ADEQUATE TRUST AVAILS,MISTAKEN TRUST MATTERS: ON THE MORAL RESPONSIBILITY OF DOCTORS AS PROXIES FOR PATIENTS' TRUST IN BIOBANK RESEARCH

In Sweden, most patients are recruited into biobank research by non‐researcher doctors. Patients' trust in doctors may therefore be important to their willingness to participate. We suggest a model of trust that makes sense of such transitions of trust between domains and distinguishes adequate trust from mistaken trust. The unique position of doctors implies, we argue, a Kantian imperfect duty to compensate for patients' mistaken trust. There are at least three kinds of mistaken trust, each of which requires a different set of countermeasures. First, trust is mistaken when necessary competence is lacking; the competence must be developed or the illusion dispelled. Second, trust is irrational whenever the patient is mistaken about his actual reasons for trusting. Care must therefore be taken to support the patient's reasoning and moral agency. Third, some patients inappropriately trust doctors to recommend only research that will benefit them directly. Such trust should be counteracted by nurturing a culture where patients expect to be asked occasionally to contribute to the common good.     

生物样本库及其伦理问题简介

随着分子和基因组信息对流行病学影响的增加,无数遗传流行病学研究和后人类基因组计划的研究都越来越依赖人类生物样本库的使用。生物样本库的范围也已横跨学术或者医院环境下的小数量收集到大规模的全国性储藏。尽管生物样本库的概念并不新,但是在基因组研究和后人类基因组计划的背景下,伴随它们十几年极大发展的是无数待解决的伦理挑战。从生物样本库的概念着手,介绍了其与一般遗传数据库的区别以及建立生物样本库的意义;然后介绍并比较国际上已有的生物样本库,以及其伦理问题和伦理法律框架的发展趋势。     

Making it transparent. On naming,framing and administrating biobank research on native people

Despite more than 50 years of genetic research on Sámi people in Sweden, there has been very little engagement with the ethical issues related to this research. My aim is to investigate the ethical challenges in biobank research on Sámi people, to identify ethical challenges that have been overlooked and to find ethical solutions. In my historical research inquiry of published material and interviews with people that have participated in this research, my research questions have been: How are blood samples from Sámi people collected, codified, governed and analyzed? What ethical strategies have been utilized? My main findings are: Sweden acquired biobank collections from Sámi people that are not registered or cannot be traced through the biobank register at the Swedish National Board of Health and Welfare. These collections entail ethical challenges concerning how the donors are identified, how the material is categorized, the regional ethical committees, governance and Sámi representation. My suggestions focus on transparency and traceability, competence and native peoples' rights and representation in biobank-related activities.     

The ethics of biobanking: Assessing the right to control problem for broad consent

The biobank consent debate is one with deeply held convictions on both the ‘broad’ and ‘specific’ side with little sign of resolution. Recently, Thomas Ploug and Soren Holm have developed an alternative to both specific and broad consent: a meta‐consent framework. The aim here is to consider whether meta‐consent provides a ‘solution’ to the biobank consent debate. We clarify what ‘meta‐consent’ actually is (arguing that the label is a misnomer and ‘consent à la carte’ is more accurate). We identify problems with Ploug and Holm's arguments, and some challenges for meta‐consent. We focus on whether there is any ethical obligation to provide consent à la carte. There may seem to be so, especially if we draw upon an unclear appeal to the ethical significance of ‘respect for autonomy’. Similarly, there might seem to be an intuitive inference from the fact that ethically legitimate research requires informed consent to the conclusion that it thereby requires consent à la carte. It is shown that this line of inference is mistaken.     

生物银行支撑全球生物多样性研究与保护的实践与探索

要更好地保护全球生物多样性, 人类不仅需要正确认知生物多样性的本质与规律, 还需要审时度势地发展生物多样性保护的载体, 以此提升生物多样性保护的社会价值和经济效益。本文旨在探讨生物银行对生物多样性研究与保护工作的促进作用, 解决生物银行资源库功能同质化严重、维护困难与急需向更高层次演化等三个主要问题。本文系统回顾了国内外生物银行的缘起与现状, 通过归纳与演绎的方法介绍了国内外人类基因组银行、动植物种质银行、生态银行与生物多样性银行的基本特征、运营模式与实践经验。本文的主要观点有: (1)不受时空限制的外向型数据驱动模式是人类基因组银行的主要特征, 本质是技术外包式的共性技术平台, 它的最主要的盈利方式是通过收集、存储人体生物样本, 并将其整理成为医学研究机构、制药企业、政府医疗部门需要的医学数据; (2)受特定时空限制的内向型需求驱动模式是动植物种质银行的主要特征, 它更聚焦代表性动植物及微生物的信息样本普查与测序, 并提倡在中试平台上进行早期小规模的实践活动; (3)自然资本与金融资本结合的发展模式是生态银行的最大特色, 它作为分散零碎的生态资源和产业投资商与运营商之间的中介平台, 把环境资源未破坏但缺乏驱动机制的区域进行人才、技术与资本的快速重组; (4)绑定实体金融机构与科研院所是生物多样性银行的最大特征, 它以第三方专业的授信与评级机构的形象出现, 其本质是通过环境破坏与环境治理、投入成本与产出收益两个维度的博弈获得两个高附加值的固定收益及增值收益。文章还提出了生物银行成为全球生物多样性研究与保护的重要载体的建议: (1)在建设层面要加强顶层设计, (2)在研究层面要理清知识产权权属, (3)在应用层面防止科技伦理的沦丧, (4)在管理层面要建立通用标准, (5)在产业层面要综合衍生品的设计。     

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.     

TRUSTED CONSENT AND RESEARCH BIOBANKS: TOWARDS A ‘NEW ALLIANCE’ BETWEEN RESEARCHERS AND DONORS

We argue that, in the case of research biobanks, there is a need to replace the currently used informed consent with trusted consent. Accordingly, we introduce a proposal for the structure of the latter. Further, we discuss some of the issues that can be addressed effectively through our proposal. In particular, we illustrate: i) which research should be authorized by donors; ii) how to regulate access to information; iii) the fundamental role played by a Third Party Authority in assuring compliance with the reciprocal expectations and obligations of donors and scientists. Finally, we briefly analyse two issues that might represent important elements of a ‘new alliance’ between researchers and donors to which the trusted consent could pave the way: i) the correlations between needs and rights of the two parties, and ii) possible economic transactions.     

A platform for efficient establishment and drug-response profiling of high-grade serous ovarian cancer organoids

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转化医学与生物样本库现状

转化医学(translational medicine)是近10年来国际生物医学领域出现的新概念和重点研究方向,其为一种倡导实验室与临床研究双向转化的模式,而这种模式的核心意义之一便体现在协作与资源共享方面。这便促使生物样本库成为了转化医学的战略资源。本文在分析发达国家促进转化医学发展政策的同时分析了生物样本库建设的现状、趋势和问题,旨在为我国制定转化医学发展战略,建设生物样本库,促进转化医学发展提供参考。