Realizing the promise of population biobanks: a new model for translation

The promise of science lies in expectations of its benefits to societies and is matched by expectations of the realisation of the significant public investment in that science. In this paper, we undertake a methodological analysis of the science of biobanking and a sociological analysis of translational research in relation to biobanking. Part of global and local endeavours to translate raw biomedical evidence into practice, biobanks aim to provide a platform for generating new scientific knowledge to inform development of new policies, systems and interventions to enhance the public’s health. Effectively translating scientific knowledge into routine practice, however, involves more than good science. Although biobanks undoubtedly provide a fundamental resource for both clinical and public health practice, their potentiating ontology—that their outputs are perpetually a promise of scientific knowledge generation—renders translation rather less straightforward than drug discovery and treatment implementation. Biobanking science, therefore, provides a perfect counterpoint against which to test the bounds of translational research. We argue that translational research is a contextual and cumulative process: one that is necessarily dynamic and interactive and involves multiple actors. We propose a new multidimensional model of translational research which enables us to imagine a new paradigm: one that takes us from bench to bedside to backyard and beyond, that is, attentive to the social and political context of translational science, and is cognisant of all the players in that process be they researchers, health professionals, policy makers, industry representatives, members of the public or research participants, amongst others.     

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.     

Biobanking and public health: is a human rights approach the tie that binds?

Ethical principles guiding public health and genomic medicine are often at odds: whereas public health practice adopts collectivist principles that emphasize population-based benefits, recent advances in genomic and personalized medicine are grounded in an individualist ethic that privileges informed consent, and the balancing of individual risk and benefit. Indeed, the attraction of personalized medicine is the promise it holds out to help individuals get the “right medicine for the right problem at the right time.” Research biobanks are an effective tool in the genomic medicine toolbox. Biobanking in public health presents a unique case study to unpack some of these issues in more detail. For example, there is a long history of using banked tissue obtained under clinical diagnostic conditions for later public health uses. But despite the collectivist approach of public health, the principles applied to the ethical challenges of biobanking (e.g. informed consent, autonomy, privacy) remain individualist. We demonstrate the value of using human rights as a public health ethics framework to address this tension in biobanking by applying it to two illustrative cases.     

Landscape ecology and urban biodiversity in tropical Indonesian cities

Indonesia has recently been faced with a number of great problems: poverty, natural disasters such as tsunami, earthquakes, flooding and typhoons, volcanic eruptions, loss of biodiversity, decreasing water quality and quantity, increased pollution, and aesthetic degradation of the landscape. These disturbances have been caused by rapid changes in land use and land cover, deforestation, the application of monoculture farming systems in commercial agriculture, urbanization, industrialization, and other types of infrastructure development. The government, urban communities and companies have promoted some programs to ameliorate the problem of environmental degradation. The government has ratified law no. 26/2007 as a commitment to sustainability; this law ensures that cities are obliged to provide green open spaces covering a minimum of 30% of urbanized areas. Many metropolitan cities have feverishly enacted policies to promote greening programs, such as those applied in Jakarta. However, a new town—Sentul City—has engaged in policies that aim to create a well-designed eco-city with urban greenery and ecological networks. This new policy is supposed to herald a better future for urban quality. It is expected that green spaces will provide environmental services: water resource management, biodiversity conservation, carbon sequestration, and landscape beauty.     

Population and abortion policies in China: Their impact on minority nationalities

The history of abortion in China is closely linked to the evolution of the country's population policy over the past four decades. Abortion in China has been legal since 1953 and is widely available through services offered by the country's national family planning program. In 1971, following the uncertain period of the Cultural Revolution (1965–1968), the government of China, confronting the reality of its population size — which in 1970 was estimated by the United Nations at 800 million people — decided to make a concerted effort to lower demographic growth by means of an effective birth planning campaign and services, backed up with legal and safe abortion. Within a decade, in 1979, China strengthened its policy and imposed on the population a reproductive norm allowing for only one child, known as the One-Child Family Policy. Ethnic minorities were at first exempt from demographic policies but more recently pressure has been increasingly applied to them to control their fertility. Abortion is now prevalent among nearly all Chinese ethnic minorities. Because of their remoteness and less favorable socio-economic circumstances, minorities lack access to quality services that would lower or make abortion unnecessary. The paper represents an effort to reverse the gap and confusion in the existing literature on ethnic group response to population and family planning policies in China.     

The category of roots and the roots of categories: what we learn from selection in derivation

Selection—the tendency of derivational affixes to choose the category of their base—has most often been couched in terms of syntactic categories such as Noun, Verb, and Adjective. In recent years several theories have claimed, however, that roots are categoryless, and receive category only by virtue of being merged with functional projections of various sorts. This article examines three such theories—Distributed Morphology, Borer’s Exo-Skeletal model, and DiSciullo’s Asymmetrical Morphology, and determines that none of them can handle the phenomenon of affixal selection. We may, however, maintain the claim that roots lack syntactic category if we make use of a system of lexical semantic categorization that allows us to state selection in terms of semantic categories. It is shown that the framework of Lieber (2004) allows for such categorization, and moreover that semantic categorization permits us to make generalizations that are not available in a theory in which selection is purely on the basis of syntactic category. I am grateful to the faculty and students of the University of Patras, Greece for discussion and comments on an earlier version of this work. Thanks also to Sergio Scalise, Antonietta Bisetto, Chiara Melloni, and three anonymous reviewers for useful comments.     

Wetland mitigation and compensation: Canadian experience

Since Canada’s accession to the Ramsar Convention on Wetlands in 1981, the nation’s commitment to wetland conservation and management has increased significantly. This includes the adoption of one of the World’s first national wetland conservation policies by the Government of Canada, and the adoption of complementary policy and legislative initiatives by most of the 13 provincial and territorial jurisdictions. Numerous habitat ‘no net loss’ and environmental assessment policies, regulations and guidelines for incorporating mitigation processes into development decisions affecting wetland resources are used throughout Canada. The governments of Canada and six provinces have so far adopted wetland mitigation measures. These are in addition to comprehensive wetland fish and wildlife habitat initiatives, such as the species and habitat joint ventures delivered in Canada through the North American Waterfowl Management Plan by all jurisdictions and numerous non-government partners. This paper examines the current policies, regulations and programs, as well as past implementation experience with wetland mitigation and compensation in Canada.     

Mobilizing for nature in southern African community-based conservation policies, or the death of the local

Community-based natural resource management policies have been seriously criticized in the last few years. Detractors have focused either on the lack of local participation, or on the lack of ecological results. Using two of the earliest and most studied community-based natural resource management (CBNRM) initiatives in Africa (ADMADE in Zambia and CAMPFIRE in Zimbabwe), the article argues that such critics miss the actual stakes of community-based policies. These policies bring local communities into a global world, both in terms of practice and narrative. From this point of view, community-based policies must be viewed as long-term approaches to change in rural Africa, which will progressively make the local/global partition fuse into processes of continual social “mobilization”.     

Fathers and Public Policy

Until recently, policy makers viewed fathers' provision of child support as the most policy-relevant form of father involvement. In contrast, other policy initiatives have not been as widely explored. This article identifies current fatherhood policies and considers the mixed implications of these policy and practice interventions for father involvement and child well-being. We conclude with suggestions for future fatherhood policies and initiatives.     

Life-cycle based government policies a survey

This paper examines how different Life-Cycle Assessment (LCA) approaches, from full LCA’s to more qualitative LCA’s, are being used internationally in the development of government policies. Examples from 14 countries are provided for recent initiatives in various forms of policy which were developed to move national environmental policies toward the more life-cycle based programs. They indicate that a broader frame of reference is beginning to be used by those who write such policies. Discussion is also provided on the barriers that slow the adoption of life-cycle approaches in the development of government policies.     

The Suicide Tourist Trap: Compromise Across Boundaries

Amongst the latest, and ever-changing, pathways of death and dying, “suicide tourism” presents distinctive ethical, legal and practical challenges. The international media report that citizens from across the world are travelling or seeking to travel to Switzerland, where they hope to be helped to die. In this paper I aim to explore three issues associated with this phenomenon: how to define “suicide tourism” and “assisted suicide tourism”, in which the suicidal individual is helped to travel to take up the option of assisted dying; the (il)legality of assisted suicide tourism, particularly in the English legal system where there has been considerable recent activity; and the ethical dimensions of the practice. I will suggest that the suicide tourist—and specifically any accomplice thereof—risks springing a legal trap, but that there is good reason to prefer a more tolerant policy, premised on compromise and ethical pluralism.     

Reconsidering the Placebo Response from a Broad Anthropological Perspective

This paper considers how the full range of human experience may catalyze a placebo response. The placebo effect has been characterized as something to control in clinical research, something to cultivate in clinical practice and something present in all healing encounters. We examine domains in which the term ‘placebo’ is used in discourse: clinical research, clinical practice, media representations of treatment efficacy and lay interpretations of placebo—an underresearched topic. We briefly review major theoretical frameworks proposed to explain the placebo effect: classical conditioning, expectancy, the therapeutic relationship and sociocultural ‘meaning.’ As a corrective to what we see as an overemphasis on conscious cognitive approaches to understanding placebo, we reorient the discussion to argue that direct embodied experience may take precedence over meaning-making in the healing encounter. As an example, we examine the neurobiology of rehearsing or visualizing wellness as a mode of directly (performatively) producing an outcome often dismissed as a ‘placebo response.’ Given body/mind/emotional resonance, we suggest that the placebo response is an evolutionarily adaptive trait and part of healing mechanisms operating across many levels—from genetic and cellular to social and cultural.

On the Role of Ideas of Human Nature in Shaping Attitudes Towards Environmental Governance

Attitudes towards the management of the natural environment have been described mainly as building on individuals’ images of nature and the human–nature relationship. However, in previous qualitative research I found strong evidence that in order to understand public views on environmental policies we also need to understand individuals’ beliefs about their fellow humans. The present study tested the hypothesis that beliefs about human nature and preferences for certain governance approaches—such as regulations and collective action—are related to individuals’ attitudes towards concrete management measures. Survey results (n = 155), analysed by means of structural equation modelling, suggest that effects of beliefs about human nature are discernible, but not significant. I could, however, identify generic preferences for particular approaches to environmental governance. These significantly explained variation in attitudes towards environmental governance in an applied context, suggesting a strong need for further research in this politically highly relevant field.     

Consent for use of clinical leftover biosample: a survey among Chinese patients and the general public

Background

Storage of leftover biosamples generates rich biobanks for future studies, saving time and money and limiting physical impact to sample donors.

Objective

To investigate the attitudes of Chinese patients and the general public on providing consent for storage and use of leftover biosamples.

Design, Setting and Participants

Cross-sectional surveys were conducted among randomly selected patients admitted to a Shanghai city hospital (n = 648) and members of the general public (n = 492) from May 2010 to July 2010.

Main Outcome Measures

Face-to-face interviews collected respondents-report of their willingness to donate residual biosample, trust in medical institutions, motivation for donation, concerns of donated sample use, expectations for research results return, and so on.

Results

The response rate was 83.0%. Of the respondents, 89.1% stated that they completely understood or understood most of questions. Willingness to donate residual sample was stated by 64.7%, of which 16.7% desired the option to withdraw their donations anytime afterwards. Only 42.3% of respondents stated they “trust" or “strongly trust" medical institutions, the attitude of trusting or strongly trusting medical institutions were significantly associated with willingness to donate in the general public group.(p<0.05) The overall assent rate for future research without specific consents was also low (12.1%). Hepatitis B virus carriers were significantly less willing than non-carriers to donate biosamples (32.1% vs. 64.7%, p<0.001).

Conclusions

Low levels of public trust in medical institutions become serious obstacle for biosample donation and biobanking in China. Efforts to increase public understanding of human medical research and biosample usage and trust in the ethical purposes of biobanking are urgently needed. These efforts will be greatly advanced by the impending legislation on biobanking procedures and intent, and our results may help guide the structure of such law.     

The implications of the precautionary principle for biological monitoring

Marine biological monitoring programmes frequently attempt to determine “safe” levels of contamination, based on assumptions about the assimilative capacity of the environment. This paper argues that such assumptions lack scientific rigour, and do not form the basis upon which a precautionary policy can be built. It notes the problems associated with assessing toxicological effects, but centres its attention on the crucial (yet far less discussed) weaknesses in theoretical ecology that make it extremely unlikely that biological monitoring can determine safe levels of contamination that leave ecosystems unaffected. It is argued that many marine biologists, if pressed, would concede these shortcomings but believe that, in the face of the technical difficulties and high costs of pollution prevention, we have no choice but to use such methods. This paper argues, with examples, that pollution prevention, often with considerable economic savings, is becoming a reality for even the most problematic substances. The difficulty is that the development of “clean production” methods lie outside the sphere of interest of those carrying out monitoring, so that measures that attempt to determine safe levels of contamination continue to be advocated. This gulf needs to be bridged so that the continuation of monitoring programmes that are part of dilute and disperse policies become regarded as inappropriate, indeed unethical. The paper concludes that this does not mean the end of marine monitoring. Instead, reliable methods for assessing physical levels of contamination will be required to determine whether the reduction targets set—as part of the introduction of clean production—are being met. Formidable difficulties will remain, requiring a precautious approach. Nevertheless, monitoring will no longer carry the burden of attempting to demonstrate that a particular level of environmental contamination is safe, which is currently destroying its scientific credibility.     

Civic integration policies from below: accounting for processes of convergence and divergence in four European cities

The introduction of integration tests on a pre-entry or post-arrival basis has drawn attention to changing national integration policies. Yet, at the local level, language and civic culture courses have often been implemented before the development of national programmes. The way these policies came into place and the extent to which they responded to similar challenges has often been overlooked. This article explores the development of these measures in four cities – Stuttgart, Vienna, Barcelona and Turin – to find out which mechanisms account for convergence in policymaking. Integration courses present traits of similarity in their contents and target groups; however, this does not imply a consistent process towards convergence. Local introduction initiatives are the product of local policy arenas, which display different policy frames of migrant integration. On the other hand, new legislation and changes in the available financial resources for integration appear to be crucial factors that trigger divergence.     

Post-Soviet Placebos: Epistemology and Authority in Russian Treatments for Alcoholism

The dominant modalities of treatment for alcoholism in Russia are suggestion-based methods developed by narcology—the subspecialty of Russian psychiatry which deals with addiction. A particularly popular method is the use of disulfiram—an alcohol antagonist—for which narcologists commonly substitute neutral substances. Drawing on 14 months of fieldwork at narcological clinics in St. Petersburg, this article examines the epistemological and institutional conditions which facilitate this practice of “placebo therapy.” I argue that narcologists’ embrace of such treatments has been shaped by a clinical style of reasoning specific to a Soviet and post-Soviet psychiatry, itself the product of contested Soviet politics over the knowledge of the mind and brain. This style of reasoning has facilitated narcologists’ understanding of disulfiram as a behavioral, rather than a pharmacological, treatment and has disposed them to amplify patients’ responses through attention to the performative aspects of the clinical encounter and through management of the treatment’s broader reputation as an effective therapy. Moreover, such therapies have generally depended upon, and helped to reinforce, clinical encounters premised on a steeply hierarchical physician–patient relationship.     

Universal grammar and the Baldwin effect: a hypothesis and some philosophical consequences

Grammar is now widely regarded as a substantially biological phenomenon, yet the problem of language evolution remains a matter of controversy among Linguists, Cognitive Scientists, and Evolutionary Theorists alike. In this paper, I present a new theoretical argument for one particular hypothesis—that a “Language Acquisition Device” of the sort first posited by Noam Chomsky might have evolved via the so-called “Baldwin Effect”. Close attention to the workings of that mechanism, I argue, helps to explain a previously mysterious feature of the Language Acquisition Device—the sheer variety of languages it allows the child to learn—thereby revealing a far stronger case than adherents of the hypothesis have previously supposed. A further unheralded consequence of the hypothesis is a conceptual shift in the Chomskyan understanding of language, wherein the essentially public nature of language is freshly emphasised. This has the effect of bringing the Chomskyan view into closer accord with Saussurean accounts of language, as well as with recent trends in evolutionary theory.     

Does proactive biodiversity conservation save costs?

Ecologists usually argue for a proactive approach to species conservation—it should start before a species is endangered and under substantial risk of extinction. In reality, however, conservation often only starts when species populations are already in a critical state. This may be the result of a policy process in which those actors who see only little or no benefits from conserving species try to delay conservation as long as possible to avoid its cost. A frequent consequence is that populations decline to critical levels so that once conservation policies set in due to legal obligations, political pressure or any other reason, additional conservation measures are required to re-establish the populations. We show that the costs associated with this policy process may be higher than those of a proactive policy. This is somewhat surprising because the costs of maintaining populations at a level at which they are not endangered may occur over a longer period. However, the costs of bringing species populations back to those levels may be so high that they outweigh the costs of the proactive approach. We develop simple cost functions that capture the main economic and ecological parameters relevant to our argument and apply them for an assessment of the costs of common hamster (Cricetus cricetus) conservation in the region of Mannheim, Germany. We find that a proactive approach would have saved between €17.2 and €36.4 mn compared to the existing policy where conservation was delayed until legal requirements forced local policy makers to implement a comprehensive hamster protection programme.