Search

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 (HREC). Consent for use of health information for research is rarely sought at an emergency department (ED) 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 (77%) 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.

Introduction: Despite known socioeconomic and health disparities affecting Indigenous populations in developed countries, stroke incidence data are sparse. With Indigenous Advisory Board oversight, we undertook a systematic review to compare Indigenous with non-Indigenous stroke incidence rates in countries with a very high Human Development Index (HDI). Methods: We identified population-based stroke incidence studies published from 1990-2022 in Indigenous adult populations of developed countries using PubMed, EMBASE and Global Health databases, without language restriction. We excluded non-peer-reviewed sources, studies with Results: Among 13,041 publications, 24 studies (19 full text, 5 abstracts) from 7 countries met inclusion criteria. Compared with respective non-Indigenous populations (Fig 1), age-standardised incidence rates were greater in Aboriginal and Torres Strait Islander Australians (ratios ranging from 1.7-3.2), American Indians (1.2), Sámi of Sweden/Norway (1.08-2.14), and Singaporean Malay (1.7-1.9), with higher rate ratios at younger ages. Studies had substantial heterogeneity in design and risk of bias. Few investigators reported Indigenous stakeholder involvement. Conclusions: In countries with a very high HDI, available data suggest marked disparities in stroke incidence in Indigenous populations, although there are gaps in data availability and quality. Indigenous stakeholder involvement in studies is infrequently reported. A greater understanding of stroke incidence in these populations is imperative for informing effective societal responses.

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.

Whilst we applaud and support a call for “a proactive form of bioethics that actively resists and denounces injustice" we contend that the authors do not go far enough. The underlying theoretical issue is that the vision of bioethics itself is too constrained. Bioethics has been conceived of as an academic discipline in which the primary activity is free, open and reasoned discussion. What is missing is a conception of bioethics that (1) entails a broader practical repertoire and (2) gives effect to ethical values at clinical, organizational, community, and health system levels. We claim that bioethics should aim not merely to describe the world but should endeavor to change it.

This chapter examines the ethical issues related to the practice of health care in an environment where human rights are absent, specifically relating to the conditions for refugees and asylum seekers who arrive by sea in Australian territory. The ethical considerations of working within the offshore detention environment are discussed. Health-care workers in these harsh environments often have divided loyalties, when duties to their patients conflict with duties to their employer or to the state. The author draws on published accounts and interviews with health-care providers who have worked on Manus Island and Nauru and Christmas Island, the sites used by Australia for offshore detention of asylum seekers.

There is currently a resurgence of interest in and debate on the role of bioethicists as advocates. However, it is also important that we discuss the appropriate role and responsibilities of bioethical associations. We must accept the responsibilities that attach to silence and inaction. Bioethics has always aimed to be practical, to make a difference to practice and policy, particularly when standing with those who are marginalised. Such actions are necessarily political. We call on the bioethics community to examine critically the myth of neutrality in bioethics.

The situation around the seeking of refuge, both in Australia and abroad, has become a core human rights issue of our time, engendering protest and activism from the public, researchers, healthcare professionals and academics. The question remains: do bioethicists have duties to advocate on behalf of such populations, and if so, why? I argue that if our work is founded upon the principle of justice, then we do have such duties, and that our research, in itself, can become a form of advocacy.

Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research.

The essays selected for this volume focus on issues that arise when attempting to design, review and undertake research involving human participants who are experiencing a private or public emergency. The main themes discussed by the essays are: the distinctive and significant ethical questions as to how research participants can be treated during emergency settings; the ethical challenges raised by emergencies for researchers undertaking research and its effects on the nature of research pursued; and procedural obstacles raised by emergencies which can affect the quality of good research ethics review. The volume is unique in that it is the first collection to exclusively deal with all of the central ethical aspects of conducting human subject research in the context of emergency.

How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger's health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU's dual role as a research unit and medical non-governmental organization.

It has been suggested that community advisory boards (CABs) 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 (T-CAB) 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.

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.

BACKGROUND: 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. METHODS: Case study research was undertaken on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial, which was performed on the Thai-Myanmar border with Karen and Myanmar refugees and migrants. We conducted nineteen in-depth interviews with trial stakeholders, including investigators, trial participants, community advisory board members, and funder representatives; directly observed at trial sites over a five-week period; and collected trial-related documents for analysis. RESULTS: The vivax malaria treatment trial drew attention to contextual features that, when present, rendered the 'research for health justice' framework's guidance partially incomplete. These insights allowed us to extend the framework to consider external research actors' obligations to stateless populations. Data analysis then showed that framework requirements are largely fulfilled in relation to the vivax malaria treatment trial by Wellcome Trust (funder), Oxford University (sponsor), and investigators. At the same time, this study demonstrates that it may be difficult for long-term collaborations to shift the focus of their research agendas in accordance with the changing burden of illness in their host communities and to build the independent research capacity of host populations when working with refugees and migrants. Obstructive factors included the research funding environment and staff turnover due to resettlement or migration. CONCLUSIONS: Our findings show that obligations for selecting research targets, research capacity strengthening, and post-trial benefits that link clinical trials to justice in global health can be upheld by external research actors from high-income countries when working with stateless populations in LMICs. However, meeting certain framework requirements for long-term collaborations may not be entirely feasible.

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.

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.

This article describes the impact of immigration detention on the health of asylum seekers. Drawing on specific examples, it explores the roles of professional staff working within the detention system and/or challenging the practices as advocates. Using oral testimony from a citizen-initiated campaign, The People's Inquiry into Detention, we interrogate the harmful experiences of force-feeding, deportation practices and the incarceration of children, including the role of the health professionals who sometimes betrayed their duty of care. Discussed are the paradoxes of dual loyalty and professional ethics.

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.

The system of asylum seeker detention in Australia is one in which those seeking refuge are stripped of many of their rights, including the right to health. This presents serious ethical problems for healthcare providers working within this system. In this article we describe asylum seeker detention and analyse the role of nurses. We discuss how far an "ethics of care" and witnessing the suffering of asylum seekers can serve to improve their situation and improve ethical nursing practice.

Australian immigration detention has been identified as perpetuating ongoing human rights violations. Concern has been heightened by the assessment of clinicians involved and by the United Nations that this treatment may in fact constitute torture. We discuss the allegations of torture within immigration detention, and the reasons why healthcare providers have an ethical duty to report them. Finally, we will discuss the protective power of ratifying the Optional Protocol to the Convention against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment as a means of providing transparency and ethical guidance.

The creation of pharmacotherapies, such as Selective Serotonin Reuptake Inhibitors (SSRIs), 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.

In the 2010-11 financial 2013, there was a dramatic reduction in the approvals granted by the Australian Electoral Commission for access to samples of the adult population derived from the electoral roll for the purposes of public health research. Much time and effort has been expended in making applications without success. Researchers refused access to electoral roll samples must rely on sampling methods that are not as robust and that may produce less reliable data. We outline a set of recommendations that, if adopted, will result in a fairer system for obtaining access to the electoral roll for public health research.

One option to increase genuine accountability would be to ratify the Optional Protocol to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (OPCAT). The OPCAT is a bipartisan-supported UN protocol signed by Australia in 2009. It is as yet unratified.6,8-10 At the time of publication, the OPCAT has been ratified by 78 countries (Box). It was established recognising the need to take measures beyond the simple agreement not to engage in the inhumane treatment of people in detention.8

Clinical trials in developing countries are often beset by ethical problems that would be considered unresolvable in countries like Australia and the U.S. Nevertheless, such trials continue to go ahead throughout Asia, Africa and South America, and are often conducted in ways that could be considered to be unethical. In this article I discuss two issues, focussing on an HIV preventative trial of a vaginal gel, the Nonoxynol 9 phase three trial being held in Kenya. The first of these is what makes such a trial unethical given that it has approval from the WHO and seemingly conforms with acceptable standards of consent. The second issue involves using material from such trials, if we accept that they were conducted unethically.

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.

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.

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.

In an attempt to broaden the current debate over proposed revisions to the Declaration of Helsinki, we define vulnerable subjects as those lacking basic rights, and examine the ethical risks inherent in research on such subjects. We then propose special ethical criteria for the conduct and publication of research on vulnerable subjects.

Issues of power and consent, confidentiality, trust, and benefit, risks to researchers, and potential harm to participants, are all contested when working with different cultures and within environments marked by violence and insecurity. Difficulty resolving these dilemmas may paralyse ethics committees, may fail to give the guidance sought by researchers, and will not help populations who are among the world's most vulnerable. Even where efforts are made to respond to ethical guidelines and to improve practice, considerable impediments are present in many developing countries, including lack of formal ethical review structures in unstable settings, lack of required skills, limited political and institutional recognition of ethical issues, competing interests, and limitations in clinical and research practice (Elsayed 2004, Macklin 2004). In conflict settings, these limitations are more marked, and the responsibilities of the researcher for ethical practice are greater, but the mechanisms for oversight are weaker. Moreover, the constant focus on vulnerabilities and problems, and the often almost total lack of recognition of strengths and resilience, can further disempower already exploited groups and individuals. The capacity of refugees and communities in conflict to take an active role in the research process is seldom acknowledged, and undermines the potential for more innovative research which can help generate the evidence for better policy and practice.

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.

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.

The Public Citizen's Health Research Group recently called attention to ethical concerns with trials of AZT which are either planned or underway in developing countries. The trials are being conducted to determine the minimum dose of AZT needed to prevent the vertical transmission of HIV from infected mothers to their unborn children. To that end, women who have given their informed consent to enter the trials are randomized into various dosage and placebo arms of the trials. The problem with this standard trial format in this case is that AZT is already proven capable of blocking approximately two thirds of transmissions of HIV to the fetus. The Public Citizen's Health Research Group therefore argues that the trials violate the Helsinki Declaration in that every patient enrolled in a clinical trial should be assured of receiving the best available treatment. Since these study subjects cannot obtain HIV prophylaxis elsewhere, they may enter the trials out of desperation, thereby invalidating their ability to autonomously consent to study participation. The author considers the ideal of informed consent which equates autonomy with competence rather than with freedom, whether freedom equals choice, and freedom, autonomy, and trials in developing countries. AZT vertical transmission trials could be markedly improved by replacing the placebo arm with a contrasting dose cohort.

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?