Beyond and within public engagement: a broadened approach to engagement in biobanking

Social studies on biobanking have traditionally focused on public engagement, that is, engagement with donors, patients and the general public as an important factor of sustainability. In this article, we claim that, in order to fully understand the way biobanks work, it is necessary to pay attention to a number of other actors, which have an equal, if not greater, impact on their practices and strategies. This means taking a broadened approach to biobank engagement. By using data collected from interviews with different biobank experts based in five different countries (UK, Canada, Finland, Spain and Iceland), we identify seven communities, including the public, that emerge as relevant. Such relationships condition the way biobanks develop, act and plan. The discussion illustrates how the relationships with those seven communities are articulated. We conclude that there is a need for a broadened approach to biobank engagement in order to understand biobank sustainability.     

生物样本库是生物医学研究的重要基础

在生物医学研究飞速发展的今天,随着对健康和疾病认识的不断深入,传统的单病因、单基因研究模式已难以胜任复杂疾病的研究.医学科学的发展需要一种能提供疾病相关的、具有普遍意义的、全局式的分子信息数据库.生物样本库在其中所能发挥的关键作用得到了越来越多的重视.它从最初的小作坊模式经过100多年,尤其是近30年的快速发展已经演化成为科研院所和政府支持的生物样本库、商业化生物样本库及以人口为基础的生物银行等多种模式.伴随存储样本数据信息的复杂度不断快速增加,生物样本库除了收集样本相关的基本数据和诊断信息外,还延伸到配套信息,包括参加人和病人的多种表型,到目前已经迅速扩展到基因组学、蛋白质组学及其他的组学信息.如何科学地建设和管理这种大型复杂模式的生物样本库成为医学科学领域亟待规范、解决的问题.本文将从生物样本库的发展入手重点讨论其建设、管理和应用.     

Democratic governance of genomics: the case of UK Biobank

Biobanks are collections of human biological tissue used for genomics research. This promises a better understanding of the gene-based contribution to common disease and development of a more personalized approach to healthcare with safer drugs and more effective treatment. However, biobanks are also controversial owing to the ethical, legal, social and political issues raised about their collection and use of biological samples. Therefore, their democratic governance is not only a normative challenge but also an empirical one. This paper is concerned with both challenges: it attempts to “evaluate” processes of democratic governance of genomics by focusing on the case of UK Biobank. The overall argument is that although the UK Biobank performs well in terms of general democratic governance structures, there are epistemological and practical limits to specific democratic governance processes.     

Getting a Fair Share: Attitudes and Perceptions of Biobank Stakeholders Concerning the Fairness of Sample Sharing

Biobanks are essential tools for furthering a broad range of medical research areas. However, despite the plethora of national and international laws and guidelines which apply to them, the access and sharing policies of biobanks are only sparsely addressed by regulatory bodies. The ‘give and take’ process of biosample sharing is largely left up to biobank stakeholders themselves to oversee; it is therefore both in stakeholders' power, and in their interest, to ensure that sample accessibility is fair. This is an important step in motivating researchers to collaborate and pool samples, and is crucial to fostering trust in the absence of universally accepted standard practices. To date, little attention has been paid to how fairness considerations affect scientific material sharing, and no empirical research has been carried out to determine the role that fairness plays in collaborative studies. In order to begin to gain understanding in this area, we interviewed 36 biobank stakeholders currently working in Switzerland, focusing on their perceptions of current and optimal fair sharing practices. Our findings reveal that fairness is an important feature of exchange situations for these stakeholders, and that they have well‐formed notions about the practical elements of fair sample access, although ideas about the concept of fairness itself are vague. In order to support efforts to network biobanks, attention should be paid to this issue to reassure all involved that they are getting a fair share in their cooperative efforts.     

Chronotype,depression and hippocampal volume: cross-sectional associations from the UK Biobank

Diurnal preference for evening time has been associated with increased odds for current depression and a number of indices of the disorder. In the current study, the association between chronotype and depression was explored in a population-based sample of 5360 adults aged between 40 and 70 years. Previous work has also suggested that larger hippocampal volume may be protective against depression. In an additional, exploratory analysis, hippocampal volume was compared in never-depressed early and late chronotypes (N= 3004). Definite eveningness was significantly associated with increased odds for probable lifetime depression after controlling for a number of confounding factors including neuroticism. Hippocampal volume did not differ between never-depressed early and late chronotypes. The current results extend previous work and add further weight to the argument that late chronotype represents a risk factor for depression.     

包容性治理：中国国家公园治理新思路

模式的选择在自然保护地有效治理过程中起着关键作用,适宜的治理模式是实现自然保护地生态、社会、经济和文化综合效益最优化的重要途径。包容性治理在建立多元共治、全民共享的国家公园治理体制、促进社会公平和容纳边缘群体等方面具有独特优势,是对保护地治理模式的优化与创新,拥有广阔的应用空间。系统总结了全球保护地治理模式,对不同治理模式进行了比较和评价,重点从理论和实践背景阐述了包容性治理的源起;从边缘性和公平性视角两方面分析了现阶段中国国家公园进行包容性治理的必要性与可行性;并对中国国家公园包容性治理框架进行了阐释,提出了中国国家公园包容性治理建议和思考。以治理主体多元化、主体间的合作、促进社会公平、容纳全体社会成员自由发展,尤其是确保边缘群体的利益为特征的包容性治理,可以成为中国国家公园协调保护和当地发展的新思路、新选择。     

Autonomy is a Right,Not a Feat: How Theoretical Misconceptions have Muddled the Debate on Dynamic Consent to Biobank Research

Should people be involved as active participants in longitudinal medical research, as opposed to remaining passive providers of data and material? We argue in this article that misconceptions of ‘autonomy’ as a kind of feat rather than a right are to blame for much of the confusion surrounding the debate of dynamic versus broad consent. Keeping in mind two foundational facts of human life, freedom and dignity, we elaborate three moral principles – those of autonomy, integrity and authority – to better see what is at stake. Respect for autonomy is to recognize the other's right to decide in matters that are important to them. Respect for integrity is to meet, in one's relationship with the other, their need to navigate the intersection between private and social life. Respect for authority is to empower the other – to help them to cultivate their responsibility as citizens. On our account, to force information onto someone who does not want it is not to respect that person's autonomy, but to violate integrity in the name of empowerment. Empowerment, not respect for autonomy, is the aim that sets patient‐centred initiatives employing a dynamic consent model apart from other consent models. Whether this is ultimately morally justified depends on whether empowerment ought to be a goal of medical research, which is questionable.     

A prospective study of inflammatory biomarkers and growth factors and risk of glioma in the UK Biobank

PurposeThe role of growth factors and inflammation in the onset of glioma is poorly understood, and conflicting reports of associations of circulating IGF-1 and inflammatory biomarkers with glioma risk exist in the literature. We examined associations between C-reactive protein (CRP), white blood cell count (WBC), neutrophil-to-lymphocyte ratio (NLR), and insulin-like growth factor-1 (IGF-1) and glioma risk in the UK Biobank cohort.MethodsHazard ratios (HR) and 95% confidence intervals (CI) for glioma according to circulating biomarkers concentrations were calculated using Cox proportional hazards regression, adjusted for age, sex, race, and education. Analyses were conducted separately for glioma overall and by glioma subtype.ResultsWe identified 417 incident glioma cases among 428,537 participants with 3,255,815 person-years of follow up. Weak, non-significant associations were observed with increasing levels of these biomarkers for risk of glioma overall or by glioma subtype. Among women only, IGF-1 in the highest quartile was positively associated with glioma risk compared to the lowest quartile (HR=1.64, 95%CI: 1.03–2.60, p-trend=0.08), as was NLR (HR=1.54, 95%CI: 1.00–2.39, p-trend=0.05).ConclusionIn this prospective cohort, we found no significant associations between the inflammatory biomarkers CRP and WBC and the development of glioma. NLR and IGF-1 were associated with risk in women, but not men. When considered with previous studies, further investigation of NLR and IGF-1 as markers of glioma risk appears warranted, particularly in women.     

The synthetic biology puzzle: a qualitative study on public reflections towards a governance framework

Synthetic biology is currently one of the most debated emerging biotechnologies. The societal assessment of this technology is primarily based on contributions by scientists and policy makers, who focus mainly on technical challenges and possible risks. While public dialogue is given, it is yet rather limited. This study explores public debates concerning synthetic biology based on a focus group study with citizens from Austria and Germany and contextualises the analysed public views with content from policy reports and previous empirical studies on public engagement. The findings suggest that discussants favoured a gradual implementation process of synthetic biology, which is receptive to questions about the distribution of possible benefits. The discussed topics correspond in many ways with content from policy reports and former investigations, yet the emphasis of the discussions was different for many aspects.     

CRISPR-Based Adenine Editors Correct Nonsense Mutations in a Cystic Fibrosis Organoid Biobank

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The art of trans-boundary governance: the case of synthetic biology

Synthetic biology raises few, if any, social concerns that are distinctively new. Similar to many other convergent technologies, synthetic biology’s interface across various scientific communities and interests groups presents an incessant challenge to political and conceptual boundaries. However, the scale and intensity of these interfaces seem to necessitate a reflection over how corresponding governance capacities can be developed. This paper argues that, in addition to existing regulatory approaches, such capacities may be gained through the art of trans-boundary governance, which is not only attentive to the crossing and erosion of particular boundaries but also adept in keeping up with the dynamics among evolving networks of actors.     

Plastic pollution challenges in marine and coastal environments: from local to global governance

Plastic pollution in the marine and coastal environment is a challenging restoration and governance issue. Similar to many environmental problems, marine plastic pollution is transboundary and therefore the governance solutions are complex. Although the marine environment is unlikely to return to the condition it was in before the “plastic era,” it is an example of an environmental restoration challenge where successful governance and environmental stewardship would likely result in a healthier global oceanic ecosystem. We argue that a holistic, integrated approach that utilizes scientific expertise, community participation, and market‐based strategies is needed to significantly reduce the global plastic pollution problem.     

Variable conceptions of population in community resource genetic projects: a challenge for governance

In recent years, human genetic research has developed rapidly, and the cost of sequencing and computational technology continues to decline. This research has also been pushed forward by a major organizational innovation: the development of large, open-access databases of human gene sequences or biospecimens known as community resource projects. This article describes a challenge for the governance of these projects: conceptions of population vary significantly across organizational contexts. This makes it difficult to manage risk appropriately, as measures intended to address hazards to one kind of population may be inadequate for others. Unstable conceptions of population may also make it difficult to identify the stakeholders interested in the governance of these projects. This argument is developed by examining two cases, the International HapMap Project and 1000 Genomes Project, which make use of at least six distinct conceptions of population in different organizational segments.     

On being a (modern) scientist: risks of public engagement in the UK interspecies embryo debate

In 2006, a small group of UK academic scientists made headlines when they proposed the creation of interspecies embryos – mixing human and animal genetic material. A public campaign was fought to mobilize support for the research. Drawing on interviews with the key scientists involved, this paper argues that engaging the public through communicating their ideas via the media can result in tensions between the necessity of, and inherent dangers in, scientists campaigning on controversial issues. Some scientists believed that communicating science had damaged their professional standing in the eyes of their peers, who, in turn, policed the boundaries around what they believed constituted a “good” scientist. Tensions between promoting “science” versus promotion of the “scientist”; engaging the public versus publishing peer-reviewed articles and winning grants; and building expectations versus overhyping the science reveal the difficult choices scientists in the modern world have to make over the potential gains and risks of communicating science. We conclude that although scientists' participation in public debates is often encouraged, the rewards of such engagement remain. Moreover, this participation can detrimentally affect scientists' careers.     

Navigating Amazonia under uncertainty: past, present and future environmental governance

One of the major environmental challenges of the twenty-first century is the continued rapid deforestation of Amazonia. The 2005 dieback crisis emphasizes the unprecedented challenges facing Brazil. The examination of past and present institutions for ecosystem management, in Amazonia, shows structural barriers across public, private and community arrangements. The adaptive governance concept helps to understand why these institutions are failing to deliver sustainable futures. In looking forward, it is encouraging to see that important networks of knowledge and a number of novel initiatives are emerging in Brazil. These new arrangements are novel in the way that they seem to be adaptive and navigate structures in the hope of overcoming insurmountable drivers of deforestation.     

我国生态治理体制构建、政策演进逻辑与治理现代化

纵观我国生态治理与环境保护实践历程,在探索、重构、深化中建立了具有中国特色的生态治理政策体系。在生态与经济发展新旧动能转换的关键时期,理清生态治理体制构建策略与政策演进逻辑,推进生态治理现代化建设,实现长效地人与自然和谐共生,具有重要的理论与现实意义。通过Citespace可视化图谱对1973-2022年间710份国家重要决策及政策法规文件深入梳理发现:(1)生态治理体制构建策略从初期的“一对一”污染问题治理导向、简单垂直的线性关系联动机制,到逐步形成生态理念导向、交叉互动的网络关系协同机制,总体上由单一部门主导决策的“上重下轻”转变为以顶层生态行政单位为核心,多领域部门参与执行的“上下联动”均衡态势;(2)生态治理政策先后经历“观念启蒙探索时期:环境污染末端管控(1973-1991年)”-“可持续发展时期:生态协同综合治理(1992-2011年)”-“生态文明时期:发展理念体系建设(2012-2022年)”的逻辑演化;(3)从机制完善、利益重构、多元统筹三个维度阐述并讨论生态治理现代化体系与改进路径,以期为相关领域的深入研究提供借鉴与参考。     

Human genetic banking: altruism,benefit and consent

This article considers how we should frame the ethical issues raised by current proposals for large‐scale genebanks with on‐going links to medical and lifestyle data, such as the Wellcome Trust and Medical Research Council's ‘UK Biobank’. As recent scandals such as Alder Hey have emphasised, there are complex issues concerning the informed consent of donors that need to be carefully considered. However, we believe that a preoccupation with informed consent obscures important questions about the purposes to which such collections are put, not least that they may be only haphazardly used for research (especially that of commercial interest)—an end that would not fairly reflect the original altruistic motivation of donors, and the trust they must invest. We therefore argue that custodians of such databases take on a weighty pro‐active duty, to encourage public debate about the ends of such collections and to sponsor research that reflects publicly agreed priorities and provides public benefits.     

Rethinking patient involvement in healthcare priority setting

With healthcare systems under pressure from scarcity of resources and ever-increasing demand for services, difficult priority setting choices need to be made. At the same time, increased attention to patient involvement in a wide range of settings has given rise to the idea that those who are eventually affected by priority setting decisions should have a say in those decisions. In this paper, we investigate arguments for the inclusion of patient representatives in priority setting bodies at the policy level. We find that the standard justifications for patient representation, such as to achieve patient-relevant decisions, empowerment of patients, securing legitimacy of decisions, and the analogy with democracy, all fall short of supporting patient representation in this context. We conclude by briefly outlining an alternative proposal for patient participation that involves patient consultants.