by Meriel CW. (Secretary)

Background

An understanding of Dr. He Jiankui’s research and subsequent backlash is necessary before delving into opinions about his experiment. In essence, Dr. He used clustered regularly interspaced short palindromic repeats (CRISPR) to cause a 32-base-pair deletion in the CCR5 gene of human embryos with HIV-negative mothers and HIV-positive fathers, all for the purpose of establishing genetic resistance to HIV. The results of this research, the birth of a healthy set of twin girls in 2018, led to a firestorm of controversy for the Chinese doctor.

Ethical Problems 

Why was the international scientific community shocked and dismayed? Well, there are a variety of reasons that generally fall into two categories: issues taken with the scientific part of Dr. He’s experiment and issues taken with the experiment itself (publication, transparency, etc.). 

Controversy Regarding the Methods

1. Dr. He modified the embryos with the intention of a potential pregnancy, meaning that the experiment would lead to the possible development of real human children.
2. The specific cells that Dr. He modified were germline cells, so the mutation would be inherited by the offspring of these children. This expands the scope of the experiment’s consequences to future generations. 
3. The procedure was medically unnecessary. Although the father was HIV-positive, there was no evidence that HIV could be transmitted to the child through IVF, which was the fertility treatment that the couple was using.  
4. Dr. He’s methods were rushed. Standard practice would have suggested that he should have tested the induced mutation on animals first. 

Controversy Regarding the Experiment Itself 

1. There are questions regarding the informed consent of the participants, since the documents relating to that appear to be inadequate. 
2. Dr. He’s work was never published in a scientific peer-reviewed journal. Although he submitted his writing to Nature and the Journal of the American Medical Association, both rejected it due to ethical issues. 
3. He also violated China’s Guidelines for Ethical Principles in Human Embryonic Stem Cell Research (2003), which bans the modification of human embryos for the purpose of reproduction.
4. Dr. He had allegedly gotten approval for his research from the Medical Ethics Committee of Shenzhen HarMoniCare Hospital, but the hospital issued a statement laying forth that it was never involved with his experiment and the documents relating to the Medical Ethics Committee had most likely been forged, since no meeting had taken place.  

Opinions 

Modification of Human Embryos in General

I do not necessarily find issue with the genetic engineering of human cells in order to prevent disease. I think that these modifications could greatly improve an individual’s wellbeing and quality of life. If it is within the power of modern medicine to correct genetic disorders or prevent certain diseases, and such changes will have a net positive effect, and there are clear guidelines in place, then it should be permissible. 

Dr. He’s Methods

However, it is necessary to differentiate between an abstract idea (see the above paragraph) and the practical application (Dr. He’s research). With respect to modification for reproduction, I do not believe that the world is ready. Opening this door leads to new questions and possibilities. Those questions need to be answered, and those possibilities need to be regulated. Before modification for reproduction becomes a viable option, if ever, such guidelines need to be in place. It would not be wise to jump in blindly. The same reasoning applies to the editing of germline cells. If induced mutations become heritable, then the scope of impact is widened greatly. This means that, similar to modification for reproduction, new channels will be opened, and they need to be managed. 

Furthermore, Dr. He’s experiment seemed rushed and had not gone through proper channels. This is evidenced by the lack of animal cell testing and the jump immediately to modification for reproduction. His hastiness is most likely what led to such backlash from the international scientific community. Perhaps if Dr. He had tested this induced mutation on animals cells instead, or even on human embryos that were not going to later be implanted, then there would be less controversy. Likewise, if his work had been published in a peer-reviewed journal, which would mean that his research had been approved by an ethics board and his methods inspected by his peers, he would have been able to mitigate the backlash. The fact that it was not published, presumably for ethical reasons, casts a long shadow over the work and suggests that it was not ready to be presented. 

Transparency and Legal Issues

I personally find Dr. He’s legal and transparency issues significantly more egregious. If the allegations regarding Dr. He’s alleged misleading of participants, the dubious informed consent, and the forgery of signatures on documents related to HarMoniCare Hospital’s Medical Ethics Committee are true, then his experiment, no matter what it means for the future of humanity, is unequivocally unacceptable. It is absolutely necessary for modern research to adhere to a certain level of scrutiny, especially when it is with regard to humans. If ethical guidelines are not adhered to, then any conclusions drawn from the work would be sullied, which makes the later use of that information inherently questionable. The pursuit of knowledge must not come at the cost of injury because doing so otherwise would taint the results and possibly discredit the field itself. 

Sources

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. Retrieved April 18, 2022, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6331330/

Liao, R. (2018, November 26). Hospital in China denies links to world’s first gene-edited babies. TechCrunch. Retrieved April 18, 2022, from https://techcrunch.com/2018/11/26/hospital-denies-gene-edited-babies-china/

Marchione, M. (2018, November 26). Chinese researcher claims first gene-edited babies. AP NEWS. Retrieved April 18, 2022, from https://apnews.com/article/ap-top-news-international-news-ca-state-wire-genetic-frontiers-health-4997bb7aa36c45449b488e19ac83e86d

Regalado, A. (2021, October 20). Exclusive: Chinese scientists are creating CRISPR babies. MIT Technology Review. Retrieved April 18, 2022, from https://www.technologyreview.com/2018/11/25/138962/exclusive-chinese-scientists-are-creating-crispr-babies/

Rothschild, J. (2020, May 29). Ethical considerations of gene editing and genetic selection. Journal of general and family medicine. Retrieved April 18, 2022, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7260159/