Faculty Editor: Dr. Heather Olins
In November of 2018, news broke that a Chinese scientist He Jiankui had performed the first successful genetic modification of human embryos. He modified the CCR5 gene of twins Nana and Lulu, in a hope to protect them from the AIDS virus, which is highly present and greatly stigmatized in China (Stein, 2019). Despite not releasing official results, techniques, or any other data that could facilitate replication of the experiment, this news incited panic amongst the scientific community. Numerous studies were launched to investigate the gene targeted, methods that could have been used, and potential side effects. He’s work brought many scientifically and ethically challenging questions to the table for discussion.
He used CRISPR gene editing technology to modify the CCR5 gene, which was hypothesized by He to protect the twins from contracting the AIDS virus (Wei & Neilsen, 2019). Since his work was released, it has been discovered that this CCR5 gene mutation also leaves individuals vulnerable to a host of other diseases, such as the West Nile Virus and Influenza (Wei & Neilsen, 2019), and could shorten a lifespan by up to two years (Weintraub, 2019). This project cost He his career in academia, helped him gain international recognition, gave hope to many fertility clinics, and, most importantly, is surrounded by ethical and scientific controversy. As of December, He’s trial that was closed to the public concluded, and He was sentenced to 3 years in prison and was fine $430,000 (Wee, 2019). Several doctors were put under review, and two other doctors were charged with conspiring with Lee, one sentenced to two years in prison, and the other a year and a half (Wee, 2019).
Generally speaking, the research carried out by He is considered premature given that there was not enough pre-existing research or evidence to validate proceeding with gene editing (Li et al., 2019). He failed to complete the proper experiments prior to testing on human subjects. In China, preclinical experiments on mice and monkeys is standard practice, and He failed to provide evidence of either (Li et al., 2019). It is also required for health care institutions and ethics committees in China to register with the government for legal approval of research to be conducted on human participants (Li et al., 2019). He claims to have received ethical approval from Shenzhen HarMoniCare Women and Children’s Hospital, however, the hospital did not have a legal ethics board (Li et al., 2019). Regardless of the approval He claims to have received, He acted without review from a legitimate research board, and without informed consent from the study’s participants. Regardless of whether He received some form of consent, it was impossible for this consent to have been informed given that the risks and benefits were unknown and unpredictable. In addition to this, He claims to have presented the native Chinese speaking participants with a 23 page consent document which was chock-full of technical jargon (Li et al., 2019), likely far beyond the comprehension level of a non-medical professional, and especially beyond that of a non-native English speaker. Beyond the issue of consent, He’s actions do not just affect an individual or a small group, they affect the entire human gene pool (Wei & Neilsen, 2019). Since CRISPR was used on embryonic cells, the mutation is heritable, and will be passed on to any of the twins’ offspring. Over generations, or if gene editing becomes more common, this has the potential to restrict the biodiversity of an edited population, giving rise to a new host of diseases and biological threats.
Given the strict nature of research on human subjects, He would have never received permission to perform this experiment. By carrying out the research regardless, he opened the world to the possibility, and application of human genome editing. This work has the potential to change the world of medicine and benefit the entire population, but it could also open the door to new threats that it is possible we are not currently protected against. Until the twins’ genome was edited, there was no prominent research indicating the other potential effects of a gene mutation in CCR5. He acted with a non-extensive scientific basis, and violated many regulations set in place to protect human subjects. Following news of this experiment, He was terminated from his professorship, but at the same time received many offers from fertility clinics to continue his work and share his techniques in other countries. This begs the question, should He be allowed to continue his work?
While the actions taken by He Jiankui were premature, unsubstantiated, and frankly unethical, He stimulated a World Health Organization global moratorium on gene editing (Weintraub, 2019). He got people to talk about a previously taboo subject that was perceived to be too distant in the future to warrant contemporary focus. It was known that the technology to make gene editing possible had already been discovered, but without the risk taken by He, who knows how long the scientific community would have debated its morality without making any strides towards putting this technology to use. He has opened the world to a new possibility that could change the fitness of the human population, yet will not publish his work out of fear of the legal repercussions. In order to properly set regulations and standards for gene editing, it is important for legislators to understand the ways in which He operated. That being said, it is important that He not be allowed to continue this type of experimentation. If He were to have completed the proper preclinical testing and received ethical approval from an ethics board, this research could have gone on without controversy. However, since He blatantly disregarded protocol, he should lose his right to continue this research, especially given the fragile nature of working with human subjects
Work like He’s expands the medical field and pushes the boundaries of science, forcing researchers to dig deeper. Despite the unethical nature of He’s actions, the world will continue to benefit from the aftermath of his research. If research was frequently performed as He’s was, the scientific community would be uncontrollable, and lacking ethics and a hierarchy of permission/reporting. However, since this was just one experiment, as of now, the benefits of He’s work are outweighing the risks he took. He got the world talking, and opened the door to new possibilities for life. Now it is up to the rest of the scientific community to decide how they will react.
Moving forward, the focus shifts to how transnational organizations will respond. What will come of the World Health Organization’s gene editing moratorium? Will there be any possibility of experiments such as He’s in the near future? How will guidelines and restrictions be set on a field that so little is known about? Could the procedural failings from He’s experiment repeat themselves, or is it the general ethical governance of research in China that allowed He to exploit the system? Thankfully, in the meantime, it appears no one will be allowed to perform further gene editing experiments on humans without substantial research and a thorough ethics review.
- Li, J. R., Walker, S., Nie, J. B., & Zhang, X. Q. (2019). Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance. Journal of Zhejiang University. Science. B, 20(1), 32–38. doi:10.1631/jzus.B1800624
- Stein, R. (2019, June 3). 2 Chinese Babies With Edited Genes May Face Higher Risk Of Premature Death. Retrieved from https://www.npr.org/sections/health-shots/2019/06/03/727957768/2-chinese-babies-with-edited-genes-may-face-higher-risk-of-premature-death.
- Wee, S.L. (2019, Dec. 30). Chinese Scientist Who Genetically Edited Babies Gets 3 Years in Prison. Retrieved from https://www.nytimes.com/2019/12/30/business/china-scientist-genetic-baby-prison.html
- Wei, X., & Nielsen, R. (2019, June 3). CCR5 -∆32 is deleterious in the homozygous state in humans. Retrieved from https://www.nature.com/articles/s41591-019-0459-6.
- Weintraub, K. (2019, June 3). Genetic Mutation in “CRISPR Babies” May Shorten Life Span. Retrieved from https://www.scientificamerican.com/article/genetic-mutation-in-crispr-babies-may-shorten-life-span/.