Thirty Years Later: An Oncologist Reflects on Kubler-Ross's Work

As compared with conventional vaccine production systems, plant-made vaccines (PMVs) are said to enjoy a range of advantages including cost of production and ease of storage for distribution in developing countries. In this article, we introduce the science of PMV production, and address ethical issues associated with development and clinical testing of PMVs within three interrelated domains: PMVs as transgenic plants; PMVs as clinical research materials; and PMVs as agents of global health. We present three conclusions: first, while many of the ethical issues raised by PMVs are familiar, PMVs add a new dimension to old issues, and raise some novel issues for ethicists and policy-makers; secondly, it is premature to promise broad applicability of PMVs across the developing world without having demonstrated their feasibility; thirdly, in particular, proponents of PMVs as a solution to global health problems must, as a condition of the ethical conduct of their research, define the commercial feasibility of PMVs for distribution in the developing world.     

Forms of benefit sharing in global health research undertaken in resource poor settings: a qualitative study of stakeholders' views in Kenya

Background  

Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to various stakeholders involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context.     

Human Rights,Cultural Pluralism,and International Health Research

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.     

The Ethics of Ethics Reviews in Global Health Research: Case Studies Applying a New Paradigm

With increasing calls for global health research there is growing concern regarding the ethical challenges encountered by researchers from high-income countries (HICs) working in low or middle-income countries (LMICs). There is a dearth of literature on how to address these challenges in practice. In this article, we conduct a critical analysis of three case studies of research conducted in LMICs. We apply emerging ethical guidelines and principles specific to global health research and offer practical strategies that researchers ought to consider. We present case studies in which Canadian health professional students conducted a health promotion project in a community in Honduras; a research capacity-building program in South Africa, in which Canadian students also worked alongside LMIC partners; and a community-university partnered research capacity-building program in which Ecuadorean graduate students, some working alongside Canadian students, conducted community-based health research projects in Ecuadorean communities. We examine each case, identifying ethical issues that emerged and how new ethical paradigms being promoted could be concretely applied. We conclude that research ethics boards should focus not only on protecting individual integrity and human dignity in health studies but also on beneficence and non-maleficence at the community level, explicitly considering social justice issues and local capacity-building imperatives. We conclude that researchers from HICs interested in global health research must work with LMIC partners to implement collaborative processes for assuring ethical research that respects local knowledge, cultural factors, the social determination of health, community participation and partnership, and making social accountability a paramount concern.     

Transcultural discussion in bioethics drawn from research experience in China: building up a theoretical and methodological framework for further research cooperation

My article discusses bioethics in transcultural context and builds on an experience of conducting research in China in partnership with Chinese scholars and institutions. Key points are about the creation of ethical committees and their prerogatives, the regulation of experimenting in human and animal, and of donating and transplanting organs. Ethical issues are approached according to an anthropological reading. Three transversal lines for further research are suggested: global/local ethical governance applied to research ethics; implications of transnationalizing and delocalizing research practices with regards to governance; theoretical positioning--conceptual pluralism versus pragmatic pluralism--following actual confrontation to transcultural variations in research ethics. Moreover, this work claims for conceptualizing and implementing an ethics in context while assessing intangible (non-relative) principles based on knowledge production and a global patrimony.     

Moving Life Science Ethics Debates Beyond National Borders: Some Empirical Observations

The life sciences are increasingly being called on to produce “socially robust” knowledge that honors the social contract between science and society. This has resulted in the emergence of a number of “broad social issues” that reflect the ethical tensions in these social contracts. These issues are framed in a variety of ways around the world, evidenced by differences in regulations addressing them. It is important to question whether these variations are simply regulatory variations or in fact reflect a contextual approach to ethics that brings into question the existence of a system of “global scientific ethics”. Nonetheless, within ethics education for scientists these broad social issues are often presented using this scheme of global ethics due to legacies of science ethics pedagogy. This paper suggests this may present barriers to fostering international discourse between communities of scientists, and may cause difficulties in harmonizing (and transporting) national regulations for the governance of these issues. Reinterpreting these variations according to how the content of ethical principles is attributed by communities is proposed as crucial for developing a robust international discourse. To illustrate this, the paper offers some empirical fieldwork data that considers how the concept of dual-use (as a broad social issue) was discussed within African and UK laboratories. Demonstrating that African scientists reshaped the concept of dual-use according to their own research environmental pressures and ascribed alternative content to the principles that underpin it, suggests that the limitations of a “global scientific ethics” system for these issues cannot be ignored.     

Psychosocial treatment research with ethnic minority populations: ethical considerations in conducting clinical trials

Because of historical mistreatment of ethnic minorities by research and medical institutions, it is particularly important for researchers to be mindful of ethical issues that arise when conducting research with ethnic minority populations. In this article, we focus on the ethical issues related to the inclusion of ethnic minorities in clinical trials of psychosocial treatments. We highlight 2 factors, skepticism and mistrust by ethnic minorities about research and current inequities in the mental health care system, that researchers should consider when developing psychosocial interventions studies that include ethnic minorities.     

Judging Public Health Research: Epistemology,Public Health and the Law

There are three broad ethical issues related to handling public health emergencies. They are the three R's—rationing, restrictions and responsibilities. Recently, a severe shortage of annual influenza vaccine in the US, combined with the threat of pandemic flu, has provided an opportunity for policy makers to think about rationing in very concrete terms. Some lessons from annual flu vaccination likely will apply to pandemic vaccine distribution, but many preparatory decisions must be based on very rough estimates. What ethical principles should guide rationing decisions, what data should inform these decisions, how to revise decisions as new data emerge, and how to implement rationing decisions on the ground are all important considerations. In addition, ethicists might be able to help policy makers think through the importance of international cooperation in surmounting global rationing dilemmas and to accept the inevitable responsibilities of government in making and implementing rationing decisions.     

Ethical challenges in the COVID-19 research context: a toolkit for supporting analysis and resolution

ABSTRACTCOVID-19 is compromising all aspects of society, with devastating impacts on health, political, social, economic and educational spheres. A premium is being placed on scientific research as the source of possible solutions, with a situational imperative to carry out investigations at an accelerated rate. There is a major challenge not to neglect ethical standards, in a context where doing so may mean the difference between life and death. In this paper we offer a rubric for considering the ethical challenges in COVID-19 related research, in the form of an ethics toolkit for global research developed at the University of Edinburgh in collaboration with more than 200 global researchers from around the world. This toolkit provides a framework to support confrontation of ethical conflicts through the integrated and iterative analysis of Place, People, Principles and Precedents, throughout the research journey. Two case analyses are offered to exemplify the utility of the toolkit as a flexible and dynamic tool to promote ethical research in the context of COVID-19.     

Masked ball: Ethics,laws and financial contradictions in hungarian health care

Corruption is a major problem in the societies of the post-communist Central European countries. Corruption in health care has some unique characteristics undermining the efficacy of and respect for Hungarian health care. One of the forms of corruption is tipping. This highly contested phenomenon is present in most of the patient/health professional’s interactions in a sophisticated manner, raising serious ethical and legal dilemmas. The present paper analyzes tipping and other corruption-related factors, such as financial conflict of interest between industry and health care and argues that since ethical and legal considerations are often ignored in the country, patient care and clinical research are affected by these controversial issues to a great extent.     

Research as therapy, therapy as research: Ethical dilemmas in new-paradigm research

Ethical dilemmas are raised by changes in research paradigms which encourage the development of a relationship between researcher and participant. In such contexts it becomes increasingly difficult to tell the difference between a therapeutic relationship and a research interview. The rapid development of research within the therapeutic world of counselling and clinical psychology poses further ethical issues relating to the use of clients as participants in research studies. It is concluded that there must be an increased awareness of these issues and a need to accept responsibility for relationships with both participants and clients.     

Ethics and Culture in Mental Health Care

This article examines the complex relationship between culture, values, and ethics in mental health care. Cultural competence is a practical, concrete demonstration of the ethical principles of respect for persons, beneficence (doing good), nonmaleficence (not doing harm), and justice (treating people fairly)—the cornerstones of modern ethical codes for the health professions. Five clinical cases are presented to illustrate the range of ethical issues faced by mental health clinicians working in a multicultural environment, including issues of therapeutic boundaries, diagnosis, treatment choice, confidentiality and informed consent, and the just distribution of limited health care resources.     

Ethical, Legal and Social Aspects of Brain-Implants Using Nano-Scale Materials and Techniques

Nanotechnology is an important platform technology which will add new features like improved biocompatibility, smaller size, and more sophisticated electronics to neuro-implants improving their therapeutic potential. Especially in view of possible advantages for patients, research and development of nanotechnologically improved neuro implants is a moral obligation. However, the development of brain implants by itself touches many ethical, social and legal issues, which also apply in a specific way to devices enabled or improved by nanotechnology. For researchers developing nanotechnology such issues are rather distant from their daily work in the lab, but as soon as they use their materials or devices in medical applications such as therapy of brain diseases they have to be aware of and deal with them. This paper is intended to raise sensitivity for the ethical, legal and social aspects (ELSA) involved in applying nanotechnology in brain implants or other devices by highlighting the short term problems of testing and clinical trials within the existing regulatory frameworks (A), the short and medium-term questions of risks in the application of the devices (B) and the long-term perspectives related to problems of enhancement (C). To identify and address such issues properly nanotechnologists should involve ethical, legal and social experts and regulatory bodies in their research as early as possible. This will help to remove pressure from regulatory bodies, to settle public concern and to prevent non-acceptable developments for the benefit of the patients.

Ethical and Legal Issues in Publication and Dissemination of Scholarly Knowledge: A Summary of the Published Evidence

Research publication and dissemination of scholarly knowledge in Higher Education Institutions (HEIs) are among the most influential roles of many academic scholars in both industrialised and developing nations, but such experience and skills are rarely taught, transferred and shared in the real world. Dealing with issues of research misconduct might be challenging as well as learning opportunities for new academics while conducting research and scholarship teaching and publication in HEIs. In this review paper, I will discuss some concepts of research misconduct, highlighting some relevant ethical and legal concerns in publication. This paper concludes that continued education and support on ethical research to graduates and scholars might help to prevent research misconduct related to publications and dissemination through developing appropriate strategies in practice.     

“Suspended Animation,” My Mother’s Wife and Cultural Discernment: Considerations for Genetic Research among Immigrants

One of the most difficult contemporary issues facing the bioethics of clinical research is balancing the maintaining of a universality of ethics standards with a sensitivity to cultural issues and differences. The concept of “vulnerability” for research subjects is especially apt for investigating the ethical and cultural issues surrounding the conduct of genetic research among new immigrants to the United States, using the Sudanese Nuer and Dinka tribes, recently settled in the Midwest, as an example. Issues of cultural vulnerability arise for some immigrants, related to relationship to the earth and to kinship issues, that threaten the narrative richness of a subject's life as well as the way she situates herself in the world.     

Placebos and the UK medical research council — and the consumer perspective

The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical — in addition to ethics review by independent Research Ethics Committees. Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to clarify the issues. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Perceptions of Nano Ethics among Practitioners in a Developing Country: A Case of India

Many developing countries have allocated significant amounts of funding for nanoscience and nanotechnology research, yet compared to developed countries, there has been little study, discussion, or debate over social and ethical issues. Using in-depth interviews, this study focuses on the perceptions of practitioners, that is, scientists and engineers, in one developing country: India. The disciplinary background, departmental affiliation, types of institutions, age, and sex of the practitioners varied but did not appear to affect their responses. The results show that 95% of the Indian practitioners working in the area of nanoscience and nanotechnology research recognized ethical issues in this research area, and 60% of them could offer specific examples, which included possible ill effects on environment and human, use as a weapon, hype, professional ethics, laboratory testing on animals, cyborgs, widening the gap between rich and poor, self-replication, and longevity of human life. The results may offer opportunities for future cross-cultural research, as well as offer examples that can be used to raise the awareness of other practitioners in India and elsewhere regarding the importance of ethical issues.     

Quantifying developing country research capacity in the areas of malaria,schistosomiasis, and leprosy

Implicit in addressing the issue of how to build and strengthen health related endogenous research capacity is that both donor organizations and developing country policymakers distinguish betweenhealth priorities andhealth research priorities. This distinction has important policy consequences in that the majority of developing countries are not in a position, either in financial or human resource terms, to simultaneously generate and implement broad-based priorities in both areas. In this context, it is important that health research priority setting be developed in tandem with existing research capacity. This underlines the importance of assessing the amount and nature of available expertise, and positioning research output, both in the national health needs, and the international science research contexts. The present article, which more properly constitutes a feasibility study, uses scientometric methods to assess the amount and nature of scientific output in three important tropical diseases: malaria, schistosomiasis and leprosy. The major goals of this study have been to i) compare the amount and nature of research produced in developed and developing countries for the three diseases; ii) determine in how far scientometric methods can be used to measure research capacity, and whether this measurement can facilitate the determination of health (research) priorities.     

How Civil Society Organisations Changed the Regulation of Clinical Trials in India

ABSTRACT

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.