Until last week, embryonic genetic modification was something usually only discussed hypothetically and with non-viable subjects in high-performing medical laboratories or scientific-fiction novels, and usually the latter. He Jianku, a researcher at the Southern University of Science and Technology in Shenzhen, China, made sure that the topic was something the entire scientific community was debating with the announcement of his controversial research findings — the world’s first genetically engineered babies.
Although it has yet to be independently verified under documentation, his research included a clinical trial involving embryonic genetic modification, where he worked with couples where the males were HIV positive, but the females were not. He began his study with in-vitro fertilization, the process of combining an egg with a sperm outside the body, usually reserved for couples experiencing fertility issues. He would then utilize CRISPR-Cas9, a microbiological tool used for genetic modification, banned in the U.S. and several western states as it targets and cuts specific genes. He specifically targeted the CCR5 gene, which is responsible for producing the protein that HIV latches onto in order to infect the human cell. By cutting this gene, HIV is unable to spread throughout the body, which renders the virus harmless. This procedure was completed successfully and reported last week in reference to a couple who gave birth to two healthy twin girls, Lulu and Nana.
Although incredibly groundbreaking, He’s investigation is inundated with several suspected bioethical violations. Bioethics are usually loosely enforced by the respective country’s government and medical regulation boards, such as the United Nations Educational, Scientific and Cultural Organization or the Council for International Organizations of Medical Sciences. They encompass the ethics and moral codes surrounding biological and medical experimentation. Furthermore, many scientists and researchers follow a strict scientific process in order to document, share, and maintain a high standard for their work, a procedure He seems to have completely disregarded.
The screening and consent processes for He’s trials remain undisclosed, but it has become apparent that He offered free in vitro-fertilization procedures to vulnerable parents in search of a solution, which created a serious conflict of interest. In addition, he also completed his trials almost in absolute secrecy, with little to zero oversight from peers and at a point in time when the effects of genetic modification have not been completely researched and are still unclear. Even the creator of the CRISPR method, Feng Zhang, has called a moratorium to halt the use of the technology in gene editing babies, due to the uncertainty surrounding the applications of the technique.
Through this chain of events, it has become apparent that genetic fieldwork requires a unifying standard in order to remain admissible under global ethical standards. For example, He used viable embryos in his study, even when much of the work done to date with genetics has been done with non-viable embryos according to the guidelines of bioethical analysis. Without an overarching board across nations with access to continuous oversight of genetic-editing studies, similar issues concerning bioethics and inhumane research will persist, and professionals like He will likely never have to face the consequences for their failure to uphold bioethical standards.
Currently, regulation of genetic engineering research is done by the government of respective countries with guidelines from CIOMS being loosely enforced, resulting in some countries having stronger and more developed ethics regulations around genetic engineering than other countries, like China. However, the bioethics and weak regulations surrounding genetic editing isn’t an issue that pertains to China alone — many Western European and Asian countries, including Russia and Japan, have varying governmental controls over eugenic research, instigating a plethora of bioethical issues regarding research and genetics globally over the last hundred years. Under the advancement of research technology, the consolidation of regulations between national borders has become critical. If scientists are to share and develop research solutions together, it is essential that both trials and projects, regardless of their location, must be held to equivalent standards of bioethics and biomedical care. This would reduce repetition across studies as well as hold researchers responsible for their actions.
It is now imperative to establish a required and universal full ethics review with all genetic-engineering research projects as well as the process that one must go through under a genetic bioethics board to be able to do so. This process can be facilitated by a subcommittee that can be easily added to CIOMS or UNESCO, with elected research representatives or experts on bioethics from any mandated country with researchers working on projects involving gene editing. By requiring an approval process, consistent reports from each project, and the revocation of any research licenses for any failure to comply, it becomes possible for a governing board to maintain standards and catch ethical violations before they occur.
Regardless of whether the benefits outweigh the risks, performing such trials and studies without previous analysis is not only dangerous to the child, but also to society, as the results of such modifications can affect future lineages and the integrity of the population’s genetic diversity. Allowing genetic engineering to continue globally without oversight as it is today would almost certainly drive the popularization of genetic modification for enhancement and cosmetic reasons.
The future monetization of the industry is unclear, especially with biotechnology companies looking to make a quick buck and profit off parental desires for healthy children. However, the establishment of a regulatory board can aid the genetic-engineering industry from spiraling out of control. An effective board with consolidated guidelines and precautions, when given access to global oversight of research operations, would not only bring biomedical and genetic engineering and research to a higher standard, but also allow for contemporary innovations on a global scale.