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The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.
807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.
High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times.
Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.
Saline lagoons are priority habitats in the United Kingdom supporting several protected specialist species. One specialist, the amphipod Gammarus insensibilis, is infected with behaviour-altering microphallid trematodes such as Microphallus papillorobustus. In saline lagoons around the coast of England (Gilkicker and Lymington–Keyhaven on the Hampshire coast and Moulton Marsh in Lincolnshire) there is variation in the prevalence of this parasite in the gammarid populations (0 at Salterns in the Lymington–Keyhaven lagoon system to 98% at Gilkicker). Infection intensity ranged from 0 to 20 metacercariae in individual amphipods. Higher infection intensity can alter the shape of the amphipod's head. Under experimental conditions respiration rate is significantly reduced in infected animals and reproductive output (expressed as early stage embryos mg g dry weight−1) is significantly lower in infected females. It is important to consider the role of host–parasite interactions in order to understand the ecology of specialist lagoon species such as G. insensibilis and their lagoon habitats.
On April 15, 2013, two improvised explosive devices (IEDs) exploded at the Boston Marathon and 264 patients were treated at 26 hospitals in the aftermath. Despite the extent of injuries sustained by victims, there was no subsequent mortality for those treated in hospitals. Leadership decisions and actions in major trauma centers were a critical factor in this response.
The objective of this investigation was to describe and characterize organizational dynamics and leadership themes immediately after the bombings by utilizing a novel structured sequential qualitative approach consisting of a focus group followed by subsequent detailed interviews and combined expert analysis.
Across physician leaders representing 7 hospitals, several leadership and management themes emerged from our analysis: communications and volunteer surges, flexibility, the challenge of technology, and command versus collaboration.
Disasters provide a distinctive context in which to study the robustness and resilience of response systems. Therefore, in the aftermath of a large-scale crisis, every effort should be invested in forming a coalition and collecting critical lessons so they can be shared and incorporated into best practices and preparations. Novel communication strategies, flexible leadership structures, and improved information systems will be necessary to reduce morbidity and mortality during future events. (Disaster Med Public Health Preparedness. 2015;9:489–495)
Nanoparticles (NPs) with either plasmonic or upconverting properties have been selectively coated onto the surfaces of polystyrene (PS) spheres, imparting their optical properties to the PS colloids. These NP coated PS spheres have many potential applications, such as in medicine as drug-delivery systems or diagnostic tools. To prepare the NP coated PS spheres, gold or core-shell NaYF4Tm0.5Yb30/NaYF4 NPs were synthesized and separately combined with amino-functionalized PS spheres. The mechanism by which the NPs adhered to the PS spheres is attributed to interactions of the NP and a polyvinylpyrrolidone additive with the surfaces of the PS spheres. Two-photon fluorescence microscopy and SERS analysis demonstrate the potential applications of these NP coated PS spheres.
The controversy surrounding the 2000 U.S. presidential election has already generated major scholarly work and will do so for years to come. Both works reviewed here were written before the historic judicial events surrounding the November election of 2000. Far from irrelevant, each work offers unique insight into the fundamental rules surrounding political conflict and the historical flow of elections with major social and economic change. As such, we learn much about political science and the struggle over the proper analytical lens for understanding politics.
As scientists become more certain that increases in concentrations of greenhouse gases will change climate, there has been growing interest in the potential economic effect of climate change. While the National Oceanic and Atmospheric Administration (NOAA) has sponsored investigations into the potential consequences of global climate change on fisheries, fisheries have received very limited attention in previous climate change damage assessments. For example, the two most commonly cited surveys of the effect of climate change on the US economy, Nordhaus (1991) and Cline (1992), provide no estimate of potential effects on the fisheries sector, although Nordhaus lists agriculture, forestry, and fisheries as economic sectors that could be severely affected by climate change.
On one level, the lack of attention to the potential effects on fisheries is understandable. First, fisheries and aquaculture are relatively small sectors of the US economy. The US fishery sector is a $3 billion contributor in a $5 trillion economy. Second, while there has been much research observing the changes in climate, there has been much less work done describing how the oceans will respond to increases in concentrations of greenhouse gases. Third, the link between ocean conditions and fisheries is complex and poorly understood. Major uncertainties and gaps in understanding make it particularly difficult to quantify the effect of global climate changes on the stocks of commercially important fish species.
A random triangle in the plane is constructed using three independent elements from a convex set of lines. Expressions are given to calculate the shape distribution from the internal width function of the line set. Two examples are given together with their maximum angle distributions; a simple inequality implies a zero collinearity constant in general. A relationship between the shape distribution and inter-line angle distribution is given.
A definition is adopted for convexity of a set of directed lines in the plane. Following this, the duals of a number of standard problems of geometric probability are formulated. Problems considered in detail are the duals of Sylvester's problem, chord length distributions and Ambartzumian's combinatorial geometry. The paper suggests some questions for further work.
Realignment of the American party system is a major focus for students of voting behavior, congressional policy making, and political history (Key, 1955; Burnham, 1970; Clubb, Flannigan, and Zingale, 1980; Kleppner, 1979; Sundquist, 1973; Campbell, 1977; Trilling and Campbell, 1980; Ladd and Hadley, 1978; Brady and Stewart, 1982; Brady, 1985; Sinclair, 1982). The transformation of the party system encompasses significant shifts in electoral support for the major political parties, changes in congressional policy making, and a redirection of national policy making. The rise of new party eras is intriguing because the constitutional structure seeks to minimize such major institutional and policy change. The separation of powers, federalism, and different recruitment patterns for political leaders are structural factors inhibiting major policy change (Brady, 1985). Realignment overcomes these barriers as highly volatile and cross-cutting issues arise. These issues produce linkages between electoral choice, congressional voting, and the broad shape of national policy making.
Revolution, like war, is an historical phenomenon of great importance, and no scholar is likely to argue that revolutions have not had a significant influence on the history of nations and regions, even on the history of the entire world. Unlike war, however, revolution has no coherent chronological history, andthere are no studies of the phenomenon comparable to William McNeill's recent work The Pursuit of Power, or to Theodore Ropp's older but equally important War in the Modem World. Despite volumes written on the subject of revolution by historians, political scientists, sociologists, and others, one searches in vain for a comprehensive history.
This note shows how the initial density of the volume of a random simplex in a body, K, depends upon the fourth moment of sectional area and so rejects the conjecture that this initial density is independent of K.
In attempting to understand more fully the U.S. Supreme Court’s impact on national policymaking, scholars have examined Supreme Court policymaking as part of the “relatively cohesive alliances that endure for long periods of time” (Dahl, 1957: 280). These alliances or “party systems” represent relatively distinctive patterns in the general shape of national policy (Chambers and Burnham, 1975). It is common for historians to characterize the Jacksonian party system of 1828-1860 as a period in American history when national policy was aimed at aiding agrarian interests, or the First and Second Republican party systems in the later part of the nineteenth century as periods when national policy favored the rising industrial and financial interests. The change from one party system to another is the result of a process political scientists and historians have termed “partisan realignment” (Key, 1955). Periods of realignment in American politics are marked by a rapid change in the social and political agenda, which results in a significant and durable change in the party support in the electorate as well as in a significant change in institutional roles and national policy (Burnham, 1970; Jahnige, 1971; Sundquist, 1973; Trilling and Campbell, 1980). The new party balance may give rise to a shift from the dominance of one party to another, or an entirely new party system may develop. A relationship between mass electoral behavior and public policy appears to exist during periods of partisan realignment. The elections that produce this change in the party systems are termed “critical elections.”
In this paper the distributions of the number of intersections of three, four and five random chords to a circle are obtained by a reduction technique employing Ptolemy's theorem. These results are then used to obtain the skewness and kurtosis of the number of intersections of n random chords to a circle.