Ethics risk of human genome editing must be addressed

By DOU PENGJUAN / 09-05-2019 / (Chinese Social Sciences Today)
Chinese researcher He Jiankui claimed to have created the world’s first gene-edited babies, but his experiment lacked transparency and supervision and violated Chinese law and regulation, as well as academic ethics and norms. Photo: CGTN


From a professional perspective, genome editing refers to the deletion, replacement and insertion of targeted genes for the purpose of obtaining new functions, new phenotypes and even creating new species. The magic of this technology is that it can modify genetic characteristics with unique and precise editing functions to improve animal and plant traits, prevent and treat malignant diseases, even strengthen humans and revive extinct species. It sounds appealing, like a gardener using a garden knife, trimming the plant at will until it fits his imagination. However, this is precisely where the ethics risk of gene editing comes in.
Human genome editing
As a neutral technology, gene editing is not inherently wrong. However, there is a major flaw in this technology, which is its off-target effects, meaning any deviation from the editing of the targeted genes. The risk of missing a target is not just that it fails to edit the target gene, but more that it could trigger potentially severe unpredicted consequences.
The powerful function of gene editing, its enormous scientific research value and huge commercial value all determine that if there is no “gatekeeper” for gene editing, whoever holds the technology may violate ethics and even conduct illegal and criminal acts under the temptation of great reward. Therefore, an ethical review procedure for gene editing is essential in all countries.
If the target of gene editing is human genes, missing the target will risk putting the edited individual and the whole of humanity in danger. Back in 1999, an American boy died after an intense immune response was triggered while undergoing gene therapy. Indeed, the editing of human reproductive genes could threaten the entire human gene pool due to genetic effects. Therefore, whether human genes, especially reproductive genes, can be edited and used in clinical trials is the most heated discussion in ethics.
In 2017, the National Academy of Sciences and the National Academy of Medicine in the United States released the report “Human Genome Editing: Science, Ethics, and Governance.” It points out that the human application of reproductive gene editing in the clinical treatment of patients requires strict ethical review. Ethical review is equivalent to having a gatekeeper of gene editing, which ensures that scientists strictly abide by the bottom line of life and scientific ethics, prevents the use of gene editing for evil purposes, and guides this technology to solve the right problems.
Ethics committee
At the end of 2018, Chinese researcher He Jiankui claimed to have created the world’s first gene-edited babies; he shocked the world and was universally condemned. He crossed the bottom line of ethics and even violated the law. This is still a grey area though, as technically there are no laws and regulations on gene editing in China at present.
Currently, the legal regulation in this field mainly relies on the normative documents and regulative rules issued by the former Ministry of Health and the Ministry of Science and Technology. Some of the contents involve the ethical review of gene editing.
For example, the regulations on the management of human-assisted reproduction stipulate that the application of human-assisted reproduction technology should conform to ethical principles, that medical institutions applying for human-assisted reproductive technology should have medical ethics committees, and that the ethical issues involved in the implementation of human-assisted reproductive technology should be submitted to the medical ethics committee for discussion.
If we examine the existing norms, the ethical review of human gene editing in China can be summarized as follows. First, China adheres to the principle of ethical review and supervision, and biomedical research involving human beings can only be done on the premise of passing the ethical review.
Second, the ethics committee should independently carry out the ethical review, and it should be subject to the supervision of relevant regulatory departments. 
Third, the ethics committee is mainly responsible for three duties: protecting participants and promoting standardized research, conducting whole-process ethical review and supervision of the research project, and carrying out relevant training.
Fourth, the selection of members of the ethics committee should include not only biomedical professionals, but also experts from other fields such as ethics and law, as well as other persons outside the institution. 
That is to say, there is a legal ground for the ethical review of human gene-editing operations. The problem, however, is that the legal hierarchy of existing norms is too low to deter and prevent wrongdoing. 
In the whole regulatory system of human gene editing, the ethics committee assumes the core responsibility, but it lacks effective and practical tools of punishment for those who do not comply with the existing norms. 
In China, the ethical review is often conducted by the ethics committee within the medical institution. However, whether the ethics committee can abide by the independent principle to review and supervise in practice is questionable. 
In fact, the scenario is not optimistic and what happened with He is not an isolated case. According to authoritative sources in the industry, China’s ethics committees are currently faced with problems such as inconsistent management along with insufficient access, certification standards and regulatory mechanisms. Any small hospital can set up an ethics committee, some of which are just superficial in form. Under the imperfect legal system, it is difficult to prevent self-regulating scientists from stepping over the red line of ethics and law.
Going forward
As Yuval Harari wrote in his Homo Deus: A Brief History of Tomorrow, biotechnology and information technology bring new powerful forces to the human race. Now, how to use them has become a pressing issue. 
As the gatekeeper of gene editing, the ethical review and supervision power of the ethics committee must be legally regulated.
Some countries introduced laws on bioethics and human embryo research as early as the 20th century. For example, a French law sponsored by French Senator Claude Huriet was passed in 1988, which provides the legal framework for protecting the participants of biomedical research, the scientists performing the research, and the persons or institutions sponsoring the research. 
Chinese scholars have also proposed a human genome editing law. When He stirred up the controversy, some scholars renewed their proposal to strengthen the medical ethics review system within the current legal framework. 
However, in reality, laws may not be perfected all at once, while human gene editing and ethical review are closely related to the future and destiny of all mankind, which means that departmental regulations and regulatory documents are far from enough. As a transition, laws may be stipulated based on existing norms.
The effectiveness of ethical review depends largely on the independence of the ethics committee. According to France’s Huriet-Sérusclat law, ethics committees are absolutely independent and endowed with legal person status. To draw from this experience, we must establish an appropriate separation mechanism between ethics committees and the bodies they report to, so as to enhance their independence in performing their duties. 
Moreover, the stakes in human gene-editing operations are so high that the power to review and oversee such research projects should be better vested in higher-level ethics committees. Considering the existing structure of ethics committees in China, it is appropriate to grant this power to the committees set up by health administrative departments above the provincial level. For important scientific research projects, the ethics review should be conducted by the highest level ethics committee.
That said, the independence of ethics committees does not mean that they are exempt from supervision. Instead, ethical reviews of human gene editing must be subject to the strictest possible oversight. The incident highlights regulatory loopholes in China’s ethical review. It has also become the common demand of the public to strengthen supervision, including self-regulation, government regulation and social regulation. 
It is particularly important to encourage social supervision by providing channels and means for the public to supervise the ethical review and even give them the right to vote on whether or not to approve scientific research projects, if necessary.
Dou Pengjuan is from the Center for Rule of Law Strategy Studies at East China University of Political Science and Law.
edited by YANG XUE