The Social Value of Knowledge and International Clinical Research

In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context‐dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings.     

The Social Value Requirement Reconsidered

It is widely assumed that it is ethical to conduct research with human subjects only if the research has social value. There are two standard arguments for this view. The allocation argument claims that public funds should not be devoted to research that lacks social value. The exploitation avoidance argument claims that subjects are exploited if research has no social value. The primary purpose of this article is to argue that these arguments do not succeed. The allocation argument has little relevance to commercial research. Social value is not necessary to avoid exploitation if subjects benefit from participation. Although the standard arguments for a social value requirement do not succeed, that view might be justified in a different way. It might be justified by appeal to the importance of social trust or the integrity of physician investigators. It is possible but doubtful that these arguments succeed.     

Partiality,impartiality and the ethics of triage

In this paper, I discuss the question of partiality and impartiality in the application of triage. Triage is a process in medical research which recommends that patients should be sorted for treatment according to the degree or severity of their injury. In employing the triage protocol, however, the question of partiality arises because socially vulnerable groups will be neglected since there is the likelihood that the social determinants of a patient's health may diminish her chance of survival. As a process that is based on the severity of a patient's injury, triage will be unfair, and hence negatively partial, to socially vulnerable people. Thus, I aim in this paper to show that the triage protocol fails as an impartial evaluative process because its only aim is to maximize survivability. I contend that: (i) triage would lead to the neglect of the social condition of patients or victims, and (ii) it will only serve the utilitarian purpose of maximization of outcomes which may not be justified in some cases.     

Social vulnerability among cancer patients and changes in vulnerability during their trajectories – A longitudinal population-based study

BackgroundIdentification of socially vulnerable cancer patients in the health care system is difficult. Only little is known concerning changes in the patients’ social circumstances during the trajectory. Such knowledge is valuable regarding the identification of socially vulnerable patients in the health care system. The objective of this study was to use administrative data to identify population-based characteristics of socially vulnerable cancer patients and investigate how social vulnerability changed during the cancer trajectory.MethodologyA registry-based social vulnerability index (rSVI) was applied to each cancer patient prior to their diagnosis, and used to assess changes in social vulnerability after the diagnosis.ResultsA total of 32,497 cancer patients were included. Short-term survivors (n = 13,994) died from cancer from one to three years after the diagnosis, and long-term survivors (n = 18,555) survived at least three years after the diagnosis. 2452 (18 %) short-term survivors and 2563 (14 %) long-term survivors were categorized as socially vulnerable at diagnosis, of these 22 % and 33 % changed category to not socially vulnerable during the first two years after the diagnosis, respectively. For patients changing status of social vulnerability, several social and health-related indicators changed, which is in line with the complexity of the multifactorial social vulnerability. Less than 6 % of the patients categorized as not vulnerable at diagnosis, changed to become vulnerable during the following two years.ConclusionDuring the cancer trajectory, social vulnerability may change in both directions. Surprisingly, more patients, who were categorized as socially vulnerable when their cancer was diagnosed, changed status to not socially vulnerable during follow-up. Future research should attempt to increase knowledge on identifying cancer patients, who experience deterioration after the diagnosis.     

Health Security and Risk Aversion

Health security has become a popular way of justifying efforts to control catastrophic threats to public health. Unfortunately, there has been little analysis of the concept of health security, nor the relationship between health security and other potential aims of public health policy. In this paper I develop an account of health security as an aversion to risky policy options. I explore three reasons for thinking risk avoidance is a distinctly worthwhile aim of public health policy: (i) that security is intrinsically valuable, (ii) that it is necessary for social planning and (iii) that it is an appropriate response to decision‐making in contexts of very limited information. Striking the right balance between securing and maximizing population health thus requires a substantive, and hitherto unrecognized, value judgment. Finally, I critically evaluate the current health security agenda in light of this new account of the concept and its relationship to the other aims of public health policy.     

Social values and scientific evidence: the case of the HPV vaccines

Several have argued that the aims of scientific research are not always independent of social and ethical values. Yet this is often assumed only to have implications for decisions about what is studied, or which research projects are funded, and not for methodological decisions or standards of evidence. Using the case of the recently developed HPV vaccines, we argue that the social aims of research can also play important roles in justifying decisions about (1) how research problems are defined in drug development, (2) evidentiary standards used in testing drug “success”, and (3) clinical trial methodology. As a result, attending to the social aims at stake in particular research contexts will produce more rational methodological decisions as well as more socially relevant science.     

The argument from intrinsic value: a critique

In his recent book Abortion and Unborn Human Life , Patrick Lee develops an argument for foetal personhood based on intrinsic value. Lee argues that since the foetus is identical with the rational, self-conscious being who will exist a few years later, and since this rational, self-conscious being indisputably is intrinsically valuable, therefore the foetus must already be intrinsically valuable; for nothing can come to be at one time but become intrinsically valuable at another. I show that this argument fails on two counts. First, the crucial premise that a thing's intrinsic value must derive from its essential properties is question-begging and devoid of support. Second, that premise is inconsistent with the pro-life position.     

On the need to redress an inadequacy in animal welfare science: toward an internally coherent framework

The time is ripe for a greater interrogation of assumptions and commitments underlying an emerging common ground on the ethics of animal research as well on the 3 R (replacement, refinement, reduction) approach that parallels, and perhaps even further shapes, it. Recurring pressures to re-evaluate the moral status of some animals in research comes as much from within the relevant sciences as without. It seems incredible, in the light of what we now know of such animals as chimpanzees, to deny that these animals are properly accorded high moral status. Barring the requirement that they be human, it is difficult to see what more animals such as chimpanzees would have to possess to acquire it. If the grounds for ascribing high moral status are to be non-arbitrary and responsive to our best knowledge of those individuals who possess the relevant features, we should expect that a sound ethical experimental science will periodically reassess the moral status of their research subjects as the relevant knowledge demands. We already can observe this reassessment as scientists committed to humane experimental science incorporate discoveries of enrichment tools and techniques into their housing and use of captive research animals. No less should this reassessment include a critical reflection on the possible elevation of moral status of certain research animals in light of what is discovered regarding their morally significant properties, characteristics or capacities, or so I will argue. To do anything short of this threatens the social and moral legitimacy of animal research.     

The role of context, colour and location cues in socially learned novel food source preferences in starlings, Sternus vulgaris

Although the opportunity for errors in social learning is widely recognised, as yet little research has been directed towards understanding specific inaccuracies, biases and limitations in social learning and the mechanisms that give rise to them. In two experiments I ask how starlings, Sternus vulgaris, identify exemplars of novel feeders previously learned about socially. I find that starlings have a stronger response to feeders in the same context as that in which social learning took place, compared to identical and nonidentical feeders in a different context. Within a context that matches where social learning took place, starlings prefer feeders that show the same location and colour as the feeder demonstrated by the demonstrator starling, and show no preference when colour and location cues are dissociated. This suggests that starlings are relatively accurate social learners, since they show strong responses to novel foraging options only if they match the context, colour and location of options learned about socially, and they do so after very few trials. Furthermore, the responses of the subjects were compatible with conditioned learning-like mechanisms, which provide a useful basis for the further investigation of the origins and implications of errors in social learning.     

The Market Triumph of Ecotourism: An Economic Investigation of the Private and Social Benefits of Competing Land Uses in the Peruvian Amazon

Annual revenue flow to developing countries for ecotourism (or nature-based tourism) could be as large as US$ 210×10¹², providing an enormous financial incentive against habitat loss and exploitation. However, is ecotourism the most privately and/or socially valuable use of rainforest land? The question is rarely answered because the relevant data, estimates of profits and fixed costs, are rarely available. We present a social cost-benefit analysis of land use in an ecotourism cluster in the Tambopata region of Amazonian Peru. The net present value of ecotourism-controlled land is given by the producer surplus (profits plus fixed costs of ecotourism lodges): US$ 1,158 ha⁻¹, which is higher than all currently practiced alternatives, including unsustainable logging, ranching, and agriculture. To our knowledge, this is the first sector-wide study of profitability and producer surplus in a developing-country ecotourism sector and the first to compare against equivalent measures for a spectrum of alternative uses. We also find that ecotourism-controlled land sequesters between 5.3 to 8.7 million tons of above-ground carbon, which is equivalent to between 3000–5000 years of carbon emissions from the domestic component of air and surface travel between the gateway city of Cusco and the lodges, at 2005 emission rates. Ecotourism in Tambopata has successfully monetized the hedonic value of wild nature in Amazonian Peru, and justifies the maintenance of intact rainforest over all alternative uses on narrow economic grounds alone.     

Consequentialism, reasons, value and justice

Over the past 10 years, John Harris has made important contributions to thinking about distributive justice in health care. In his latest work, Harris controversially argues that clinicians should stop prioritising patients according to prognosis. He argues that the good or benefit of health care is providing each individual with an opportunity to live the best and longest life possible for him or her. I call this thesis, opportunism. For the purpose of distribution of resources in health care, Harris rejects welfarism (the thesis that the good of health care is well-being) and argues that utilitarianism in general may lead to de facto discrimination against groups of people needing health care. I argue that well-being is a superior theory of the good of health care to Harris' opportunism. Harris' concerns about utilitarianism can be better addressed by: (i) relating justice more closely to reasons for action; (ii) by conceptualising the relationship between reasons for action and the value of the consequences of those actions as a plateau rather than scalar relationship. Justice can be understood as satisfying as many equally rational claims on resources as possible. The rationality of a person's claim on health resources turns on the strength of that person's reasons to promote certain health-related states of affairs. I argue that the strength of that reason does not track the expected value of that state of affairs in a fully scalar fashion. Rather a person can have most reason to promote some state of affairs, even though he or she could promote other more valuable states of affairs. Thus there can be equal reason for a distributor of public resources to save either of two people, even though one will have a better and more valuable life. This approach, while addressing many of Harris' concerns about utilitarianism, does not imply that doctors should give up prioritising patients according to prognosis altogether, but it does allow that patients with lower but reasonable prognosis should have a share of public resources.     

Bioprospecting the African Renaissance: The new value of <Emphasis Type="Italic">muthi</Emphasis> in South Africa

This article gives an overview of anthropological research on bioprospecting in general and of available literature related to bioprospecting particularly in South Africa. It points out how new insights on value regimes concerning plant-based medicines may be gained through further research and is meant to contribute to a critical discussion about the ethics of Access and Benefit Sharing (ABS). In South Africa, traditional healers, plant gatherers, petty traders, researchers and private investors are assembled around the issues of standardization and commercialization of knowledge about plants. This coincides with a nation-building project which promotes the revitalization of local knowledge within the so called African Renaissance. A social science analysis of the transformation of so called Traditional Medicine (TM) may shed light onto this renaissance by tracing social arenas in which different regimes of value are brought into conflict. When medicinal plants turn into assets in a national and global economy, they seem to be manipulated and transformed in relation to their capacity to promote health, their market value, and their potential to construct new ethics of development. In this context, the translation of socially and culturally situated local knowledge about muthi into global pharmaceuticals creates new forms of agency as well as new power differentials between the different actors involved.     

From humanized mice to human disease: guiding extrapolation from model to target

Extrapolation from a well-understood base population to a less-understood target population can fail if the base and target populations are not sufficiently similar. Differences between laboratory mice and humans, for example, can hinder extrapolation in medical research. Mice that carry a partial or complete human physiological system, known as humanized mice, are supposed to make extrapolation more reliable by simulating a variety of human diseases. But what justifies our belief that these mice are similar enough to their human counterparts to simulate human disease? I argue that, unless three requirements are met in the process of humanizing mice, very little does. My requirements are not meant to provide necessary and sufficient conditions that guarantee a particular outcome. Instead, they serve as a heuristic for guiding scientific judgments involving extrapolation. In developing each requirement, I engage with philosophical issues concerning the nature of model-based science and the mechanistic approach (and its limits) to making generalizations in the life sciences.     

After Dolly--ethical limits to the use of biotechnology on farm animals

The cloning of Dolly the sheep gave rise to a widespread call for limits on interference with life. Until recently, the main limits were technical: what it is possible to do. Now scientists are faced with ethical limits as well: what it is acceptable to do. In this context, we take ethics to involve systematic and rational reflection on moral issues raised in the public sphere. The concerns of the general public are not necessarily valid, but they are the best point of departure if the discussion is to lead to a socially robust framework for setting limits to the use of animal biotechnology. To assess public understanding, we examine two sources of data: Eurobarometer surveys from 1991 to 2002 and a qualitative interview study carried out in Denmark in 2000. Based on these sources, we formulate, and then discuss closely, the following concerns: dangers to human health and the environment, animal welfare, animal integrity, and usefulness. In the final part of the article, it is proposed that a principle of proportionality should be the foundation for socially robust applications of animal biotechnology. Only in cases where the usefulness of the technology can be said to outweigh countervailing moral concerns, as in biomedical research, will applications of animal biotechnology stand up to scrutiny in the public sphere.     

Consensus statement understanding health and malnutrition through a systems approach: the ENOUGH program for early life

Nutrition research, like most biomedical disciplines, adopted and often uses experimental approaches based on Beadle and Tatum’s one gene—one polypeptide hypothesis, thereby reducing biological processes to single reactions or pathways. Systems thinking is needed to understand the complexity of health and disease processes requiring measurements of physiological processes, as well as environmental and social factors, which may alter the expression of genetic information. Analysis of physiological processes with omics technologies to assess systems’ responses has only become available over the past decade and remains costly. Studies of environmental and social conditions known to alter health are often not connected to biomedical research. While these facts are widely accepted, developing and conducting comprehensive research programs for health are often beyond financial and human resources of single research groups. We propose a new research program on essential nutrients for optimal underpinning of growth and health (ENOUGH) that will use systems approaches with more comprehensive measurements and biostatistical analysis of the many biological and environmental factors that influence undernutrition. Creating a knowledge base for nutrition and health is a necessary first step toward developing solutions targeted to different populations in diverse social and physical environments for the two billion undernourished people in developed and developing economies.     

Rationale for an integrated approach to genetic epidemiology

Conclusion: Genetic knowledge is now in the public domain and its interpretation by the media and the citizens brings the issues into the public forum of discussion for the necessary ethical, legal and socio-cultural evaluation of its application. Science is being perceived by some as dangerous and as requiring international regulation. Others feel that genetic knowledge will be the breakthrough that will permit medical progress and individual autonomy with regards to personal health and lifestyle choices. The mapping of the human genome has already yielded valuable information on an increasing number of diseases and their variants. Prevailing popular and journalistic archetypes ("imaginaires") used in the media are perceived by the producers as slowing down the possible application of genetic knowledge. The answers to these dilemmas are not readily apparent nor are they prescribed by classical philosophy of medicine. Since genetic knowledge eventually resides with the individual who carries the genes of disease and/or susceptibility, a logical approach to integration of this knowledge at a societal level would seem to reside with individual education and decision-making. The politics of the ensuing social debate could transform the current social contract since an individual's interests need to be balanced against those of his or her immediate family in the sharing of information. The ethical foundations of such a contract requires the genetic education of "Everyone" as a matter of urgent priority. Genetic education should not serve ideological power struggles between the medical establishment and the ethical-legal alliance. Instead, it should ensure the transfer of knowledge to physicians, to patients, to users, to planners, to social science and humanities researchers and to politicians, so that they may make "informed" and free decisions....     

Randomized Controlled Trials of Maternal‐Fetal Surgery: A Challenge to Clinical Equipoise

This article focuses on maternal‐fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence‐based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable.     

African communal basis for autonomy and life choices

I argue that the metaphysical capacity of autonomy is not intrinsically valuable; it is valuable only when used in relation to a community's values and instrumentally for making the proper choices that will promote one's own and the community's well‐being. I use the example of the choice to take one's life by suicide to illuminate this view. I articulate a plausible African conception of personhood as a basis for the idea of relational autonomy. I argue that this conception is better understood as a social‐moral thesis, and not a metaphysical thesis. A metaphysical thesis gives an account of the abstract nature of an atomic individual, his agency, and rational choice. The social‐moral thesis indicates that personhood and autonomy are positive and relational to the life plans, well‐being, material conditions, and the best means for achieving them that are made available and possible by harmonious living in a community. This idea of autonomy is not just having the capacity of freewill; it also involves how such freewill is used, in terms of how an individual's choices are guided by internalized communal values.     

Expression of markers of differentiation in a transformed human keratinocyte line induced by coculture with a fibroblast line

SVK14, an SV40-transformed human keratinocyte line, has previously been reported to be almost completely unable to differentiate, and indeed, to express a set of keratins characteristic of simple epithelia rather than the stratifying epithelium from which they were derived. We have recently shown that IGF I stimulation of SVK14 results in expression of keratin 14, a marker of stratifying epithelia, as well as expression of markers which are characteristic of differentiation in normal human keratinocytes such as involucrin and keratin 10. To study further the capacity of SVK14 to differentiate, we have cocultured SVK14 with a variety of fibroblastic cell lines with a view to examining whether the cocultured partner can promote or interfere with their differentiation. We have observed that SVK14, when cocultured with Swiss 3T3, form organized structures through specific cell-cell interactions in which SVK14 express keratins 14 and 5 and involucrin, while maintaining T-antigen expression. These results are interesting since they show coculturing of a transformed human keratinocyte cell line and a particular fibroblast line can result in induction of characteristics of stratifying epithelia in a cell line with characteristics of simple epithelia. This may be analogous to the epithelial-mesenchymal interactions seen during epithelial development in the very early embryo.     

Responsible choices: situating pregnancy intention among Haitians in South Florida

In this article, I focus on unintended pregnancy as a means to interrogate the intersections of abortion and prenatal discourses in the United States, and the ways in which these discourses assume certain kinds of moral, liberal subjects. Using media material, congressional legislation, public health policy, and ethnographic data from South Florida (2004-06), I trace how these discourses assume that women will behave in "rational," "responsible" ways to plan their reproductive futures, and how these assumptions intersect with Haitian women migrants' lived experiences in South Florida. My research illustrates how decisions about family planning are situated within particular local moral worlds, where gender relations, religion, power, and desires for children inform women's everyday lives.