总体国家安全观下合成生物学风险和应对策略研究*

合成生物学是近年来兴起的一门兼材料学、医学和信息学等学科特性的交叉学科,在促进医学进步和科技转化应用的同时,也在总体国家安全内涵中被赋予了特殊的重要地位。如何在新时期应对错综复杂的安全形势和严峻挑战,是世界各国和国际社会所面临的科技治理和生物安全的重要命题。重点介绍合成生物技术相关生物武器威胁、生物恐怖威胁、生物安全国际公约条例、生物安全伦理治理框架,总结近年来合成生物技术领域生物安全风险相关问题,提出合成生物学安全风险应对策略和国家总体安全观下科技发展建议。     

Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed ‘too great an emphasis on guidelines and research ethics review’, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities.     

Focus: Vaccines: Achieving Global Vaccine Equity: The Case for an International Pandemic Treaty

This paper presents an ethical argument in support of an international Pandemic Treaty. It argues that an international Pandemic Treaty is the best way to mark progress on global vaccine equity and broader issues of global pandemic preparedness and response which came to light during the coronavirus disease 2019 (COVID-19) pandemic. Section I evaluates principles of multilateral charity, national security, and international diplomacy standardly invoked in debates about global vaccine allocation and argues that these approaches fall short. Section II explicates notions of solidarity, duties to the least well-off, and mutual aid as ethical values more fitting for an era of emerging infectious diseases. Section III relates the discussion to an international Pandemic Treaty and presents legal, pragmatic, and ethical reasons to support it. The paper concludes that in an interconnected world, fair sharing of vaccines between nations is morally mandatory.     

中国生态安全屏障体系建设现状、主要问题及对策建议

中国生态安全屏障体系建设是生态文明建设的重要组成部分，在维护国家安全方面具有重大战略意义。研究从生态安全屏障功能特点、建设、监测与评估及规划和实施等方面阐述了我国生态安全屏障体系建设现状；分析了在生态安全屏障建设中，自然生态系统的破坏、社会-生态系统脆弱性、生物多样性保护受到威胁、科技体系支撑不足、公众参与意识薄弱和保护与发展的矛盾等方面面临的主要问题和挑战；进而提出了基于生态安全格局的整体布局方略，指出了开展社会-生态脆弱性调查和评估的重要性，强调了国家公园在生态安全屏障体系建设的引领示范作用。最终，希望通过围绕生态文明建设，引导社会公众深度参与，构建“生态-生产-生活”统筹协调机制，以求积极探索生态安全屏障体系建设高质量、高速和可持续发展道路，迈向新时代生态安全屏障建设新征程。     

Ethics,the Law,and Prisoners: Protecting Society,Changing Human Behavior,and Protecting Human Rights

Restricting a person’s liberty presents society with many inherent ethical challenges. The historical purposes of confinement have included punishment, penitence, containment, rehabilitation, and habilitation. While the purposes are indeed complex, multifaceted, and at times ambiguous or contradictory, the fact of incarceration intrinsically creates many ethical challenges for psychiatrists working in correctional settings. Role definition of a psychiatrist may be ambiguous, with potential tensions between forensic and therapeutic demands. Privacy may be limited or absent and confidentiality may be compromised. Patient autonomy may be threatened to address real or perceived security concerns. Care delivery may actually have harmful consequences in court cases for pretrial detainees or lethal consequences for those under a death sentence. An absence of data and targeted research hampers the development of evidence-based care delivery for the disenfranchised, understudied, and disproportionately ill prisoner population. In this review paper, I discuss a few of the challenges and dilemmas routinely faced and present a series of questions. Where feasible, proposed resolutions are offered.     

Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis

Background

Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.

Methods and Findings

To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs'' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.

Conclusions

Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines. Please see later in the article for the Editors'' Summary     

TACKLING SOCIALLY DETERMINED DENTAL INEQUALITIES: ETHICAL ASPECTS OF CHILDSMILE, THE NATIONAL CHILD ORAL HEALTH DEMONSTRATION PROGRAMME IN SCOTLAND

Many ethical issues are posed by public health interventions. Although abstract theorizing about these issues can be useful, it is the application of ethical theory to real cases which will ultimately be of benefit in decision-making. To this end, this paper will analyse the ethical issues involved in Childsmile, a national oral health demonstration programme in Scotland that aims to improve the oral health of the nation's children and reduce dental inequalities through a combination of targeted and universal interventions. With Scotland's level of dental caries among the worst in Europe, Childsmile represents one of the largest programmes of work aimed at combating oral health inequalities in the UK. The areas of ethical interest include several contrasting themes: reducing health inequalities and improving health; universal and targeted interventions; political values and evidence base; prevention and treatment; and underlying all of these, justice and utility.     

‘VAGUE OVIEDO’: AUTONOMY,CULTURE AND THE CASE OF PREVIOUSLY COMPETENT PATIENTS

The paper examines the ethical and legal challenges of making decisions for previously competent patients and the role of advance directives and legal representatives in light of the Oviedo Convention. The paper identifies gaps in the Convention that result in conflicting instructions in cases of a disagreement between the expressed prior wishes of a patient, and the legal representative. The authors also examine the legal and moral status of informally expressed prior wishes of patients unable to consent. The authors argue that positivist legal reasoning is insufficient for a consistent interpretation of the relevant provisions of the Convention and argue that ethical argumentation is needed to provide guidance in such cases. Based on the ethical arguments, the authors propose a way of reconciling the apparent inconsistencies in the Oviedo Convention. They advance a culturally sensitive approach to the application of the Convention at the national level. This approach understands autonomy as a broader, relational consent and emphasizes the social and cultural embeddedness of the individual. Based on their approach, the authors argue that there exists a moral obligation to respect the prior wishes of the patient even in countries without advance directives. Yet it should be left to the national legislations to determine the extent of this obligation and its concrete forms.     

Ethical reasoning in pandemic preparedness plans: Southeast Asia and the Western Pacific

The emergence of H1N1 in 2009 shows that it is a mistake to regard the scenario of having to implement pandemic plans as merely hypothetical. This recent experience provides an opportunity to inquire into the current state of pandemic preparedness plans with regard to their ethical adequacy. One aspect that deserves consideration in this context is the disclosure of ethical reasoning. Accordingly, the following is an analysis of examples of pandemic plans and drafts of plans from Southeast Asia and the Western Pacific. It is an analysis of the occurrence of explicit ethical reflection in these documents as well an inquiry into the related question of how ethical reflection can be understood as a constitutive element of ethical pandemic preparedness. In the analysis, different fields of ethical consideration concerning equity, personal rights and accountability are distinguished. There are both pragmatic and genuinely ethical reasons to explicitly address issues of these types in pandemic plans. The extent to which ethical language appears in the national plans in South East Asia and the Western Pacific suggests that there is limited awareness of ethical considerations, or at least insufficient ethical substantiation of pandemic action. The aim of the analysis is to show that further inclusion of ethical considerations into pandemic plans is ethically demanded. It is of particular significance that these considerations are formulated and remain discernible as instances of ethical deliberation.     

Setting priorities,can Britain learn from Sweden?

The Swedish government recently published a report on priorities in health care. It was written by a cross party group of politicians and drew extensively on the views of the public, health professionals, experience of earlier local exercises in priority setting, and research based evidence. It laid down an ethical framework for approaching issues of health care rationing. Underpinning the framework are the principles of human dignity, need and solidarity, and cost efficiency. The Swedish approach thus contrasts with the British experience of many local initiatives but an absence of national political guidance. The absence of political consensus on many aspects of social policy in the United Kingdom is a major obstacle to developing an agreed ethical framework within which decision makers in the National Health Service can work.     

Ethical issues relating to supply of human tissue to the commercial biomedical sector

Demand for an ethical supply of human tissue for research in the commercial biomedical sector is increasing substantially. This article sets out to review ethical issues specifically relating to acquisition of tissue from patients in a publicly funded national health service (NHS), for research use in a commercial setting. Some of the background to recent high profile Inquiries in England is discussed and is used to illustrate legal and ethical differences between living and dead people. Issues relating to patient consent are investigated and the case is made for a clear distinction between tissue acquisition and tissue processing. Future possibilities for regulation are discussed. This revised version was published online in July 2006 with corrections to the Cover Date.     

Assessment of the ethical review process in Sudan

The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the country; these committees have no institutional regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies' requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define 'ethics committee'.     

Biosecurity in the age of Big Data: a conversation with the FBI

New scientific frontiers and emerging technologies within the life sciences pose many global challenges to society. Big Data is a premier example, especially with respect to individual, national, and international security. Here a Special Agent of the Federal Bureau of Investigation discusses the security implications of Big Data and the need for security in the life sciences.     

The politics of genealogical incorporation: ethnic difference,genetic relatedness and national belonging*

This paper explores the relationship between genomic accounts of ethnic origins and distinctiveness and genealogical models of ethnic and national similarity and difference. It does so by focusing on genetic investigations of Irish Traveller origins in the context of ongoing campaigns for state recognition of Irish Travellers as an ethnic group, and in relation to the politics of national belonging. The ostensibly ethical practice of liberal genomics is entangled with the fraught politics of the Irish state’s commitments to addressing ethnic minority rights, insistence on differentiating between Travellers and other ethnic groups on the basis of genealogical difference, and the genealogical incorporation of Travellers within the national community of shared descent. Though ideas of ancestral relatedness across social or cultural boundaries are often figured as politically progressive, locating groups within a national family tree on the basis of genealogical relatedness can simultaneously deny ethnic difference and naturalize exclusive models of nationhood.     

Environmental Security as a Case Study in Industrial Ecology

Environmental security is the integration of environmental and national security considerations at a national policy level. It is a relatively new and still somewhat contentious concept, although in some countries, such as the United States, it is increasingly being embedded in traditional security and foreign policy institutions. It is of interest to the industrial ecologist for several reasons. First, from the methodological perspective, environmental security issues are frequently complex, multidisciplinary, and multiscalar in both temporal and geographic dimensions. They are thus good opportunities to apply existing industrial ecology tools such as industrial metabolism stock and flow studies, as well as to support the development of new industrial ecology methods. Second, environmental security offers an important case study of an important fundamental industrial ecology dynamic: the movement of environment from overhead to strategic for society. This process occurs at many different scales, from implementation of design for environment methodologies within firms to integration of environmental and trade considerations in the World Trade Organization; and it is important for the industrial ecologist to begin to understand its underlying dynamics. Finally, national security is the quintessential raison d'etre of the national state. Accordingly, the integration of environmental considerations into national security policies and institutions, using industrial ecology methodologies and patterns of analysis, is a significant validation of the field.     

The social and ethical issues of post-genomic human biobanks

Biobanking - the organized collection of biological samples and associated data - ranges in scope from small collections of samples in academic or hospital settings to large-scale national repositories. Biobanks raise many ethical concerns, to which authorities are responding by introducing specific regulations. Genomics research, which thrives on the sharing of samples and information, is affected by two prominent ethical questions: do ethical principles prevent or promote the sharing of stored biological resources? How does the advent of large-scale biobanking alter the way in which ethical issues are addressed?     

Module one: introduction to research ethics

This module will introduce you to the ethical concepts underlying applied ethical decision-making in the area of research involving human participants. We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an understanding of historical and legal context makes arguably little sense. It is for this reason that this module will begin with a brief history of research ethics and ends with a brief overview of the relevant national and international guidelines pertaining to ethical issues in research involving human participants.     

闽江流域生态安全格局及其生态保护修复措施

流域及其生态环境问题受到国内外的广泛关注,我国面临的流域生态环境问题突出亟待解决,体现流域生态系统完整性的山水林田湖草生命共同体理念对我国流域生态保护修复工作具有重要意义。以福建省山水林田湖草生态保护修复试点的工程区——闽江流域为例,在介绍其生态环境特征的基础上,通过梳理分析,根据区域生态功能的重要性构建“一江一带一区一屏”的闽江流域总体生态安全格局,面临的主要生态环境问题包括闽江水环境污染、流域岸带水土流失、矿区生态破坏、森林屏障和生物多样性退化等一系列威胁;分析提出了闽江水环境综合治理、干支流沿岸带水土流失防治、矿区废弃土地修复、武夷山地等重要生态屏障森林和生物多样性保护等主要任务及相应工程措施,体现了流域整体性、系统性的保护修复需求和内在逻辑;讨论了监测、评价等保障措施,为改善闽江流域生态系统和开展山水林田湖草生态保护修复工程提供科学依据和实践经验。     

Informed consent,and an ethico- legal framework for paediatric observational research and biobanking: the experience of an Italian birth cohort study

Birth cohort studies are important tools for life-course epidemiology, given the spectrum of the environmental, behavioural, and genetic factors that should be considered when making judgements on human health. Biobanks are valuable components of studies designed to investigate the genetic variability of diseases and improve phenotypic characterisation. In studies involving vulnerable populations and biobanks, it is essential to provide ethical reasoning and analyse the legal requirements. We describe the processes and the tools used in the iterative design of an appropriate informed consent model and the ethico-legal framework of the Piccolipiù study. The Piccolipiù study is a prospective population-based study funded by the Italian Ministry of Health that intends to enrol 3,000 newborns and their mothers in five Italian cities, and to store biological samples for future use. To realise these objectives, we performed a thorough evaluation of the literature, of national and international guidelines, and of the impact of the Italian legal requirements for research biobanking. Discussions among stakeholders facilitated the design of the informed consent and the ethico-legal framework. Several topics are addressed, including the suitability of a broad informed consent for paediatric biobanks, infant vulnerability, access to and sharing of data, and the disclosure of individual’s genetic results. Discussion of the ethical and legal procedures adopted in epidemiological biobanking might be a fruitful ground for comparison both at the national level, where standardization and homogeneity are lacking, and at the international level, where different regulatory issues are often in the background and might hamper research biobanks networking.