Stakeholder Involvement in the Governance of Human Genome Editing in Japan

Asian Bioethics Review https://doi.org/10.1007/s41649-023-00251-8 ORIGINAL PAPER Stakeholder Involvement in the Governance of Human Genome Editing in Japan Tatsuki Aikyo1,2 · Atsushi Kogetsu1 · Kazuto Kato1 Received: 22 December 2022 / Revised: 7 April 2023 / Accepted: 13 April 2023 © The Author(s) 2023 Abstract Genome editing is a technology that can accurately and efficiently modify the genome of organisms, including the human genome. Although human genome editing (HGE) has many benefits, it also involves technical risks and ethical, legal, and social issues. Thus, the pros and cons of using this technology have been actively debated since 2015. Notably, the research community has taken an interest in the issue and has discussed it internationally. However, for the governance of HGE, the roles of government agencies and the general public are also important for an effective regulatory system. Here, we examine the roles of the research community, government, and public in the governance of HGE through an analysis of discussions in the Japanese Expert Panel on Bioethics. During the discussion of the research ethics review system, the professionalism of the research community and the pros and cons of state oversight have become issues for debate. Furthermore, through an examination of the overall policy-making process, three stakeholders are clearly involved in the governance of emerging medical technologies in the Expert Panel on Bioethics, a discussion forum established by government agencies. The contrast among these roles provides insight into the positive roles of government agencies and the research community and the conditions under which these roles are played. We also note that there are diverse actors in the public, which may have an impact on their participation. Our results may serve as a guide for countries and organizations to establish governance on emerging medical technologies. Keywords Human genome editing · Human embryo research · Expert panel on Bioethics · Japan · Ethics review · Governance · Stakeholder involvement * Kazuto Kato 1 Department of Biomedical Ethics and Public Policy, Graduate School of Medicine, Osaka University, Osaka, Japan 2 Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan 13 Vol.:(0123456789) Asian Bioethics Review Introduction In several countries, the treatment of human embryos for medical research has long been debated from ethical and social perspectives. Whether research involving human embryos is acceptable has been regulated differently in each country, reflecting differences in social backgrounds and attitudes. On the one hand, the United Kingdom has a long history of research in embryology and stem cell biology; for example, the world’s first in vitro fertilization baby was born in the United Kingdom in 1978 (Steptoe and Edwards 1978). This has led to the establishment of the Human Fertilisation and Embryo Authority (HFEA), a regulatory authority that controls research and clinical practice of human embryos, in 1990 (Lovell-Badge 2008). On the other hand, in the USA, federal funding was greatly restricted by the so-called Dickey–Wicker amendment that was introduced in 1996, and there was little federal regulation; thus, guidelines were developed by scientific organizations, and these are operating well (Hynes 2008). In recent years, the development of genome editing technologies has led to an increased interest in human embryo research. Genome editing technology using the CRISPR/Cas9 system was developed in 2012 (Jinek et al. 2012), for which Emmanuelle Charpentier and Jennifer A. Doudna were awarded the Nobel Prize in Chemistry in 2020. This breakthrough technology excels in accuracy and efficiency, and its potential for application in medical research, that is, the broad applicability of genome editing of human DNA, has become a reality (National Academy of Sciences, Engineering, and Medicine 2017). This has led to the emergence of various ethical, legal, and social issues (ELSI). The issues associated with human embryo genome editing technology are also relevant to conventional human embryo research. As a result, in the discussions on human genome editing, ethical issues on the use of human embryo, and thus germ cells, are separately considered from those on somatic genome editing. However, some people have pointed out that since safety is the only thing currently supporting this distinction, this will immediately cease to exist once germline HGEs become safe (Evans 2021). With the advent of genome editing technologies, the need for establishing proper research governance has arisen. Tools for the effective governance of human genome editing, such as declarations, treaties, conventions, legislation, and regulations, and organizations responsible for governance, such as national science and medicine societies and institutions, professional self-regulation, public advocacy, and activism, (World Health Organization 2021) have been pointed out. In other words, multiple actors play different roles not only in government agencies, but also in non-government agencies. For example, the research community has discussed with interest the use of genome editing technologies for human embryos (Kaiser and Normile 2015). Scientific self-regulation helps clarify the responsibilities of scientists, implications of their research, and potential reactions from the public (Gregorowius et al. 2017). However, experts have been criticized for dismissing public views as simply ill-informed (Jasanoff et al. 2015). Others have argued that the role of government entities is also important 13 Asian Bioethics Review for an effective regulatory system (Lei and Qiu 2020). Furthermore, the role of the general public in genome editing governance has also received attention (National Academy of Sciences, Engineering, and Medicine 2017). Thus, in light of the advent of genome editing technologies, the roles of stakeholders in research governance, including the research community, government, and public, are being questioned. However, presently, there is no consensus on the desired involvement of each actor, and further research on the involvement of these actors in research governance is required. Studies on human embryos using genome editing in the countries that allow this kind of research are governed by a research ethics review system (hereafter, the ethics review system). The HFEA in the UK and the Embryonic Stem Cell Research Oversight Committee (ESCRO) in the USA are well-known ethics review systems for human embryo research. On the one hand, HFEA is characterized as a national review system that handles everything from basic research to clinical applications involving human embryos. On the other hand, ESCRO is an ethics review system established at the local level for basic research. The ethics review systems for basic research in the medical and life sciences in Japan differ from those (...truncated)