Justice in human research ethics : a conceptual and practical guide

One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice – whether distributive or commutative - and what counts as a just distribution or exchange – are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished and the manner in which they can be applied meaningfully in the ethical review all human research is identified. The way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (NHMRC, ARC, UA, 2007) (National Statement) is explained. The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. It also provides guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. It also provides practical guidance to researchers on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement is also provided

Globalisation and Health : Challenges for Health Law and Bioethics

This timely collection explores ethical and legal dilemmas in healthcare arising from globalization. Conflicts between public interests and individual rights, the challenge of regulating professionals and access to health services, and the effects of a global market all feature prominently in contemporary debates in this area. As a result of globalization, issues in health law and bioethics can no longer be understood solely within political boundaries that define traditional notions of individuals and communities. Rather, solutions for emerging problems require a global conception of rights and obligations, including the re-evaluation of ethical frameworks and legal regimes that currently govern exchanges in healthcare. Leading scholars in bioethics, law, medicine and philosophy from various jurisdictions engage these themes in this volume, and demonstrate the need for transnational solutions in a global age of healthcare.

Health, Rights and Globalisation

Draws together essays from leading scholars on the challenges that arise for health, law, policy and ethics at the intersections of health, rights and globalization. This book addresses global issues in public health, globalization and bioethics, and globalization and biotechnology.

Introduction - research ethics : women, sex, and gender in biomedical research

The ethical governance of biomedical research is an area of intense international debate. Scholars argue about who should regulate and how, the appropriate role for ethics committees, what kind of research should be included, and who should be involved in monitoring compliance. A particular aspect of these debates concerns the inclusion of women as research participants and the efforts to ensure that researchers consistently investigate questions of sex and gender in health research. There is increasing evidence of the role of sex in the manifestation and course of some illnesses and their treatment. Moreover, evidence suggests that gendered expectations also affect health outcomes. This special issue investigates how researchers are addressing these issues and debates the appropriate roles of policy makers, ethicists, and lawyers in ensuring that sex and gender differences are taken into account in the development, conduct, and reporting of health research.

Review: "Controversies in Health Law" by In Freckelton and Kerry Peterson

During the past couple of decades health law has been transformed. Within that period we have been confronted with advances in medical science, particularly in genetics, reproductive technology and life-sustaining treatments. Health care has become more expensive, more consumer oriented and more litigious. In addition, the ethical implications of these developments, and the role for law, both as a regulator of health care and in its responses to emerging challenges, have occupied policy-makers, law reformers, health professionals, ethicists and the broader community in Australia and overseas. While many issues have emerged from these developments, there have been few easy solutions...

New challenges for old laws? The development of e-health in Australia

Increasing role of electronic health care in Australia - possibilities of e-health in terms of provider-to-consumer initiatives and of business-to-business initiatives - challenges of e-health in the context of existing laws and recent reforms - assessment of the adequacy of existing laws to meet the challenges posed by e-health

The value of respect in human research ethics: A conceptual analysis and a practical guide

In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices.

The IHR (2005), disease surveillance, and the individual in global health politics

Since the revisions to the International Health Regulations (IHR) in 2005, much attention has turned to two concerns relating to infectious disease control. The first is how to assist states to strengthen their capacity to identify and verify public health emergencies of international concern (PHEIC). The second is the question of how the World Health Organization (WHO) will operate its expanded mandate under the revised IHR. Very little attention has been paid to the potential individual power that has been afforded under the IHR revisions – primarily through the first inclusion of human rights principles into the instrument and the allowance for the WHO to receive non-state surveillance intelligence and informal reports of health emergencies. These inclusions mark the individual as a powerful actor, but also recognise the vulnerability of the individual to the whim of the state in outbreak response and containment. In this paper we examine why these changes to the IHR occurred and explore the consequence of expanding the sovereignty-as-responsibility concept to disease outbreak response. To this end our paper considers both the strengths and weaknesses of incorporating reports from non-official sources and including human rights principles in the IHR framework.

Reproductive Health as a Human Right: A Matter of Access or Provision?

This article seeks to understand why, despite over three decades of claiming women's reproductive health as a human right, we have seen little progress in reducing their health inequalities and poor health outcomes. I argue that one reason for this lack of progress may be due to a failure to clearly articulate the responsibilities of key actors, crucially states, in ensuring that women have access to, and provision of, services required to realize their reproductive rights. What is needed, this article suggests, is a framework that can translate decades of rights language into action and specifically identify the provisions required to address women's health.

The Healthy Trends of International Relations Research

As the end of the Cold War approached in 1989, Caroline Thomas argued: “It is important that the discipline [International Relations, IR] should address the issue of disease and more broadly, health, not simply to facilitate containment of disease transmission across international borders but also because central notions of justice, equity, efficiency and order are involved” (1989:273).1 Ten years later, Craig Murphy echoed these sentiments. Murphy (2001: 352) proposed that IR had yet to grapple with the political consequences of growing inequality between the world’s rich and poor, and areas such as health—where these inequalities were most stark—should become the field’s core business. How IR’s theories and methods would approach these issues was less clear. Bettcher and Yach (1998) cautioned that IR would be unable to develop progressive research projects that explored global health diplomacy as a global public good without adopting new perspectives and methods. Others warned that the expansion of security studies into areas such as global health would weaken the intellectual coherency of the field (Walt 1991:213). Taking its cue from the recent Ng and Prah Ruger (2011) study, this paper returns to these concerns to briefly explore key trends and potential future concerns of research in IR on health...

What contribution can International Relations make to the evolving global health agenda?

This article presents two approaches that have dominated International Relations in their approach to the international politics of health. The statist approach, which is primarily security-focused, seeks to link health initiatives to a foreign or defence policy remit. The globalist approach, in contrast, seeks to advance health not because of its intrinsic security value but because it advances the well-being and rights of individuals. This article charts the evolution of these approaches and demonstrates why both have the potential to shape our understanding of the evolving global health agenda. It examines how the statist and globalist perspectives have helped shape contemporary initiatives in global health governance and suggests that there is evidence of an emerging convergence between the two perspectives. This convergence is particularly clear in the articulation of a number of UN initiatives in this area—especially the One World, One Health Strategic Framework and the Oslo Ministerial Declaration (2007) which inspired the first UN General Assembly resolution on global health and foreign policy in 2009 and the UN Secretary-General's note ‘Global health and foreign policy: strategic opportunities and challenges'. What remains to be seen is whether this convergence will deliver on securing states’ interest long enough to promote the interests of the individuals who require global efforts to deliver local health improvements.

Book reviews : "Biosecurity interventions: global health and security in question"

International Relations’ engagement with global health governance has proliferated in the last decade. There are a number of excellent works that seek to understand how the relationship between politics and health shapes and informs people’s lives and governments’ policies. However, the overt securitization of health by the IR field has, Biosecurity interventions argues, remained relatively unproblematized...

From prototype to exploitation : mobile services for patients with chronic lower back pain

Many research and development projects that are carried out by firms and research institutes are technology-oriented. There is a large gap between research results, for instance in the form of prototypes, and the actual service offerings to customers. This becomes problematic when an organization wants to bring the results from such a project to the market, which will be particularly troublesome when the research results do not readily fit traditional offerings, roles and capabilities in the industry, nor the financial arrangements. In this chapter, we discuss the design of a business model for a mobile health service, starting with a research prototype that was developed for patients with chronic lower back pain, using the STOF model and method. In a number of design sessions, an initial business model was developed that identifies critical design issues that play a role in moving from prototype toward market deployment. The business model serves as a starting-point to identify and commit relevant stakeholders, and to draw up a business plan and case. This chapter is structured as follows. We begin by discussing the need for mobile health business models. Next, the research and development project on mobile health and the prototype for chronic lower back pain patients are introduced, after which the approach used to develop the business model is described, followed by a discussion of the developed mobile health business model for each of the STOF domains. We conclude with a discussion regarding the lessons that were learned with respect to the development of a business model on the basis of a prototype.