Turning Ethics into Institutions: The Techno-politics of Human Research Regulation in Taiwan

Abstract

This article provides a critical assessment of the development of Taiwan’s ethical framework for regulating medical and biopharmaceutical innovations. Advancing science, technology and society scholarship that treats ethics as subject to modification, adjustment and negotiation rather than as an abstract set of principles, this article examines the dominant role of East Asian states in the development of the life sciences. It also looks at the logic these states utilise to legitimise their therapeutic standards and to support the biopharmaceutical infrastructure in order to increase their economic competitiveness. In particular, this article traces the establishment of legal regulations in different social settings where innovations in clinical practice and medicine are introduced. It argues that, instead of a comprehensive, coherent ethical framework based on the adoption of international conventions, Taiwan’s 2011 Human Subjects Research Act is a techno-political assemblage, an inconsistent legal product involving not only policy makers but also physicians, the pharmaceutical industry and the state. This article also takes a critical stance towards institutional review boards (IRBs), which resolve jurisprudential conflicts within this legal framework of human research. It argues that, rather than being passive organisations that protect research from unethical fraud, IRBs in Taiwan have been institutions in which negotiations among investigators, research sponsors and the government are conducted in the name of health governance.

Situating Ethics in the Techno-politics of East Asia

Life science and biotechnology experienced drastic changes in the first two decades of this century, and many ethical issues have yet to be addressed in order to cope with these shifts. This is especially true in East Asian states, where the gap between the advancement of biopharmaceutical research and ethical practices for these endeavours is widening. There were debates regarding ethics and scientific advancement when the leading cloning scientist Woo Suk Hwang was found to have committed fraud in 2003, and this happened again when stem-cell researcher Haruko Obokata faced allegations concerning her 2014 Nature article on stimulus-triggered acquisition of pluripotency cells. The recent retractions of articles by Chinese authors make obvious the problem of research misconduct in the East Asian context and urge an ethical reform on the increasing volume of research from this region.

In addition to discussions on the integrity of individual scientists and research ethics, STS literature has directed attention to the social concerns behind these clinical trial enterprises (Epstein, 2008). Along with ethical aspects of access to medical care, concerns have increased about the expanding subject pool of global clinical trials. In When Experiments Travel (2009), for example, Adriana Petryna (2009) portrays how the experimental subjects in the offshoring of clinical trials have been identified with the management of contract research organisations (CROs). Observing trials of treatment for AIDS in Africa using placebos, Petryna (2009) notices an ethical change in clinical trials in which ‘protection and safety considerations are weighed against immediate health benefits or the knowledge to be gained, leading to a cost-effective variability in ethical standards’ (p. 7). She suggests that between international ethical codes and the social and political realities of research, clinical trials will ‘flow’ into areas where the gap between the two is wide, further creating a public health crisis.

Meanwhile, an emerging body of literature addresses the institutional aspect of ethical regulation, including that conducted in institutional review boards (IRBs), research ethics committees (RECs) and research ethics boards. A pioneering piece of research on the history of the IRB and the challenges it faces, Laura Stark’s Behind Closed Doors (2012) pointed to the origin of IRBs in the United States and the organisational concern about ensuring that all research is conducted ethically. Advancing Stark’s observation, Robert Klitzman’s The Ethics Police? (2015) provides a comprehensive assessment on how IRBs can function while keeping to their promise to make human research safe. Contending IRBs’ regulatory power over social science research, Zachary M. Schrag (2010) traces the evolution of IRBs and argues that they facilitate ‘ethical imperialism’ when the ethical regulations imposed by them spread beyond the realm of biomedical research and become simple, universal rules for academic research.

In spite of their theoretical depth, empirical gaps do exist in how to situate ethics in research practices. For example, Petryna’s account, though powerful, does not capture the concerns of East Asia (in particular Japan, Taiwan, Korea and Singapore),² where human research is considered as both an advancement of medical science and one of the coming century’s more promising ‘industries’. An account that generalises a dichotomy of ‘rich customers/poor test-subjects’ cannot explain why people in these states are crying out for the rapid introduction of the most advanced medication, while at the same time asking for high standards for clinical research so that they will not be ‘guinea pigs’ for the pharmaceutical industry. They also create their own narratives on bioethics. As Jennifer Robertson (2005) points out in her analysis of the concept of the ‘East Asian bioethics’ created in the 1990s, these narratives have roots in nationalistic ideologies; they transformed into ethical discourses by ‘dehistoricising’ traces of these nationalistic origins.

Departing from a relativist claim that simply honours local practices or the concepts behind them, Aihwa Ong (2010) provides an analytical framework which features ethics as socially conditioned. She argues for investigations into local responses to global trends of biotechnology, which ‘make ethical judgments about particular ethnographic situations; seek to rectify them according to some universalizing ethical standard’ (p. 12). Ong’s approach can be applied to the reflection on the rise of IRBs in Taiwan. Since the enactment of the Human Subjects Research Act in 2011, numerous IRBs have been founded to cope with an increasing number of research proposals from a wide range of disciplines using human subjects. At first glance, the introduction of such a regulatory framework and the formation of agencies to exercise it was an important move towards safer, misconduct-free research. Yet, just as Stark (2012) reminded us of the path-dependent development of IRBs in the United States during the Cold War, we are keenly aware of the social context behind this rapid institutionalisation of the IRB, in which not only progressive ideology but also narratives of state development prevail.

In fact, ethics in East Asia has to do with states’ narratives for development. Charis Thompson’s and Jennifer Liu’s work (Liu, 2012; Thompson, 2010) have captured how cutting-edge science such as biotech is incorporated into the discourse of state development. Comparing stem-cell research in South Korea and Singapore, Thompson (2010) reveals the vision that accommodates each country’s cultural, ethical, economic and scientific strategies, pointing out that ‘both countries are operating within geographic, historical, and economic patterns that are importantly located in and as Asia’ (p. 114). Differing from the categorisation of an innovation system that is featured as ‘technoglobal’ and ‘technonational’, Liu shows that ‘nationalistic goals and international aspirations often play out in unpredictable and sometimes contradictory ways that exceed more static, categorical framings’ (p. 412).

Aiming to fill in the intellectual gaps on the dynamics of medical innovation and the development of ethical frameworks for them, this article will explore Taiwan’s techno-politics in terms of its ethical/legal framework for human research with a critical assessment of the boom of IRBs in Taiwan. In my previous work (Kuo, 2011), I argue that the prefix ‘techno’ denotes not only the technical aspect of public policies, but also echoes Sheila Jasanoff’s notion of science policy (2005), in which scientific projects require social settlements and a nation’s specific political culture plays a key role in shaping the way these settlements are made. This article’s first goal, therefore, is to explore techno-politics as seen in the regulations concerning human research.

There have already been studies addressing the social surroundings of ethical regulations via what Sheila Jasanoff would call the ‘official bioethics’ of biotechnology (2005, p. 173). For example, in her study of multiple-embryo transfer in Taiwan’s IVF regulations, Chia-Ling Wu (2012) draws on the historical phases, each of which features a dominant social actor that led to legal change. Jennifer Liu (2011), in an assessment of Taiwan’s biobank project, argues that the establishment of such a bioethical structure fails to account for, or to shape, the specific social relationships in which scientific research is conducted. Following this trajectory, this article traces the legal amendments concerning human research in Taiwan. It will argue that there is an uneven development in the fields of clinical practice and drug regulation, which reflects what Joseph Wong (2010) observes in the regulatory regimes of Korea, Taiwan and Singapore, which ‘rather than being coherent and comprehensive wholes, are a reflection of contending industrial, transnational, domestic political, and economic pressures’ (p. 141).

This article’s second goal is to elaborate on the social assemblages that facilitated the creation of Taiwan’s ethical framework, in which the IRB featured as a solution to the inconsistencies of such a framework. Inspired by Sheila Jasanoff’s notion of ‘unofficial bioethics’,³ it will analyse the conflicts and interactions of the social actors as seen in various events surrounding biomedical innovation in Taiwan. These led to the formation of a loose, umbrella-like common law on human research. Departing from the conventional legal interpretation that this law is the consequence of several special laws and serves as the jurisprudential base for human research, this article argues that it was the specific attention paid to privacy information and the protection of research subjects that in reality became its basis.

My argument does not end with the creation of the Human Subjects Research Act. Noticing the social context in which IRBs were introduced and the social effects they had on research, this article aims to offer a preliminary critique on the institutionalisation of IRBs in Taiwan, as they function within this legal framework. Focusing on the accreditation of IRBs and the training courses offered on ethical concerns in clinical research, it will argue that IRBs as a social institution do not just work as gatekeepers for human research but represent Taiwan’s profound ambiguity as a latecomer in the global enterprise of academic research. As this article will reveal, this ambiguity has both ethical and social dimensions. In Taiwan’s case, ethics are not abstract sets of principles that can be designed and transferred but are always subject to modifications, adjustments and negotiations. They are interwoven through the medium of state regulation.

Method

This article applies interpretive social science methods to investigate complex social and political phenomena. Following the ethno-history approach developed by Joseph Dumit (2004) in his investigation of the development of positron emission tomography, this article focuses on the cultural specificity of the past, aiming to achieve a critical understanding of their emergence through interactions with key institutions and actors.

The primary collection of materials for this article took place between 2010 and 2014 and focused on the following themes: (a) the social and scientific merits of medical innovation, in particular new procedures and therapeutics, in advancing medical services and regulations; (b) the regulatory impact of accommodating global standards of pharmaceutical registration and clinical trials and (c) the attempt to create a population-based genomic database and consequent controversies, resulting in the recognised need to create a comprehensive ethical framework.

The texts analysed in this study include laws and regulations regarding medical innovation and human research, and public documents such as newspapers and magazines. For pharmaceutical regulations, I reviewed scientific publications, policy statements, and expert reports and articles. Communications and face-to-face discussions were held with experts from government, industry and academia: physicians and surgeons involved in early medical innovations, three high-level government officials, four legal and policy scholars, five senior experts from IRBs, and two biotechnology industry representatives. I also interviewed former legislator Sue-ying Huang, the main proponent of legal regulation of human subject research in Taiwan.

I conducted all interviews in person. In addition to general questions on the regulation of human subject research, most participants were asked more specific questions about ethical regulations in medical innovations, pharmaceutical development, bio-databanking and the Human Subjects Research Act. Intensive participation observation has been conducted since 2015, when I started serving as secretary to the IRB of the university I work for. In addition to the routine work of this IRB, I attend training courses on research ethics and participate in on-site investigations for IRB accreditation.

Clinical Innovation and Industrial Visions: Two Rationales in Regulating Human Research

In Taiwan there is a standard narrative on the development of bioethics. For example, in a widely used textbook on clinical research (Tai & Lee, 2012), events such as the Nuremberg Code for human experimentation (1949), the Declaration of Helsinki (1964), the Tuskegee study (1932–1972) and the Belmont Report (1978) are introduced as evidence for why an ethical standard should be implemented in Taiwan. They seem to construct a universal trend that what the global has gone through the local should follow.

In practice, however, Taiwan engaged in ethical regulations not via these universal narratives, but through clinical innovations. In a period known today as the ‘age of transplants’ (Tsai, 2002), Taiwan first became aware of the necessity of regulating clinical research when separation surgery was performed on a pair of conjoined twins, united at the pelvis, on 10 September 1979. Performed within a year after the severance of diplomatic ties between the United States and Taiwan, this high profile operation, carried out at the National Taiwan University (NTU) hospital, carried political meaning. The entire procedure of this 12-hour operation was broadcast live on TV and the president welcomed the medical team after the operation to celebrate their success.

Despite an enthusiastic mass media, the medical community was much more guarded. To prevent legal risks, the NTU team had the twins’ father sign a consent form, which stated that the operation was highly experimental, with physical deformity foreseeable even if it succeeded. Unlike Japan’s first heart transplant in 1968, which ended with accusations of not having explained the procedure clearly, followed by a thirty-year ban on such operations, the twins’ case did not receive much criticism until the twins grew up, and the physicians involved enjoyed successful careers because of their achievement.

The clinical breakthroughs continued, accompanied by ethical dilemmas. In 1984, when Chao-Long Chen’s team at Chang-Gung Memorial Hospital attempted a liver transplant, the issue of brain death appeared as an ethical concern. Although Taiwan did not have conceptual confusion or resistance, as did Japan, about the definition of death (Lock, 2001), increasing competition pushed this newly established medical centre to produce guidelines on brain death before its surgical venture. The liver transplant was a success. Not only local media but also the Taiwanese edition of Reader’s Digest (Scott, 1985) praised it as simply a ‘miracle’. This spurred Taiwan’s Department of Health (DoH) to pass the first Medical Care Act, promulgated on 24 November 1986, to regulate experimental practices. In this 92-article Act, human research was referred to as ‘experimental research of new medical technology, new medicaments, new medical implements’ (Article 7), while the pertinent regulations on clinical research were recognised as a part of medical practice (Articles 56 and 80). This research had to be done by an accredited medical centre, and could not be conducted without the DoH’s permission. In addition to the Medical Care Act, organ transplants had to follow the Regulations on Human Organ Transplantation Guidance on the Criteria of Brain Death, promulgated in June 1987.

Just a month later, however, on 17 July 1987, the NTU hospital challenged this law by conducting its first heart transplant. The operation was successful, but the medical team did not follow the required process, claiming that the case was too much of an emergency to seek permission. This time, in spite of media praise, medical professionals denigrated it as ‘illegal’. As a result, the DoH fined the hospital 150,000 NTD, as per the regulations; yet, it quickly approved all other applications for heart transplants.

Given its complexity and the medical skill required, this operation is often cited as a milestone for organ transplants. From a regulatory perspective, nonetheless, it marked an exemplar of the techno-political assemblage that demonstrated the rationale behind regulating clinical research. Research was recognised as a clinical practice, and it was also recognised that the physician who conducted it and the hospital where the study was executed should be responsible for any ethical problems that arose. As a physician later commented, there was nobody at fault; they (each) just did what they were committed to do as senior physician and as minister of the DoH.

Created in the same year as NTU’s experimental surgery, the Guidance on the Proposal for Human Research on New Medical Technology nonetheless focused on emerging pharmaceuticals and medical devices under a different regulatory rationale—one based on the facilitation of biotechnology as a global business. As Chu-Yuan Cheng (2012) summarises, the development of biotechnology in Taiwan took place in three phases, alongside changes in national policy. The first started with the Science and Technology Development Program in 1982, which designated biotechnology as one of the eight key technologies for development. As biotechnology gradually grew, the second phase featured the Strengthening the Biotechnology Industry Promotion Program, announced in 1995, with strategies to construct infrastructure that facilitated clinical trials. In response to the rapid advancement of biotechnology, the third phase started in 2005 with the Biomedical Technology Island Program (hereafter the Bio-Tech Island Program), which claimed that it would make Taiwan a centre in the value chain of pharmaceutical innovation.

Accompanying these industrial policies was the Guidance on the Proposal for Human Research on New Medical Technology. After some institutional reforms, such as the establishment of the Development Center for Biotechnology (DCB) and a government-controlled company for producing vaccines, the regulations on human research for drug development can be viewed as a means to level up the standards of product testing and, also, as a ‘non-tariff’ barrier for foreign companies. Unlike physician-initiated human research, these clinical trials were product-oriented. The regulatory rationale for such research, therefore, was to protect people from dangerous medication while strengthening the ability of producers.

When it comes to the regulatory development of clinical trials, the introduction of global guidelines, such as, those created by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), was crucial (Kuo, 2009). For example, although the DoH had been working on its own good clinical practice (GCP) guidelines for three years, it quickly decided to adopt the ICH’s GCP guideline after learning of its establishment. The DoH also decided to establish the Center for Drug Evaluation (CDE) in 1997 to achieve internationally acceptable reviews, and international trials subsequently increased. After an intensive revision of the GCP guidelines in 2002, its legal status was raised by executive command in 2005 and revised again in 2010.

Although the regulations discussed here demonstrate an extension of legal applicability to various human research projects, from surgical procedures to bio-pharmaceutical products, their rationales did not form a comprehensive, coherent legal framework. Responding to pressure from activists and legislators, minor regulations were created for clinical innovations, such as, the Guidelines for Collection and Use of Human Specimens for Research in 2002, and the Human Research Ethics Policy Guidelines and Policy Instructions on the Ethics of Human Embryo and Embryonic Stem Cell Research in 2007. The Medical Care Act, the legal source for these regulations, remained unrevised until 2009.

Meanwhile, the regulations for clinical trials required for pharmaceutical development underwent substantial changes based on the GCP guidelines. Through cases and orders, the regulations evolved from simple trials for a formulary list to a complicated system for conducting trials that were internationally acceptable. In addition, as an institution that aimed to integrate all existing regulatory agencies, the Taiwan Food and Drug Administration (Taiwan FDA) was founded in 2010 to oversee clinical trials. In spite of legal and institutional reforms, however, ‘loopholes’ still exist due to the lack of comprehensive regulation. As a result, the legislator Sue-ying Hwang has pushed the DoH to take responsibility for revising laws, not just creating regulations.

This situation can also be seen in other East Asian states that are coping with emerging technologies. For example, while analysing the revisions to the Korean Medical Law, Shawn H. E. Harmon and Na-Kyoung Kim (2008) revealed two different ethical standards in biomedical governance as Korea attempted to accommodate biotechnology into its development plan. While people urge regulation, to avoid possibly unethical clinical interventions, the state, using a more utilitarian approach, incorporates international ethical standards as a part of its development strategy.

Techno-political Assemblage for Regulation: The Taiwan Biobank and the Shifting Interface between Science and Ethics

Taiwan’s case is further complicated when it comes to a new dimension in regulating human research―genomics and bio-databases. Around the time that the Human Genome Project announced its completion, Taiwan put forward the idea of establishing a national genetic database. Originally claiming that this database was to improve public health and economic competitiveness, the latter became the more obvious in 2002 when the Taiwanese government announced its five-year national development plan, ‘Challenge 2008’. Through the streamlining of funding sources and reviews, the National Research Program for Genomic Medicine (NRPGM) aimed to integrate related studies to discover Taiwan’s research strengths, and genomic databases were promoted as guiding ‘basic construction’ for all genomic projects.

In 2004, as a major part of the NRPGM, the ‘Taiwan DNA database’ project completed its collection of DNA samples from randomly selected households. Each sample included plasma, DNA and lymphocytes, plus information about the subject’s ethnic background, health status and disease history (Pan et al., 2006). Meanwhile, the Taiwanese government let the idea of a population-based database morph into a much larger national plan, the Bio-Tech Island Program referred to earlier. The government announced that the Taiwan Biobank results were to be transferred to commercial applications, creating enormous benefits and opportunities (Science and Technology Advisory Group, 2005).

I have argued in a comparative study of state-sponsored biobanking in Japan and Taiwan (Kuo, 2011) that nationalistic rhetoric—what Herbert Gottweis and Byoungsoo Kim (2010) would call ‘bionationalism’—has played a crucial role in sustaining the pursuit of such big science projects. In fact, as Margaret Sleeboom-Faulkner points out in her analysis of the Taizhou Biobank (2013), even the adoption of global bioethical standards should be understood in the context of state competitiveness and China’s collaborative research strategies. The completion of Taiwan’s legal framework on human research did not go this way however; in fact, it fuelled opposition to the rushed start of the Taiwan Biobank. When the Taiwan Biobank research team, led by Yuan-Tsong Chen at Academia Sinica, attempted to proceed to large-scale sampling in 2005, it encountered difficulties in negotiating approval with Academia Sinica’s IRB, which contained not only scientists but also humanities scholars and social leaders (e.g., Liu, 2009; C-Y Liu & H-E Liu, 2009). The IRB returned Chen’s proposal five times between October 2005 and June 2006, citing various ethical concerns, approving only a pilot study to test the sampling process. Thus, instead of an immediate, island-wide data collection, the research was downgraded to a four-year ‘Phase I’ study to collect 15,000 samples in selected areas (Fan, Lin, & Lee, 2008).

For Chen and other leading scientists, this was an unanticipated scenario. Before the revision of the Medical Care Act in 2004, there were no state legal requirements for an IRB. Even Article 78, in which the functions of the IRB were first mentioned, only stated that this institution should have medical and legal experts and social workers to join the review process. Academia Sinica founded its IRB on Biomedical Science Research (IRB-BM) in October 2004 accordingly, and the Taiwan Biobank was one of the first to go through this kind of review process.

Originally, scientists thought that the Taiwan Biobank project was scientifically valid, and its importance was obvious; however, they soon faced resistance during IRB discussions. Even worse, in January 2006 it was reported that the research team had collected blood samples before the review process was completed, infuriating human rights scholars. The latter organised an online civil forum called ‘Overseeing Taiwan Biobank’ and criticised this project as the review proceeded.⁴

The project continued, but haltingly. From the IRB review process to obtaining participant consent, its every step was taken under stringent ethical scrutiny. After another year of review, a resolution was put forward in May 2008 to initiate an additional ethics review mechanism, with the Ethics Governance Council (EGC) overseeing this project.⁵ Finally, in May 2009, the viability project had collected information on the health conditions of 1,032 volunteers, but not samples of their blood and no cross-links could be made to the National Health Insurance databank. But some EGC members did not give their approval. Among the seven members who voted to suspend the research, two openly criticised the discussion process and the decisions made at EGC (C-Y Liu & H-E Liu, 2009). The Control Yuan initiated an investigation into the Taiwan Biobank in October 2009, suggesting that legal reforms on human research should be in place for the era of genomics.

During the time that the Taiwan Biobank was under investigation, its working group on ethical, legal, social issues had for three years been drafting legal regulations on biobanks (Chen, 2010). Originally, the Human Biobank Management Act aimed to regulate only national biobanks, such as the Taiwan Biobank, but later its applicability extended to all datasets for biomedical research. After the final draft was sent to the Legislative Yuan, the definition of a biobank was further extended to any dataset that contains ‘participants’ biological specimens, natural persons’ information and other related data and information based on human population or specific groups’ (Article 3, Clause 4). In other words, with the Taiwan Biobank as its target for regulation, this law was a legal reaction to (if not resolution of) the ethical concerns regarding all human research.

Figure 1.

Source: Adopted from Wen-Tsong Chiou’s speech (2012).

Sue-ying Hwang, the legislator who facilitated the settlement of this law, expressed her perspective in an interview with me: ‘I did not care whether this could work out or not’, she recalled. ‘What I am concerned about is whether we can have a healthy regulatory framework within which people can be free from the harm done by inappropriate trials. We cannot sacrifice some regulations just to speed up these trials’. It was this same concern that that urged Hwang to draft a common law for human research, the Human Subjects Research Act, promulgated in December 2011. Working with scholars who had been involved in the Taiwan Biobank controversy and physicians who had been concerned about human research since 2006, Hwang considered this a perfect finale to her six years of service as the legislator specialising in medical affairs. The Human Subjects Research Act became the first ever legal attempt to integrate all existing special laws and regulations on biomedical research.

If previous regulations used different logics in seeking to regulate human research, the Human Subjects Research Act is an umbrella-like law that simply incorporated them without much deliberation. To take genomic biobanking as an example, in addition to the specific law of the Human Biobank Management Act, pertinent regulations include the Personal Information Protection Act and the Indigenous Peoples Basic Law (for ethical issues relating to indigenous peoples), among other administrative rules made between the 1980s and the 2000s. As is evidenced in lecture material for the Human Subjects Research Act (e.g., in Figure 1), it was a legal realisation of policy guidance on ethical concerns over human experimentation, providing a conceptual architecture to accommodate overlapping and sometimes conflicting regulations.

Criticisms of the Act appeared immediately after its release: It covered too wide a range of different types of research with human subjects and could not properly deal with the ethical problems in new ways of conducting research, a pertinent example being the use of human tissues collected before the Act came into force. Some collections had long histories and potential for new research methodology, but even so, they had to be discarded, since the original purpose for collecting their specimens had been achieved and re-consent was now required for any new research (Article 19). Although advocates of clinical research have kept on asking for its amendment, this article remains intact.

The IRB Boom and the Transformation of Ethics to Social Practices

Built on fragile legal ground, the Human Subjects Research Act does not create much trouble in practice. It introduced an institution that was never clearly mentioned in previous regulations―the IRB. This mechanism was revealed to be a productive defender of ethics in the controversy over the Taiwan Biobank. Now, between the protection of human subjects and the promotion of biomedical research, the IRB would become the social institution expected to resolve all ethical problems. As Chien-Te Fan, Tsu-Hsun Hung and Chan-Kun Yeh point out (2015), the keystones of Taiwan’s privacy framework are IRB reviews and informed consent from participants.

The IRB in Taiwan is not new; its history can be traced back to a request from a study sponsored by US National Institute of Health that recruited leprosy patients in Taiwan in 1969 (Han, 2004: 148–153). Yet it was not until 1997 that a Joint Institutional Review Board (JIRB) was formed to facilitate fast clinical trials. In 1999, the National Health Research Institute (NHRI) introduced an IRB for the research it sponsored, and this policy was followed by the DoH and the National Science Council in 2000 and 2001 (Kuo, 2001). Even so, these IRBs were unregulated. As Chih-Liu Lin (2004) pointed out, there were even numerous different names used to refer to these regulatory bodies, such as independent review board, human subject committee, ethics committee, committee on medical ethics and ethics committee on medical research.

Finally, the Human Subjects Research Act gave IRBs a single name—ethical review committees. However, how an IRB was to work in different institutional settings and how to regulate existing IRBs remained confused. If human research was considered important and thus in need of more intensive interventions from government, then an IRB should be a governmental organisation, such as is the Bureau of Standards, and not one established by a research institution. Lacking proper legal guidance, IRBs are actually eager for instructions as to their new role in human research.

When the Human Subjects Research Act was enacted, there were four organisations that offered instruction. They were founded for different purposes, to facilitate internationally acceptable clinical trials. Founded in 1992 by a group of medical reformists, the Medical Professionals Alliance in Taiwan (MPAT) was the first organisation to address the importance of clinical trials and the roles of IRBs. With support from the DoH, MPAT has offered training courses since 1995 for those involved in clinical trials. In its first two decades it provided 44 advanced courses (theme focused) and 50 foundation courses—9,481 medical professionals have benefited from the former and 6,600 from the latter.

Also supported by the DoH, the JIRB provided a qualified IRB that consisted not only of members from the medical professions but also legal experts and non-medical members. In the beginning, it attracted 38 hospitals whose IRBs could not conduct GCP-approved reviews. However, as the JIRB’s former Secretary General Benjamin Kuo admitted, more and more hospitals started to recognise ethical reviews as a business and formed their own IRBs. Thus, in 2004 the JIRB established the Medical Research Ethics Foundation, shifting its focus to education, global connections, and improving review quality. Since then, the JIRB has offered training courses for clinical trial centres and investigators of human research.

To revive the JIRB’s functions, the Taiwan Association of IRBs (TAIRB) was founded in 2009. Initiated by the former Director of the CDE, Herng-Der Chern, and the former DoH Director Wen-Ta Chiu, the TAIRB began as an alliance of well-established IRBs (mainly hospital IRBs); it aimed to provide solutions to speeding up multisite clinical trials by mutually accepting reviews. Even so, suffered from recruiting too few qualified IRBs, the TAIRB started offering speakers and training courses on clinical trials and IRBs, and established a relationship with the Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP). By asserting that service on an IRB was a profession, the Human Subject Protection Association in Taiwan (HuSPAT) was also founded in 2009 by Benjamin Kuo after he left the JIRB. Like TAIRB, HuSPAT has its international connections. It worked with the professional organisations of the Association for the Accreditation of Human Research Protection Programs and Public Responsibility in Medicine and Research, and now with Training and Resources in Research Ethics Evaluation (TRREE), a consortium that offers an online learning programme on research ethics evaluation. Backed by international organisations, these institutions identified their positions as genuine instructors and organisers for IRBs.

Meanwhile, the Human Subjects Research Act has created a need for experts and training courses. According to this new legal scheme, everyone involved in human research—including the principle investigators, the institutes where they work, and the IRB that oversees their research—share legal responsibility when a study is conducted in an unethical manner. Therefore, not only are IRBs asked to receive inspection and accreditation but also every principle investigator is asked to take at least thirty hours of training in human trials and nine hours of medical ethics classes in six years. Although the number of training hours has been reduced for those who do not participate in clinical trials, the requirement has been imposed on humanities scholars alike, whose work is interpreted as human research. All of these changes emerged suddenly, and the necessity for training courses thus increased.

The change in the number of such classes is notable. In the first year after the promulgation of the Human Subjects Research Act, I counted 185 training courses on human research. Most of them were organised by individual IRBs, but the speakers often overlapped. The organisations mentioned here performed as facilitators and consultants. Some principle investigators have complained about the quality of these courses and took them just to fulfil the legal obligation. On the other hand, in addition to assisting with their courses and offering information on qualified instructors, HuSPAT is able to issue training certificates for international online learning programmes, such as those by the Collaborative Institutional Training Initiative (CITI) and TRREE.

IRB accreditation has its problems. Although the DoH had asked the NHRI to draft working guidelines in 2004, leading IRBs (such as those at medical centres) have tended to get accreditation from international organisations such as FERCAP. Since 2005, the DoH has outsourced this daunting job to the Taiwan Joint Commission on Hospital Accreditation (TJCHA). In its first survey, the TJCHA reported a huge gap between the standards and the practices of the 43 IRBs they inspected. Courses on IRB accreditation were provided beginning in 2006, before they became a mandatory process after the promulgation of the Human Subjects Research Act. Some IRBs complained about the redundancy of this accreditation, since they had already met international standards. What makes the situation more complicated are those IRBs in non-medical institutions such as universities. Under the Human Subjects Research Act they have to receive regular inspections from their competent authority and in the case of universities, this is the Ministry of Education, which itself is no authority on IRB practice.

How can we assess such a great enterprise, carried out in the name of ethics? C. K. Gunsalus et al. (2006) provide us with insights. While recognising the merit of IRBs, these researchers found that effort has been shifted to bureaucratic work rather than focusing on the protection of research subjects. They warn that ‘[o]ur IRB system is endangered by excessive paperwork and expanding obligations to oversee work that poses little risk to subjects. The result is that we have simultaneous over-regulation and under protection’ (p. 1441). Some of what they observe has already come to pass in Taiwan, where policy makers believe that oversights and accreditations are a powerful means to raise organisational quality. I have not judged these efforts, but considered IRBs to be social institutions that solve jurisprudential conflicts within the legal framework of human research.

In this context, IRB service and management seem to turn first into a profession and then into a potential business. A newspaper report revealed in 2015 that there were about 6,000 non-medical human subject research projects that needed IRB review, but the review process was long and cumbersome, creating an opportunity to make ethical reviewing a service-sector business (Ho, 2015). In fact, HuSPAT had predicted this. As I browed its website back to 2013, one poster intrigued me. ‘You are professionals in research’, it read, ‘and so are we in IRBs’ (Figure 2). Just like life coaches as a profession and a business specialising in guiding peoples’ lives and careers, in the era of ethical/legal uncertainties researchers need a guide like HuSPAT to secure their research and careers.

Figure 2.

Source: Retrieved from the HuSPAT website on 1 June 2013.

Beyond Ethical Variability: Following Situated Ethics and Communities of Fate

Seven years have passed since the implementation of the Human Subjects Research Act, and the number of IRBs keeps increasing. Nonetheless, the quality of these IRBs and to what extent they have helped the prevention of unethical research practices and research misconduct remains in question. In a recent piece of research, Adam Hedgecoe (2017) points out the minimal role scandals over research misconduct play in shaping the regulatory system and the vulnerability of this system to produce scandals in the absence of a single coherent professional associated with biomedical research. Taiwan’s case accords with some of Hedgecoe’s observations on the trends in the regulatory system, yet it has structural problems of its own.

As this article has traced, the regulations governing human research in Taiwan cannot be isolated from the larger narratives concerning medical progress, strategies for state development and international ethical standards. Advancing Adriana Petryna’s observation of the uneven distribution of ethics (2005), I argue that these narratives are difficult to reduce to the algorithm of global trials in terms of ‘ethical variabilities’. Both adoptions and modifications of mainstream ethical principles, these narratives are techno-political; they have built up a dynamic context in which regulations on human subject research evolve. As a latecomer to techno-society, Taiwan failed to form a comprehensive narrative for its legal framework regulating human research. No narrative, such as, that of state development, can dominate the ways human research should be conducted ethically. Unlike Chia-Ling Wu’s observations of the settlement of the policy on numbers of IVF embryos (2012), these conflicts were not resolved through the creation of ethical requirements for human research. On the contrary, the majority of clinical innovations, uniquely individual as they are, do not undergo sufficient discussion before being conducted at the hospital bedside.

This article has also characterised IRBs as social institutions that accommodate such legal inconsistencies. Policy analyst Joseph Wong is right when he says that a state’s readjustments are meant to keep the protection-and-promotion ‘pendulum’ swinging. However, the readjustment mechanism of the IRB is more complicated. Take, for example, the issue of the use of tissue collections established before the enactment of the Human Subjects Research Act. A major attempt to ‘deregulate’ the use of these collections was a proposal to allow the IRB of each collection to decide, on a case-by-case base, whether it was ethical to use it. As this article has revealed, the social debates about the nature and practice of human research turn into technical ones within the IRB; knowing the rules of IRB reviewing, fulfilling the requirements for ‘ethical’ research and passing review all become a business with great potential.

It is beyond this article’s scope to discuss the social nature of IRBs and how they might develop in the future. Yet, problematising the concept of ‘East Asian bioethics’, it is certain that the techno-social assemblages that contributed to the creation of the Human Subjects Research Act will continue to work on IRBs as social institutions. Sheila Jasanoff (2005) rightly calls science a series of ‘republics’. Echoing this notion, I would like to add that ethics, as situated, like science, in a socio-political embedding, is an essential part of these republics. It institutionalises and regulates what science we want and how it should be conducted.

Let me conclude this article by returning to Aihwa Ong’s (2010) notion that links ‘ethics’ with ‘communities of fate’. For her, ethics is not universal but always situated in ‘the network of collectivities that become connected as a result of diverse ethical decisions and feelings associated with technological innovations’ (Ong, 2010, p. 20). In this sense, the evolution of human research regulation in Taiwan adds a social/institutional cultural aspect to this notion. In addition to clinical experts, policy makers and industry figures, IRBs have now joined the shaping of communities of fate. Differing from Ong’s focus on individual ethical imaginings of shared fate, I argue that IRBs as institutions for practicing ethics evoke conversations and debates on techno-political imaginaries. Therefore, by moving beyond a simple notion of ethical variability, let us do more work on IRBs so as to follow where these republics, or communities, drift in a global world.

Footnotes

Notes

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