In this book, T. M. Scanlon offers new answers to these questions, as they apply to the central part of morality that concerns what we owe to each other.

Research ethics is predominantly taught and practiced in Anglophone countries, particularly those in North America and Western Europe. Initiatives to build research ethics capacity in developing countries must attempt to avoid imposing foreign frameworks and engage with ethical issues in research that are locally relevant. This article describes the process and outcomes of a capacity-building workshop that took place in Kinshasa, Democratic Republic of Congo in the summer of 2011. Although the workshop focused on a specific ethical theme – the (...) responsibilities of researchers to provide health-related care to their research participants – we argue that the structure of the workshop offers a useful method for engaging with research ethics in general, and the theme of ancillary care encourages a broad perspective on research ethics that is highly pertinent in low-income countries. The workshop follows an interactive, locally driven model that could be fruitfully replicated in similar settings. (shrink)

Background: This article describes the types of community-wide benefits provided by investigators conducting public health research in South Asia as well as their self-reported reasons for providing such benefits. Methods: We conducted 52 in-depth interviews to explore how public health investigators in low-resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned to our narrative dataset (...) to find answers to two questions: What types of community-wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community-wide benefits? Findings: The types of community-wide benefits delivered were directed to the health and well-being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self-reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance. (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)

Health researchers working in low-resource settings routinely encounter serious unmet health needs for which research participants have, at best, limited treatment options through the local health system (Taylor, Merritt, and Mullany 2011). A recent case discussion features a study conducted in Bamako, Mali (Dickert and Wendler 2009). The study objective was to see whether children with severe malaria develop pulmonary hypertension in order to improve the general understanding of morbidity and mortality associated with malaria. In the study team's interactions with (...) participating children, they encountered not only malaria but also "eye infections, upper respiratory tract illnesses, rashes, pericardial effusions," .. (shrink)

Biomedical research is increasingly globalized with ever more research conducted in low and middle-income countries. This trend raises a host of ethical concerns and critiques. While community engagement has been proposed as an ethically important practice for global biomedical research, there is no agreement about what these practices contribute to the ethics of research, or when they are needed.

Ancillary care is care that research participants need that is not essential to make the research safe or scientifically valid and is not needed to remedy injuries that eventuate as a result of the research project itself. Ancillary care duties have recently been defended on the grounds of beneficence, entrustment, utility and consent. Justice has also been mentioned as a possible basis of ancillary care duties, but little attention has been paid to this approach. In this paper, the author seeks (...) to rectify this omission by arguing that ancillary care duties can be based on a principle of justice as rectification. (shrink)

Background: This article describes the types of community‐wide benefits provided by investigators conducting public health research in South Asia as well as their self‐reported reasons for providing such benefits.Methods: We conducted 52 in‐depth interviews to explore how public health investigators in low‐resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned to our narrative dataset to (...) find answers to two questions: What types of community‐wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community‐wide benefits?Findings: The types of community‐wide benefits delivered were directed to the health and well‐being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self‐reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance. (shrink)

This paper argues that, in a community of rights, the prima facie responsibilities of researchers to attend to the ancillary-care needs of their participants would be determined by a four-stage test . This test, it is suggested, sets a standard for common law courts that are invited to recognize the ancillary-care responsibilities of researchers, whether as a matter of contract or tort law.

It is axiomatic that the first responsibility of researchers, whether they are working in the developed or the developing world, is to do no harm to those who participate in their studies or trials. However, on neither side of the Atlantic is there any such settled view with regard to the responsibility of researchers to attend to the ancillary-care needs of their participants – that is, a responsibility to advise or assist participants who have medical condition X in circumstances where (...) the research concerns medical condition Y, and the research did not contribute to the presence of condition X in participants, nor did the having of condition X contribute to the research. Consider, for example, the following hypothetical posed by Leah Belsky and Henry Richardson:Researchers testing a new treatment for tuberculosis in a developing country discover some patients have HIV infection. Do they have a responsibility to provide antiretroviral drugs? (shrink)

A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The (...) model lends itself to a decision tree that can be adapted to the local context and resources so as to provide procedural guidance. This approach can help in planning and establishing organisational policies that govern the provision of ancillary care. (shrink)

This book is a collection of eleven essays by one of the most interesting moral philosophers currently writing. It examines challenges to liberal thought posed by the changing circumstances of the modern world such as the conflicting tendencies toward global integration, and greater ethnic and communal identification. The author considers whether liberal principles of justice can accommodate social and global interdependencies while reaffirming the importance of individual responsibility and acknowledging the significance of people's diverse personal and communal allegiances.

Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.