The process of how we get from gene to protein is one of the most intensely studied and best understood in biology. The reading of DNA, the generation of a messenger ribonucleic acid (mRNA) and the translation of that transcript into a protein through assembling chains of amino acids. But what we thought we knew about the gene pathway changed forever in 1993, when Gary Ruvkun and Victor Ambros discovered microRNAs. This chapter begins by explaining the basic biochemistry of genes and proteins before moving on to the seminal work of 30 years ago. The objective of those experiments was to understand which genes controlled the timing of animal development in a worm called Caenorhabditis elegans. That led to the realisation that a gene called lin−4, crucial for worms to transition from juvenile to adult stages, did not code for a protein; instead, its RNA acted by sticking to the mRNA of a protein-coding gene. Lin−4 was a gene silencer, working to lower the amounts of protein in cells. The finding of a new step on the journey from gene to protein would go on to transform our understanding of the biology of living organisms.

Human germline genetic modification (HGGM) has been the subject of bioethical attention for over four decades. Recently, however, two areas of biomedical technology have revived debates over HGGM. The current ‘regulatory moment’ with respect to HGGM thus perhaps represents something of a watershed for the global governance of science more generally. This chapter considers broader lessons we might learn from examining the challenges of HGGM for the future of health research regulation. HGGM, I suggest, is a contemporary global regulatory experiment-in-progress through which we can re-imagine the regulation of (in particular, ethically contentious) science and innovation: what it should address, what its purposes might be, and how, therefore, we should go about shaping global scientific regulation. Through examining this, I argue that such regulation should focus on processes and practices, rather than objects; and that its utility lies more in mediating these processes than in establishing absolute prohibitions or bright lines.

In this chapter, we review the key elements of the larger international and transnational framework within which the national legal regimes regulating human germline genome modification exist. Part I is a quick primer to international law and international human rights for the benefit of those who are not familiar with them. Part II presents the relevant norms of international bioethics law, including three main declarations adopted by UNESCO touching on human genome modification. It discusses also the relevant governance activities of the World Health Organization, Organisation for Economic Co-operation and Development and civil society, nationally and transnationally. Part III discusses relevant international human standards, and in particular the so-called ‘right to science’ and the ‘rights of science’. Finally, Part IV discusses how these rights can contribute to the emerging international regulatory framework. This chapter argues that, by itself, international bioethics law and its instruments provide a narrow and inadequate description of the range of human rights that must be taken into account in the conversation on the regulation of germline engineering. These instruments must be integrated with the broader international human rights law corpus. When they are integrated, five key principles emerge as foundations of the emerging regulatory framework: freedom of research; benefit sharing; solidarity; respect for dignity; and the obligation to respect and to protect the rights and individual freedoms of others.