HE JIANKUI, GENE RESEARCH, AND GENE THERAPY

Norman K. Swazo

ABSTRACT

The international reaction to the human germline editing undertaken in China by Dr. He Jiankui is morally warranted by standards of research ethics and biomedical ethics generally. Here the distinction of gene research and gene therapy is taken into account to argue that Dr. He and his research associates failed in their expected research integrity, violating both Chinese and international best practice standards.  He himself was not a trained and licensed allopathic physician, in which case the goals of medical research and medical practice were unacceptably conflated in the experimental setting that combined CRISPR/Cas9 gene editing with in-vitro fertilization (IVF) treatment. Further, ex post facto effort to provide clinical registration of the experiment violated normal procedures for ethical clearance of such a protocol. The case presents a manifest need for heightened bioethics training for researchers so that they understand the priority of doing no harm (non-maleficence) over providing benefit according to ability (beneficence).