Access Rules Research Articles

Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development.

BackgroundClinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations.ObjectiveThe objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations.MethodsThis study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations.ResultsIn this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects.ConclusionsThe CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws.

Can banks be owned?

Abstract A now well-established literature in economics assesses the effect of different forms of bank ownership on various measures of banks’ performance. Such literature has its theoretical roots in a surprisingly narrow framework, broadly identified with property rights theory. However, such theory – or bundle of theories – has been increasingly criticized for its inability to account for the emergence, the existence and the functioning of business firms. Indeed, many works and authors counter mainstream property rights theory, arguing instead that firms are entities that cannot be possessed – and that equity ownership should not be equaled with firm ownership. Nowhere is perhaps this critique more salient than in the field of banking. As the 2007/08 crisis reminded many observers, banks are not just firms or corporations: they are institutions, endowed with a dual social purpose (the creation of money and the setting of rules for access to credit). If the ownership of firms is difficult to conceive, the ownership of institutions such as banks is obviously harder still to envision. However, over the past twenty to thirty years, regulatory reform in finance has led to the empowerment of ownership, and especially private ownership, in the field of banking. This is apparent, for instance, with the 2007/44 European Directive, which fully liberalized equity ownership (and control) of banks. Yet, even within the actual legal and regulatory framework, there are many limitations to property rights as applied to banks. This paper thus has two aims: firstly, to develop a theoretical explanation of the heuristic and empirical limitations of “bank ownership”; and, secondly, to analyze, on the basis of an empirical case study of Italian banking law, the nature and extent of the property rights associated with ownership in banks.

A balancing act: The revised rules of access to the ICRC Archives reflect multiple stakes and challenges

AbstractThe International Committee of the Red Cross (ICRC) revised the access rules to its archives in 2017 for reasons that are complex, fascinating and deeply contemporary to our times. As these rules define when and to what extent the ICRC Archives are made available to the public, their contents are important for the institution as well as for wider audiences. The ICRC must ensure that it can implement its humanitarian mandate to protect and assist victims of armed conflicts and other situations of violence and preserve confidentiality, while sharing its past with the world at large. This article offers a historical overview of the ICRC Archives and the development of their access regulations until their latest revision in 2017. It shows that both today and in the past, the rules of access to the archives have resulted from choices made by the ICRC on how to balance its mandate and long-standing interests with contemporary opportunities and risks related to independent scrutiny.

Governing Grazing and Mobility in the Samburu Lowlands, Kenya

Pastoral mobility is seen as the most effective strategy to make use of constantly shifting resources. However, mobile pastoralism as a highly-valued strategy to manage grazing areas and exploit resource variability is becoming more complex, due to recurrent droughts, loss of forage, government-led settlement schemes, and enclosure of land for community conservation, among other reasons. Yet knowledge of how Samburu pastoralists perceive these changes, and govern and innovate in their mobility patterns and resource use, has received limited attention. This paper seeks to understand how Samburu pastoralists in the drylands of northern Kenya use and govern natural resources, how livestock grazing and mobility is planned for, and how boundaries and territory are constructed and performed both within and beyond the context of (non)governmental projects. Fieldwork for this paper was conducted in Sesia, Samburu East, and consisted of interviews, focus group discussions, and participatory observation. Findings show that livestock mobility involves longer periods and more complex distances due to a shrinking resource base and new rules of access. Although access was previously generated based on the value of reciprocity, the creation of new forms of resource management results in conditional processes of inclusion and exclusion. Policy and project implementation has historically been driven by the imperative to secure land tenure and improve pasture in bounded areas. Opportunities to support institutions that promote mobility have been given insufficient attention.

Prospects for research in haemophilia with real-world data-An analysis of German registry and secondary data.

Open questions in haemophilia, such as effectiveness of innovative therapies, clinical and patient-reported outcomes (PROs), epidemiology and cost, await answers. The aim was to identify data attributes required and investigate the availability, appropriateness and accessibility of real-world data (RWD) from German registries and secondary databases to answer the aforementioned questions. Systematic searches were conducted in BIOSIS, EMBASE and MEDLINE to identify non-commercial secondary healthcare databases and registries of patients with haemophilia (PWH). Inclusion of German patients, type of patients, data elements-stratified by use in epidemiology, safety, outcomes and health economics research-and accessibility were investigated by desk research. Screening of 676 hits, identification of four registries [national PWH (DHR), national/international paediatric (GEPARD, PEDNET), international safety monitoring (EUHASS)] and seven national secondary databases. Access was limited to participants in three registries and to employees in one secondary database. One registry asks for PROs. Limitations of secondary databases originate from the ICD-coding system (missing: severity of haemophilia, presence of inhibitory antibodies), data protection laws and need to monitor reliability. Rigorous observational analysis of German haemophilia RWD shows that there is potential to supplement current knowledge and begin to address selected policy goals. To improve the value of existing RWD, the following efforts are proposed: ethical, legal and methodological discussions on data linkage across different sources, formulation of transparent governance rules for data access, redefinition of the ICD-coding, standardized collection of outcome data and implementation of incentives for treatment centres to improve data collection.

OECI TuBaFrost tumor biobanking.

OECI TuBaFrost harbors a complete infrastructure for the exchange of frozen tumor samples between European countries. OECI TuBaFrost consists of: * A code of conduct on how to exchange human residual samples in Europe, * A central database application accessible over the Internet (www.tubafrost.org) where data can be uploaded and searched from samples that can be selected and ordered, * Access rules with incentives for collectors, * Standardization needed to enable the analysis of high quality samples derived from different centers, * Virtual Microscopy to support sample selection with difficult pathology. The entire infrastructure was, after completion, which was entirely financed by the European Commission, implemented in the OECI. But so far it has not been used to its capacity. A recent survey held amongst the OECI members shed light on the causes. The main conclusion is that all responders see OECI TuBaFrost as a good platform for exchange of samples, however, the biggest bottleneck found was that potential users are too unfamiliar with the communication between their own biobank tracking system and the TuBaFrost central database application. Therefore, new future plans are drawn. In addition, new infrastructure plans have been developed and the first preparatory steps have been set. For biobanks the BBMRI project has started aiming for Pan-European Biobanking and Biomolecular Resources Research Infrastructure.

Access patterns mining from massive spatio-temporal data in a smart city

Facing with massive spatio-temporal data, the traditional pattern mining methods fail to directly reflect the spatio-temporal correlation and transition rules of user access in a smart city. In this paper, we analyze the characteristics of spatio-temporal data, and map the history of user access requests to the spatio-temporal attribute domain. Then, we perform correlation analysis and identify variation rules for access requests by using regional meshing, association rules and ARIMA in the spatio-temporal attribute domain, for the purpose of mining user access patterns and predict the user’s access request. Experimental results show that our pattern mining algorithms is simple yet effective, and it achieves a prediction accuracy of 84.3% for access requests.

An integrated analysis of capacity allocation and patient scheduling in presence of seasonal walk-ins

This study analyzes two decision levels in appointment system design in the context of clinics that face seasonal demand for scheduled and walk-in patients. The macro-level problem addresses access rules dealing with capacity allocation decisions in terms of how many slots to reserve for walk-ins and scheduled patients given fixed daily capacity for the clinic session. The micro-level problem addresses scheduling rules determining the specific time slots for scheduled arrivals. A fully-integrated simulation model is developed where daily demand actualized at the macro level becomes an input to the micro model that simulates the in-clinic dynamics, such as the arrivals of walk-ins and scheduled patients, as well as stochastic service times. The proposed integrated approach is shown to improve decision-making by considering patient lead times (i.e., indirect wait), direct wait times, and clinic overtime as relevant measures of performance. The traditional methods for evaluating appointment system performance are extended to incorporate multiple trade-offs. This allows combining both direct wait and indirect wait that are generally addressed separately due to time scale differences (minutes vs. days). The results confirm the benefits of addressing both decision levels in appointment system design simultaneously. We investigate how environmental factors affect the performance and the choice of appointment systems. The most critical environmental factors emerge as the demand load, seasonality level, and percentage of walk-ins, listed in the decreasing order of importance.

The Development of Archives in the Slovak Republic

Summarizing analysis of development of the archive system in Slovakia is carried out. The author outlines basic steps of formation of Slovakia archive business. He considers formation of archival institutions and the activities of the State Inspectorate of Archives and Libraries in Slovakia during the interwar period. The active organizational function of the archival services did not stop during the Second World War, and the authorities of the Slovak state were especially patronizing the church archives. The post-war communist Czechoslovakia government paid a great deal of attention to the archival affair. The legislative base of its functioning is found out. Bibliographic systematization of archival documents is started and the basic laws (1975, 2002) about the regulation of archival affair are accepted in the second half of the 20th century. This article examines the main archive institutions of the Slovak Republic on the modern stage. The author schematically described the function of the Slovak National Archives, the Archives of the Institute of National Memory, the State Archives in Prešov. The basic rules of access to the archive materials in Slovakia archives repository for researcher are reflected. The author touched on the modern Slovak projects of the digitization of archival documents and their application in the Internet. He also clearly identified the main problems in the development of the Slovak archival affair at the present stage, including reducing the staff of archivists, insufficient funding, and a sharp increase in the volume of documents arriving in the archives.   Borovets, I. (2018). The Development of Archives in the Slovak Republic. Mìžnarodnì zv’âzki Ukraïni: naukovì pošuki ì znahìdki – The International relations of Ukraine: scientific searches and findings, 27, 349-362 [in Ukrainian].

Legal instruments of approximation for national legal systems in the context of civil procedure law

The article offers an overview of the legal instruments existing in the world for approximation of civil procedure law, and also defines the basic concepts in this area (approximation, harmonization, unification). The author analyzes in detail the advantages and disadvantages of each instrument of convergence, and also presents examples of their use (tools) that are available today. The spectrum of legal instruments for the approximation of law makes it possible to trace in the historical perspective the development of the convergence process (from the reception of Roman law to the Principles of the Transnational Civil Procedure in 2004). Such diversity allows us to see how flexible this process can be, depending on the goals of rapprochement proclaimed by states, international organizations, and research teams. Flexibility is also given to the process by its object — the law in its social understanding, as well as by taking into account the economic, social and cultural components of the participating states of the convergence process. The focus on civil procedure law is related to the principle of forum shopping in the international civil process on the one hand and the inadmissibility of large-scale competition of legal (judicial) systems within the framework of integration associations, on the other. A study of modern integration processes shows that such phenomena as the growth of the domestic market and the proclamation of freedom of movement of services and capital, one way or another, lead to a convergence of civil procedure law of the respective states. Restriction of domestic trade is unacceptable due to the very different legal norms and rules of access to justice. Comparable provisions of the procedural legislation of individual member states of the integration association on the protection of rights and legitimate interests in civil proceedings are no less important than the comparable substantive law. The existing experience of European integration, in which the removal of barriers in the judicial protection of the rights of citizens and organizations, ensuring the real accessibility of justice for all members of the integration association, have become the basic and initial elements of building a integrated legal space, is a clear confirmation of this. Analysis of the advantages and disadvantages of various legal instruments for rapprochement, as well as the inclusion of civil procedure law in the list of areas of rapprochement, should be included in the current agenda of Eurasian integration. It should be emphasized that today in domestic procedural science there is almost no discussion on the issue of an adequate model for approximating the legal systems of the EAEU member states, on the advantages and disadvantages of the legal instruments for approximation proposed in the constituent documents. This state of affairs only increases the importance of scientific research in this area, built on the basis of a comparative legal approach, as well as a broad scientific and practical discussion of emerging problems.

A Commentary on the 'OECD Review of Health Systems. Mexico 2016'

OECD reports have become influential in Mexico. The “2016 OECD Review of Health Systems, Mexico” is analyzed in this note from an industrial perspective. Health reform has been debated in Mexico for decades. However, the map of suppliers and insurers, as well as of costs and rules of access is the same than in past decades. Law and regulation determine the hard vertical integration of public agencies, from financing to provision of services. In consequence, Mexican health insurance and service markets are segmented. Buyers cannot identify and access low cost sources of services and families are tied to a specific public insurer. A result is the extensive use of private services to overcome waiting times offered by public providers. So far, public policy has tried to face the problem through centralized mechanism, an approach supported by the OECD. Probably, a decentralized approach that allows the revelation of costs and value of needs will be needed to overcome the costs of fragmentation of the system.

Behavioural and organisational interventions to prevent trespass and graffiti vandalism on railway property

Trespassing behaviour is a problem for railway operations because it leads to train–pedestrian collisions and important delays. Trespassing incidents result from the violation of the rail track access rules by pedestrians. In many cases, this behaviour is driven by vandalism intentions. Various measures have been developed and implemented to reduce trespass and vandalism on railway premises, but to date there is no publication to show which of these measures are more effective. This paper aims to review the good practices and recommendations on the prevention of railway trespass and vandalism and to provide a summary of the most promising preventive measures that involve human factors namely collaborative measures, enforcement, staff training, public education and environmental measures, which are likely to influence people’s behaviour. Physical measures (e.g. fencing) and purely technical ones (e.g. detection systems) are not within the scope of this paper, since there is consistent literature indicating the effectiveness of these interventions. The method included a systematic review of the literature on the topic, as well as a collection of prevention practices from the railway operating community. Both the procedures were conducted during the EU-funded projects RESTRAIL (REduction of Suicides and Trespasses on the RAILway property) and GRAFFOLUTION (Awareness and prevention solutions against graffiti vandalism in public areas and transport). Although the results reveal promising preventive measures, very few studies show evidence for their effectiveness. We discuss how measures can be combined to increase their efficiency for trespass and vandalism prevention in the background of a behavioural theoretical framework applied to the rail context.

Fast Science and Sluggish Policy: The Herculean Task of Regulating Biodiscovery

New rules for access and benefit sharing (ABS) of genetic resources and associated traditional knowledge have been established by the Nagoya Protocol but have not kept up with rapid scientific and technological advances in biodiscovery. This suggests the need for innovative, transdisciplinary approaches to regulate ABS and emerging technologies.

Four Cases in Sports Competition Policy: Baseball, Judo, Football, and Motor Racing

Practices and conducts in professional and even amateur sports can be subject to competition laws as soon as commercial activities are involved. From an economic perspective, this implies that both directly commercial activities like the sale of broadcasting/media rights and indirectly commercial activities like defining and enforcing the rules of the games can be hit by competition policy interventions. Setting and enforcing the rules of the game is an activity with commercial effects because it influences attractiveness and marketability of the sports in question. After discussing fundamental issues, this contributions reviews selected landmark cases in sports competition policy from an economic perspective. This includes the U.S. baseball antitrust exemption, access rules to Judo tournaments, sale systems of media rights in European football as well as a unique combination of long-run exclusivity contracts, skewed allocation of common revenues, and special influences on rule-setting by some competitors in Formula One motor racing. Eventually, the areas of state aid to football clubs and mergers in Danish football are sketched.

A formal approach to derive an aspect oriented programming-based implementation of a secure access control filter

Context: Nowadays, Information Systems (IS) are at the heart of most companies and constitute then a critical element that needs an adequate attention regarding security issues of sensitive data it manages.Objective: This paper presents a formal approach for the development of a filter to secure access to sensitive resources of information systems.Method: The proposed approach consists of three complementary steps. Designers start by modeling the functionalities of the system and its security requirements using dedicated UML diagrams. These diagrams are then automatically translated into a formal B specification suitable not only for reasoning about data integrity checking but also for the derivation of a trustworthy implementation. Indeed, a formal refinement process is applied on the generated B specification to obtain a relational-like B implementation which is then translated into an AspectJ implementation, connected to a SQL Server (release 2014) relational database system. Such a generation is performed following the aspect oriented programming paradigm which permits a separation of concerns by making a clear distinction between functional and security aspects.Results: A systematic formal approach to derive a secure filter that regulates access to the sensitive data of an information system. The filter considers both static and dynamic access rules. A tool that supports the proposed approach is also provided.Conclusion: The approach has been applied on several case studies that demonstrate that the development of a tool permits to free the developers from tedious and error-prone tasks since they have just to push a button to generate the AspectJ code of an application.

Pro-poor Land Transfers and the Importance of Land Abundance and Ethnicity in The Gambia

Summary We ask whether there is empirical evidence that supports the existence of norm-based access rules that give poor households access to important production resources. A substantial literature has investigated informal insurance schemes, which trigger supporting exchanges after negative shocks have occurred. This paper is instead concerned with material exchanges that take place before shocks occur, which has received far less attention in the economic literature. We employ a dataset of 51 rural villages in The Gambia, and we focus on access to the most important production resource in our context—land. We find that poor households are more likely to receive seasonal land usage rights. We also show that these exchanges are more likely to occur in villages where land is abundant and where ethnic fractionalization is low. We argue that this is consistent with the existing qualitative evidence, which argues that informal exchange is thought to be disappearing due to population increases and ethnic fractionalization. Our findings highlight the importance of attention to the local (i.e., village-level) context for assessing welfare and conducting effective policy.

Legal Access to the Global Cloud

Increased use of the cloud and its international scope raise significant challenges to traditional legal authorities that permit access to data stored outside the United States. The resulting stakes are high. This area of law affects a wide range of important matters concerning law enforcement, national security, and civil litigation. Up until now, however, policymakers in this area have failed to fully appreciate the technological distinctions between different types of data clouds. This Article develops and distinguishes between three models of cloud computing to provide greater clarity for courts when evaluating international data access requests. These models are the Data Shard, Data Localization, and Data Trust clouds. This new typology reveals how the same legal authority will lead to notably different results in data access cases depending on the technical architecture of the cloud network. To illustrate, this Article assesses the likely results for each type of cloud under the full range of American legal authorities that permit parties to seek digital information held abroad — namely, the Fourth Amendment, the Stored Communications Act, Mutual Legal Assistance Treaties, administrative or grand jury subpoenas, and the Foreign Intelligence Surveillance Act. This Article’s analysis of cloud models also points to the profound instability of current American data access rules. The writing is on the wall. Companies and individuals outside of the United States now have multiple ways, including changing their cloud management models, to shelter data beyond the exclusive reach of U.S. law, which will increase the importance of non-U.S. access rules. This trend will spell the end of unilateral decisionmaking by U.S. courts concerning the legal process to be applied when the government or civil litigants seek data stored extraterritorially. In response, this Article advances two principles for a world of omnipresent global cloud computing. First, U.S. law should treat extraterritorial data requests equally, regardless of the location of the cloud provider’s headquarters. This legal approach would foster a level playing field for global cloud companies and encourage innovation, rather than further balkanization of the internet. Second, there is a need for international cooperation to create reciprocity. The “Pax Americana” of unilateral U.S. governance in this area is ending, and the wisest course for U.S. policy is to establish new international agreements for global data access. As this Article details, the CLOUD Act of 2018 takes a major step toward incorporation of these principles in an effort to preserve the internet as a global space. But the Act also encourages a know-your-customer regime, where the ultimate cost may be paid in users’ privacy.

Las bases de datos descriptivas: Un diseño de Modelo conceptual orientado a objetos

El presente artículo teórico es resultado de una investigación que conjuga la Ingeniería de Sistemas y la Bibliotecología; muestra una aproximación interdisciplinaria ante la problemática que presentan las bases de datos descriptivas de la biblioteca digital, problema generado por el cambio en los principios organizativos de la información y las demandas que el ambiente digital impone a las bibliotecas. El análisis conduce a un replanteamiento sobre la construcción de bases de datos descriptivas, migrando del Modelo entidad-relación (E-R) para adoptar el Modelo orientado a objetos (MOO) el cual en la actualidad es usado para la construcción y desarrollo programático de la web semántica. Por lo anterior, este artículo teórico propone un Modelo conceptual orientado a objetos bajo una metodología propia, la cual desarrolla el proceso para generar el modelo propuesto en dos etapas. La primera es de aproximación al problema, mientras que la segunda corresponde a la identificación de los elementos que incluye componentes de las normas Recursos, Descripción y Acceso (RDA) y observa los principios teóricos que establecen las FRBR (Requerimientos Funcionales para Registros Bibliográficos). Ya en su conjunto se analizan todos los datos para generar la propuesta de diseño de tres modelos conceptuales orientado a objetos para bases de datos descriptivas: 1) el Modelo de obra, 2) el Modelo de dominio y 3) el Modelo de instancia, para conformar una base de datos descriptiva más adecuada y propia de la biblioteca en esta era digital.

European boundaries in question?

This introduction provides a descriptive typology and normative analysis of the ways boundaries are being questioned in Europe. We distinguish between boundary-making (defining or redefining the territorial borders of a polity), boundary-crossing (determining the rules of access to territorial borders) and boundary-unbundling (allowing boundary-making and boundary-crossing to vary between policies and polities), noting each of these categories possesses internal and external dimensions. Cosmopolitans and statists offer contrasting normative evaluations of these processes, favouring weakening and maintaining or strengthening state boundaries respectively. We endorse a demoicratic approach lying between these two as better reflecting how individuals relate to each other and to the EU, a view shared by some but not all contributors to this volume. We conclude by situating the contributions within our topological framework, highlighting how they illustrate the contemporary questioning of European boundaries.

Transmitter authentication using hierarchical modulation in dynamic spectrum sharing

One of the critical challenges in dynamic spectrum sharing (DSS) is identifying non-conforming transmitters that violate spectrum access rules prescribed by a spectrum regulatory authority. One approach for facilitating identification of the transmitters in DSS is to require every transmitter to embed an uniquely-identifiable authentication signal in its waveform at the PHY-layer. In most of the existing PHY-layer authentication schemes, the authentication signal is added to the message signal as noise, which leads to a tradeoff between the message signal's signal-to-noise ratio (SNR) and the authentication signal's SNR under the assumption of constant average transmitted power. This implies that one cannot improve the former without sacrificing the latter, and vice versa. In this paper, we propose a novel PHY-layer authentication scheme called Hierarchical Modulation with Modified Duobinary Signaling for Authentication (HMM-DSA), which relaxes the constraint on the aforementioned tradeoff. HMM-DSA utilizes a modified duobinary filter to introduce some controlled amount of inter-symbol interference into the message signal, and embeds the authentication signal in the form of filter coefficients. Our results show that the proposed scheme, HMM-DSA, improves the error performance of the message signal as compared to the prior art.