Ethical issues in medical research in the developing world: a report on a meeting organised by Fondation Mérieux

This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future.
Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged.     

Ageing Prisoners’ Views on Death and Dying: Contemplating End-of-Life in Prison

Rising numbers of ageing prisoners and goals on implementing equivalent health care in prison raise issues surrounding end-of-life care for prisoners. The paucity of research on this topic in Europe means that the needs of older prisoners contemplating death in prison have not been established. To investigate elderly prisoners’ attitudes towards death and dying, 35 qualitative interviews with inmates aged 51 to 71 years were conducted in 12 Swiss prisons. About half of the prisoners reported having thought about dying in prison, with some mentioning it in relation with suicidal thoughts and others to disease and old age. Themes identified during data analysis included general thoughts about death and dying, accounts of other prisoners’ deaths, availability of end-of-life services, contact with social relations, and wishes to die outside of prison. Study findings are discussed using Allmark’s concept of “death without indignities,” bringing forth two ethical issues: fostering autonomy and removing barriers. Attributing the identified themes to these two ethical actions clarifies the current needs of ageing prisoners in Switzerland and could be a first step towards the implementation of end-of-life services in correctional systems.     

STAKEHOLDER PERSPECTIVES ON ETHICAL CHALLENGES IN HIV VACCINE TRIALS IN SOUTH AFRICA

There is little published literature on the ethical concerns of stakeholders in HIV vaccine trials. This study explored the ethical challenges identified by various stakeholders, through an open-ended, in-depth approach. While the few previous studies have been largely quantitative, respondents in this study had the opportunity to spontaneously identify the issues that they perceived to be of priority concern in the South African context. Stakeholders spontaneously identified the following as ethical priorities: informed consent, social harms, collaborative relationships between research stakeholders, the participation of children and adolescents, access to treatment for participants who become infected with HIV, physical harms, fair participant and community selection, confidentiality, benefits, and payment.
While there is some speculation that research in developing countries poses special ethical challenges, overall no issues were identified that have not been anticipated in international guidance, literature and popular frameworks. However, the South African context affords a distinctive gloss to these expected issues; for example, respondents were concerned that the predominant selection of black participants may perpetuate racist practices of apartheid. Stakeholders should be aware of contextual factors impacting on the implementation of ethical principles. We make a series of recommendations for South African trials, including amendments to the ethical-legal framework and research policies, and, for further research.     

Building for the future: essential infrastructure for rodent ageing studies

When planning ageing research using rodent models, the logistics of supply, long term housing and infrastructure provision are important factors to take into consideration. These issues need to be prioritised to ensure they meet the requirements of experiments which potentially will not be completed for several years. Although these issues are not unique to this discipline, the longevity of experiments and indeed the animals, requires a high level of consistency and sustainability to be maintained throughout lengthy periods of time. Moreover, the need to access aged stock or material for more immediate experiments poses many issues for the completion of pilot studies and/or short term intervention studies on older models. In this article, we highlight the increasing demand for ageing research, the resources and infrastructure involved, and the need for large-scale collaborative programmes to advance studies in both a timely and a cost-effective way.     

Tragedy and delight: the ethics of decelerated ageing

Biogerontology is sometimes viewed as similar to other forms of biomedical research in that it seeks to understand and treat a pathological process. Yet the prospect of treating ageing is extraordinary in terms of the profound changes to the human condition that would result. Recent advances in biogerontology allow a clearer view of the ethical issues and dilemmas that confront humanity with respect to treating ageing. For example, they imply that organismal senescence is a disease process with a broad spectrum of pathological consequences in late life (causing or exascerbating cardiovascular disease, cancer, neurodegenerative disease and many others). Moreover, in laboratory animals, it is possible to decelerate ageing, extend healthy adulthood and reduce the age-incidence of a broad spectrum of ageing-related diseases. This is accompanied by an overall extension of lifespan, sometimes of a large magnitude. Discussions of the ethics of treating ageing sometimes involve hand-wringing about detrimental consequences (e.g. to society) of marked life extension which, arguably, would be a form of enhancement technology. Yet given the great improvements in health that decelerated ageing could provide, it would seem that the only possible ethical course is to pursue it energetically. Thus, decelerated ageing has an element of tragic inevitability: its benefits to health compel us to pursue it, despite the transformation of human society, and even human nature, that this could entail.     

Republication: In That Case

The case study examines an issue of public health ethics and obesity. How should healthy diets be developed? Can schools associate themselves with commercial fastfood companies? What are the ethical issues related to diet campaigns in an Asia context. The case study elicits several responses from different perspectives. The case study invites readers to think of different cultural contexts and broad issues.     

The Seven Sisters: Subgenres of <Emphasis Type="BoldItalic">Bioi</Emphasis> of Contemporary Life Scientists

Today, scientific biography is primarily thought of as a way of writing contextual history of science. But the genre has other functions as well. This article discusses seven kinds of ideal–typical subgenres of scientific biography. In addition to its mainstream function as an ancilla historiae, it is also frequently used to enrich the understanding of the individual construction of scientific knowledge, to promote the public engagement with science, and as a substitute for belles-lettres. Currently less acknowledged kinds of scientific biography include its use as a medium for public and private, respectively, commemoration. Finally, the use of scientific biography as a research (virtue) ethical genre, providing examples of ‘the good life in science’, is emphasized.     

Helical Biography and the Historical Craft: The Case of Altruism and George Price

The life of George Price (1922–1975), the eccentric polymath genius and father of the Price equation, is used as a prism and counterpoint through which to consider an age-old evolutionary conundrum: the origins of altruism. This biographical project, and biography and history more generally, are considered in terms of the possibility of using form to convey content in particular ways. Closer to an art form than a science, this approach to scholarship presents both a unique challenge and promise.     

Ethical concerns in the research and treatment of complex disease

Research on and treatment of complex diseases raise familiar ethical issues concerning informed consent, privacy, confidentiality, insurability, employability and social stigma. Consideration of the family as the unit of study, or point of medical intervention, presents some additional twists to these common ethical concerns. In addition, complex diseases present particular ethical challenges because different social and political incentives accompany placing emphasis on either the genetic or the environmental components of the diseases (e.g. in allocating research funds or ascribing responsibility for illness).     

Closure of population biobanks and direct-to-consumer genetic testing companies

Genetic research gained new momentum with the completion of the Human Genome Project in 2003. Formerly centered on the investigation of single-gene disorders, genetic research is increasingly targeting common complex diseases and in doing so is studying the whole genome, the environment and its impact on genomic variation. Consequently, biobanking initiatives have emerged around the world as a tool to sustain such progress. Whether they are small scale or longitudinal, public or private, commercial or non-commercial, biobanks should consider the possibility of closure. Interestingly, while raising important ethical issues, this topic has hardly been explored in the literature. Indeed, ethical issues associated with sale, insolvency, end of funding, or transfer of materials to other entities (which are all issues either related to or possible consequences of closure) are seldom the subject of discussion. In an attempt to fill this gap, this paper will discuss—using population and direct-to-consumer (DTC) genetic testing companies’ biobanks as case studies—(1) international and national normative documents addressing the issue of closure and (2) the internal policies of population biobanks and DTC genetic testing companies. The analysis will inform the debate on biobank closure and elucidate the underlying ethical issues, which include, but are not limited to informed consent, storage and privacy.     

Evidence and ethics in medicine

Ethics and epistemology in medicine are more closely and more interestingly intertwined than is usually recognized. To explore this relationship, I present a case study, clinical trials of extracorporeal membrane oxygenation (ECMO; an intervention for persistent pulmonary hypertension of the newborn).Three separate ethical issues that arise from this case study-whether or not it is ethical to perform a certain trial at all, whether stopping rules for trials are ethically mandated, and the issue of informed consent-are all shown to be intimately related to epistemological judgments about the weight of evidence. Although ethical issues cannot, of course, be resolved by consideration of epistemological findings, I argue that no informed view of the ethical issues that are raised can be adopted without first taking an informed view of the evidential-epistemological ones.     

Mapping out structural features in clinical care calling for ethical sensitivity: a theoretical approach to promote ethical competence in healthcare personnel and clinical ethical support services (CESS)

Clinical ethical support services (CESS) represent a multifaceted field of aims, consultancy models, and methodologies. Nevertheless, the overall aim of CESS can be summed up as contributing to healthcare of high ethical standards by improving ethically competent decision-making in clinical healthcare. In order to support clinical care adequately, CESS must pay systematic attention to all real-life ethical issues, including those which do not fall within the 'favourite' ethical issues of the day. In this paper we attempt to capture a comprehensive overview of categories of ethical tensions in clinical care. We present an analytical exposition of ethical structural features in judgement-based clinical care predicated on the assumption of the moral equality of human beings and the assessment of where healthcare contexts pose a challenge to achieving moral equality. The account and the emerging overview is worked out so that it can be easily contextualized with regards to national healthcare systems and specific branches of healthcare, as well as local healthcare institutions. By considering how the account and the overview can be applied to i) improve the ethical competence of healthcare personnel and consultants by broadening their sensitivity to ethical tensions, ii) identify neglected areas for ethical research, and iii) clarify the ethical responsibility of healthcare institutions' leadership, as well as specifying required institutionalized administration, we conclude that the proposed account should be considered useful for CESS.     

The current situation of health research and ethics in Sudan

At the beginning of the twentieth century, health research in the Sudan developed primarily as a function of the colonial British administration. Ethical issues in the medical profession in the Sudan are governed by the Sudan Medical Council. To address these issues, the Sudan Medical Council issued Medico-legal and Ethical Guidelines in 1967. This important document has focused principally on ethical issues arising in clinical medicine. Throughout the history of health research in Sudan it is very difficult to find any reference to research ethics. Nevertheless, there have been a few attempts to articulate ethics in health research. In 1979, Sudan witnessed the establishment of the first ethical review committee, which was established by the initiative of a group of doctors and scientists from the national health research laboratory. This committee got neither political nor institutional recognition. Therefore, it was not developed and came to an end shortly after its inception. Yet, in 2000 the FMOH established an ethical review committee (ERC). The functions of this committee were to review proposals of health research to be carried out in the country for ethical issues irrespective to the funding agents. Unfortunately, the committee devoted all the jobs in reviewing only externally-sponsored health research and research carried out by expatriate researchers or international organisations.     

Conscientious objection in medicine

Recognition of conscientious objection seems reasonable in relation to controversial and contentious issues, such as physician assisted suicide and abortion. However, physicians also advance conscience-based objections to actions and practices that are sanctioned by established norms of medical ethics, and an account of their moral force can be more elusive in such contexts. Several possible ethical justifications for recognizing appeals to conscience in medicine are examined, and it is argued that the most promising one is respect for moral integrity. It is also argued that an appeal to conscience has significant moral weight only if the core ethical values on which it is based correspond to one or more core values in medicine. Finally, several guidelines pertaining to appeals to conscience and their ethical evaluation are presented.     

A Reflective Lens: Applying Critical Systems Thinking and Visual Methods to Ecohealth Research

Critical systems methodology has been advocated as an effective and ethical way to engage with the uncertainty and conflicting values common to ecohealth problems. We use two contrasting case studies, coral reef management in the Philippines and national park management in Australia, to illustrate the value of critical systems approaches in exploring how people respond to environmental threats to their physical and spiritual well-being. In both cases, we used visual methods—participatory modeling and rich picturing, respectively. The critical systems methodology, with its emphasis on reflection, guided an appraisal of the research process. A discussion of these two case studies suggests that visual methods can be usefully applied within a critical systems framework to offer new insights into ecohealth issues across a diverse range of socio-political contexts. With this article, we hope to open up a conversation with other practitioners to expand the use of visual methods in integrated research.     

Ethical Issues in a Stage 1 Cognitive-Behavioral Therapy Feasibility Study and Trial to Reduce Alcohol Use Among HIV-Infected Outpatients in Western Kenya

epidemics of both HIV/AIDS and alcohol abuse in sub-Saharan Africa have spurred the conduct of local behavioral therapy trials for these problems, but the ethical issues involved in these trials have not been fully examined. In this paper, we discuss ethical issues that emerged during the conduct of a behavioral intervention adaptation and trial using cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. The study was performed within our multinational collaboration, the USAID-Academic Model Providing Access to Healthcare Partnership. We discuss relevant ethical considerations and how we addressed them.     

Module one: introduction to research ethics

This module will introduce you to the ethical concepts underlying applied ethical decision-making in the area of research involving human participants. We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an understanding of historical and legal context makes arguably little sense. It is for this reason that this module will begin with a brief history of research ethics and ends with a brief overview of the relevant national and international guidelines pertaining to ethical issues in research involving human participants.     

How stem cells remember their past

Somatic stem cells are required for tissue development, homeostasis, and repair. Recent data suggested that previous biographical experiences of individual stem cells influence their behavior in the context of tissue formation and govern stem cell responses to external stimuli. Here we provide a concise review how a cell's biography, for example, previous rounds of cell divisions or the age-dependent accumulation of cellular damage, is remembered in stem cells and how previous experiences affect the segregation of cellular components, thus guiding cellular behavior in vertebrate stem cells. Further, we suggest future directions of research that may help to unravel the molecular underpinnings of how past experiences guide future cellular behavior.     

Going to the roots of the stem cell controversy

The purpose of this paper is to describe the scientific background to the current ethical and legislative debates about the generation and use of human stem cells, and to give an overview of the ethical issues underlying these debates.
The ethical issues discussed are 1) stem cells and the status of the embryo, 2) women as the sources of ova for stem cell production, 3) the use of ova from other species, 4) slippery slopes towards reproductive cloning, 5) the public presentation of stem cell research and 6) the evaluation of scientific uncertainty and its implications for public policy.     

Biographies for Artistic and Social Intervention: A Youth-Driven Project

This article discusses how biographical materials may be used in youth arts education projects to develop new methodologies and approaches that can stimulate artistic and social intervention in contemporary urban communities, thus changing the field of arts education policy at the community level. Through their creation of Artistic Society Projects, a group of young people from the arts education project Bando à Parte: Youth Cultures, Arts and Social Inclusion (O Teatrão, Coimbra, Portugal) have created a voice that may be used to transform their own communities. The starting points for this transformation are the young peoples’ biographical paths. The influence of youth on education policy may be strategically understood in the context of formal and nonformal school curricula. How can youth use their biographies to develop specific contributions both to change in individual behaviors and to social change in urban communities, influencing arts education policies to instigate action? The exploration of these processes through the work of artistic creation, inspired by collected biographical materials, represents a contribution to ongoing reflection on the issues of memory, identity, youth resistance, and community change in urban settings, influencing the ways in which arts education policy is understood and implemented.