Ethics of mitochondrial gene replacement: from bench to bedside

Medical research in humans is highly regulated and has embedded ethical procedures and standards. However, whereas review and formal oversight have been established for drugs and medical treatments, this is not the case for new reproductive genetic technology. Many questions of safety are wholly or partly resolved by experience from use of the technique—a try it and see approach.1 Attention has now been drawn to this gap. The European Society of Human Reproduction and Embryology, the US President’s Council, and the UK Medical Research Council concluded that professional societies and clinicians should develop a more systematic mechanism for reviewing experimental procedures before they become standard clinical practice.2 3 4

The importance of revisiting research ethics for reproductive genetic technology has been underscored by recent technical successes that may pave the way for the development of mitochondrial gene replacement for carriers of mitochondrial DNA (mtDNA) mutations.5 6 This novel technique could be a valuable addition to current reproductive strategies but also raises an array of technical and ethical issues,7 especially in relation to first human application. Here we identify some pressing issues for the purpose of initiating timely debate.