Federally regulated institutional review boards: The aspects of a "model" IRB---Is the current system in need of a tune up or complete overhaul?

Institutional Review Boards (IRBs) are the primary gatekeepers for the protection of ethical standards of federally regulated research on human subjects in this country. This paper focuses on what general, broad measures that may be instituted or enhanced to exemplify a "model IRB". This is done by examining the current regulatory standards of federally regulated IRBs, not private or commercial boards, and how many of those standards have been found either inadequate or not generally understood or followed. The analysis includes suggestions on how to bring about changes in order to make the IRB process more efficient, less subject to litigation, and create standardized educational protocols for members. The paper also considers how to include better oversight for multi-center research, increased centralization of IRBs, utilization of Data Safety Monitoring Boards when necessary, payment for research protocol review, voluntary accreditation, and the institution of evaluation/quality assurance programs. ^ This is a policy study utilizing secondary analysis of publicly available data. Therefore, the research for this paper focuses on scholarly medical/legal journals, web information from the Department of Health and Human Services, Federal Drug Administration, and the Office of the Inspector General, Accreditation Programs, law review articles, and current regulations applicable to the relevant portions of the paper. ^ Two issues are found to be consistently cited by the literature as major concerns. One is a need for basic, standardized educational requirements across all IRBs and its members, and secondly, much stricter and more informed management of continuing research. There is no federally regulated formal education system currently in place for IRB members, except for certain NIH-based trials. Also, IRBs are not keeping up with research once a study has begun, and although regulated to do so, it does not appear to be a great priority. This is the area most in danger of increased litigation. Other issues such as voluntary accreditation and outcomes evaluation are slowing gaining steam as the processes are becoming more available and more sought after, such as JCAHO accrediting of hospitals. ^ Adopting the principles discussed in this paper should promote better use of a local IRBs time, money, and expertise for protecting the vulnerable population in their care. Without further improvements to the system, there is concern that private and commercial IRBs will attempt to create a monopoly on much of the clinical research in the future as they are not as heavily regulated and can therefore offer companies quicker and more convenient reviews. IRBs need to consider the advantages of charging for their unique and important services as a cost of doing business. More importantly, there must be a minimum standard of education for all IRB members in the area of the ethical standards of human research and a greater emphasis placed on the follow-up of ongoing research as this is the most critical time for study participants and may soon lead to the largest area for litigation. Additionally, there should be a centralized IRB for multi-site trials or a study website with important information affecting the trial in real time. There needs to be development of standards and metrics to assess the performance of the IRBs for quality assurance and outcome evaluations. The boards should not be content to run the business of human subjects' research without determining how well that function is actually being carried out. It is important that federally regulated IRBs provide excellence in human research and promote those values most important to the public at large.^

Errors in the administration of medication in inpatient hospitals: A systematic review of the research literature on commercial computerized physician order entry systems

Errors in the administration of medication represent a significant loss of medical resources and pose life altering or life threatening risks to patients. This paper considered the question, what impact do Computerized Physician Order Entry (CPOE) systems have on medication errors in the hospital inpatient environment? Previous reviews have examined evidence of the impact of CPOE on medication errors, but have come to ambiguous conclusions as to the impact of CPOE and decision support systems (DSS). Forty-three papers were identified. Thirty-one demonstrated a significant reduction in prescribing error rates for all or some drug types; decreases in minor errors were most often reported. Several studies reported increases in the rate of duplicate orders and failures to remove contraindicated drugs, often attributed to inappropriate design or to an inability to operate the system properly. The evidence on the effectiveness of CPOE to reduce errors in medication administration is compelling though it is limited by modest study sample sizes and designs. ^

Elevated CO2 alters larval proteome and its phosphorylation status in the commercial oyster, Crassostrea hongkongensis

Ocean acidification (OA) is beginning to have noticeable negative impact on calcification rate, shell structure and physiological energy budgeting of several marine organisms; these alter the growth of many economically important shellfish including oysters. Early life stages of oysters may be particularly vulnerable to OA-driven low pH conditions because their shell is made up of the highly soluble form of calcium carbonate (CaCO3) mineral, aragonite. Our long-term CO2 perturbation experiment showed that larval shell growth rate of the oyster species Crassostrea hongkongensis was significantly reduced at pH < 7.9 compared to the control (8.2). To gain new insights into the underlying mechanisms of low-pH-induced delays in larval growth, we have examined the effect of pH on the protein expression pattern, including protein phosphorylation status at the pediveliger larval stage. Using two-dimensional electrophoresis and mass spectrometry, we demonstrated that the larval proteome was significantly altered by the two low pH treatments (7.9 and 7.6) compared to the control pH (8.2). Generally, the number of expressed proteins and their phosphorylation level decreased with low pH. Proteins involved in larval energy metabolism and calcification appeared to be down-regulated in response to low pH, whereas cell motility and production of cytoskeletal proteins were increased. This study on larval growth coupled with proteome change is the first step toward the search for novel Protein Expression Signatures indicative of low pH, which may help in understanding the mechanisms involved in low pH tolerance.

Soft perches in an aviary system reduce incidence of keel bone damage in laying hens.

Keel bone fractures and deviations are one of the major welfare and health issues in commercial laying hens. In non-cage housing systems like aviaries, falls and collisions with perches and other parts of the housing system are assumed to be one of the main causes for the high incidence of keel bone damage. The objectives of this study were to investigate the effectiveness of a soft perch material to reduce keel bone fractures and deviations in white (Dekalb White) and brown laying hens (ISA Brown) kept in an aviary system under commercial conditions. In half of 20 pens, all hard, metal perches were covered with a soft polyurethane material. Palpation of 20 hens per pen was conducted at 18, 21, 23, 30, 38, 44 and 64 weeks of age. Production data including egg laying rate, floor eggs, mortality and feed consumption were collected over the whole laying period. Feather condition and body mass was assessed twice per laying period. The results revealed that pens with soft perches had a reduced number of keel bone fractures and deviations. Also, an interaction between hybrid and age indicated that the ISA hybrid had more fractured keel bones and fewer non-damaged keel bones compared with the DW hybrid at 18 weeks of age, a response that was reversed at the end of the experiment. This is the first study providing evidence for the effectiveness of a soft perch material within a commercial setting. Due to its compressible material soft perches are likely to absorb kinetic energy occurring during collisions and increase the spread of pressure on the keel bone during perching, providing a mechanism to reduce keel bone fractures and deviations, respectively. In combination with genetic selection for more resilient bones and new housing design, perch material is a promising tool to reduce keel bone damage in commercial systems.

Distribution System of China's Industrial Clusters: Case Study of Yiwu China Commodity City

This paper discusses the issue of upgrading industrial clusters from the perspective of external linkages. It is taken for granted that in most developing countries, due to the limited domestic market and poor traditional commercial networks, industrial clusters are able to upgrade only when they are involved in global value chains. However, the rise of China’s industrial clusters challenges this view. Historically, China has had a lot of industrial clusters with their own traditional commercial networks. This fact combined with its huge population resulted in the formation of a unique external linage to China’s industrial clusters after the socialist planning period ended. In concrete terms, since the 1980s, a traditional commercial institution . the transaction market . began to appear in most clusters. These markets within the clusters get connected to those in the cities due to interaction between traditional merchants and local governments. This has resulted in the formation of a powerful market network-based distribution system which has played a crucial role for China’s industrial clusters in responding to exploding domestic demand. This paper explains these features in detail, using Yiwu China Commodity City as a case study.

Transformation of the Financial Sector in Indonesia

Introduction : The source and deployment of finance are central issues in economic development. Since 1966, when the Soeharto Administration was inaugurated, Indonesian economic development has relied on funds in the form of aid from international organizations and foreign countries. After the 1990s, a further abundant inflow of capital sustained a rapid economic development. Foreign funding was the basis of Indonesian economic growth. This paper will describe the mechanism for allocating funds in the Indonesian economy. It will identify the problems this mechanism generated in the Indonesian experience, and it will attempt to explain why there was a collapse of the financial system in the wake of the Asian Currency Crisis of 1997. History of the Indonesian Financial system The year 1966 saw the emergence of commercial banks in Indonesia. It can be said that before 1966 a financial system hardly existed, a fact commonly attributed to economic disruptions like the consecutive runs of fiscal deficit and hyperinflation under the Soekarno Administration. After 1996, with the inauguration of Soeharto, a regulatory system of financial legislation, e.g. central banking law and banking regulation, was introduced and implemented, and the banking sector that is the basis of the current financial system in Indonesia was built up. 　　　The Indonesian financial structure was significantly altered at the first financial reform of 1983. Between 1966 and 1982, the banking sector consisted of Bank Indonesia (the Central Bank) and the state-owned banks. There was also a system for distributing the abundant public revenue derived from the soaring oil price of the 1970s. The public finance distribution function, incorporated in Indonesian financial system, changed after the successive financial reforms of 1983 and 1988, when there was a move away from the monopoly-market style dominated by state-owned banks (which was a system of public finance distribution that operated at the discretion of the government) towards a modern market mechanism. The five phases of development The Indonesian financial system developed in five phases between 1966 and the present time. The first period (1966-72) was its formative period, the second (1973-82) its policy based finance period under soaring oil prices, the third (1983-91) its financial-reform period, the fourth (1992-97) its period of expansion, and the fifth (1998-) its period of financial restructuring. The first section of this paper summarizes the financial policies operative during each of the periods identified above. In the second section changes to the financial sector in response to policies are examined, and an analysis of these changes shows that an important development of the financial sector occurred during the financial reform period. In the third section the focus of analysis shifts from the general financial sector to particular commercial banks’ performances. In the third section changes in commercial banks’ lending and fund-raising behaviour after the 1990s are analysed by comparing several banking groups in terms of their ownership and foundation time. The last section summarizes the foregoing analyses and examines the problems that remain in the Indonesian financial sector, which is still undergoing restructuring.

Market discipline by depositors : impact of deposit insurance on the Indonesian banking sector

This paper investigates market discipline by depositors in the Indonesian banking sector. Does depositor discipline fulfill its role in Indonesia? Does deposit insurance affect depositor behavior thereby imposing discipline on banks? These questions are empirically examined using panel data on Indonesian commercial banks from 1998 to 2009. In Indonesia deposit insurance was introduced in 2005. Depositor discipline is examined by two measures: change in the amount of deposits and interest rate. The empirical results show that depositors pay attention to bank soundness and riskiness and select banks based on the bank's condition with particular attention paid to equity ratio. It is found that depositors impose discipline on banks, but it varies according to regulatory and economic circumstances.

Impact of foreign capital entry in the Indonesian banking sector

After the Asian financial crisis of 1997/98, the Indonesian banking sector experienced significant changes. Ownership structure of banking sector is substantially-changed. Currently, ownership of major commercial banks is dominated by foreign capital through acquisition. This paper examines whether foreign ownership changes a bank’s lending behavior and performance. Foreign banks tend to lend mainly to large firms; this paper examines whether the credit to small and medium-sized enterprises (SMEs) is affected by foreign capital entry into the Indonesian banking sector. Empirical results show that banks owned by foreign capital tend to decrease SME credit.

The asset/liability structure of the Philippine banks and non-bank financial institutions in 2000s : a preliminary study for financial access analyses

Based on the consolidated statements data of the universal/commercial banks (UKbank) and non-bank financial institutions with quasi-banking licenses, this paper presents a keen necessity of obtaining data in detail on both sides (assets and liabilities) of their financial conditions and further analyses. Those would bring more adequate assessments on the Philippine financial system, especially with regard to each financial subsector's financing/lending preferences and behavior. The paper also presents a possibility that the skewed locational and operational distribution exists in the non-UKbank financial subsectors. It suggests there may be a significant deviation from the authorities' (the BSP, SEC and others) intended/anticipated financial system in the banking/non-bank financial institutions' real operations.

Ultra-High Efficiency, High-Concentration PV System Based On Spectral Division Between GaInP/GaInAs/Ge And BPC Silicon Cells

A novel HCPV nonimaging concentrator concept with high concentration (>500×) is presented. It uses the combination of a commercial concentration GaInP∕GaInAs∕Ge 3J cell and a concentration Back‐Point‐Contact (BPC) concentration silicon cell for efficient spectral utilization, and external confinement techniques for recovering the 3J cell′s reflection. The primary optical element (POE) is a flat Fresnel lens and the secondary optical element (SOE) is a free‐form RXI‐type concentrator with a band‐pass filter embedded it, both POE and SOE performing Köhler integration to produce light homogenization. The band‐pass filter sends the IR photons in the 900–1200 nm band to the silicon cell. Computer simulations predict that four‐terminal terminal designs could achieve ∼46% added cell efficiencies using commercial 39% 3J and 26% Si cells. A first proof‐of concept receiver prototype has been manufactured using a simpler optical architecture (with a lower concentration, ∼ 100× and lower simulated added efficiency), and experimental measurements have shown up to 39.8% 4J receiver efficiency using a 3J with peak efficiency of 36.9%

ITER fast plant system controller prototype based on PXIe platform

The ITER CODAC design identifies slow and fast plant system controllers (PSC). The gast OSCs are based on embedded technologies, permit sampling rates greater than 1 KHz, meet stringent real-time requirements, and will be devoted to data acquisition tasks and control purposes. CIEMAT and UPM have implemented a prototype of a fast PSC based on commercial off-the-shelf (COTS) technologies with PXI hardware and software based on EPICS

Stability and Transient Performance Assessment in a COTS-Module-Based Distributed DC/DC System

This paper introduces a method to analyze and predict stability and transient performance of a distributed system where COTS (Commercial-off-the-shelf) modules share an input filter. The presented procedure is based on the measured data from the input and output terminals of the power modules. The required information for the analysis is obtained by performing frequency response measurements for each converter. This attained data is utilized to compute special transfer functions, which partly determine the source and load interactions within the converters. The system level dynamic description is constructed based on the measured and computed transfer functions introducing cross-coupling mechanisms within the system. System stability can be studied based on the well-known impedance- related minor-loop gain at an arbitrary interface within the system.

Driving assistance system applied in curves for real vehicles | Sistema de ayuda a la conducción en curvas para vehículos reales

Decreasing the accidents on highway and urban environments is the main motivation for the research and developing of driving assistance systems, also called ADAS (Advanced Driver Assistance Systems). In recent years, there are many applications of these systems in commercial vehicles: ABS systems, Cruise Control (CC), parking assistance and warning systems (including GPS), among others. However, the implementation of driving assistance systems on the steering wheel is more limited, because of their complexity and sensitivity. This paper is focused in the development, test and implementation of a driver assistance system for controlling the steering wheel in curve zones. This system is divided in two levels: an inner control loop which permits to execute the position and speed target, softening the action over the steering wheel, and a second control outer loop (controlling for fuzzy logic) that sends the reference to the inner loop according the environment and vehicle conditions. The tests have been done in different curves and speeds. The system has been proved in a commercial vehicle with satisfactory results.

Upper Limb Portable Motion Analysis System Based on Inertial Technology for Neurorehabilitation Purposes

Here an inertial sensor-based monitoring system for measuring and analyzing upper limb movements is presented. The final goal is the integration of this motion-tracking device within a portable rehabilitation system for brain injury patients. A set of four inertial sensors mounted on a special garment worn by the patient provides the quaternions representing the patient upper limb’s orientation in space. A kinematic model is built to estimate 3D upper limb motion for accurate therapeutic evaluation. The human upper limb is represented as a kinematic chain of rigid bodies with three joints and six degrees of freedom. Validation of the system has been performed by co-registration of movements with a commercial optoelectronic tracking system. Successful results are shown that exhibit a high correlation among signals provided by both devices and obtained at the Institut Guttmann Neurorehabilitation Hospital.

The ciao prolog system

Ciao is a public domain, next generation multi-paradigm programming environment with a unique set of features: Ciao offers a complete Prolog system, supporting ISO-Prolog, but its novel modular design allows both restricting and extending the language. As a result, it allows working with fully declarative subsets of Prolog and also to extend these subsets (or ISO-Prolog) both syntactically and semantically. Most importantly, these restrictions and extensions can be activated separately on each program module so that several extensions can coexist in the same application for different modules. Ciao also supports (through such extensions) programming with functions, higher-order (with predicate abstractions), constraints, and objects, as well as feature terms (records), persistence, several control rules (breadth-first search, iterative deepening, ...), concurrency (threads/engines), a good base for distributed execution (agents), and parallel execution. Libraries also support WWW programming, sockets, external interfaces (C, Java, TclTk, relational databases, etc.), etc. Ciao offers support for programming in the large with a robust module/object system, module-based separate/incremental compilation (automatically -no need for makefiles), an assertion language for declaring (optional) program properties (including types and modes, but also determinacy, non-failure, cost, etc.), automatic static inference and static/dynamic checking of such assertions, etc. Ciao also offers support for programming in the small producing small executables (including only those builtins used by the program) and support for writing scripts in Prolog. The Ciao programming environment includes a classical top-level and a rich emacs interface with an embeddable source-level debugger and a number of execution visualization tools. The Ciao compiler (which can be run outside the top level shell) generates several forms of architecture-independent and stand-alone executables, which run with speed, efficiency and executable size which are very competive with other commercial and academic Prolog/CLP systems. Library modules can be compiled into compact bytecode or C source files, and linked statically, dynamically, or autoloaded. The novel modular design of Ciao enables, in addition to modular program development, effective global program analysis and static debugging and optimization via source to source program transformation. These tasks are performed by the Ciao preprocessor ( ciaopp, distributed separately). The Ciao programming environment also includes lpdoc, an automatic documentation generator for LP/CLP programs. It processes Prolog files adorned with (Ciao) assertions and machine-readable comments and generates manuals in many formats including postscript, pdf, texinfo, info, HTML, man, etc. , as well as on-line help, ascii README files, entries for indices of manuals (info, WWW, ...), and maintains WWW distribution sites.