To quote Yogi Berra, writing this editorial is a “déja vu all over again” experience for us. It entails not only collaborating once more as coauthors but also reiterating some of the criticisms and concerns that have figured prominently in virtually all our previous publications about bioethics—most recently in our book Observing Bioethics.

Researchers studying health systems in low-income countries face a myriad of ethical challenges throughout the entire research process. In this article, we discuss one of the greatest ethical challenges that we encountered during our fieldwork in West Africa: the difficulty of protecting the confidentiality of participants while locally disseminating results of health systems research to stakeholders. This reflection is based on experiences of authors involved in conducting evaluative research of interventions aimed at improving health systems in West Africa. Our observation (...) and collaboration with the research projects’ stakeholders informed our analysis. Examples from two research projects illustrate the issues raised. We found that in some cases there is a risk that local stakeholders may be able to identify research participants, or at least groups of participants, during the dissemination of results, even if they are anonymized. Four factors can interact and influence this challenge: 1) hierarchical structure, 2) small milieu, 3) immersion in a few sites, and 4) vested interests of decision-makers. For example, local stakeholders can sometimes find out when and where the data were collected. Moreover, health systems, especially rural healthcare centres, in West African countries can be small settings, so people often know each other. Some types of participants have unique characteristics or positions in the health system that may make them more easily identifiable by local stakeholders familiar with the environment. We identified a number of potential strategies that can help researchers minimize this difficulty and improve ethical research practices. These strategies pertain to the development of the study design, the process of obtaining informed consent, the dissemination of results, and the researchers’ reflexivity. Researchers must develop and adopt strategies that enable them to respect their promise of confidentiality while effectively disseminating sometimes sensitive results. Reflections surrounding ethical issues in global health research should be deepened to better address how to manage competing ethical responsibilities while promoting valuable research uptake. (shrink)

The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy, non-maleficence, or justice. On the other hand, non-participation may preclude the building of a knowledge base that is a prerequisite for defining the optimal clinical management of vulnerable patients. Such clinical uncertainty may also incur substantial economic costs. We present the participation of pre-menopausal women with atrial fibrillation in trials of novel oral (...) anticoagulant drugs as a case study. Due to their non-participation in pivotal trials, it is uncertain whether for them, the risks that are associated with these drugs are outweighed by the advantages compared with conventional treatment. We addressed the question whether research of this new class of drugs in this subgroup would be appropriate from both, an ethical as well an economic perspective. We used the method of specifying norms as a wider framework to resolve the apparent ethical dilemma, while incorporating the question whether research of oral anticoagulants in premenopausal women with atrial fibrillation can be justified on economic grounds. For the latter, the results of a value-of-information analysis were used. Further clinical research on NOACs in premenopausal women with atrial fibrillation can be justified on both, ethical and economic grounds. Addressing apparent ethical dilemmas by invoking a method such as specifying norms can improve the quality of public practical reasoning. As such, the method should also prove valuable to committees that have formally been granted the authority to review trial protocols and proposals for scientific research. (shrink)

Background: The importance of trust between patients and healthcare personnel is emphasised in nurses’ and physicians’ ethical codes. Trust is crucial for an effective healthcare personnel–patient relationship and thus for treatment and treatment outcomes. Cultural and linguistic differences may make building a trusting and positive relationship with ethnic minority patients particularly challenging. Although there is a great deal of research on cultural competence, there is a conspicuous lack of focus on the concepts of trust and distrust concerning ethnic minority patients, (...) particularly in relation to the concept of ‘othering’. Aim: To study which factors help build trust or create distrust in encounters between healthcare professionals and hospitalised ethnic minority patients, as well as study the dynamic complexities inherent within the process of ‘othering’. Research design: Qualitative design, in-depth interviews and hermeneutic analysis. Participants and research context: The interviewees were 10 immigrant patients (six women and four men – eight Asians, two Africans – ages 32–85 years) recruited from a south-eastern Norwegian hospital. Ethical considerations: Study approval was obtained from the hospital’s Privacy Ombudsman for Research and the hospital’s leadership. Participation was voluntary and participants signed an informed consent form. Conclusion: Distrust and othering may be caused by differences in belief systems, values, perceptions, expectations, and style of expression and behaviour. Othering is a reciprocal phenomenon in minority ethnic patient–healthcare personnel encounters, and it influences trust building negatively. Besides demonstrating general professional skill and competence, healthcare personnel require cultural competence to create trust. (shrink)

Economic globalization has profound implications for health. The scale of injustice at a global level, reflected in inexorably widening disparities in wealth and health, also has critical implications for health related research – in particular when the opportunities for exploiting research subjects are carefully considered. The challenge of developing universal guidelines for international clinical research is addressed against the background of a polarizing, yet interdependent, world in which all are ultimately threatened by lack of social justice. It is proposed that (...) in such a world there is a need for new ways of thinking about research and its relevance to health at a global level. Responsibility to use knowledge and power wisely requires more radical changes to guidelines for research ethics than are currently under consideration. (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.