In the field of medically assisted reproduction (MAR), there is a growing emphasis on the importance of introducing new assisted reproductive technologies (ARTs) only after thorough preclinical safety research, including the use of animal models. At the same time, there is international support for the three R’s (replace, reduce, refine), and the European Union even aims at the full replacement of animals for research. The apparent tension between these two trends underlines the urgency of an explicit justification of the use of animals for the development and preclinical testing of new ARTs. Considering that the use of animals remains necessary for specific forms of ART research and taking account of different views on the moral importance of helping people to have a genetically related child, we argue that, in principle, the importance of safety research as part of responsible innovation outweighs the limited infringement of animal wellbeing involved in ART research.

The field of reproductive medicine has been criticized for introducing ARTs without systematic research on possible safety risks and for failing to meet the standards of evidence-based innovation held elsewhere in medicine. In this paper, firstly, we ask whether ‘responsible innovation’ has been a concern for the field, and if so, how it has understood the practical implications of this idea for the development and introduction of potentially risky new ARTs. Secondly, we consider whether the field has indeed fallen short of its responsibilities in this respect, and if so, how things can be improved. To answer these questions, we present three case studies involving the introduction of a new reproductive technology: ICSI, preimplantation genetic testing and mitochondrial replacement therapy. As a framework for analyzing these cases, we used Per Sandin’s account of the four dimensions of dealing with risks (threat, uncertainty, action, command) that are central to debates about the possible role of the so-called precautionary principle. We conclude that, although offspring safety concerns have been on the agenda of the debate about bringing the relevant technologies to the clinic, systematic safety and effectiveness studies were not always conducted. As professionals in assisted reproduction have a responsibility to take account of the welfare of the children they are creating, we suggest a policy of proceeding with systematic caution. Legal measures may be needed to ensure that professional guidance is followed in practice. Finally, an open question concerns the threshold for acceptable risk in the context of introducing new ARTs. Multiple stakeholders, including professional societies and patient organizations, should have a role in the urgent debate about this.

It is widely acknowledged that the responsible introduction of new assisted reproductive technologies (ARTs) requires preclinical safety research, including the use of animal models and human embryos. However, the moral sensitivity of human embryo research has led to regulations and guidance stating that human embryos may only be used for research that cannot also be conducted with animals. We call this the 'use animals first' (UAF) rule. In the field of ART research, this translates into the notion of an ideal chain of consecutive preclinical research steps, where research using human embryos may only be considered as a further step after promising results have been obtained in animals first. This may lead to research ethics committees requiring animal studies that are in fact a waste of time and money, while exposing animals to an infringement of their wellbeing for no good purpose. In this paper, we explore the possible moral arguments behind the UAF-rule and test their validity. We conclude that there are no convincing grounds for upholding this rule and recommend replacing it.

is a PhD Candidate at the University of Maastricht, the Netherlands, and specializes in biomedical ethics. Her research investigates how new medically assisted reproductive techniques can be introduced into clinical practice in an ethically responsible way.

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