not doing). Finally, there are regional and institutional disparities in governing capacity and in general awareness of what constitutes research ethics. For example, the informed consent that He used was more like a business contract aimed at protecting researchers and research institutions from future legal obligation than an ethics document designed to inform and ensure patient welfare.
China was quick to address regulatory gaps exposed by He Jiankui. Within a couple of months of his announcement, China’s National Health Commission started work to update its 2016 “Measures on the Ethical Reviews of Biomedical Research Involving Humans.” One of us, Ruipeng Lei, provided a series of expert consultations in the drafting of the updated Measures. In 2020, the idea of promoting ethical governance was officially incorporated into China’s national agenda through the central government’s founding of the National Science and Technology Ethics Committee. In March 2021, a draft version of the new ethics review measures in biomedical research was released for public consultation. A year later, a draft of the Implementing Rules for Human Genetic Resources Management was released for public comment. (The final version is expected to be released this year.) The 2022 promulgation of the Guidelines on Enhancing Ethical Governance of Science and Technology led to the establishment of a dedicated task force on university education on ethics in science and technology. The promulgation of the 2023 Measures was the latest, and arguably the most important and comprehensive national legislation on bioethics China introduced since 2018.
While the 2023 Measures provides substantial regulatory upgrade on a range of issues, the impact of He’s scandal was also quite evident. This can be seen in the following categories of changes.
First is a much anticipated widening of regulatory scope. The 2023 Measures broadens ethics reviews beyond conventional human subject research to include studies involving human cells, tissues, organs, bodily fluid, flora, fertilized eggs, embryos, fetuses, bioinformation and associated data, health records, and human behavior (Articles 3, 50, 51). In addition, all research institutes—including medical institutions, universities, and institutes collaborating with industry and business–must observe the ethical clearance and supervision stipulated by the 2023 Measures (Articles 2, 28). There is special caution for research relating to human reproduction or involving cloning, heritable genome editing, germline cells, embryos, and fetuses (Article 17). In other words, the 2023 Measures makes it less likely for life science research to evade ethics reviews.
Second, the 2023 Measures further identifies a list of inactions and wrongdoings subject to penalty. They include using (or fabricating) one hospital’s ethics review for research conducted in another hospital, as He did in his 2018 experiment. Researchers are also subject to sanctions when they fail to report to the ethics committee on research progress or fail to submit records on the national research database (Article 46). These changes help to reduce disparities in ethics oversight across different research entities and research topics.
The third category of updates is the policy’s specification of how research participants are to be informed and empowered. For example, Article 36 stipulates what must be included in informed consent. Furthermore, for the first time, institutions are obliged to ensure that ethics committees are sufficiently funded and have appropriate human and material resources, and that they provide regular ethical trainings to scientists, administrators, and students (Article 39). These requirements will no doubt increase governing capacity and general awareness of responsible research.
However, key ambiguities remain in the 2023 Measures, which make it potentially vulnerable to exploitation. To begin with, it falls short of directly addressing privately funded life science research, even though the ability to collect and access health data and bioinformation extends beyond academia and is exercised by social and private ventures.
We draw particular attention to Article 32, which allows ethics review exemptions for life science research with publicly available data, anonymized bioinformation, existing biosamples, and biomaterials within the scope of original consent (with the exception of germline cells, embryos, and reproductive research). For the time being, projects that meet the exemption criteria will be based in hospitals, universities, and research institutions with codes of conduct that will keep research in check. However, as scientific practice continues to evolve beyond and across traditional research institutions, such a broad description of ethics review exemption may create regulatory loopholes.
Another missed opportunity in the 2023 Measures is that while it requires individual and institutions to record research activities in a consolidated national medical research database, a recording (bei-an) is not registration, which would necessitate review and approval of the record submitted. Having a consolidated national database itself does not help prevent or identify possible research misconduct. It is important to remember that He Jiankui submitted a record of his CRISPR research to China’s database, but the information was not reviewed by an authority.
For China to minimize the chance of future regulatory failure and advance the credibility and influence of its ethical governance, new policies are not enough. China also requires a cultural change to encourage more of its academic researchers to initiate and contribute to open and inclusive bioethical discussion on new technologies, especially those that raise controversial issues.
Normalize inclusive participation, resist politicization
One governance challenge exposed by He’s case that has been largely ignored is how the politicization of research misconduct and scandals often impedes collective reflection and finding appropriate solutions.
In China, He and his research have been seen as a national disgrace. Public academic and media discussions on this topic have become extremely scant because it is seen as politically sensitive. In fact, at the time of writing, details of He’s three-year prison sentence, which ended last year, and the restrictions put on his research involving humans are still not in the public domain and are opaque to most scientists and bioethicists. In contrast, He has been marketing his new private venture on gene therapy for DMD. But concerns of political sensitivity in China have restrained public discussion of He’s statements, giving him considerable freedom to spread misinformation to patients, and leaving his hyperbolic claims on his DMD research unchecked and unchallenged.
Internationally, events with He such as Harvard’s small circle closed-door discussion in 2022, have fueled his PR strategy. No findings from the Harvard meeting have been made public. Gatekeeping access to information to a small circle seems to legitimize China’s lack of transparency on He and his research. The distorted image of an elite Western university conducting a closed-door investigation of He also fans national divides within global scientific community. The perceived lack of transparency of Western institutions and an already pervasive nationalist sentiment in China have made public reflections on He and his work even more difficult in China.
To resist the stagnating effect that the politicization of He’s scandal has brought to ethical and regulatory dialogue, we convened the first open bioethics discussion on CRISPR technology for and with Chinese academics on February 11. Called ‘Looking Back into the Future: CRISPR and Social Values, it was also the first public event at which He agreed to interact with Chinese bioethicists and other CRISPR scientists.
We consider it important for Chinese bioethics to develop its credibility and influence by enabling academics to discuss controversial cases in public. Approximately 110 participants from 13 countries attended this meeting, including at least 70 Chinese academics from 12 provincial jurisdictions in China. We originally hoped that He, with the three other Chinese CRISPR scientists we invited as speakers, would look back at his research experience and comment on how ethics and scientific research can be better integrated in China. But we also anticipated that He may use this event as a publicity stunt and refuse to engage with critical questions. However, we considered that, given his active recruitment of DMD patients for his new study, his refusal to clarify key questions recorded in a public event was also of public interest.
At the meeting, He did not discuss his past work and refused to answer questions from the audience, raising concern with Chinese scientists and their global peers that he does not have a plan in place to carry out his DMD gene therapy research responsibly and ethically. More significantly, the event prompted Chinese scientists to consider the administrative gaps in their everyday research. It also nudged Chinese mainstream media to publicly challenge He for the first time on his DMD research and call for further public oversight. As a result, He halted his online marketing to patients.
On March 2, more than 200 Chinese bioethicists, lawyers, and scientists, along with DMD patient representatives, had an online meeting on how to better govern genome editing in China. It was co-sponsored by the Center for Ethics and Moral Construction Research at Renmin University of China, the Center for Technological Ethics Research at the Beijing Stem Cell and Regenerative Medicine Research Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, the Center for Bioethics Research, and the Research Center for Life Ethics at Huazhong University of Science and Technology. A consensus statement was later jointly endorsed by the speakers, condemning He’s irresponsible gene therapy research and calling for regulatory transparency and the open discussion of controversial issues globally.
As we have argued elsewhere, the best way to promote a more transparent and accountable regulatory culture in China is to enable more ordinary scientists to have a voice in both domestic and international debates. Ethical governance cannot be achieved simply by extending rules and regulations. It is crucial for Chinese scientists to feel supported and respected when participating ethical discussions, especially on controversial issues. Is Chinese bioethics ready to move forward from the CRISPR baby scandal? As one Chinese academic platform, ScholarSet, summarized, for He Jiankui, a denial of the past is a denial of a future, yet Chinese science and Chinese bioethics must walk out of the shadows and turn a new page, collectively and responsibly.
Joy Y. Zhang, PhD, is a sociologist and founding director of the Centre for Global Science and Epistemic Justice at the University of Kent in the U.K. (@DrJoyZhang)
Ruipeng Lei, PhD, is a professor in the School of Philosophy and Executive Director of HUST Centre for Bioethics, Huazhong University of Sciences and Technology in China, vice president of Chinese Society for Bioethics, a member of WHO COVI-19 Ethics and Governance Working Group, and a Hastings Center fellow.