Problems with precaution: the transfusion medicine experience

The precautionary principle is a dominant paradigm governing risk-based decision-making. Today, there are increasing pressures to re-examine aggressive precautionary approaches, and to assess how the principle should be applied in the modern system. In this paper, we examined three key applications of precautionary approaches in the field of transfusion medicine to provide insight into the risks and benefits of these approaches. The three case studies examined were the donor deferral policies to safeguard against transfusion transmission of human immunodeficiency virus, variant Creutzfeldt–Jacob disease, and, lastly, xenotropic murine leukemia virus-related virus. Characterization of precautionary applications was conducted using an embedded case study design. Our findings indicate that transfusion transmission mitigation strategies have become increasingly aggressive in the face of theoretical risks. In contrast, the review processes for implementation and reversal of precautionary policies have been slow, and historical donor deferral policies are still in place today. Application of precautionary approaches has proved challenging with both benefits and pitfalls. In light of emerging threats to the blood system, policy-makers should consider the implementation of frameworks to guide the appropriate application of precaution in transfusion medicine in the future.     

Two paths of risk regulation: the concurrence of scientific and sociocultural decision-making in the European law of agricultural genetic engineering

Future hazards which may result from genetically engineered plants can currently only be anticipated. Therefore, the handling of the potential risks is becoming a crucial political and legal question. The following article describes the differing national regulatory approaches in Europe: an economic, a scientific, and a sociopolitical approach pre-existed the European Union’s deliberate release Directive, which itself follows a primarily science-based approach. The latter is based on objective technological assessments of individual cases. At the same time, however, the Directive contains elements of a sociocultural approach, which is open to value-based judgments and thus, necessarily takes a subjective, general assessment of the use of genetically modified organisms. As a result, the European law of Agricultural Genetic Engineering provides two paths of risk regulation in parallel.     

Challenges for current quantitative risk assessment (QRA) models to describe explicitly the road tunnel safety level

The number of road tunnels in Europe has increased rapidly over the last years. Nevertheless, this increasing number is raising upfront an endogenous problem, which is the severity of accidents that may occur. After the spate of tunnel fires in Europe over the past decade, the European Commission embarked upon a major review of road tunnel safety and launched the Directive 2004/54/EC that sets minimum safety requirements and suggests, apart from the measures imposed based on tunnel characteristics, the implementation of a risk assessment in several cases. As a result, many risk assessment methods have been proposed worldwide, most of them based on quantitative risk assessment (QRA) models. Although QRAs are helpful to address physical aspects and facilities of the infrastructures, current approaches in the road tunnel field have several challenges to meet in order to provide decision-makers with the overall risk picture. Taking into account that QRAs are progressively becoming the selected method to manage tunnel safety and risk, this paper’s purpose is twofold. On the one hand, it aims to inform safety managers and engineers about items which are not adequately handled by current road tunnel QRA models. On the other hand, it aims to suggest potential areas in which improvements should be made. Taking into consideration the challenges and the limitations discussed herein, this paper concludes that QRA models should not be the single criterion for the safety assessment process of these critical infrastructures.     

Standards for risk assessment of standards: how the international community is starting to address the risk of the wrong standards

Technical standards pervade commerce and society and allow the complexity of modern life to operate at all levels, global included. They also provide protection against many risks, whether from food, from dangerous products or from fraud. They are so self-evidently worthy that they are rarely challenged, yet anything as powerful and pervasive as the web of standards needs some element of oversight and quality assurance. There is a danger of over-regulating and the placing of unnecessary constraints on the market and, cumulatively, a constraint on liberties. Technical standards are derived from many sources and for many reasons. The oversight function may need to relate to these reasons, such as the World Trade Organisation controls on damage to trade through protectionist standards. A very common reason for standards is safety, which tends to be treated as an absolute, as an objective technical matter, and there is less oversight or quality assurance of standards set for safety reasons. But safety is a relative term and increases in safety will usually have costs. Judgement needs to be applied in a risk assessment but that raises institutional issues as to who is qualified to apply that judgement. There are also issues of the accountability of those who increase the safety ratchet, which are also related to the institutional issue. This paper explores a case study of one draft standard as an illustration of the need for oversight and then goes on to consider methods of managing the risks inherent in standardisation and technical regulation. It looks in particular at two recent initiatives from within the standards community itself. One is a broad-based proposal for the community to focus on risk management and the other is an instance where a technical regulator has commissioned and designed an impact assessment system in order to provide that quality assurance and accountability.     

Procedure for the Implementation of the Precautionary Principle in Biosafety Commissions

In order to fulfil their responsibilities under the precautionary principle, biosafety commissions should lay down guidelines concerning the understanding and application of this principle and work towards an operational procedure. With this contribution, we propose a step‐wise procedure that aims to establish the understanding of the precautionary principle within biosafety commissions and to provide a methodological approach for the application of this principle to specific cases in the course of risk assessment. This approach is based on systematically investigating the consensus view within a group of 15 biosafety experts with the help of sets of checklists. For step 1, we propose a checklist of 13 criteria aimed at defining the understanding of the precautionary principle. For step 2, we propose 4 criteria for the decision on whether or not to use the precautionary principle. For step 3, 11 criteria for the use of the precautionary principle are presented. In step 4, additional criteria for specific applications could be included. In step 5, possible recommendations to decision‐making authorities are proposed.     

Application of early risk detection concepts and methods to environmental health. A German feasibility study

Early risk detection is essential for being able to address the most important environmental health risk‐topics in a persistent and prospective manner. In support of the action programme “Environment and Health” (APUG) of the German Federal Ministry of Health and Social Security (BMGS) and the Federal Ministry for the Environment, Nature Conservation, and Nuclear Safety (BMU) which recommended that a detection and evaluation system for the timely recognition of emerging risk problems be developed, a qualitative feasibility study was commissioned. The results of this study are presented here and support the development of an early risk detection system based on the insights gained from the investigation of case studies and the differentiation and presentation of a risk typology, methods, tools, and suggested organizational processes.

The study has shown that early risk detection includes the identification, characterization, evaluation and dissemination of information on possible risks as well as the circumstances of appearance and distribution. The goal is the recognition of possible risks in order for risk management to be able to introduce swift and appropriate measures. Consequently, it can also serve as an instrument towards further development of a balanced and structured implementation of the precautionary principle in the environmental health policy.     

From risk to the government of uncertainty: the case of mobile telephony

Confronted with complex and wicked issues, public authorities turn to science and expertise to provide answers that will help reduce the level of uncertainty that characterizes these issues. Yet, the paper argues that more often than not, it is the application of a risk framework to a given issue that fosters uncertainty, not the other way round. Hence, the more authorities and experts attempt to apply a risk approach to an issue, the more they encourage the production of uncertainty. Taking mobile telephony as a case in point, the paper then goes on to show that to reduce uncertainties, authorities in some countries have recently experimented with new forms of knowledge in the process of expertise; paradoxically, this may raise in a first moment the general level of uncertainty, but it may also provide in the longer term more robust knowledge. The larger aim of the paper is to expand conceptions of uncertainty commonly used in risk governance.     

How to deal with dissent among experts. Risk evaluation of EMF in a scientific dialogue

This article describes the results of a scientific discourse which aimed at exploring the reasons for differences in expert health risk assessment of radio frequency electromagnetic fields of mobile telephony.

It starts with describing the structure of the discourse. Then, the reasons for the conflicting risk assessments are discussed. Differences are due to the selection and evaluation of relevant scientific studies by applying different scientific quality standards, to the methods used for generating a research synthesis and an overall risk evaluation. Consensus could be achieved regarding the selection of and the quality requirements for the scientific studies used for risk assessment as well as their significance for risk evaluation. However, dissent remained about the synthesis of scientific evidence into an overall risk evaluation and about the relevance of the precautionary principle for risk evaluation and its implications for the risk assessment framework.

Based on the analysis of these problems, a transparent, consistent and rational procedure for risk assessment is suggested to facilitate a risk characterization which better meets the demands of policy making and the public for an appropriate risk evaluation.     

模糊聚类分析在金融机构洗钱风险评估中的应用

聚类分析是数理统计中的一种分析方法,是用数学方法定量地确定样本的亲疏关系,从而客观地进行分类。本文主要以模糊聚类分析在金融机构洗钱风险评估中的应用进行实例研究,对聚类的结果进行了分析,并提出了建议措施。     

Risk assessment of option performance for new product and process development projects in the chemical industry: a case study

This paper presents as a case study, empirical research forming part of a large EPSRC‐funded project to decrease new product and process development times within the UK fine chemicals industry. The work aimed to design a decision support system to evaluate competing options in such development projects. Theoretical and practical contributions from academic and industrial collaborating groups were integrated using Action Research. High levels of risk when bringing new products to market or new processes on line means that risk assessment features significantly when evaluating different project options. A key research target, and the concern of this paper, is the design and use of a risk assessment tool (RAT) to fit the context of the overall decision support system. Collectively the tools enabled the options within individual projects to be evaluated on risk and other performance dimensions. Industrialists provided a number of comprehensive case studies to test the suite of tools. Theoretical and empirical implications are discussed.     

Responsiveness of Auditors to the Audit Risk Standards: Unique Evidence from Big 4 Audit Firms

We examine the effect of changes in audit risk standards on the conduct of financial statement audits in a European setting. We investigate this by analysing the audit hours and audit fees for clients of Big 4 audit firms in Finland in 1996 and 2010. Our results show that audit firms became more sensitive to clients’ business risk due to the introduction of the new audit risk standards, with more audit hours allocated to owner-managed companies in 2010 than in 1996, and fewer audit hours allocated to low-risk clients in 2010 than in 1996. Also, the labour mix in the audit team changed for owner-managed companies, with a greater work load carried by junior auditors in 2010 than in 1996. Regarding the price of audit, we find an increase in audit fees for clients with high business risk, while audit fees remained at roughly the same level for low-risk clients. These findings should be of interest to the auditing profession and those involved in the development of auditing regulations.     

论促进高等学校毕业生就业的法律制度构建原则

法律制度是一种长效的人权保障机制,能够为高校毕业生实现宪法赋予的劳动权提供坚实的法律依据。构建促进高等学校毕业生就业的法律制度的首要问题是确定其基本原则。构建促进高等学校毕业生就业的法律制度,应当以保护高等学校毕业生的就业权、反对就业歧视、就业信息公开和自主择业为基本原则和精神。     

宏观审慎监管框架对银行业的影响与启示

加强宏观审慎监管已成为后危机时代国际金融监管改革的主旋律。本文在介绍宏观审慎监管内容的基础上,深入分析了该监管对中国银行业带来的影响:资本质量要求提高,发展表外业务受限;动态拨备制度建立,挑战传统盈利模式;流动性要求提高,调整结构势在必行。据此提出应积极调整业务结构,构建资本节约型发展模式;实现综合化经营,推动业务转型;实施跨国经营,加快国际化进程。中国银行业还要特别关注监管与中国国情相适应,引进的工具方法与转变风险管理理念相统一,监管与宏观经济调控相结合。     

Estimating the marginal contribution of adjustable-rate mortgage selection to termination probabilities in a nested model

In this study we measure the marginal contribution of ARMs to termination probabilities. To do this we develop a modified nested-logit model of mortgage selection and termination and identify the role of risk aversity in the selection process. Simulations of termination probabilities under different economic scenarios indicate how ARMs decrease overall portfolio risk through declines in prepayment probabilities which more than offset the increases in default probabilities associated with them.     

Assessing the contribution of banks,insurance and other financial services to systemic risk

The aim of this paper is to contribute to the debate on systemic risk by assessing the extent to which distress within the main different financial sectors, namely, the banking, insurance and other financial services industries contribute to systemic risk. To this end, we rely on the $\mathrm{\Delta }\mathit{CoVaR}$ systemic risk measure introduced by Adrian and Brunnermeier (2011). In order to provide a formal ranking of the financial sectors with respect to their contribution to systemic risk, the original $\mathrm{\Delta }\mathit{CoVaR}$ approach is extended here to include the Kolmogorov–Smirnov test developed by Abadie (2002), based on bootstrapping. Our empirical results reveal that in the Eurozone, for the period ranging from 2004 to 2012, the other financial services sector contributes relatively the most to systemic risk at times of distress affecting this sector. In turn, the banking sector appears to contribute more to systemic risk than the insurance sector. By contrast, the insurance industry is the systemically riskiest financial sector in the United States for the same period, while the banking sector contributes the least to systemic risk in this area. Beyond this ranking, the three financial sectors of interest are found to contribute significantly to systemic risk, both in the Eurozone and in the United States.     

论商业保险基础风险原理对建立基本医疗保障制度的适用价值

2009年新医改重大举措不断,它对于我国相对薄弱的医疗保障体系无疑是必需和及时的。本文从理论上初步论述了商业保险基础风险原理对完善建立我国全民基本医疗保障制度的适用价值。通过总结国际医疗保障制度改革及其研究的趋势,论证以医疗保险的基础风险为依据,是实现社会医疗保险预期绩效的基本保证。同时指出定性定量分析我国全民医保的基础风险,才能从根本上找到完善建立相关制度的措施和方法,促进我国医疗保障体系的进一步科学发展。     

论商法公法化的体现和影响

私法公法化是私法自近代向现代转变过程中出现的一种趋势。商法在本质上具有私法属性,但是商法公法化赋与了商法公法色彩。大量公法性规范注入商法,可是商法的私法性质并未因私法公法化而改变。     

基于金融消费者权益保护视角的宏、微观审慎监管模式比较

次贷危机的发生再次引发人们对微观审慎监管模式的反思,由于缺乏统一的监管者,忽略金融控股集团在衍生品市场上共同风险暴露、对顺周期性效应无能为力等原因,使得单纯的微观审慎监管在降低单个金融机构的个体风险的同时提高了系统性风险,难以保证金融体系的稳定。后危机时代加强宏观审慎监管成为改革的主要方向,文章从金融消费者保护视角反思微观审慎监管模式的缺陷,提出必须完善我国宏、微观审慎监管,切实加强对金融消费者权益保护的建议。     

The contribution of (shadow) banks and real estate to systemic risk in China

We empirically evaluate how accounting and financial variables affect the level of systemic risk in traditional and shadow banks, and in real estate finance services in China over the period 2006–2019. We also conduct some stability analysis by evaluating the impact of crisis sub-periods. We find that systemic risk increases in the Size of large financial institutions, particularly shadow entities, while it is insensitive to the Size of real estate finance services. Real estate finance services are instead particularly sensitive to Maturity Mismatch and Leverage. Finally, systemic risk differs across state and non state owned banks.     

Measures of risk associated to regulations compliance: a laboratory experiment on the use of common-pool resources

The present research examined the influence of different risk perspectives by the use of four different target persons (who could be affected: abstract person, self, specific person, and specific others) and of four different questionnaire answer formats (rating, open percentage, open, and closed frequency) on risk assessments. It was assumed that subjects use two different systems in terms of probabilistic reasoning: a distributional approach for abstract targets leading to higher risk estimates and a singular approach for specific targets leading to lower risk assessments. According to unrealistic optimism (UO) research (showing higher risk assessments for an abstract person than for self), the assumption was that risk assessments for a specific (named) target lead to lower risk assessments compared to an abstract target. Further, common quantitative answer formats for assessing risk were compared to explore differences in risk estimates. The hypotheses were tested using data of a sample of 512 students from a Bavarian university. The frequently confirmed finding of UO could be replicated with both rating scale and open frequency scale, which appeared to be more sensitive compared to the other used scales. However, UO disappeared when the comparison target was specific. Further, risk assessments for an abstract target were highest within every answer format and lowest for specific targets. Furthermore, results revealed that the type of answer format has a moderating effect on the extent of the influence of risk perspective on risk assessments. Overall, this study gives evidence that both the chosen scale and the risk perspective strongly influence risk assessments. Results aim to contribute to the research fields of quantitative assessment of perceived risk. They suggest that probabilistic reasoning in regard to risk not only underlies motivational or cognitive ego-defensive mechanisms but is rather presumably caused by the use of different systems of inferential strategies.