(2010). Response to Open Peer Commentaries on “How to Do Research Fairly in an Unjust World”. The American Journal of Bioethics: Vol. 10, No. 6, pp. W4-W6.

When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical Practice, these irregularities (...) occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on health research conducted in resource-poor settings. (...) I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

In his article “The Real Problem of Equipoise,” Chiong (2006) advances arguments that culminate in an assertion that the equipoise requirement “must be given uP′ if international clinical research...

In light of rapid globalization, there has been an increase in U.S. psychologists conducting international cross-cultural research. Such researchers face unique ethical dilemmas. Although the American Psychological Association has its own Code of Ethics with guidelines regarding research, these guidelines do not specifically address international and cross-cultural research. The purposes of this article are to (a) provide a review of current ethical guidelines for research on human subjects, (b) provide a review of major ethical challenges and dilemmas in conducting cross-cultural (...) research, (c) highlight several existing frameworks that maybe useful for increasing cross-cultural understanding of these ethical challenges for U.S. psychologists, and (d) issue a call to the American Psychological Association to begin to assess and evaluate the nature and extent of ethical problems in conducting cross-cultural research among its members. (shrink)

Although international research is increasing in volume and importance, there remains a dearth of knowledge on similarities and differences in “national human research ethics”, that is, national ethical guidelines, Institutional Review Boards, and research stakeholder’ ethical attitudes and behaviors. We begin to address this situation by reporting upon our experiences in conducting a multinational study into the mental health of children who had a parent/carer in prison. The study was conducted in 4 countries: Germany, Great Britain, Romania, and Sweden. Data (...) on NHREs were gathered via a questionnaire survey, two ethics-related seminars, and ongoing contact between members of the research consortium. There was correspondence but even more so divergence between countries in the availability of NEGs and IRBs and in researcher’ EABs. Differences in NHREs have implications particularly in terms of harmonization but also for ethical philosophy and practice and for research integrity. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

The changing milieu of research—increasingly global, interdisciplinary and collaborative—prompts greater emphasis on cultural context and upon partnership with international scholars and diverse community groups. Ethics training, however, tends to ignore the cross-cultural challenges of making ethical choices. This paper confronts those challenges by presenting a new curricular model developed by an international team. It examines ethics across a very broad range of situations, using case studies and employing the perspectives of social science, humanities and the sciences. The course has been (...) developed and taught in a highly collaborative way, involving researchers and students at Zhejiang University, the Indian Institute of Technology, Bombay and Brown University. The article presents the curricular modules of the course, learning outcomes, an assessment framework developed for the project, and a discussion of evaluation findings. (shrink)

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)

A major strength of this capacity building programme is that it encourages cross-cultural considerations in the application of research ethics principles to research in developing countries.

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...) risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

The curriculum design, faculty characteristics, and experience of implementing masters' level international research ethics training programs supported by the Fogarty International Center was investigated. Multiple pedagogical approaches were employed to adapt to the learning needs of the trainees. While no generally agreed set of core competencies exists for advanced research ethics training, more than 75% of the curricula examined included international issues in research ethics, responsible conduct of research, human rights, philosophical foundations of research ethics, and research regulation and ethical (...) review process. Common skills taught included critical thinking, research methodology and statistics, writing, and presentation proficiency. Curricula also addressed the cultural, social, and religious context of the trainees related to research ethics. Programs surveyed noted trainee interest in Western concepts of research ethics and the value of the transnational exchange of ideas. Similar faculty expertise profiles existed in all programs. Approximately 40% of faculty were female. Collaboration between faculty from low- and middleincome countries (LMICs) and high-income countries (HICs) occurred in most programs and at least 50% of HIC faculty had previous LMIC experience. This paper is part of a collection of papers analyzing the Fogarty International Research Ethics Education and Curriculum Development program. (shrink)