Human genetic research databases and biobanks: towards uniform terminology and Australian best practice

This article examines international best practice for the establishment, maintenance and use of human genetic research databases (HGRDs), particularly focusing on large-scale population biobanks, and considers the measures that should be taken in Australia to comply with this best practice. These HGRDs play a pivotal role in basic research aimed at understanding the basis of human disease at the genetic level, and applied research aimed at putting that basic knowledge into practical application. In particular, the large-scale biobanks are vital research tools in the drive to uncover the causes and consequences of human health and disease. Biobanks are being established at regional, national and international levels throughout the world. Although their governance structures are uniformly complex, some best practices are emerging with regard to consent (particularly consent to future research and withdrawal of consent), privacy and data protection and intellectual property ownership and access. Best practices with regard to benefit-sharing are emerging much more slowly. This article reviews these international best practices with the aim of providing guidance for the development of appropriate regulatory structures in Australia.     

Population bio-banks: a juridical analysis based on Icelandic and Estonian experience]

Large-scale collections of human biological samples and associated data are becoming increasingly common as a means of identifying, in a particular population, genetic predispositions to complex diseases that result from an interaction of environmental, lifestyle and genetic factors. This paper compares the recent experiences of Iceland and Estonia in the establishment of population biobanks as well as the specific law passed by both countries to deal with this matter. In the light of this comparative analysis, this paper summarizes the main ethical and policy dilemmas posed by large-scale biobanks and suggests some possible solutions to these new challenges.     

A comparative analysis of selected European guidelines and recommendations for biobanks with special regard to the research / non-research distinction.

Classifying an activity as research has considerable normative consequences: On the one side research activities are especially protected ("freedom of research"), on the other side stricter ethical rules legal regulations may apply to such activities, e.g. compulsory review by ethics committees. It is therefore important to find criteria to delimit research from non-research activities. The aim of the present study is to analyse some European guidelines and recommendations for biobanks and to see whether these documents provide comments that help to elucidate the research/non-research distinction.     

地方政府之间合作的制度化协调——区域政府的法治化路径

为了解决跨地区性公共物品供给不足和跨地区性公共事务治理失灵等问题,需要建立地方政府制度化协调模式,即成立区域政府。与地方政府相比,区域政府在其属性、设立、功能、权力来源、经费来源、组织机构等方面具有特殊性,在解决跨区域问题方面有其优越性。建立适合我国国情的区域政府,要在借鉴其他国家先进的区域治理模式基础上,从区域立法机制、区域执法机制和区域司法机制的角度构建区域政府的基本框架。     

Tackling legal challenges posed by population biobanks: reconceptualising consent requirements

This paper examines, from an Australian and international perspective, the phenomenon of population 'biobanks' (research platforms comprising collections of human genetic samples or 'biospecimens' and relevant personal information) and the legal challenges that this development presents. In particular, the paper focuses on the legal concept of consent and the tensions on the traditional understanding of consent that large-scale, long-term population biobanks exert. The aim of the paper is to review the operation of consent principles as they apply to population biobanks and to propose a way forward for how the consent concept can be reconceptualised to meet their demands. In particular, the paper argues for a more liberal approach which allows for 'broad' (or 'enlarged' or 'open') consent in circumstances where permission is sought for future use of samples in, as yet unspecified, genetic research. In pursuing this aim, the objectives underlying this paper are to ensure that unnecessary impediments to research are removed and, at the same time, to facilitate research participation and respect for autonomous choices by research subjects.     

The emergence of biobanks in the legal landscape: towards a new model of governance

Biobanks are increasingly seen as new tools for medical research. Their main purpose is to collect, store, and distribute human body materials. These activities are regulated by legal instruments which are heterogeneous in source (national and international), and in form (binding and non-binding). We analyse these to underline the need for a new model of governance for modern biobanks. The protection initially ensured by respect for fundamental rights will need to focus on more interactions with society in order to ensure biobanks' sustainability. International regulation is more oriented on ethical principles and traces the limits of the uses of genetics, while European regulation is more concerned with the protection of fundamental rights and the elaboration of standards for biobanks' quality assurance. But is this protection adequate and sufficient? Do we need to move from the biomedical research analogy to new forms of legal protection, and governance systems which involve citizens?     

《反垄断法》中的基础设施条款探析

基础设施条款为竞争执法机构提供了一种强迫企业允许竞争对手利用其设施的手段,能够防止公用企业滥用市场支配地位行为的发生,促进市场竞争的发展。基础设施条款是对契约自由的限制,为企业设定不得拒绝其他企业以适当的条件进入自己的网络或其他基础设施的义务,科学界定其适用条件,这是正确适用反垄断法的重要条件。我国已颁布《反垄断法》,科学地引入这一制度可以推动企业的改革以及竞争秩序的建立。     

刑事附带民事诉讼制度的思考与重新构建

我国刑事附带民事诉讼制度的设计遵循的是＂公权优于私权＂、＂效率优于公正＂的指导思想,因而造成了附带民事诉讼缺乏应有的独立性,在司法实践中成为刑事诉讼附庸的后果,偏离了设立这一制度的目的。本文指出了附带民事诉讼制度在受案范围、请求赔偿范围、诉讼证明标准、审理期限、裁判结果公正、保障执行机制等方面存在的问题和局限,进而通过确立＂在公权有限优先的前提下,最大限度保护私权＂、＂在首先保证公正的前提下兼顾效率＂的理念,以完善附带民事诉讼相关制度。     

Consent forms in genomics: the difference between law and practice

Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant information and consent documentation in the future studies.     

An opportunity for research and bioethics]

This article looks at the draft bill of the law on Biomedical Research. It analyses its novelties, such as: the creation of a Spanish Bioethics Committee, the new regulation on nuclear transfer, biobanks and finally the setting of the groundwork for the fostering of the professional degree of researcher in the National Health System. This draft bill is a great opportunity for the scientific community.     

论我国行政诉讼调解的正当性构建

传统行政法理论中,"公权力不可处分"等观点否定行政诉讼适用调解。受此影响,我国法律规定行政诉讼不适用调解。但行政审判实践中,以"协调"、"和解"等形式变通适用调解的做法一直存在。这一矛盾根源在于将"公权力不可处分"、"当事人法律地位不平等"等学说的绝对化。行政裁量权的广泛存在和契约行政的渐成趋势,使行政诉讼中调解制度的建立具有了充分的正当性。但同时,行政裁量权的有限性和契约行政的局限性,又决定了行政诉讼中的调解应当是一种有限的调解。     

论中国在建立国际经济新秩序中的战略定位——兼评“新自由主义经济秩序”论、“WTO宪政秩序”论、“经济民族主义扰乱全球化秩序”论

1980年代以来,国际社会中力图阻挠或扭曲建立国际经济新秩序(NIEO)历史潮流的各种学说层出不穷,诸如"新自由主义经济秩序"论、"WTO宪政秩序"论、"经济民族主义扰乱全球化秩序"论等等。这类学说虽然激发了一些新的有益思考,却确实造成了一系列新的思想混乱。建立NIEO乃是1950年代以来全球弱势群体数十亿人口争取国际经济平权地位的共同奋斗目标,当代中国人应当全面、完整、准确地加深理解邓小平的"韬光养晦、有所作为"方针,将中国在建立NIEO历史进程中的战略坐标和基本角色,定位为旗帜鲜明、言行一致的积极推动者。中国理应进一步发扬传统的具有独特内涵的中华民族爱国主义,通过BRICSM类型的"南南联合"群体,成为建立NIEO的积极推手和中流砥柱之一。总之,中国人务必保持清醒,谨防落入上述各种"时髦"理论的陷阱。     

论营业行政许可的法律属性与合理边界

从民事主体营业自由权的应然性和正当性来分析,营业行政许可行为应视为行政机关基于无害性审查对营业申请者获得营业资格和营业能力的行政解禁行为。基于此,法律和制度关于营业行政许可事项的设定,就应主要去考虑营业是否关涉到公共安全、公共秩序、公共利益和环境生态,营业行政许可事项也应严格锁定在公共利益的无害性审查范围内,舍此,就无须设定营业行政许可。     

政府诚信论纲

现代政府是服务型政府,担负着为社会提供秩序、安全与自由的重任。社会成员对于政府的依赖正逐步增强。在此背景下,政府是否遵循诚实信用原则从事管理活动,能否为社会成员提供稳定的生活预期,便成为行政法学需要认真研究的课题。文章对政府诚信的含义、引入公法的理由、建立的基础、意义及具体作用领域等问题进行了勾勒,对现代政府所遵循的诚信原则做出了初步分析。     

'Alternative' music obtained from free download music websites does not entitle SGAE to claim royalties

Proof that the music played in a public establishment is obtainedfrom free download music websites, considered together withother factors such as the fact that the establishment is a non-profitmaking cultural entity and that the music played is exotic andunknown— which the Court describes as ‘alternative’music—is sufficient to avoid the infringement of the publiccommunication copyright, even if it has not been proved thatall the songs played have been downloaded from the websitesin question.     

公务员创新行为:文献述评与研究展望

创新行为俨然成为公务员适应新时代高素质干部队伍建设要求的典型行为模式,以及公共部门适应职能转变和服务再造要求的内生动力。本研究基于对已有研究的系统梳理与深入分析,构建了一个系统的公务员创新行为研究框架。本研究从公私部门成员创新行为差异及争议切入,围绕公务员创新行为的概念内涵、多层次影响因素及复杂作用机制进行系统回顾并展开评述,呈现新制度主义理论、自我决定理论等在公务员创新行为塑造中的深层逻辑。在此基础上,本研究展望未来方向:(1)以回应跨国文化背景、科层制组织特征、现实工作场景实现公务员创新的情境化研究;(2)在新时代中国场景中实现公务员创新行为的量表开发、跨层次系统性形成机理探索;(3)拓展公务员创新行为的效能机制研究,实现微观层面行为创新与中观层面组织创新、宏观层面政策创新的呼应衔接。     

检察机关提起民事公益诉讼研究

建立由检察机关提起民事公益诉讼的制度现时已为大势所趋,而且在理论上进行深入分析,其实并无障碍,并已经具备了相应的实现条件和法理基础。当然,检察机关提起民事公益诉讼也需要确立相应的原则和准入条件,以确保该项制度效应的正常发挥。     

试论卫生应急“机制”建设中不容忽视的几个问题

卫生应急工作要迈上科学发展轨道,应多关注从"机制"建设上找寻亟待解决的问题。本文拟从突发公共卫生事件特点及应急机制建设重要性入手,探究卫生应急机制建设过程中尚存的"拦路虎",找寻卫生应急机制建设应对之策,即:关口前移,建立应急预案动态更新机制;瞄准实战,建立突发疫情应对处置机制;筑牢"后墙",建立突发事件储备保障机制;紧盯"重心",建立医院危机攻关应急机制。     

论限售股司法拍卖的法律效果——以“公开承诺承继”为视角

资本市场不少股东在取得限售股份的同时作出公开承诺,如期限锁定承诺、业绩保障承诺、不占用资金承诺等。在限售股被质押融资的情况下,一旦债务逾期可能会被法院强制执行,强制执行后新取得股东是否需要承继这些公开承诺所附的权利负担,现行法律与监管规则不一致,各证券交易所的监管规则也有差异,导致实践中呈现"混乱"局面。从公开承诺的性质以及现行法律关于法院强制执行的权利负担承继原则来看,强制执行后公开承诺义务不应被新股东承继,但可能会造成法院强制执行成为原股东逃废债务的渠道,进而损害上市公司及其他投资者的合法权益,不利于建立健康的证券市场秩序环境。参考"买卖不破租赁"等案例,将公开承诺义务物权化,赋予其追溯效力,可能是解决这一问题的有效方案。