Bioethics is not a single academic discipline; rather it is a field of interdisciplinary activities including philosophical exploration, empirical studies, legal studies, social activism , and policy development. Some of the early pioneers in East Asia n bioethics were medical educators who tried to strengthen the professionalism in medicine. There are various reasons to introduce bioethics discourse to a country: sheer academic interest in applied ethics; help inform a policy before investment in Research and Development; or introduce a topic of bioethics in which society should become engaged. Some cases related to research fraud compelled the development of bioethics, such as WS Hwang’s Nuclear Transfer Stem Cell scandal in South Korea (NTSC scandal 2005). These cases caused public alarm and first elicited professional responses in positive as well as negative ways, and then garnered academic interest. Bioethicists from various disciplinary backgrounds came together, trying to understand and resolve the concerns raised by each case. Meanwhile ethical frameworks began to take shape, depending on their urgency and potential (Sulmasy 2010). Following the introduction of bioethics into East Asian countries, bioethics analysis was initially focused more on the legalization of practices involving bioethical issues such as abortion, organ transplantation, genomic research and cloning. Most ethical issues were discussed in response to the regulatory measures proposed for certain practices but were also related to clinical and research activities. In the case of genetic research and human cloning, robust ethical debates took place involving various stakeholders, including the public, and consequently many governments enacted human subject protection codes and required national or institutional research ethics oversight. Such trends in enhancing governance of biomedical research continue and many countries have adopted the necessary legislations to regulate controversial areas of clinical practice.

As observed by several commentators in this region, bioethics was first imported, and then developed (Akabayashi 2009; Li and Cong 2008). Although it can be said that bioethics standards were initially adopted to address pressing administrative and practice issues, there has now been time for reflection on how these Western bioethical approaches can be adapted to the local context. While ethical principles must be accepted because they are based on a common understanding, the development of bioethics and bioethical approaches still require the on-going processes of: introduction; execution; critical appraisal of the theory; and the adoption of bioethical theories, frameworks and approaches. For example, countries have chosen one of three approaches to research ethics oversight: autonomous regulation by professional associations; the establishment of institutional ethical oversight mainly by research ethics committees, also called Institutional Review Board (IRB); or national bioethics advisory bodies established by bioethics-influenced legislation. It is worth noting that bioethics discourse in East Asia n countries developed as a result of the interaction between government, researchers, physicians and bioethicists. Government has been a supporter of bioethics by funding activities and enacting legislation, even though bioethicists are not always in agreement with the government’s approach. While limited in their ability to effect change, researchers and bioethicists are sensitive to the ethical issues raised by research and health care, and have launched discussions on many important bioethical issues. It should be noted that the UNESCO-IBC’s documents on bioethical issues have also provided support to the relatively few bioethicists when engaging the public’s interest on bioethical issues. In addition, the UNESCO-IBC has responded to bioethical issues with deep insight, developed guidelines by international consensus and also suggested practicable alternatives.

The above summary has described the social and political influences on the development of East Asia n ethical approaches. Next, the influences of law, institutional and organizational policy and academia on current East Asian bioethics will be discussed.

Bioethics was introduced around the 1970s, yet many countries had already identified ethical issues and enacted laws to regulate related practices, for example abortion laws. Since that time, many more bioethics-related laws have been enacted on a variety of topics, such as organ transplantation, medical practice (professionalism, informed consent), end-of-life care, biomedical research, human research subject protection, and human reproduction. Many of these laws reflect each country’s particular understanding of socio-cultural norms and human rights principles. However, laws related to international bioethical issues, such as organ trafficking, stem cell research, medical tourism, and multinational clinical trials, remain greatly influenced by international regulations and guidelines. For instance, while international biomedical research is directed by the Declaration of Helsinki and CIOMS guidelines in general, genetics and human cloning are guided by UNESCO Declarations (WMA 2008; CIOMS 2002; UNESCO 1997).

As the legislative process in a given parliament is a political response to social attitudes and reflects the necessities of that time, a review of legislative history tells us something about a particular society’s ethical norms. For example, Korean laws have resulted from the differing social dynamics: the abortion act was set up during a period of rapid economic development (1960 to 1970s); the organ transplantation act was introduced after rapid development in clinical medicine in 1990s; and Bioethics and Safety Act resulted from turbulent stem cell and human cloning debates (Hahm and Lee 2012). In the year 1999, the Korean National Commission for UNESCO (KNCU) organized the ‘Consensus Conference on Cloning’ in order to listen to the public’s opinion on human cloning, and through which the citizens reached consensus that: human life starts at the point in time right after fertilization, and human or embryo cloning should be prohibited because human dignity would be harmed if embryonic tissue were used as research material. This consensus was the starting point of Korea ’s Bioethics and Safety Act (2005).

In 2002, the KNCU organized a workshop on ‘Science Technology and Ethics’ celebrating the World Science Day for Peace and Development, in which participants opened up discussions on topics such as human cloning and lack of privacy of personal information when using the Internet (KNCU 2002).

Bioethics committees and research ethics committees are important contributors to bioethical deliberations and decision-making processes (UNESCO 2010). In many East Asia n countries, bioethics development was initiated by discussion about research ethics and strengthened by the establishment of research ethics committees (RECs). All countries in East Asia except Thailand , have established both committees for the review of research studies as well as national bioethics (advisory) committees, many of which were set up after the successful cloning of Dolly, the sheep in 1996.

In East Asia n countries, ethical oversight of research and consultation is a basic role of REC. These committees were introduced in the late 1980s to early 1990s, and research ethics review became mandatory in the early 2000s. The current issue is how to improve the quality of ethics review by these committees. Domestic accreditation systems (i.e. the Korean IRB registration system) and international accreditation organizations such as The Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP 2011) are currently operational (Son et al. 2014). Even though accreditation or certification of ethics review committees is not required, all committees have developed and follow Standard Operating Procedures (SOPs), and regularly offer continuing education to IRB members to ensure quality ethics review.