Ethics dumping is a global phenomenon involving the ‘off-shoring’of research. Research that would be prohibited, severely restrictedor regarded as highly patronizing in high-income regions is instead conducted inresource-poor settings. Twenty-eight case studies of ethics dumping were examined through inductive thematic analysis to reveal predisposing factors from the perspective of researchers from high-income regions. Six categories were agreed and further illuminated: Patronizing conduct, unfair distribution of benefits and/or burdens, culturally inappropriate conduct, double standards, lack of due diligence and lack of transparency. (...) The ultimate aim of the paper is to deepen understanding of thesehighly unethical practicesamongst academics who stand against poverty, leading to theirfurther reduction. (shrink)

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to (...) prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion. (shrink)

Collaborations in global health research are on the rise because they enhance productivity, facilitate capacity building, accelerate output and make tackling big, multifactorial research questions possible. In this paper, I examine the concepts of trust and reliance in scientific collaborations in general, but also in the particular context of collaborations in global health research between high‐income countries and low‐and‐middle income countries (LMIC). I propose and defend the argument that given the particular characteristics of collaborations and demands of trust relationships, reliance (...) is a better relational mode for successful collaborations. Although reliance can be difficult to establish in situations where asymmetry of power exists, trust should not be the only relational mode available to LMIC researchers because of the type of vulnerability it introduces to the relationship. I conclude that the promotion of good collaborations requires addressing the power imbalances between partners, and establishing an even playing field in global health research. (shrink)

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of shortcomings (...) in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees. (shrink)

On site monitoring of research is one of the most effective ways to ensure compliance during research conduct. However, it is least carried out primarily for two reasons: presumed high costs both in terms of human resources and finances; and the lack of a clear framework for undertaking site monitoring. In this paper we discuss a model for research site monitoring that may be cost effective and feasible in low resource settings.

Abstract Benefit sharing as envisaged by the 1992 Convention on Biological Diversity (CBD) is a relatively new idea in international law. Within the context of non-human biological resources, it aims to guarantee the conservation of biodiversity and its sustainable use by ensuring that its custodians are adequately rewarded for its preservation. Prior to the adoption of the CBD, access to biological resources was frequently regarded as a free-for-all. Bioprospectors were able to take resources out of their natural habitat and develop (...) commercial products without sharing benefits with states or local communities. This paper asks how CBD-style benefit-sharing fits into debates of justice. It is argued that the CBD is an example of a set of social rules designed to increase social utility. It is also argued that a common heritage of humankind principle with inbuilt benefit-sharing mechanisms would be preferable to assigning bureaucratic property rights to non-human biological resources. However, as long as the international economic order is characterized by serious distributive injustices, as reflected in the enormous poverty-related death toll in developing countries, any morally acceptable means toward redressing the balance in favor of the disadvantaged has to be welcomed. By legislating for a system of justice-in-exchange covering nonhuman biological resources in preference to a free-for-all situation, the CBD provides a small step forward in redressing the distributive justice balance. It therefore presents just legislation sensitive to the international relations context in the 21st century. (shrink)

This open access book offers insights into the development of the ground-breaking Global Code of Conduct for Research in Resource-Poor Settings (GCC) and the San Code of Research Ethics. Using a new, intuitive moral framework predicated on fairness, respect, care and honesty, both codes target ethics dumping – the export of unethical research practices from a high-income setting to a lower- or middle-income setting. The book is a rich resource of information and argument for any research stakeholder who opposes double (...) standards in research. It will be indispensable for applicants to European Union framework programmes, as the GCC is now a mandatory reference document for EU funding. (shrink)

Contemporary bioethics has evolved over the past 40 years predominantly as a “Western” construct drawing fundamental inspiration for its conceptual and methodological frameworks from secular, Anglo-American philosophical traditions. American bioethicists can be credited with playing a defining role in the globalization of this new discipline to the developing countries of the world, but in this process, in the words of LaFleur, “Bioethics has become international without becoming internationalized.” Among the criticisms leveled against the dominant American model of bioethics is that (...) in its focus on universalism it ignores local cultural and religious influences that are vital to the comprehension of the moral life in many societies. Medical sociologist Renée C. Fox and historian Judith P. Swazey have termed this as a form of “cultural myopia.”. (shrink)