Human subjects research regulation: perspectives on the future.

This book is the 43rd in a series entitled ‘Basic bioethics’, and is intended to make work in bioethics accessible to a broad audience. This volume looks at the regulations safeguarding research involving human participants, and explores the legislative framework governing research in the US, in particular the ‘Common Rule for the Protection of Human Subjects’. The reason for this focus is that there have been a number of proposed changes (described within the Advanced Notice for Proposed Rulemaking, or ANPRM) which aim to take a risk-based approach to targeting regulatory oversight, as well as modifying regulations to keep pace with research, particularly regarding multi-site trials and the challenges facing research involving use of biological specimens. One of the points made in the introduction is that at the time of writing (late 2013) little progress had been made in terms of this legislative review. Indeed, at the time of writing this review, the process is far from complete. The aim of the book, therefore, is to stimulate dialogue around the proposed changes

A nullstellensatz for sequences over F_p

Let p be a prime and let A=(a_1,...,a_l) be a sequence of nonzero elements in F_p. In this paper, we study the set of all 0-1 solutions to the equation a_1 x_1 + ... + a_l x_l = 0. We prove that whenever l >= p, this set actually characterizes A up to a nonzero multiplicative constant, which is no longer true for l < p. The critical case l=p is of particular interest. In this context, we prove that whenever l=p and A is nonconstant, the above equation has at least p-1 minimal 0-1 solutions, thus refining a theorem of Olson. The subcritical case l=p-1 is studied in detail also. Our approach is algebraic in nature and relies on the Combinatorial Nullstellensatz as well as on a Vosper type theorem.Comment: 23 page

Educational Plans of Community College Students: An Expansion of Two College Choice Models.

The purpose of this study was to determine if the factors posited by previous researchers to affect predisposition to attend college in high school students also affect the predisposition to transfer in the two-year college student population, and to investigate whether or not an expansion of the Hossler and Gallagher (1987) three-phase model of college choice and the Hossler and Stage (1992) Model of High School Students\u27 Predisposition to College would yield great benefits. This analogy uses variables that have been advanced as effectual in the predisposition stage of the college choice process on the selected student population. The problem is that previous research has not examined the college choice process that students in two-year colleges undertake. Moreover, it ignores the duplicative nature of the college choice process for community college students. Specifically, this study investigates the simple bivariate relationship between predictors reported in the predisposition literature for high school students (socioeconomic status, parents education, etc.) and measures 2-year college students\u27 decisions to transfer or not transfer to a baccalaureate institution upon leaving the community college. For the nine included variables (SES, parents\u27 education, GPA, parents\u27 and significant others\u27 expectation and encouragement, students\u27 personal expectation, college involvement, gender, ethnicity and age), the simple bivariate relationship with a measure of community college student\u27s decision to transfer or not transfer to a baccalaureate institution upon departing from community college is measured. To test the explanatory power of the expanded Hossler and Stage model, hierarchial logistic regression procedures are employed. Model 9, which included all variables, was significant at the $\propto$ =.05 level. Of all the variables introduced in the hierarchical logistic regression analysis, EXPECT 2 (the personal educational expectations and aspirations students have for themselves) produced the most statistically significant relationship to predisposition to transfer (r =.2921). The results of this study have implications for state and federal officials who are responsible for developing student financial aid policies, administrators at community colleges and baccalaureate institutions, and for those responsible for enrollment management and recruiting functions at both two- and four-year institutions

Translating the fashion story: analyzing fashion captions in two women\u27s magazines

Fashion magazines are the most accessible source for women to learn the latest about fashion and trends. Publishing company Condé Nast owns many consumer fashion magazines including the American editions of Lucky and Vogue. Even though both magazines are classified under the genre of fashion, these magazines are branded differently. Vogue features editorial styling, which is garments arranged lavishly and creatively for the glossy fashion spreads. However, Lucky magazine contains both editorial and lifestyle styling. To reinforce the styled image, fashion magazines place captions in these editorials. Captions transform these garments into written language. Since each magazine uses different types of styling, editors are writing captions in different formats. The purpose of the study is to investigate the stylistic similarities and differences of fashion captions in Lucky and Vogue. Additionally, semantic-syntax tree diagrams were used to determine how the fashion captions communicate meaning. This study followed a mixed methods approach using a purposive sample (n=14). The March and September issues were examined from 2010-2013. Data results show magazines are written primarily in grammatical modifiers. Different from prior research, nouns were the largest category, and adjectives composed the second largest category. Some captions did not have verbs resulting in mainly a descriptive narrative. Each magazine differed in the types of verbs used, frequency of proper nouns, and types of prepositions. Furthermore, when editors are not telling a ‘fashion story’, then captions are written as imperative commands. When telling a ‘fashion story’, the garment is often personified to take on human characteristics or described as possessing certain characteristics. Both magazines use these writing styles to convey different ideas and content to the reader. The results of this study strengthened the belief that a distinct stylistic form of writing exists in fashion captions. From this study, fashion editors and scholars may become more aware of the current stylistic formations featured in fashion captions, and further enhance their knowledge of how to communicate editorial trends and themes to their intended audience

Sampling Errors in Observed Gravity Wave Momentum Fluxes from Vertical and Tilted Profiles

Observations from radiosondes or from vertically pointing remote sensing profilers are often used to estimate the vertical flux of momentum due to gravity waves. For planar, monochromatic waves, these vertically integrated fluxes are equal to the phase averaged flux and equivalent to the horizontal averaging used to deduce momentum flux from aircraft data or in numerical models. Using a simple analytical solution for two-dimensional hydrostatic gravity waves over an isolated ridge, it is shown that this equivalence does not hold for mountain waves. For a vertical profile, the vertically integrated flux estimate is proportional to the horizontally integrated flux and decays with increasing distance of the profile location from the mountain. For tilted profiles, such as those obtained from radiosonde ascents, there is a further sampling error that increases as the trajectory extends beyond the localised wave field. The same sampling issues are seen when the effects of the Coriolis force on the gravity waves are taken into account. The conclusion of this work is that caution must be taken when using radiosondes or other vertical profiles to deduce mountain wave momentum fluxes

Some thoughts on Darcy-type flow simulation for modelling underground CO 2 storage, based on the Sleipner CO 2 storage operation

We take three flow simulators, all based on Darcy’s Law but with different numerical solver implementations, to assess some of the issues surrounding their use to model underground CO2 storage. We focus on the Sleipner CO2 injection project, which, with its seismic monitoring datasets, provides unique insights into CO2 plume development during a large-scale injection operation. The case studies firstly compare simulator performance in terms of outputs and run-times on carefully matched model scenarios; then we compare numerical with analytical Darcy solutions to explore the potential for modelling simplification; finally we look at the effects of including conservation of energy in the simulations. The initial case-study used simplified axisymmetric model geometry to simulate the upward flux of CO2 through a heterogeneous reservoir, incorporating multiphase flow with coupled CO2 dissolution into formation brine. All three codes produced near-identical results with respect to CO2 migration velocity and total upward CO2 flux at the reservoir top. The second case-study involved 3D modelling of the growth of the topmost layer of CO2 trapped and migrating beneath topseal topography. Again the three codes showed excellent agreement. In the third case-study the simulators were tested against a simplified analytical solution for gravity currents to model the spreading of a single CO2 layer beneath a flat caprock. Neglecting capillary effects, the numerical models showed similar layer migration and geometry to the analytical model, but it was necessary to minimise the effects of numerical dispersion by adopting very fine cell thicknesses. The final case-study was designed to test the non-isothermal effects of injecting CO2 into a reservoir at non-ambient temperature. Only two of the simulators solve for conservation of energy, but both showed a near identical thermal anomaly, dominated by Joule-Thomson effects. These can be significant, particularly where reservoir conditions are close to the critical point for CO2 where property variations can significantly affect plume mobility and also seismic response. In conclusion, the three simulators show robust consistency, any differences far less than would result from geological parameter uncertainty and limitations of model resolution. In this respect the three implementations are significantly different in terms of computing resource requirement and it is clear that approaches with simplified physics will pay rich dividends in allowing more detailed reservoir heterogeneity to be included. Contrary to this, including conservation of energy is heavier on computing time but is likely to be required for storage scenarios where the injectant stream is significantly different in temperature to the reservoir and most critically for shallower storage reservoirs where CO2 is close to its critical point

Factors influencing the development of effective error management competencies in undergraduate UK pharmacy students

Patient safety (PS) is a key healthcare goal, yet health professionals struggle to acquire appropriate expertise, including Human Factors/Ergonomics skills, reflected in undergraduate curricula content. More than 50% of adverse events are medicines-related, yet focus on pharmacists as experts in medicines is scant. This pilot investigation used focus groups and interviews to explore undergraduate PS teaching in purposively-selected UK pharmacy schools. Results revealed barriers to PS teaching including risk-averse pharmacist ‘personality’ and Educational Standards negatively influencing students’ error-management behaviours

The NHS health check for developing HFE competencies.

Patient safety is an emergent property of complex sociotechnical healthcare systems. Human Factors and Ergonomics (HFE), with its design-based systems focus, offers frameworks for developing resilient systems, although use in healthcare has been limited to date. Most healthcare educational curricula articulate requirements for students to develop patient safety competencies, but there is scant direction as to how this might be achieved. The authors have produced guidance on embedding HFE in healthcare curricula, but recognise that examples of effective HFE teaching would further support educational practice. This case study outlines a related set of activities based around the NHS Health Check, a population-wide screening programme designed to identify and manage cardiovascular risk. The Health Check represents a cardiovascular risk management system and is amenable to analysis using HFE frameworks. The educational activities described support students in developing a deep awareness of HFE theory, and early development of HFE competencies. The Health Check is a highly relevant professional activity for pharmacy students but would also be relevant to medical and nursing students, as well as healthcare management staff. This case study will form the focus of a discussion that will provide delegates with an opportunity to share experiences of different approaches to HFE education