For several years, molecular biologists have tried to develop methods that would enable them to repair cellular damages or cure gene-linked diseases by rectifying the associated changes in the DNA. To meet the requirements, genome editing technologies have been developed. However, the use of genome editing technique has always remained highly debated. The discovery of CRISPR technology’s power in terms of its simple approach, cost-effectiveness, and high accuracy, has sparked the debate once again.
All these advantages have led to increased use of CRISPR/Cas9 genome editing in diverse fields related to plants, animals, humans, and environments. However, the major concern of using a genome editing technology arises from its use in humans to alter germline cells and embryos. In addition to human genome editing, ethical concerns also include the risks of using CRISPR/Cas9 genome editing in agriculture, animal breeding, and the environment.
Compared to somatic cell editing, germline cell editing has serious bioethical issues since any undesired gene edit in the human genome and the consequent adverse effects could be inherited by future generations. The creation of genetically edited babies by Dr. He Jiankui in 2018 reignited the fierce debate. The possibility of off-target effects and mosaicism in genome editing technology raises the primary concern.
In general, scientists and researchers believe that until deemed safe through research and thorough evaluation, germline editing should not be used for clinical purposes and should be avoided at best. As of 2014, 40 countries prohibit germline editing.
In addition to the concern regarding the safety of genome editing technology including the CRISPR/Cas9 method, there are other ethical issues that need to be considered. Firstly, obtaining informed consent from patients for germline therapy would be difficult since their decision would impact their children and future generations to come. The easy availability of genome editing technology could increase the disparity between the rich and the poor in terms of the healthcare facility that they can avail of. At an extreme end, the extensive use of genome editing for germline editing could also mean that in the future, the quality of genome editing technology would predict the class of individuals created. An increase in the use of genome editing in therapies would also imply that the use of conventional medicine would gradually decline. Moreover, genome editing of embryos could have moral and religious objections.
Due to these ethical concerns, NIH and Federal funds cannot be used for any gene editing research on human embryos. However, the ethical stand remains divided. Some countries allow non-viable human embryos to be used in gene editing studies, while there are others that allow the use of both viable and non-viable embryos (leftover from in vitro fertilization). However, most agree that genetically edited embryos should not be implanted with the intent of giving birth.
Thus, although Dr. He Jiankui was condemned globally for his irrational act of using CRISPR/Cas9 to genetically modify babies, opinions remained divided on whether CRISPR/Cas9 technology should be acceptable in the future for embryos and germline cell editing. However, scientists unanimously agree that there is a need to continue research efforts to develop gene therapies and to prove them to be safe and effective.