Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of research participants in low-income countries over recent decades , has intensified the debate on the ethics of international research and led to increasing attention both to exploitation of vulnerable subjects and to considerations of how the 10:90 gap in health and medical research could be narrowed. In 2000, prompted by the (...) discussions over several years that led to the US NIH launching a capacity building programme on research ethics for members of research ethics committees in developing countries, we advanced a ‘new look’ for the ethics of international research.1 Since then progress has been made on several fronts.First, our ideas—considered somewhat radical and impractical at the time—have been provocatively addressed by scholars who have either contested them or advanced similar conceptions of what obligations international researchers have to research participants and communities in low income countries before, during and after clinical trials. Second, those researchers who have been sympathetic to our ideas have either endeavoured to put these into practice or have investigated the feasibility of doing so. Third, the intractability of the 10/90 gap and the escalation of interest in global health have sensitised many to the need to amplify the uptake of these ideas in practice.Here, we briefly review the conceptual and practical developments in international research ethics. While much conceptual progress has been made (and the concepts are now appearing …. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care upwards for research (...) participants and their communities is an ethical obligation of those in resource-rich countries who sponsor and implement research in poorer ones. (shrink)

This article reviews some of the ethical aspects of collaborative research. Scientific collaboration has known potential benefits but it’s a challenging task to successfully accomplish a collaborative venture on ethically sound grounds. Current trends in international healthcare research collaboration reflect limited benefits for the majority of world population. Research collaboration between scientists of academia and industry usually has financial considerations. Successful cross-cultural and international collaborations have to overcome many regional and global barriers. Despite these difficulties, many scientific collaborations usually begin (...) with an informal meeting or contact. With advancement in global communications, scientists have greater responsibility towards the world community while considering the impact of their collaborative partnerships. I review the basic factors that are required for forging a collaborative partnership and responsible attitudes to sustain the relationship. Finally I conclude that scientists in healthcare research can play important roles beyond collaborations and contribute to bringing harmony, resolving differences across the nations and countries in today’s troubled world. (shrink)

Efforts to build research capacity and capability in low and middle income countries (LMIC) has progressed over the last three decades, yet it confronts many challenges including issues with communicating or even negotiating across different cultures. Implementing global research requires a broader understanding of community engagement and participatory research approaches. There is a considerable amount of guidance available on community engagement in clinical trials, especially for studies for HIV/aids, even culturally specific codes for recruiting vulnerable populations such as the San (...) or Maori people. However, the same cannot be said for implementing research in global health. In an effort to build on this work, the Pakistan Institute of Living and Learning and University College London in the UK sought to better understand differences in beliefs, values and norms of local communities in Pakistan. In particular, they have sought to help researchers from high income countries (HIC) understand how their values are perceived and understood by the local indigenous researchers in Pakistan. To achieve this end, a group discussion was organised with indigenous researchers at Pakistan Institute of Living and Learning. The discussion will ultimately help inform the development of a cultural protocol for researchers from HIC engaging with communities in LMIC. This discussion revealed five common themes; (1) religious principles and rules, (2) differing concepts of and moral emphasis on autonomy and privacy, (3) importance of respect and trust; (4) cultural differences (etiquette); (5) custom and tradition (gift giving and hospitality). Based on the above themes, we present a preliminary cultural analysis to raise awareness and to prepare researchers from HIC conducting cross cultural research in Pakistan. This is likely to be particularly relevant in collectivistic cultures where social interconnectedness, family and community is valued above individual autonomy and the self is not considered central to moral thinking. In certain cultures, HIC ideas of individual autonomy, the notion of informed consent may be regarded as a collective family decision. In addition, there may still be acceptance of traditional professional roles such as ‘doctor knows best’, while respect and privacy may have very different meanings. (shrink)

As compared with conventional vaccine production systems, plant-made vaccines are said to enjoy a range of advantages including cost of production and ease of storage for distribution in developing countries. In this article, we introduce the science of PMV production, and address ethical issues associated with development and clinical testing of PMVs within three interrelated domains: PMVs as transgenic plants; PMVs as clinical research materials; and PMVs as agents of global health. We present three conclusions: first, while many of the (...) ethical issues raised by PMVs are familiar, PMVs add a new dimension to old issues, and raise some novel issues for ethicists and policy-makers; secondly, it is premature to promise broad applicability of PMVs across the developing world without having demonstrated their feasibility; thirdly, in particular, proponents of PMVs as a solution to global health problems must, as a condition of the ethical conduct of their research, define the commercial feasibility of PMVs for distribution in the developing world. (shrink)

The research ethics committee is a key element of university administration and has gained increasing importance as a review mechanism for those institutions that wish to conduct responsible...

The ethics of benefit sharing has been a topical issue in global health research in resource-limited countries. It pertains to the distribution of goods, benefits and advantages to the research participants, communities and countries that are involved in research. One of the nuances in benefit sharing is the ethical justification on which the concept should be based. Extensive literature outlining the different principles underlying benefit sharing is available. The purpose of this paper is to examine the proposed principles using Aristotelian (...) principles of justice. The paper assesses the central idea of Aristotelian justice and applies and evaluates this idea to benefit sharing in research, especially when commercial research sponsors conduct research in resource-limited countries. Two categories of Aristotelian justice—universal and particular—were examined and their contribution to the benefit-sharing discourse assessed. On the one hand, benefit sharing in accordance with universal justice requires that for-profit research sponsors obey the legal regulations and international standards set for benefit sharing. On the other hand, benefit sharing in accordance with particular justice transcends obeying legal requirements and standards to a realm of acting in an ethically accepted manner. Accordingly, the paper further examines three perspectives of particular justice and develops ethical justification for benefit sharing in global health research. As Aristotelian justice is still relevant to the contemporary discourse on justice, this paper broadens the ethical justifications of benefit sharing in global health research. (shrink)