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.^

Fine Bird Books

The Department of Special Collections is fortunate to have a number of 19th Century illustrated bird books. These books, filled with hand-colored plates, were produced at a time when there was tremendous interest in the descriptions of new species of birds. At the same time, a new printing technique, lithography, made illustration of new species a simpler process. This combination of art and science resulted in lovely volumes like those on display.

Illustrated Botanical Books, Fifteenth, Sixteenth, Seventeenth Centuries

No attempt has been made for a comprehensive coverage of the many outstanding illustrated botanical books for this three hundred year period. Rather the aim has been for a combination of interesting illustrators and famous botanists. Like the exhibit on fine bird books, these books on display have been taken from the Rare Books division of Special Collections.

Reproducción, norma y valor en el entorno digital : Google Books o la biblioteca de la discordia

Fil: Hutnik, Elizabeth. Universidad Nacional de La Plata. Facultad de Humanidades y Ciencias de la Educación. Instituto de Investigaciones en Humanidades y Ciencias Sociales (UNLP-CONICET); Argentina.

Reproducción, norma y valor en el entorno digital : Google Books o la biblioteca de la discordia

Fil: Hutnik, Elizabeth. Universidad Nacional de La Plata. Facultad de Humanidades y Ciencias de la Educación. Instituto de Investigaciones en Humanidades y Ciencias Sociales (UNLP-CONICET); Argentina.

Reproducción, norma y valor en el entorno digital : Google Books o la biblioteca de la discordia

Fil: Hutnik, Elizabeth. Universidad Nacional de La Plata. Facultad de Humanidades y Ciencias de la Educación. Instituto de Investigaciones en Humanidades y Ciencias Sociales (UNLP-CONICET); Argentina.

Newer optics efficiently mix, dim, and color-tune LED light

Low-cost, plastic-injected optics mix light from different color LED dies without a significant decrease in average brightness, simplifying luminaire design both optically and electronically. In solid-state lighting, high-flux and high-color rendering index (CRI) light engines may be achieved by arraying and mixing the light from different color dies or phosphors, or a combination of the two, in the LED package. However, these nonhomogeneous sources, when combined with luminaire optics, tend to produce patterns with undesirable artifacts such as spatial and angular nonuniformities and color separation.

Fernando García Mercadal y el Movimiento Moderno

La tesis plantea el estudio de la figura de Fernando García Mercadal (1896- 1985) y su obra, en el contexto del proyecto moderno perteneciente a la racionalidad teórica colectiva de la segunda generación del Movimiento Moderno en Europa, y explora la vida y circunstancias de un arquitecto que aunque nacido en el XIX, trajo la modernidad a España. El Movimiento Moderno en España, se articula en las décadas de los años 20 y 30 a través del GATEPAC y un grupo de arquitectos racionalistas en Madrid que Carlos Flores denomina Generación del 1925. Fernando García Mercadal, primero de su promoción en 1921 y pensionado en Roma, pertenece a ambos y pronto se convierte junto con Josep Lluis Sert, en una de las figuras más relevantes del panorama moderno español. Único miembro fundador del GATEPAC que había nacido en el siglo XIX, publica habitualmente en la revista AC (1931-1937), y en la revista Arquitectura desde 1920. Organiza en la Residencia de Estudiantes, entre 1928 y 1932, un famoso ciclo de Conferencias que imparten Le Corbusier, Mendelsohn, Van Doesburg, Gropius y Giedion. También asiste a la reunión constituyente de los CIAM en La Sarraz en 1928, al CIAM II en Frankfurt en 1929 y al CIAM III en Bruselas en 1930. Fue profesor en la Escuela de Arquitectura de Madrid y Arquitecto Jefe de la Oficina de Urbanismo y de Parques y Jardines del Ayuntamiento de Madrid, cargo al que accede por oposición en 1932. Tras la guerra fue depurado e inhabilitado profesionalmente, hasta que en 1946 comienza a trabajar en el Departamento de Arquitectura del I.N.P. donde continúa hasta los años 70. En 1979 es nombrado Académico de número de la Real Academia de Bellas Artes de San Fernando y muere en Madrid en 1985. Estos son los datos conocidos y aunque en la tesis se aportan nuevos datos inéditos, es en las premisas para su interpretación donde este trabajo de investigación pone el acento. En la historiografía de nuestra arquitectura moderna, pervive una tendencia a suponer una desconexión entre la vanguardia arquitectónica en los años 20 y 30 y el movimiento moderno internacional. El manto de silencio que cayó sobre la generación anterior a la guerra, una vez terminada esta, contribuye a reforzar la idea, cuyo origen y causas exceden el ámbito de trabajo, aunque se tratarán tangencialmente por ser ineludible hacerlo. La tesis pone en cuestión ese planteamiento desde el convencimiento fundamentado en los datos y en la consulta de fuentes originales, que la arquitectura española anterior a la guerra, aun con las circunstancias particulares del país, estuvo en sintonía con la europea, siendo esta la hipótesis de partida de la investigación. Las aportaciones más significativas que, a mi entender, presenta la tesis doctoral, y tienen mayor originalidad, son las siguientes; 1.Puesta en valor de la arquitectura de FGM, antes y después de la guerra, abandonando la idea de su supuesta renuncia a las ideas modernas a partir de los 30; 2. Puesta en valor, con aportación de datos concretos, de la Intensa relación mantenida por FGM y otros arquitectos españoles del Movimiento Moderno con los arquitectos de igual tendencia en el resto de Europa, a través de contactos recíprocos y continuos; 3. Estudio de la obra de FGM en el marco del Movimiento Moderno como una nueva arquitectura basada no tanto en la epidermis, como en una forma de hacer y encarar los problemas donde el proceso es tan importante como el resultado; con el Urbanismo como una nueva ciencia, y con el desarrollo de nuevos programas funcionales acordes a las necesidades de la sociedad contemporánea como el Rincón de Goya y el Hospital de Zaragoza. Se manejan tres métodos de trabajo. Los dos primeros aportan un nuevo enfoque al análisis crítico de FGM y su obra, situándole en el contexto internacional, además del español. El tercero, de carácter instrumental, permite el manejo y sistematización de la documentación. El primer método, consiste en aplicar el criterio generacional de Pevsner o Giedion entre otros, al Movimiento Moderno en España, situando a Fernando García Mercadal como arquitecto de la segunda generación, para hacer un análisis crítico comparativo de su trayectoria con otros arquitectos europeos de la misma, que permita establecer semejanzas y diferencias. El segundo método, complementario al anterior, consiste en estudiar las relaciones internacionales de FGM con las figuras más próximas a él y sus posibles influencias. Por último, y en relación con la documentación de obras y proyectos, se manejan a su vez dos criterios. Para la obra completa, y debido a la inexistencia de originales del Legado García Mercadal, se utiliza con carácter general el material ya publicado, disperso en libros y revistas. En el caso de las cinco obras seleccionadas, se completa con búsqueda en archivos, toma de datos in situ actualizados cuando es posible, y una recopilación de su repercusión en prensa escrita de su momento. ABSTRACT This research study focuses on Fernando Garcia Mercadal (1896-1985) and his work in the context of the Modern project as part of the collective theoretical rationality of the second generation of European Modern architecture. It explores the life and circumstances of the architect, who even though born in 19th century introduced Modern architecture in Spain. Modern architecture (Modern Movement) in Spain covered two decades between 20's and 30's through GATEPAC and a group of rationalists in Madrid that Carlos Flores named “generation of '25”. Fernando Garcia Mercadal, top of his class in 1921 and granted with the scholarship in Rome, belonged to both groups and early in his career he became, along with Josep Lluis Sert, one of the most relevant figures of Modern Architecture in Spain. He was the only member of GATEPAC who was born in 19th century. He frequently published on the magazine “AC” (1931-1937) and on “Arquitecture” magazine since 1920. He organized a series of famous lectures at “Residencia de Estudiantes” (Madrid) between 1928 and 1932 in which Le Corbusier, Mendelsohn, Van Doesburg, Gropius or Giedion took part. He was a member of the constituent meeting of CIAM in La Sarraz in 1928, CIAM II in Frankfurt in 1929 and CIAM III in Brussels in 1930. Mercadal was a teacher at Escuela de Arquitectura de Madrid and the Chief of the Urban Planning, Parks and Gardens Office of the Council of Madrid. He earned his position by public examination in 1932. After the civil war he was disqualified professionally until 1946, when he started working at the Architecture Department at INP until 70's. In 1979 he was elected as an academic member of “Real Academia de Bellas Artes de San Fernando” and later died in 1985. These are the well-known facts and even though this research study provides unpublished facts, it focuses on the premises to interpret them. Throughout the historiographical discourse of Spanish Modern architecture there is a tendency to assume a disconnection between the Avant-garde architecture movements in 20's and 30's and International Modern architecture (Modern Movement). The generation preceding the war remained silent in regard to this issue and once the war was over, they contributed to support the disconnection. The origin and cause exceed the frame of this work, even though they are incidentally commented due to its importance. This research study questions the approach explained above, based on the facts and the original sources. Its first hypothesis states that Spanish architecture before the civil war was, under its own circumstances, in tune with European architecture. The most important and original contributions of this research study are the following under my point of view: 1. To highlight the architecture of FGM, before and after the war, leaving behind his reputed withdrawal of Modernity after 30's; 2. To highlight the intense relationship between FGM and other Modern Spanish architects and other European architects sharing the same ideas, providing detailed facts; 3. Study of FGM's work in the context of Modern architecture as a new architecture based on its know-how and the way problems are faced. The process is as important as the result, not so much based on the dermis; with urban planning as the new science and with the development of the new functional programs based on the needs of contemporary society as in Rincón de Goya or Hospital de Zaragoza. Three work methods are used. The first two add a new vision of the critical analysis related to FGM and his work, positioning him in the international context in addition to Spain. The third is used as an instrument to manage and systematize the documentation. The first method applies the generational criteria of Pevsner or Giedion (among others) to Modern architecture in Spain, positioning Fernando Garcia Mercadal as a second generation architect. A critical-comparative analysis of his career and contemporary European architects is made to establish similarities and differences. The second method is complementary to the previous one and studies the international relationships of FGM with other recognised architects that were close to him and their possible influences. At last, in relation to his works and projects, two methods are used. For the complete works, due to the lack of originals, published material found on magazines and books is used as the source. In the case of the five selected buildings, it is complemented with archive search, onsite data collection when possible and the impact on the press at that moment.

Online tables of contents for books: effect on usage*

Objectives: To explore whether the presence of online tables of contents (TOC) in an online catalog affects circulation (checkouts and inhouse usage). Two major questions were posed: (1) did the presence of online tables of contents for books increase use, and, (2) if it did, what factors might cause the increase?

Brandon/Hill selected list of print books and journals for the small medical library*

After thirty-six years of biennial updates, the authors take great pride in being able to publish the nineteenth version (2001) of the “Brandon/Hill Selected List of Print Books and Journals for the Small Medical Library.” This list of 630 books and 143 journals is intended as a selection guide for health sciences libraries or similar facilities. It can also function as a core collection for a library consortium. Books and journals are categorized by subject; the book list is followed by an author/editor index, and the subject list of journals, by an alphabetical title listing. Due to continuing requests from librarians, a “minimal core list” consisting of 81 titles has been pulled out from the 217 asterisked (*) initial-purchase books and marked with daggers (†*) before the asterisks. To purchase the entire collection of 630 books and to pay for 143 2001 journal subscriptions would require $124,000. The cost of only the asterisked items, books and journals, totals $55,000. The “minimal core list” book collection costs approximately $14,300.