It has been suggested that community advisory boards can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings – namely, where individuals join with a (...) very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. (shrink)

This article investigates whether or not theories of justice from political philosophy, first, support the position that health research should contribute to justice in global health, and second, provide guidance about what is owed by international clinical research (ICR) actors to parties in low- and middle-income countries. Four theories?John Rawls's theory of justice, the rights-based cosmopolitan theories of Thomas Pogge and Henry Shue, and Jennifer Ruger's health capability paradigm?are evaluated. The article shows that three of the four theories require the (...) conduct of health research for justice in global health. The theories help identify the ends of justice to which ICR is to contribute, but they cannot tell us how to organize ICR to promote these ends. Aside from Ruger's health capability paradigm, the theories also lack an allocative principle for assigning specific duties to specific actors. This creates difficulties for establishing obligations for certain types of ICR actors. (shrink)

Australia has one of the harshest regimes for the processing of asylum seekers, people who have applied for refugee status but are still awaiting an answer. It has received sharp rebuke for its policies from international human rights bodies but continues to exercise its resolve to protect its borders from those seeking protection. One means of doing so is the detention of asylum seekers who arrive in Australia by boat. Health care providers who care for asylum seekers in these conditions (...) experience a conflict of “dual loyalty,” whereby their role in preserving and maintaining the health of patients can run counter to their employment in detention facilities. Many psychiatrists who have worked in the detention setting engage in forms of political activism in order to change the process of seeking refuge. (shrink)

Dual loyalty issues confront health and welfare professionals in immigration detention centres in Australia. There are four apparent ways they deal with the ethical tensions. One group provides services as required by their employing body with little questioning of moral dilemmas. A second group is more overtly aware of the conflicts and works in a mildly subversive manner to provide the best possible care available within a harsh environment. A third group retreats by relinquishing employment in the detention setting. A (...) fourth group is activist in intent and actions. Derived from research and ethnography conducted in Australia, the article explores the moral dilemmas confronting those who are duty-bound by professional codes of ethics while also bound by loyalty to their employers and silenced by confidentiality statements. It provides particular focus on psychiatry, nursing and social work. We conclude by speculating whether a politics of compassion and acts of solidarity can forge a pathway through the ethical terrain. In doing so we draw upon human rights considerations as well as on the works of Joan Tronto and Elisabeth Porter. (shrink)

We applaud and support the call by Mithani et al. for “a proactive form of bioethics that actively resists and denounces i...

Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low- and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed if research groups and (...) other actors are to successfully translate them into practice because doing so is often a complicated, context-specific process. Case study research methods offer one avenue for collecting data to develop this guidance. The authors describe how such methods have been used in relation to the Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying on the VHX trial example, the paper shows how information can be gathered from not only international clinical researchers but also trial participants, community advisory board members and research funder representatives in order to: (1) measure evidence of responsiveness, provision of ancillary care, access to post-trial benefits and research capacity strengthening in international clinical research; and (2) identify the contextual factors and roles and responsibilities that were instrumental in the fulfilment of these ethical obligations. Such empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements. (shrink)

Australia's policy of mandatory indefinite detention of those seeking asylum and arriving without valid documents has led to terrible human rights abuses and cumulative deterioration in health for those incarcerated. We argue that there is an imperative to research and document the plight of those who have suffered at the hands of the Australian government and its agents. However, the normal tools available to those engaged in health research may further erode the rights and well being of this population, requiring (...) a rethink of existing research ethics paradigms to approaches that foster advocacy research and drawing on the voices of those directly affected, including those bestowed with duty of care for this population. (shrink)

This paper explores ethical questions arising from the work of health practitioners in immigration detention centres in Australia. It raises questions about the roles of professional disciplines and the ways in which they confront dual loyalty issues. The exploration is guided by interviews conducted with health professionals who have worked in asylum seeker detention and an examination of the outsider advocacy role undertaken by the social work profession. The paper discusses the stance taken by individuals and professional associations on participation (...) in controlled settings, including as participant, bystander and advocate, and asks when the provision of care becomes collusion with oppression. (shrink)

In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework—‘research for health justice’—was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how (...) external funders, sponsors, and researchers can fulfill their obligations under the framework. (shrink)

Many assumptions are made about public willingness to participate in epidemiological research, yet few empirical studies have been conducted to ascertain whether such assumptions are correct. Our qualitative study of the public and of expert stakeholders leads us to suggest that people are generally prepared to participate in epidemiological research, particularly if it is conducted by a trusted public institution such as a government health department, charity, or university. However, there is widespread community distrust of research conducted or sponsored by (...) pharmaceutical companies. Individuals are prompted to take part if the study concerns an illness they or a family member or friend have personally experienced or if they believe the research will confer a widespread public benefit. Preferences vary about the mode of contact for the research to be conducted. Willingness to participate in telephone surveys has decreased in recent years, and this may be a consequence of an increase in calls to homes by telemarketers and market researchers. Participants also stressed the importance of knowing where their names and contact details were sourced and suggested that this information be available to prospective study participants as a matter of course in the first approach or letter. We provide valuable information to epidemiologists in designing studies. (shrink)

This paper analyses the way in which being in possession of an adequate range of options is an essential component of autonomy. I discuss the way in which the conceptualisation of options in terms of basic rights might assist this argument, and apply these ideas to HIV/AIDS clinical research in the developing world. Finally, I suggest that mechanisms should be put in place through which vulnerable research participants can express their views about the relationship between the research in which they (...) are involved, and needs of a worthwhile life. (shrink)

Research Ethics, Volume 18, Issue 1, Page 51-63, January 2022. Aboriginal and Torres Strait Islander peoples in Australia, have historically experienced research as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, the risk of exploitation and oppression arising from research still raises challenging ethical questions. Since the 1990s the National Health and Medical Research Council in Australia has developed specific sets of guidelines that govern research with these (...) populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead to research and research practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships. (shrink)

In a recent edition of the Medical Journal of Australia, Greg Dore and David Cooper called on persons in developed nations like Australia to bridge the divide between resource-rich countries to nations in the developing world, where therapies to ease or halt the ravages of the virus are nonexistent or in short supply.

BackgroundHealth research often uses health information, a subcategory of personal information, collected during clinical encounters. Conditions under which such health information can be used for the secondary purpose of research are set out in state, national and international law. In Australia, consent is required or the relevant conditions for a waiver of consent must be met and approved by a human research ethics committee. Consent for use of health information for research is rarely sought at an emergency department presentation. Research (...) often occurs after the index visit and gaining consent can be difficult. Waiver of consent provisions are frequently used, but acceptability of this approach to patients is unclear.ObjectiveTo identify ED patients’ knowledge and attitudes towards the use of health information for research, consent preferences and acceptability of waiver of consent.MethodsAn online, anonymous survey of adult patients attending two large EDs in Melbourne, Australia.Results103 patients completed the survey. We found that 52% were unaware that health information might be used for research. A majority felt that HREC approval for use of health information without consent was acceptable. However, 36% would prefer to be contacted regarding consent.ConclusionThese findings suggest a lack of awareness that health information can be used for research and that waiver of consent is acceptable, but not necessarily preferred, in most of the ED patient population. Efforts to increase awareness and provide opportunities to express preferences about health information use for research are needed. (shrink)

Australia's policy of mandatory indefinite detention of those seeking asylum and arriving without valid documents has led to terrible human rights abuses and cumulative deterioration in health for those incarcerated. We argue that there is an imperative to research and document the plight of those who have suffered at the hands of the Australian government and its agents. However, the normal tools available to those engaged in health research may further erode the rights and well being of this population, requiring (...) a rethink of existing research ethics paradigms to approaches that foster advocacy research and drawing on the voices of those directly affected, including those bestowed with duty of care for this population. (shrink)

The creation of pharmacotherapies, such as Selective Serotonin Reuptake Inhibitors, for the treatment of depression was hailed as a great breakthrough in mental health care. However, since that time, serious questions have arisen as to their safety and the way they are prescribed without full information being provided to patients about a range of important issues, including the possible aetiologies of depression, and the efficacy and potential side-effects of medication. These issues have been especially important in the care and treatment (...) of young people, as there is evidence that SSRIs may be implicated in increased suicidal behaviour. In this article, we examine the experiences of five individuals who were prescribed an SSRI in their late teens or early twenties, and discuss some of the ethical issues that arise from their accounts. (shrink)

Before sailing past the sirens' “flowery meadow,” Ulysses instructed his sailors to lash him to the mast so that he would not succumb to the siren's singing. His advance directive demonstrated that he valued his dispositional or long-term autonomy over his unquestioned right to make decisions. He also indicated to his oarsmen that he understood the nature of temptation and his inability to resist it. Ideas of autonomy and sexual choice are central to this discussion of new AIDS treatments, especially (...) the trials of preventative vaccines. Questions arise over the rights of individuals and the extent that these should be limited by concerns of the gay community. Should the gay community intervene in the risky decisions of individuals if no explicit advance directive exists? If so, how do they justify their paternalism? Could their aims not be better served through strengthening the individual dispositional autonomy of trial participants rather than making specific claims about the common good? (shrink)

The advent of HIV focussed broad social attention on the group of people most affected by it in Australia, the so-called ‘gay community’. However, what a gay community actually was, and what kind of rights and duties were being attached to it remained unclear. However, it is obvious that such a community — or communities — did not fit the model proposed by communitarian writers like Michael Sandel and Charles Taylor, whereby subjects cannot stand outside their own constitutive attachments. I (...) also consider the common criticism of communitarianism, and see what kinds of collectives can in fact be considered ethical.The first part of this paper looks at the ethical issues surrounding community attachment of this kind in Australia in relation to the ethics of HIV/aids clinical research. In particular I examine the way in which certain forms of gay community attachment can be used to strengthen personal autonomy and check exploitation within the prevention and research process.The second part of this paper draws upon the issues just discussed. In particular I focus on the use of ‘community’ in the research process in developing countries, and suggest ways in which cultural considerations might strengthen autonomy. However, I go on to suggest that in many cases the idea of community has served the opposite purpose, and has in fact been used to oppress certain individuals and groups within the developing world, in the so-called interests of the greater good. In order to avoid this, I suggest a model of social and ethical research whereby all subjects and researchers in the clinical process might stand in greater relationships of equality with each other. (shrink)