From subjects to relations: Bioethics and the articulation of postcolonial politics in the Cambodia Pre-Exposure Prophylaxis trial

Abstract

Controversies about global clinical trials, particularly HIV trials, tend to be framed in terms of ethics. In this article, I explore debates about ethics in the Cambodia Pre-Exposure Prophylaxis trial, which was designed to test the safety and efficacy of tenofovir as a prevention for HIV infection. Bringing together studies of public participation in science with studies of bioethics, I show how activists around the Cambodian Pre-Exposure Prophylaxis trial circulated and provoked debates about standards of research ethics, as opposed to research methodology. This postcolonial bioethics was configured through the circulation of and debate about ethics guidelines, and historically and culturally specific relations of vulnerability and responsibility between foreigners and Cambodians and between Cambodian leaders and Cambodian subjects. I argue that this shift in the object of ethical concern, from the experimental human subject to the relation between subjects and researchers, illustrates how a postcolonial field of articulation reformulates classical bioethics.

Keywords

activism Cambodia controversy HIV prevention trials postcolonial bioethics

In the early and mid-2000s, the first wave of HIV Pre-Exposure Prophylaxis (PrEP) clinical trials was being planned or was underway in Africa, Asia, and North and South America.¹ PrEP trials were designed to test the safety and efficacy of the antiretroviral drug tenofovir disoproxil fumarate (hereafter tenofovir) for prevention of HIV infection. Tenofovir was already used in some parts of the world for treatment of HIV, but the question addressed by PrEP trials was whether taking the pill once daily would be safe for HIV-negative people and whether it could prevent HIV infection. PrEP trials involved different funders, implementing institutions, and study populations, such as female sex workers, heterosexual couples, injection drug users, and gay men. At the time, large-scale international collaborations between state agencies, research universities, private foundations, and non-governmental organizations (NGOs) were not as common in the global health landscape as they are today (see McGoey et al., 2011; Nguyen, 2005; Rottenburg, 2009). Indeed, the PrEP trial in Cambodia was to be the first large-scale clinical trial in the country. It was also the first of the PrEP trials to be canceled.

The Cambodia trial preparations were canceled in 2004, after the country’s Prime Minister spoke against experimentation on Cambodians. This followed criticism from local NGOs about inclusion in trial planning, treatment and insurance for long-term side effects, and access to tenofovir should it prove effective. In 2005, three other PrEP trials were suspended: the Cameroon trial due to controversy about lack of participant education, and the Nigeria and Malawi trials due to concerns about laboratory procedures and the availability of tenofovir on the open market. Other trials continued despite controversy, as in Thailand, or with less public debate, in the United States and Peru. In 2005, the International AIDS Society hosted a meeting of some of the PrEP investigators, sponsors, and community representatives to discuss ways forward for the active PrEP trials (Halima and Collins, 2005), and the same year, an international group of researchers, clinicians, and activists published a statement in Science in support of PrEP trials. They argued for the need to test tenofovir’s safety and efficacy in different groups, including poor and vulnerable populations, not only in ‘Paris, San Francisco, or New York’ (Grant et al., 2005: 2171). PrEP research continued, and in 2012, the US Food and Drug Administration approved Truvada, a combination of tenofovir and emtricitabine, for use as PrEP. There is ongoing debate among medical professionals, advocacy groups, and social scientists about the ethics of providing medicine as prevention for HIV-negative people rather than treatment for HIV-positive people, given scarce resources. There is also debate about cost, adherence, resistance, privileging pharmaceutical over behavioral prevention methods, and norms of sexuality and gender.²

The Cambodia trial was a bellwether of PrEP as a controversial prevention technology; however, in this article I am interested in the trial as a critical moment in global health, when controversies about transnational clinical trials revolved around ethics. I argue that the Cambodia PrEP trial shows the emergence of a postcolonial bioethics, one configured through the circulation of and debate about ethics guidelines, and historically and culturally specific relations of vulnerability and responsibility between foreigners and Cambodians and between Cambodian leaders and Cambodian subjects. Much has been written about the events of the Cambodia trial and whether the trial was ethical (e.g. Forbes and Mudaliar, 2009; Hammer and Lundstrom, 2006; Page-Shafer et al., 2005; Sandy, 2013), but we know less about how research ethics became the ground of engagement and critique.

In Cambodia, activists, media, and the Prime Minister configured research as a relation between researchers and subjects through ongoing reference to national identities. This tethered categories of Cambodian/non-Cambodian to relations of extreme material difference and potential for exploitation. Furthermore, it shifted the object of concern of classical bioethics: from the experimental human subject to the relation between researchers and subjects, what I refer to as a political relation. Bioethicists, practitioners, and social scientists are consumed with the question of how locally to implement ethical principles of rights of research participants. In classical bioethics,³ rights are universal, yet the techniques to ensure these rights take different forms depending on context. For example, in the case of consent, issues include how best to inform potential participants unfamiliar with the notion of placebo, or the differentiation between research and care, or whether relatives or bosses must also consent to participation. The conception of local tailoring in global health bioethics had been focused on the experimental subject or setting, with the researcher outside the frame, abstract. Within the debates around the Cambodia PrEP trial, however, a different configuration of bioethics came into relief, involving both the researcher and the subject. Local tailoring, I show, is not just about the specific research subject or population; ‘local’ includes the relations between researchers and subjects.

This argument complements a rich recent literature on the politics of transnational research, much of which focuses on biomedicine in Africa (e.g. Fairhead et al., 2006; Molyneaux and Geissler, 2008; Parker and Bull, 2009). These studies show how participants, researchers, and bioethicists understand the political economy of research, illuminating, for example, how bioethical framings can ‘silence’ discussion of global inequalities in which research is embedded (Fairhead et al., 2006: 1118–1119). In contrast, my attention here is on the techniques and discourses through which key actors articulate, rather than silence, global inequalities in terms of research ethics and how ethics can be a mode for participating in debates about scientific practices and making geopolitical critique.

Science, technology, and society (STS) studies of public participation tend to rely on analytics of (lay) expertise and its evaluation, but tend to exclude ethics. In the Cambodia PrEP trial, publics engaged with and altered research ethics rather than research epistemology or methods. This novel piece of science, the PrEP trial, was configured in terms of its ethics, rather than its assumptions or methods. Moreover, the ethical concerns were configured in terms of the relation between researchers and subjects, rather than the subject or setting.

‘Postcolonial bioethics’ is shorthand for bioethics at a conjuncture of experiences of decolonization and struggles over sovereignty, and global circulatory capacities of human rights, biomedical research ethics, and medical interventions themselves. Inspired by Ananya Roy (2011), I use the term ‘postcolonial’ not so much as a temporal condition or a category of agency, but as a field of articulation. The concept of postcolonial bioethics captures how global health science is explicitly about relations, relations intertwined with other formations of vulnerability and responsibility. Both STS (e.g. Mol, 2002; Montgomery, 2012) and postcolonial studies (e.g. Roy, 2011; Said, 2003) have tools for thinking the relational coproduction of categories and their instabilities, but, as Itty Abraham (2013) stresses, postcolonial studies foreground coproduction ‘in unequal but simultaneous global formation’ (pp. 407–408). The field of articulation of bioethics in the Cambodia PrEP trial is specific to Cambodia – its histories of disease and subjugation, its practices of public health and resistance – and to HIV activism and global health science, whose specificities are not defined in the geography of the nation state. The configuration of ‘research’, ‘ethics’, ‘Cambodian’, and ‘foreign’ in the trial happens within this field. The specificity of the Cambodia PrEP trial and the omnipresence of ‘equivalent’ HIV prevention controversies must be considered at once (cf. Thompson, 1993: 519).

The emergence and demise of the Cambodia PrEP trial came at a moment when biomedical research was becoming increasingly transnational, and the diseases that burden Cambodians – HIV/AIDS, malaria, tuberculosis (TB) – were (and still are) of interest to international researchers and donors. After 30 years of conflict, Cambodia had re-established the government and health structures to collaborate with international researchers. In the decade since Cambodia was a United Nations (UN) mandate (1992–1993), NGOs came to be seen as advocates for civil society and human rights and as intermediaries between donors and specific publics. Human rights and health are now merged into a discourse of moral force. Forms of public protest, such as petitioning the Prime Minister, echo forms of protest against French colonial practices. This moment of simultaneous expansion of global health and stabilization of post-conflict Cambodia did not determine but certainly gave shape to how ethics became the ground for public engagement with clinical trials research.

Methods and sources of data

This article draws primarily upon research conducted in Phnom Penh and San Francisco in 2005 and is informed by ongoing ethnographic research on biomedicine and ethics in Cambodia and conversations about the trial with key informants between 2003 and 2015. The original aims of this study were to examine the terms and framings of the PrEP controversy. The sources of data include articles in local news media and medical journals; postings to email listservs and eForums;⁴ documents from the websites of the two main groups that criticized the trial, the Women’s Network for Unity (WNU) and Womyn’s Agenda for Change (WAC); and semi-structured interviews and informal conversations with PrEP staff from the United States, Cambodia, and Australia (n = 8), staff at Cambodian NGOs that work with sex workers (n = 6), and staff working on HIV/AIDS-related issues at French and US organizations in Phnom Penh (n = 3). These informants were selected because they were directly involved with trial planning or because their work brought them into contact with the trial on account of the communities they serve or health problems they address. Across these different types of data, I analyzed discourse about ethics practices and bioethics principles. What I offer in this article is analysis of primarily public discourse about ethics; I do not seek to provide a definitive chronicle of events, nor do I focus on causes of the trial’s cancellation.

Background

The Cambodia PrEP trial began in 2003, when researchers from the University of California, San Francisco (UCSF) and the University of New South Wales, funded by the US National Institutes of Health and the Bill & Melinda Gates Foundation, respectively, entered into a collaboration with the Cambodian National Center for HIV, AIDS, Dermatology, and Sexually Transmitted Infections (NCHADS). The objective of the Cambodia PrEP trial was to determine whether once-daily oral tenofovir was safe and effective for prevention of HIV infection in female sex workers. This was to be a randomized, double-blind placebo trial that recruited 960 women in Phnom Penh, Cambodia’s capital (Page-Shafer et al., 2005).⁵ HIV prevalence in the general population in Cambodia was 2.6 percent, the highest rate in Asia, and sex workers, with prevalence between 19 and 31 percent in 2002, were a risk group targeted for surveillance and intervention (Saphonn et al., 2004). At the time, tenofovir and antiretrovirals, more generally, were not widely available in Cambodia (Bourdier, 2006).

In Cambodia, the most vocal critics of the PrEP trial were the WNU, a sex worker union, and the WAC.⁶ Most of the members of the WNU were current or former Cambodian sex workers. The WAC had largely Cambodian membership, was coordinated by an Australian, and involved interns from other countries (Forbes and Mudaliar, 2009). Their primary concerns were that the rights of sex workers would not be adequately protected and that the WNU, as a primary stakeholder, was not adequately consulted during trial planning (Loff et al., 2005; WNU, 2004). The WNU wanted provisions for long-term care should tenofovir have side effects and asked for 30 years of post-trial insurance. If tenofovir was effective, there was no guarantee that participants, or other Cambodians, would have access to the drug. As such, the WNU said that Cambodians would bear the risk of the research and non-Cambodians would receive the benefits. The WNU also suggested that the research consortium was aligned with tenofovir’s manufacturer, Gilead Sciences, and in search of profit (WNU, 2004, 2005b, 2005c). The views of the WNU and WAC on the PrEP trial were communicated in press conferences, on their websites, on listservs, in the Cambodian and international media, in Internet and print medical journals, and at a demonstration at the 2004 International AIDS Conference in Bangkok.⁷ In the growing press coverage, the figure of the sex worker linked the trial to a web of issues, often sensationalized, that dominated media and development discourse about Cambodia: prostitution, HIV, poverty, and trafficking.

PrEP researchers, who were working with other local sex worker NGOs, did not at first address these concerns with the WNU. In the local press, heads of the Australian, Cambodian, and US collaborating groups insisted they were abiding by international bioethical standards, and the protocol had passed ethical review in three countries. They emphasized the voluntary nature of participation, that care would be provided during the trial and that there was no funding to provide long-term health insurance. They agreed to provide two years of post-trial care, but argued that significant benefits, such as 30 years of post-trial care, might be undue inducements to participate and thus be unethical (Collins and Kuch, 2004; Doyle and Kuch, 2004; Watt, 2004). They secured support from the Global Fund and Gilead for access to tenofovir at reduced prices. The project had built a new clinic, laboratory, and offices and continued to train staff and conduct formative research. A comprehensive statement of the researchers’ perspective was published in The Lancet in 2005 (Page-Shafer et al., 2005).

On 12 August 2004, during a groundbreaking ceremony for an expansion of the Kantha Bopha I hospital in Phnom Penh, Cambodian Prime Minister Samdech Hun Sen spoke against the trial. According to the translation in an English-language daily, Hun Sen said, ‘Cambodia is not a trash bin country’. So far, they have tested Cambodians with antiretroviral drugs. ‘They should not conduct experiments with Cambodians. They should do it with animals’ (Purthill and Yun, 2004). The speech came as a surprise to the researchers, NCHADS officials, and NGO staff with whom I spoke in 2004 and 2005. Following Hun Sen’s widely cited statement, trial preparations were officially stopped, and speaking publicly about the trial became a liability for Cambodian and foreign researchers, as well as collaborating NGOs. This is exemplified by a quote from the head of research at NCHADS, published in The Cambodia Daily in August 2004: ‘Please, I don’t want to comment on my prime minister’ (Purthill and Yun, 2004).

Discussion of the trial continued in medical journals, on listservs, and in media (see Cha, 2006). In part, this was due to the WNU understanding that researchers were lobbying the Cambodian Ministry of Health and other government officials for reinstatement of the trial. The WNU mobilized accordingly, conducting training sessions for sex workers on their rights in a clinical trial and posting letters to the editor of journals (Loff et al., 2005; WAC, 2005a; WNU, 2005a, 2005b, 2005c). Other articles were published in support of the WNU and its concerns (Bourdier, 2005; Hammer and Lundstrom, 2006).

Two main tactics of the WNU were to criticize the ethics of the PrEP trial and to educate sex worker and NGO communities about the trial and their rights as research participants. The critique of the ethics of the trial centered around unequal relations between trial researchers, funders, and regulatory bodies, on one hand, and the participant community, on the other. At the heart of these issues was the implication that the health and well-being of Cambodians would be exploited at the hands of non-Cambodians. These sentiments were echoed in the actions of the Prime Minister, the headlines of the local press, and discussions with NGO staff whom I interviewed in Phnom Penh in 2005.

Because the research was often configured as a binary relationship where foreigners act upon Cambodians, the roles of Cambodian researchers and collaborators were not very visible.⁸ NCHADS staff invested significant time, energy, and reputation in preparations for the PrEP trial and represented the trial to the press at public meetings and in the formative research focus groups. However, after the Prime Minister’s speech, Ministry of Health officials who supported the research would not speak about it for fear of losing their jobs, according to an official with whom I spoke in 2005. Another erasure in a binary configuration of foreign researchers and Cambodian subjects are the local NGOs who collaborated with the researchers. Several NGO staff said that the terms of the debate about PrEP were such that supporting the trial meant supporting foreign exploitation of Cambodian sex workers, terms that discouraged them from vocalizing their stance.⁹ They did not want to be seen as failing to protect those with whom they worked, nor did they want to take the political risk of going against the government. The Prime Minister’s statement produced a double-bind, framing Cambodians as passive recipients and foreign researchers as agents acting upon them, rendering Cambodian researchers and NGO collaborators, and their labor, invisible.

Bioethics as a domain of public engagement with science

Studies of public participation in science in cases of controversy emphasize contests over valid forms of expertise, assumptions, or methods.¹⁰ Yet ethics, too, have been crucial to debates about global health research, debates which have affected the practice of global health science. In this article, I show how activists, potential participants, and researchers intervened on issues to do with the ethical guidelines for the Cambodia PrEP trial, rather than on issues to do with scientific expertise, assumptions, or methods. My objectives are to illuminate how postcolonial concerns with rights, vulnerability, and sovereignty configure authoritative grounds for participation in controversies.

Studies of public participation in science analyze diverse actors and problems, yet they are similar in that they demonstrate how non-scientist participants in contests over biomedical and scientific knowledge production achieve their aims by becoming ‘culturally competent’ in practices and discourses of science, a broad movement that Steven Epstein (1996) calls ‘the democratization of science’. In Impure Science, Epstein shows how US activists questioned the ethics of AIDS research practices by linking their ethical criticisms to epistemic ones. Epstein (1996) describes this as ethical questioning that leads to questioning science or pitting ‘good science’ against ‘real world’ science (pp. 246–264). Soheir Morsy’s (1998) study of health activism in 1980s Egypt shows how scientists, intellectuals, and human rights activists opposed human experimentation and health-threatening development initiatives in scientific terms, and as forms of resistance to global mechanisms of control and exploitation. In the Cambodia PrEP trial, WNU invocation of international guidelines, such as the Declaration of Helsinki, engaged biomedicine on its own terms, calling for a better practice of research according to acknowledged standards.

Epstein (1996) details how US AIDS activists distributed their knowledge about treatments and research using community media, meetings, and education sessions for their members. AIDS activists’ success in affecting research and policy in the United States was attendant upon their self-education and entering the world of biomedical knowledge – learning the intricacies of research design and basic science, for example. Epstein maintains that those groups who privileged becoming ‘lay experts’ eventually began to frame their causes as biomedical and scientific. In the case of the PrEP trial in Cambodia, the WNU’s claim for inclusion in trial planning focused on self-education and community education about the ethical guidelines of clinical trials.

In previous studies that relate public participation in science to some kind of expertise, the ground of analysis (often implicit) is that scientific or technical expertise has broad cultural authority.¹¹ In the Cambodia PrEP trial, the authoritative ground of engagement was ethical rather than epistemological science: the WNU’s demand for 30 years of health insurance in a country that has only scattered and experimental health insurance schemes is either very strong bargaining or rejecting the clinical trial itself. The Prime Minister clearly rejected the trial as a debasement of Cambodian dignity. Although the WNU did educate itself and the community about the conduct of clinical trials and the safety of tenofovir, its tactics were not limited to self-education and technical engagement with scientific and regulatory professionals. The WNU made the relationship between resource-rich and resource-constrained countries central to this clinical trial. They did so through idioms of foreign intervention, the responsibility of leaders, and human rights.

There is a vast body of scholarship about the formulation and interpretation of bioethics guidelines for transnational research. Some studies examine challenges that are particular to research in developing countries (Benatar, 2002; Bhutta, 2002; Emanuel et al., 2004; Farmer, 2002; see also the journal, launched in 2001, Developing World Bioethics). Other studies ask whether principles of respect for persons (autonomy and dignity), beneficence, and justice are universal or to what extent they vary and why (Brodwin, 2001; Lurie and Greco, 2005; Petryna, 2005; Sleeboom-Faulkner, 2013; Tangwa, 2004). There is a subgenre of scholarship on HIV prevention research ethics (e.g. Lo and Bayer, 2003; MacQueen et al., 2004), on implications of ethics debates for understanding the variability of norms of health and care (Crane, 2010; Reubi, 2010), and specifically on the ethics of using antiretrovirals as prevention (see the August 2013 special issue of Developing World Bioethics). Issues in these literatures, such as methods of informed consent, control groups, placebos, treatment for side effects, ethical review, responsibilities for post-trial care, and research as health care in resource-constrained settings, were also central issues in the Cambodia PrEP trial. As I describe below, ethics guidelines revised after the early PrEP controversies (e.g. UNAIDS, 2007) directly address issues relevant to prevention trials, which experiment with ‘healthy’ people. The WNU and WAC questioned whether researchers were adequately abiding by international standards, and researchers stated that they were abiding by, if not exceeding, existing standards. Discourse of ‘international standards’ rendered the trial exemplary and negligent; the experimental status of the trial itself – new to Cambodia, new to HIV prevention science – was evident in this paradoxical position.

Mechanisms of protection and their ambiguity

In addition to being a novel clinical trial in any country, the Cambodia PrEP trial was the largest, most complicated, and most expensive project to be managed by NCHADS and the Ministry of Health. With this trial came new social forms. In 2002, the National Ethics Committee (NEC) for Health Research was established by the Ministry of Health, with support from the European Commission (EC) Regional Malaria Control Programme, as an institutional mechanism of local review (Saray, 2007). As Eng Hout, Minister of Health Director General, told The Cambodia Daily at the time, ‘We must prevent human beings from getting used as guinea pigs’ (Vachon, 2002). Previously, there was no governmental body in Cambodia for ethical review of research; research protocols might have been discussed with the Ministry of Health Coordinating Committee for Development Assistance, the National Institute of Public Health, relevant institutes within the Ministry of Health, or Provincial Health Departments (Hill, 2004: 142–143).

Efforts to promote awareness of bioethics in Cambodia had begun a few years before the PrEP trial as a result of increasing biomedical research in the country (Chheng, 2002). In 2000, the Ministry of Health translated the World Health Organization (WHO) Operational Guidelines for Ethics Committees that Review Biomedical Research into Khmer. In 2001, Cambodia joined the Forum for Ethical Review Committees in Asia and the Western Pacific and participated in regional workshops and conferences (Hill, 2004; Saray, 2007). In 2002, the EC Regional Malaria Control Programme supported translation of the Declaration of Helsinki, the Nuremberg Code, and the CIOMS Guidelines for Biomedical Research Involving Human Subjects into Khmer (Hill, 2004).

PrEP study staff were involved in modifying the NEC to meet standards for US government funding. This included training members of the Ministry of Health, community groups, and NCHADS, as well as clinicians, around issues specific to a prevention trial and requiring a woman and a lay person on the review board. The PrEP trial protocol was one of the protocols used as a test case in the training. When I interviewed Anna, a US researcher, in 2005, she described how conducting the ethics training brought forward dilemmas that she had to sort out for herself before joining the trial. Foremost were the ethics of providing an antiretroviral for chemoprophylaxis when it was not available for treatment and whether it would be possible to explain the complexity of the study given the novelty of clinical research in Cambodia.

The PrEP trial was one of the first studies approved by the NEC, in July 2003 (Coren, 2003). The trial protocol was also approved by ethical review boards in the United States and Australia. In the Lancet position paper, researchers write in detail about the consultation and approval process, involving the NEC, the US National Institutes of Health, and multiple revisions of the study protocol. The authors state their confidence that trial planning ‘followed, and in many respects went well beyond, accepted ethical standards’ but that they could have improved their interactions with potential participants and their representatives (Page-Shafer et al., 2005: 1502). However, instead of finding confidence in the three levels of ethical review, the WNU argued that the review boards were essentially redundant as they were peopled by individuals from the researchers’ home countries or individuals trained by the researchers (WNU, 2005b). Thus, the WNU claimed that the review boards were biased in favor of the researchers and not motivated to understand or protect the interests of the local sex worker population.¹²

Neither the NEC nor its individual members participated in public debates about ethics of the PrEP trial. This is most likely due to the Prime Minister’s opposition to the trial and its subsequent cancellation by the Ministry of Health. Members of the NEC and NCHADS were in a difficult position, sitting between their government and foreign research universities and in unclear relationship to the international ethics guidelines they were trained to uphold in Cambodia.¹³ Two Cambodian researchers with whom I spoke in 2005 expressed concern about the implications of trial cancellation for future international research and treatment efforts. They told me that the PrEP trial would have benefited the Cambodian people primarily if tenofovir were found to be an effective prevention for sexual transmission of HIV, but also through the construction of laboratories and clinics, and training of scientists, clinicians, research staff, and government officials. They were also concerned that both sex workers and the average Cambodian would generalize a negative valence as applying to other forms of biomedical research.

In addition to developing the NEC, trial preparations involved a variety of translation activities. Researchers piloted multiple versions of consent documents and different configurations, visual and verbal, of HIV transmission and prevention information. In focus groups, they explored how best to explain the trial design and the nature of participation. One of the Cambodian researchers told me that ‘placebo’ emerged in the focus groups as an object that was particularly difficult to explain and comprehend. Qualitative data from focus groups show research staff replying to specific questions about drug side effects and repeatedly clarifying what ‘voluntary’ means in the context of the PrEP trial. In the Khmer newspaper, Rasmei Kampuchea, the head of the Cambodian research group states, ‘This is a research study on the effects of tenofovir amongst sex workers, on a voluntary basis, without any coercion’ (Yin, 2004). These efforts suggest the nature of participation was a highly salient issue for potential participants and researchers alike.

Activists engaging research ethics

In addition to new research infrastructure, such as the NEC, the Cambodia PrEP trial ushered in new forms of civil society engagement with AIDS-related research and care. Frédéric Bourdier and Ève Bureau (2010) note that the PrEP trial mobilized at-risk and HIV-affected people, including ‘patient experts’, who achieved political visibility as legitimate actors in the fight against AIDS in Cambodia (p. 196). In this section, I describe modes of self-education and community education that grounded WNU and WAC claims to be legitimate stakeholders in the PrEP trial. The WNU engaged two aspects of clinical trials – international guidelines for research with human subjects and risk of side effects from medicine – that underscore a sense of vulnerability to the unknown that characterized many PrEP trial participant communities. Biomedical research of this kind had never been conducted, and rights and obligations involved in clinical trials were far from patent.

I describe three pamphlets, targeting three audiences, produced in the period after the trial had been stopped, but before it was clear that the trial was definitively cancelled. The WNU pamphlet ‘WNU Guide to Collaborating on Ethical Drug Trials’ (WNU, 2005c) was addressed to researchers. It outlines six steps to collaboration on future drug trials: (1) contact community groups, (2) produce understandable translations of all documents and presentations, (3) set up a series of meetings with community members, (4) establish a community-elected Community Advisory Board, (5) have that Board, the Institutional Review Board, and researchers together negotiate ethical guidelines for the trial, and (6) have them present the trial to the community. The WNU (2005c) wrote that it ‘would like to create a new way of collaborating on research’ (p. 1). This pamphlet displays WNU’s familiarity with international guidelines and with the need to tailor ethics to local situations. Such knowledge, facilitated by a global anti-PrEP community as well as the researchers themselves, grounded the organization’s demand to be a full partner in research.

A second example of WNU (2005b) engagement with ethics guidelines can be seen in a pamphlet addressed to sex workers. ‘Sex Workers Have Rights in Drug Trials’ contains six sections:

What are ethical trials?

Who decides what is an ethical trial?

Are ethical trials the same around the world?

Are there good drug trials?

Does this mean there are no risks to drug trials?

You have rights in drug trials.

Referencing the Declaration of Helsinki and WHO’s Guidelines for Ethical Trials, among other international guidelines, the pamphlet lists such basic rights as the right to confidentiality, information, and care for side effects, in addition to community development in exchange for participation.

A third example is a pamphlet for a two-day workshop entitled ‘Workshop of ethics of clinical trials in Cambodia: What community leaders should know about the ethical implications of HIV/AIDS clinical trials in Cambodia’ (WAC, 2005b). The workshop was targeted at ‘lay participants’, defined in the pamphlet as ‘members of community groups, sex workers and other vulnerable groups and their representatives, NGOs, health activists, and health researchers’ (WAC, 2005b: 2). The following excerpt describes the rationale and objectives for the workshop:

Analyzing ethical implications of clinical trial demands increasingly complex skills and expertise. In this context, Clinical trial participants drawn from vulnerable populations and their representatives are often in a disadvantageous position.

The primary objective of this workshop is to increase the capacity of community leaders to analyze the ethical implications of clinical trials, by introducing them to the principles of ethics of clinical trials, regulatory mechanisms in the area of clinical trials and to enhance their understanding about the best interest of clinical trial participants. (WAC, 2005b: 1)

Day 1 covered ‘Introduction to ethics’ and Day 2 was a review of international standards and instructions on how to establish a community-based ethics review committee.

These pamphlets illustrate how the WNU and WAC engaged with the PrEP trial through community education about ethical principles and rights of participants. The WNU did not engage clinical trial methodology. Whereas Epstein argues that US activists were able to participate in decision-making because they mastered the methodological aspects of clinical trials, the WNU became a key actor in the PrEP trial by learning the language of ethical research. Ethics and ‘human rights talk’ (Rabinow, 2002) are central to activist mobilizations around transnational HIV prevention research.

The WNU also questioned PrEP trial staff about the nature and extent of harms from taking tenofovir. Whereas asking questions about drug side effects may seem unremarkable, it is not part of a typical conversation one has with a doctor, pharmacist, or drug seller in Cambodia. This was not a treatment trial, and thus, the calculus of tolerable risk was different from the early azidothymidine (AZT) trials for HIV-positive people described by Epstein (1996). Furthermore, the benefits, and access to benefits, were uncertain for Cambodian sex workers. The demand for long-term health insurance was a way to manage these uncertainties about drug side effects and access to treatment. Questioning side effects expressed concerns about vulnerability and demonstrates awareness of a right to information about experimental medicine. As we shall see, vulnerability is the ground on which the WNU and the Cambodian Prime Minister based claims about exploitive relations of research.

The (geo)political relations of research

In addition to community education about participant rights and potential harms, the WNU’s second important tactic was to reference geopolitical and economic relations between trial researchers, funders, and regulatory bodies, on one hand, and the participant community, on the other. At the heart of these references was the implication that the health and well-being of Cambodians would be exploited at the hands of non-Cambodians. This sentiment resonated in the actions of the Prime Minister, the headlines of the local press, and in my interviews with NGO staff in 2005.

PrEP researchers told me they were aware of this concern about exploitation, but they did not publicly address it in geopolitical terms or as a relation within which they were implicated. Many of them viewed their research as a form of activism itself, locating the site of knowledge production in the site where the knowledge would be used. The researchers’ public position was that voluntary participation, informed consent, and repeated ethical review by regulatory bodies would ensure protection of participant rights.

But how do participant rights become Cambodian rights? How do research ethics become a way to talk about relations of responsibility, vulnerability, and sovereignty? In this section I show how enactments of ‘participant rights’ as ‘Cambodian rights’ involve a local media fixated on exploitation, the petition as historical form of anti-colonial protest, and the ambiguity of human rights discourse in post-conflict times, when perpetrators and protectors may shift roles.

The prominence of rights-related discourse among NGOs and media in Cambodia can be traced to civil society and democracy promotion activities beginning with the UN Transitional Authority in Cambodia (1992–1993), when Cambodia was under UN mandate following the Paris Peace Accords (Ledgerwood and Un, 2003). Hun Sen and his government have had an uneasy relationship with human rights discourse, initially critical of it as lenient on criminals and threatening to bring chaos to a fragile post-conflict society (Ledgerwood and Un, 2003), and more recently challenging it as a form of Western imperialism or hypocrisy. In typical human rights discourse in Cambodia, the (imagined or explicit) perpetrators of abuses are the military, the state, and powerful elites. In WNU and WAC articulations of rights in the PrEP trial, the potential perpetrators of abuses are foreign researchers. A shift in the potential perpetrator from the state to foreign researchers accompanies an expansion of the category of potential victim from experimental subjects to the Cambodian people. The leader is no longer perpetrator; he is (obligated to be) protector of his people. The concept of postcolonial bioethics captures how global health research is explicitly about relations, articulated within multiple idioms of vulnerability and responsibility.

The first detailed criticism of the PrEP trial by the WNU occurred on 29 March 2004 at ‘the first ever Cambodian sex worker-planned and run press conference’ (WNU, 2004) and was reported in local papers (Collins, 2004; Watt, 2004). The WNU background statement contains a range of points that, woven together, generate a complex portrait of possible abuses to women in an already precarious situation:

The trial is ‘experimentation’ on poor Cambodian sex workers;

Sex workers are ‘the first healthy humans to test the drug’;

Sex workers support families, in addition to themselves, and these families will also suffer if the sex worker falls ill;

Researchers will leave Cambodia once the trial is over, without taking responsibility for insurance of long-term side effects or long-term care;

‘People in richer countries and the drug company’ may benefit from the study, while sex workers in Cambodia risk their health and income, in addition to the future of their families.

This document configures research as a set of relations between researchers, ‘people in richer countries’, and ‘the drug company’, on one hand, and poor Cambodian sex workers and their families, on the other. The funders and research institutions are named at the beginning, although the Cambodian partner, NCHADS, is not. This omission amplifies the sense of clear separation between research subjects and researchers along Cambodian/non-Cambodian lines. And as with the Prime Minister’s statement about the trial, it renders invisible Cambodian actors who do not quite fit into the dichotomy, such as researchers and NGO collaborators.

In making reference to those not immediately involved in the study, the WNU asserts that the PrEP trial has broad social consequences. The need for post-trial care is not just an individual need on the part of sex workers; it is a need for family members and others that they would be unable to support should they become ill from side effects of tenofovir. Cambodian NGO staff I interviewed in Phnom Penh emphasized this point and phrased it in terms of researchers’ responsibility. Sreylak, a coordinator for an HIV/AIDS NGO that works with sex workers, conveyed this in a straightforward manner: ‘If the results [of taking tenofovir] are negative then it will become a burden in their social community’.

Local English-language papers emphasized conflict between unequal actors and the potential for exploitation given the economic and geopolitical dynamic of the PrEP trial. Titles like ‘Researchers threaten to bypass sex union’ (Kuch and Collins, 2004), ‘Sex workers threaten to block Bill Gates HIV study’ (Watt, 2004), and ‘Sex workers stand firm on Bill Gates drug trial’ (Rith, 2004) give a sense of a David-and-Goliath-type conflict between participants and funders. The name of one of the richest men in the world highlights the extreme disparity between researchers and participants and suggests a question, ‘Why can a US mogul provide money for research but not for health care for Cambodian sex workers?’ While central to WNU and media accounts, researchers did not address this issue in detail, beyond the notion of ‘undue inducement’. The newspapers also focused on the possibility of exploitation, as can be seen in the title: ‘Sex workers leery about HIV trial’ (Collins, 2004), and ‘The slippery ethics of third world drug trials’ (Doyle and Kuch, 2004).¹⁴

In speaking against the trial, Hun Sen positioned himself as acting to protect the rights and well-being of the Cambodian people. In fact, he did not mention the specific population for the study: sex workers. His comments echo a broader global rhetoric of reactions against ‘developed’ world incursions into the ‘developing’ world, a genre that is his forte. The image of Hun Sen as protector of the Cambodian people was reiterated in a 2005 open letter to the Prime Minister from the WNU. Concerned that researchers were trying to restart the trial without engaging WNU participation, the organization started its letter thus:

We the vulnerable people of Cambodia would like to express our deep thankfulness to the Prime Minister who has supported us in stopping the unethical clinical trial of a HIV prevention drug, last August 2004. Samdech is a true father who always has compassion and is very thoughtful about the benefits to his children, and stays with us when we are in difficulty. Dear Prime Minister!

After articulating their concerns about researchers pressuring sex workers to participate, without consultation with the WNU, they conclude their letter by linking their position directly to Hun Sen’s words in 2004:

Every Cambodian has the right to live, to participate, to make decisions but the research group does not give us these rights, but only thinks about their benefits and exploits us, the poor and powerless instead. ‘Cambodian people are not waste and Cambodia is not a waste bin!’ We would like to thank you for your meaningful statement when you stopped the unethical clinical trial. We would like to wish you good health and that you stay in power, to continue to govern and lead Cambodia to peace and development. (WNU, 2005a)

Both the WNU and Hun Sen articulate ‘we’ as Cambodians, not sex workers specifically. Discourse asserting that Cambodians are not waste or guinea pigs is a claim to the same rights to dignity, choice, and freedom from harm as non-Cambodians.

This letter represents a form of politics in Cambodia with deep roots. Historian of medicine Sokhieng Au (2006) describes how petitioning the King was one of several strategies people used to resist French colonial medical policies. Petitioning could take the form of a demonstration at the residence of the King or a letter to the King detailing grievances. In present-day Cambodia, the King has lost political and perhaps moral power, and it is common to petition the Prime Minister instead.¹⁵ As Penny Edwards (2008) has noted, Hun Sen’s taking the title ‘Samdech’ in the mid-1990s was a claim to the moral authority and semi-divinity of the King. This moral authority can take a paternalistic form, following the precedent set by the previous king, Norodom Sihanouk, who often referred to himself as the father of his people.¹⁶ The WNU combined local forms of protest, such as petitioning a leader and using paternal/child rhetoric, with strategies of international activism, such as teach-ins and press conferences, which use a quite different discourse of empowerment.

By indexing geopolitical relations, the resolution of concerns about the PrEP trial moved beyond the scope of adherence to, or negotiation of, bioethics codes. It moved into a more diffuse realm that includes histories and active national narratives of predation upon Cambodians by foreigners. To much of the world, recent Cambodian history is defined by the Khmer Rouge era, marked by severe abuses of Cambodians by Cambodians.¹⁷ But it is worth noting that exploitation by foreign others is as, if not more, prominent in the Cambodian national imaginary.¹⁸ Hun Sen has cultivated a persona of standing strong against ‘Western’ moral imperialism, favoring close relations with Vietnam and China. Prominent members of the other main political party, the Cambodian National Rescue Party, focus on Vietnamese imperialism, often in openly racist terms, and have cultivated close relations with France and the United States. The simplified narrative of threat to sovereignty from abroad or from others within requires continuous fashioning. Biomedical research framed as an exploitive relationship between foreigners and Cambodians hooks on to these imaginaries.

The WNU and WAC repeatedly referenced the vulnerability inherent in the Cambodian versus non-Cambodian relationship of participants and researchers. It is a token of a type of relation of underdevelopment and postcoloniality vis-à-vis national and transnational entities. In this sense, controversy about the Cambodia PrEP trial is part of a phenomenon of controversies about HIV-related experimentation around the world (see Crane, 2010; Hoad, 2005). However, it is also a very specific translation of human rights discourse in Cambodia into a form in which Hun Sen can participate. The translation of human rights discourse into rights of experimental subjects worked for Hun Sen because of a shift in the imagined or potential perpetrator, from the state to foreign researchers. The mobilization of ethics in the PrEP trial fused debates about bioethics happening around the globe with discourse about human rights in Cambodia. The focus on unequal relations in bioethics thus illuminates how global health research takes shape within multiple idioms of vulnerability and responsibility. Postcolonial concerns with rights, vulnerability, and sovereignty configure authoritative grounds for participation in global health research controversies.

Discussion

The Cambodia PrEP trial offers an opening for critical reflection on the centrality of ethics in debates about the practice of global health science. The institutional and textual forms of bioethics in the Cambodia PrEP trial – the National Ethics Committee, translations of ethics guidelines, activist education pamphlets, press conferences, and letters to political leaders – illustrate how bioethics takes shape with other idioms of vulnerability and sovereignty. The object of bioethics becomes the relation between subjects and researchers, rather than the subject/population itself, in a field of articulation of simultaneous and unequal expansion of global health and ongoing projects of postcolonial and post-conflict nation-building.

This article shows how attending to a postcolonial field of articulation can shift understandings of public participation in science within STS. ‘Postcolonial’ here is not about valorizing other epistemologies or expertises, but following cases where epistemology and expertise are not the relevant or authoritative grounds for participation in scientific practices. Research ethics as a domain of public engagement with science, and transnational bioethics in particular, has been undertheorized within STS. In contrast to previous studies of public or activist engagement with science, I show how activists engaged with research ethics rather than research design or epistemology. They did this through the circulation of and debate about ethics guidelines, reference to historically and culturally specific relations of vulnerability and responsibility, and discourse of human rights. Bioethics is transformed as a result. I argue that this shift in ethical concern, from focus on the experimental human subject to focus on the relation between researchers and subjects, illustrates how a postcolonial field of articulation reformulates classical bioethics.

Almost a decade later, we inhabit the futures prefigured in part by debates around the Cambodia PrEP trial. Ethics are a technical core of transnational HIV prevention research, and engagement with ethics may come in the form of local review boards developed in collaboration with researchers and Ministries of Health, such as the NEC for Human Research, formative research, or participant community education by activist groups, such as the workshops hosted by the WNU and WAC.

In revised guidelines for transnational HIV prevention research, we can see an emphasis on political economic relations between researchers and research subjects, and acknowledgement that inequalities in these relations present challenges for ethical research practice (see Rennie et al., 2009; UNAIDS, 2007: 10–11; UNAIDS/AVAC, 2007). Revised guidelines prioritize community consultation and public participation. These new emphases, and the specificities of testing healthy people rather than sick ones, differentiate transnational HIV prevention research from ‘offshored’ clinical trials managed by pharmaceutical companies and clinical research organizations (CROs) for drug development, such as those analyzed by Petryna (2009) and Sunder Rajan (2010). Rosengarten and Michael (2009) write that an emphasis on community consultation in international guidelines ‘may lead to new forms of knowledge exchange, affecting the expertise of those involved in research and consequently its outcomes programs’ (p. 1052). Although community consultation implies a pre-existing collectivity, the community may also emerge in response to research. And, the representatives that emerge may not endure. For instance, after achieving a significant level of visibility, the WNU does not seem to be involved in research with sex workers, whereas other NGOs continue to collaborate, and former PrEP researchers continue to conduct prevention and treatment research in Cambodia in partnership with the Ministry of Health. Perhaps this is an illustration of Geissler and Pool’s (2006) observation that relations between researchers and communities are more often cordial than conflicted, despite economic and political tension (p. 978; see also Geissler, 2013; Redfield, 2013). In this article, I have analyzed controversy not as an inevitable outcome of political or historical circumstances or pre-existing social groups, but as an outcome of convergences, some of which can be untangled and some of which remain unknown.

In addition to being a novel clinical trial for any location, the PrEP trial was the first major experimental clinical trial in Cambodia, and thus, both the standards and the means to evaluate them were not given. In this article, I have shown how ethics and research were produced in terms of each other in the Cambodia PrEP trial, through the mobilization of international standards and the transmutation of participant rights into Cambodian rights. Recent STS scholarship on HIV prevention clinical trials (e.g. Brives, 2013; Montgomery, 2012) have explicitly not focused on the ethics of biomedical research over concern that an ethics focus relies on pre-determined categories of knowledge, power, standards, or social groups. However, a focus on ethics need not preclude an interest in coproduction. I have argued that transnational biomedical research is constituted in terms of ethics, both for communities and for researchers. For the WNU and WAC, this involved learning ethics guidelines for research, disseminating this knowledge, and questioning researchers about their adherence to them. For researchers, this involved testing local implementation of guidelines, expanding the scope of the National Ethics Committee, and conducting formative research, including focus groups and pilot testing of the informed consent process.

In conclusion, it is possible to see, in the polarized space between bioethics and geopolitics in the Cambodia PrEP trial, an opening, one that was not recognized as such. This opening is to consider ethical principles as locally constituted, but here, ‘local’ is not just about the place or the population, but the multiple historical and political relations within which the research comes to be or, in this case, does not come to be.

Footnotes

Acknowledgements

I thank the people in Phnom Penh, San Francisco, and the interstices who spoke with me about the trial. I also thank The Cambodia Daily, Phnom Penh Post, Rasmei Kampuchea, and National Archives of Cambodia for permission to photocopy materials. Erica Prussing, Virginia Dominguez, Doug Midgett, Thomas Riess, Nanette Barkey, Frédéric Bourdier, Emily Yates-Doerr, Vinh-Kim Nguyen, MAWG comrades (in particular, Nicola Bulled, Kate Goldfarb, Britt Dahlberg, and Ali Kenner), Vivian Choi, the Editors, and anonymous reviewers for providing invaluable comments on different versions of this paper. I am grateful to them all.

Funding

The research was supported by a Presidential Fellowship from the University of Iowa, and a portion of the writing was completed while a fellow at the International Institute for Asian Studies at Leiden University.

Notes

Author biography

Jenna M Grant is Assistant Professor of Anthropology at the University of Washington. She works on medicine, technology, and visuality in Cambodia. She is currently writing about medical imaging in Phnom Penh, and developing a collaborative project on malaria drug resistance. She is also Reviews Editor at Medicine Anthropology Theory (MAT), and Co-editor of Visual & New Media Review, a blog on Cultural Anthropology online.

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