People expect medical science research to proceed at an orderly pace and in an ethical manner. In order to avoid the mistakes of the past, there are government agencies, university ethics boards, and personal responsibility codes to prevent investigators from acting inadvisably and taking unnecessary risks. Occasionally, however, an individual or individuals will decide to push against those boundaries and proceed in a manner that seems to run counter to these ethical constructs in order to further their research. The most recent of example of this behavior was announced to the world on November 28, 2018.
On November 28, 2018, He Jiankui announced to the world that he has used CRISPR-Cas9 technology to genetically modify to human embryos. These embryos were successfully transplanted into a womb and has resulted in the birth of twin girls (Botting, 2018) (Marchione, 2018) (Stein, 2018) (Zimmer, 2018). If true, this represents the first instance of CRISPR technology use to produce genetically modified human beings.
Prior to this action, modification of human germlines has been discouraged by the majority of scientific bodies with over forty countries having a ban on such research in place (Lanphier et al., 2015). It is, perhaps, significant to consider that the announcement was made at the Second International Summit on Human Genome Editing, a conference with the express purpose of exploring the questions related to the possibility of human germline editing. As Dr. He has jumped the scientific gun, as it were, the questions of the safety, ethics, and governance of these procedure take on even more importance and urgency.
- Is CRISPR-Cas9 a safe technology for human germline editing?
- Did Dr. He act in an ethical manner by proceeding with this study?
- Is this work an example of unregulated human experimentation?
- How should this type of work be regulated in the future?
- How might this work affect the rights of the newborn children?
Background
Dr. He has a faculty position at the Southern University of Science and Technology in Shenzhen, China and owns two companies dealing with genetic engineering (Stein, 2018). While on leave from the University, He began a project to knock out the CCR5 gene. This gene produces a protein critical to the HIV infection pathway, and it has been shown in models that knockout of the CCR5 gene can prevent HIV infection (Baba, 1999) (Elsa et al., 2018). In this specific case, the embryos were created with invitro fertilization. The egg was provided by the HIV– mother and the sperm provided by the HIV+ father. The hope of the work was to offer HIV protection to the resulting offspring.
The above question is rather broad. Therefore, before considering the ramifications of this situation, it would be helpful to examine a case study of another instance of researchers rushing ahead. A recent example is provided by the work on H5N1 virus modification.