The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to (...) care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

Thus far, little work in bioethics has specifically focused on global health research priority-setting. Yet features of global health research priority-setting raise ethical considerations and concerns related to health justice. For example, such processes are often exclusively disease-driven, meaning they rely heavily on burden of disease considerations. They, therefore, tend to undervalue non-biomedical research topics, which have been identified as essential to helping reduce health disparities. In recognition of these ethical concerns and the limited scholarship and dialogue addressing them, we (...) convened an international workshop in September 2015. The workshop aimed to initiate discussion on the appropriate relationship between global and national levels of health research priority-setting and to begin exploring what might be ethically required for priority-setting at each of those levels. This paper comprises our reflections following the workshop. Its main objective is to launch a research agenda for the ethics of global health research priority-setting. We identify three domains of global health research priority-setting—scope, underlying values and substantive requirements, and procedural considerations. For each domain, specific research questions are highlighted and why they need to be explored is explained. Some preliminary thoughts and normative arguments as to how the research questions might be answered are also offered. For example, we provide initial ideas about the appropriate relationship between different priority-setting levels and what values and substantive considerations should guide or underpin global health research priority-setting as a matter of justice. We anticipate that framing a new research agenda for the ethics of global health research priority-setting will spur ethicists, researchers, and policymakers to refocus their efforts on developing more rigorous and ethically sound approaches to priority-setting. (shrink)

In the coming weeks and months SARS-CoV-2 may ravage countries with weak health systems and populations disproportionately affected by HIV, tuberculosis, and other infectious diseases. Without safeguards and proper attention to global health equity and justice, the effects of this pandemic are likely to exacerbate existing health and socio-economic inequalities. This paper argues that achieving global health equity in the context of COVID-19 will require that notions of reciprocity and relational equity are introduced to the response.

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)

The concept of benefit sharing pertains to the act of giving something in return to the participants, communities, and the country that have participated in global health research or bioprospecting activities. One of the key concerns of benefit sharing is the ethical justifications or reasons to support the practice of the concept in global health research and bioprospecting. This article evaluates one of such ethical justifications and its meaning to benefit sharing, namely justice. We conducted a systematic review to map (...) the various principles of justice that are linked to benefit sharing and analysed their meaning to the concept of benefit sharing. Five principles of justice have been shown to be relevant in the nuances of benefit sharing in both global health research and bioprospecting. The review findings indicate that each of these principles of justice provides a different perspective for a different benefit sharing rationale. For example, commutative justice provides a benefit sharing rationale that is focused on fair exchange of benefits between research sponsors and communities. Distributive justice produces a benefit sharing rationale that is focused on improving the health needs of the vulnerable research communities. We have suggested that a good benefit sharing framework particularly in global health research would be more beneficial if it combines all the principles of justice in its formulation. Nonetheless, there is a need for empirical studies to examine the various principles of justice and their nuances in benefit sharing among stakeholders in global health research. (shrink)

Scholarship focusing on how international research can contribute to justice in global health has primarily explored requirements for the conduct of clinical trials. Yet health systems research in low- and middle-income countries has increasingly been identified as vital to the reduction of health disparities between and within countries. This paper expands an existing ethical framework based on the health capability paradigm – research for health justice – to externally-funded health systems research in LMICs. It argues that a specific form of (...) health systems research in LMICs is required if the enterprise is to advance global health equity. “Research for health justice” requirements for priority setting, research capacity strengthening, and post-study benefits in health systems research are derived in light of the field's distinctive characteristics. Specific obligations are established for external research actors, including governments, funders, sponsors, and investigators. How these framework requirements differ from those for international clinical research is discussed. (shrink)

Volume 19, Issue 9, September 2019, Page 39-41.

With developed country governments and high resource institutions engaging in research in low- and middle-income countries, we argue that these entities have a moral obligation to help build and strengthen research infrastructure and capacity so local scientists and institutions can adequately conduct studies to understand and resolve the health burdens in low and middle income countries. We explore the moral justifications and motivations behind engaging in research capacity strengthening in the health sector in LMIC at multiple levels. In highlighting these (...) issues, this paper aims to initiate a global discourse around why capacity development in LMIC has a moral basis at the individual, institutional and system levels. (shrink)

Volume 19, Issue 9, September 2019, Page 37-39.

There has been growing consensus to develop relevant guidance to improve the ethical review of global health policy and systems research and address the current absence of formal ethics guidance.

Social justice has been identified as a foundational moral commitment for global health research ethics. Yet what a commitment to social justice means for community engagement in such research has not been critically examined. This paper draws on the rich social justice literature from political philosophy to explore the normative question: What should the ethical goals of community engagement be if it is to help connect global health research to social justice? Five ethical goals for community engagement are proposed that (...) promote well-being, agency, and self-development, particularly for those considered disadvantaged and marginalized. The paper also considers how key terms used in the proposed goals should be defined using existing theories of health and social justice. This analysis is done to give global health researchers and their partners a better idea of what the ethical goals mean. Patterns of convergence amongst different theories are identified that support relying on particular definitions of key terms. (shrink)

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. (shrink)

Global health research partnerships are increasingly taking the form of consortia of institutions from high-income countries and low- and middle-income countries that undertake programs of research. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Although such consortia typically aim to reduce health disparities between and within countries, what is required for them to do so has not been clearly defined. This article takes a (...) conceptual approach to explore how the governance of transnational global health research consortia should be structured to advance health equity. To do so, it applies an account called shared health governance to derive procedural and substantive guidance. A checklist based on this guidance is proposed to assist research consortia determine where their governance practices strongly promote equity and where they may fall short. (shrink)