Since at least the 1970s and the advent of recombinant DNA technology, there have been debates about the wisdom, value and potential perils of human genetic modification. Until now, however, we have not had the technological tools that define a viable path to realizing this possibility. There was little reason to be concerned about the application of such technology due to the absence of the technology itself and the policy barriers to human application. In the last several years, however, both of these hurdles have been substantially lowered, with the emergence of improved gene-editing technologies, and discussions in the UK and US of permitting modification of human eggs through mitochondrial transfer IVF.
While genetic modification methods have been used successfully for 30 years to alter genes in experimental animals and animals of agricultural importance, these methods have been inefficient, and have often lacked specificity or otherwise relied on a series of steps that made them both inappropriate and unsafe to use in humans. These challenges made it simple to state on scientific grounds alone, with little need for further moral analysis, that it would be wrong to even attempt human germline genetic modification, which has effectively been subject to a universal ban.
More recent advances in gene-editing technology, however (i.e., TALENs, ZFN nucleases, CRISPR/Cas9), mean it is now possible to insert, delete, or modify DNA with greatly increased specificity and efficiency. These techniques are already beginning to be used in somatic gene therapy trials. The application of such technologies in pluripotent and other stem cells, to correct genetic defects or introduce other potentially therapeutic changes, now provides vast scope for applications in human disease and health. This includes the potential for modification of the human germline through the manipulation of early embryos, pluripotent stem cells, or any cell type in the lineage of eggs or sperm. In recent months, there have been several calls for a moratorium on such experiments, and for international discussion and debate.
The Hinxton Group is committed to fostering international efforts to proactively develop guidance on emerging ethical and policy challenges in stem cell science. We believe that clear, well-supported guidance on these issues can help minimize the diversity of national policy responses, easing transnational collaboration, while fostering scientific and ethical integrity.