For a research ethics founded on human rights

Este estudo visa sustentar teoricamente que os direitos humanos devem ser o referencial ético fundamental da ética em pesquisa. Para tanto, dividiu-se a abordagem da interconexão entre o referencial dos direitos humanos e a ética em pesquisa em três fases: a primeira, marcada pela instituição dos princípios de Nüremberg; a segunda, pela hegemonia da Declaração de Helsinque e a terceira, pelo incremento das pesquisas internacionais, pelo declínio da Declaração de Helsinque e adoção da Declaração Universal sobre Bioética e Direitos Humanos. Com fundamento na tripartição metodológica, concluiu-se que, não obstante a relevância incontestável da Declaração de Helsinque para a edificação da cultura de respeito e proteção do sujeito da pesquisa, assume-se o enfraquecimento de sua legitimidade, depreendendo-se que a Declaração Universal sobre Bioética e Direitos Humanos e o Direito Internacional dos Direitos Humanos devem ser os novos parâmetros da eticidade da pesquisa no mundo e no Brasil.This study aims to demonstrate that human rights should be the fundamental ethical framework of research ethics. We have divided the approach of the interrelationship between human rights framework and research ethics in three phases, the first marked by the introduction of the principles of Nüremberg, the second by the hegemony of the Declaration of Helsinki, and the third is characterized by the increase in international research, the decline of the Helsinki Declaration and the adoption of the Universal Declaration on Bioethics and Human Rights. Based on the tripartite methodology employed, we have concluded that, despite the unquestionable relevance of the Declaration of Helsinki for building a culture of respect and protection of the research subject, we can verify its loss of legitimacy, so, it must be understood that the Universal Declaration on Bioethics and Human Rights and the International Law of Human Rights should be the new parameters of the research ethics worldwide and in Brazil.Este estudio se propone a sostener teóricamente que los derechos humanos deben ser el marco ético fundamental de la ética de la investigación. Por lo tanto, hemos dividido el enfoque de la relación entre el referencial de los derechos humanos y la ética de la investigación en tres fases: la primera marcada por la introducción de los principios de Núremberg, la segunda por la hegemonía de la Declaración de Helsinki, y la tercera por la expansión de las investigaciones internacionales, la debilidad de la Declaración de Helsinki y la adopción de la Declaración Universal sobre Bioética y Derechos Humanos. Basado en la metodología tripartita, se concluye que, a pesar de la importancia indiscutible de la Declaración de Helsinki para la construcción de una cultura de respeto y protección del sujeto de la investigación se reconoce la debilidad de su legitimidad, infiriéndose que la Declaración Universal acerca de la Bioética y Derechos Humanos y el Derecho Internacional de los Derechos Humanos deben ser los nuevos parámetros de la ética de investigación en todo el mundo y en Brasil

A new paradigm evaluating cost per cure of HCV infection in the UK

Background: New interferon (IFN)-free treatments for hepatitis C are more effective, safer but more expensive than current IFN-based therapies. Comparative data of these, versus current first generation protease inhibitors (PI) with regard to costs and treatment outcomes are needed. We investigated the real-world effectiveness, safety and cost per cure of 1st generation PI-based therapies in the UK. Methods: Medical records review of patients within the HCV Research UK database. Patients had received treatment with telaprevir or boceprevir and pegylated interferon and ribavirin (PR). Data on treatment outcome, healthcare utilisation and adverse events (AEs) requiring intervention were collected and analysed overall and by subgroups. Costs of visits, tests, therapies, adverse events and hospitalisations were estimated at the patient level. Total cost per cure was calculated as total median cost divided by SVR rate. Results: 154 patients from 35 centres were analysed. Overall median total cost per cure was £44,852 (subgroup range,: £35,492 to £107,288). Total treatment costs were accounted for by PI: 68.3 %, PR: 26.3 %, AE management: 5.4 %. Overall SVR was 62.3 % (range 25 % to 86.2 %). 36 % of patients experienced treatment-related AEs requiring intervention, 10 % required treatment-related hospitalisation. Conclusions: This is the first UK multicentre study of outcomes and costs of PI-based HCV treatments in clinical practice. There was substantial variation in total cost per cure among patient subgroups and high rates of treatment-related discontinuations, AEs and hospitalisations. Real world safety, effectiveness and total cost per cure for the new IFN free combinations should be compared against this baseline

Advanced therapies for the treatment of hemophilia: future perspectives

Monogenic diseases are ideal candidates for treatment by the emerging advanced therapies, which are capable of correcting alterations in protein expression that result from genetic mutation. In hemophilia A and B such alterations affect the activity of coagulation factors VIII and IX, respectively, and are responsible for the development of the disease. Advanced therapies may involve the replacement of a deficient gene by a healthy gene so that it generates a certain functional,structural or transport protein (gene therapy); the incorporation of a full array of healthy genes and proteins through perfusion or transplantation of healthy cells (cell therapy); or tissue transplantation and formation of healthy organs (tissue engineering). For their part, induced pluripotent stem cells have recently been shown to also play a significant role in the fields of cell therapy and tissue engineering.Hemophilia is optimally suited for advanced therapies owing to the fact that, as a monogenic condition, it does not require very high expression levels of a coagulation factor to reach moderate disease status. As a result, significant progress has been possible with respect to these kinds of strategies, especially in the fields of gene therapy (by using viral and non-viral vectors) and cell therapy (by means of several types of target cells). Thus, although still considered a rare disorder, hemophilia is now recognized as a condition amenable to gene therapy, which can be administered in the form of lentiviral and adeno-associated vectors applied to adult stem cells, autologous fibroblasts, platelets and hematopoietic stem cells; by means of non-viral vectors; or through the repair of mutations by chimeric oligonucleotides. In hemophilia, cell therapy approaches have been based mainly on transplantation of healthy cells (adult stem cells or induced pluripotent cell-derived progenitor cells)in order to restore alterations in coagulation factor expression

Travel of studies: cities of João Pessoa, Maceio, Natal and Recife: a look on the urban space and brazilian architectural production

Ponencia presentada a Session 8: Dimensiones psicosociales de la arquitectura y el urbanismo / Psycological dimensions of architecture and planningThis article aims to present the methodology and the final results of the elective course “Travel of Studies” which belongs to the new pedagogical project from the Architecture and Urbanism course at the University Federal of Pernambuco. It was offered for the first time in 2013.The discipline was organized to occur in four long weekends through visits of four capitals of the Northeast of Brazil: Recife, João Pessoa, Natal and Maceió. The purpose was to allow the students to apprehend the cities through four axis: intervention in historical center (axis 1), production of urban space (axis 2), production of coastline space (axis 3) and contemporary architecture (axis 4). After the four visits were complete, we prepared a poster with the comparison of the cities based on the identification of the similarities and differences of each axis we have studied

Induced Pluripotent Stem Cells: Therapeutic Applications in Monogenic and Metabolic Diseases, and Regulatory and Bioethical Considerations

Depto. de Genética, Fisiología y MicrobiologíaFac. de Ciencias BiológicasTRUEpu

Competitive adsorption of heavy metals by two different types of soils

Soil is a key element in human survival and can be described by various definitions according to its main utility. Nowadays, it is accepted that soil is a very complex heterogeneous medium which consists of solid phases containing minerals and organic matter and soil solution, defined as the fluid phase where soil reactions, transport and adsorption occurs (Alloway, 1995). Unfortunately, in the last decades, soils have been used as a deposit of residues. Therefore, the contamination and pollution of soils, sediments, surface and groundwater are of main concern. There are several ions and compounds of organic or inorganic nature that can contaminate soil and water. The inorganic contaminants include heavy metals like cadmium, chromium, cooper, lead and zinc, which are focused in this study. These metals are commonly present in industrial wastes (electroplating, textile and dyes, etc.), in fertilizers or in sewage sludge, but they can also contaminate soils through atmospheric deposition or runoff water (Serrano et al., 2005). Since adsorption is well recognized as the main process affecting the mobility of heavy metals through soils (Bradl, 2004), the aim of this work is the study the non competitive adsorption of these five metals, as well as the competitive adsorption in two different typical soils of the North of Portugal The soil samples were collected in Póvoa de Varzim, from O-horizon and A-horizon (0 cm -30 cm), one from a culture land and another from a beach land. To evaluate the adsorption equilibrium, batch tests were performed by adding to 2 g of air dried soil, 20 mL of 0.01 M CaCl2 solution, containing different initial concentrations of Pb [Pb(NO3)2], Cd [CdN2O6·4H2O], Cu [Cu(NO3)2·3H2O], Zn [Zn(NO3)2·6H2O] and Cr [K2Cr2O7], isolated (non-competitive system) and coupled (competitive system).To eliminate the mass effect, the multi-metal solutions were prepared in terms of molar concentrations (Echeverría et al., 1998). To avoid precipitation the pH of initial solution was adjusted to 2. Isotherm models like Freundlich and Langmuir equations were adjusted to experimental data. Batch tests are useful for the understanding of the adsorption process. However, advection and dispersion may occur in dynamic systems justifying the need of flow experiments (Miretzky et al., 2006). For continuous experiments, soil samples were packed in a column (25 cm × 3.2 cm) and a single – or multi – element solution of 50 mg/L was pass upwards during seven days. Then, using the CXTFIT code, the convection-dispersion equation was adjusted to the breakthrough curves in order to determine the retardation factor (R) and to compare the behavior of the different ions and soils

Molecular identification, phylogeny and geographic distribution of Brazilian mangrove oysters (Crassostrea)

Oysters (Ostreidae) manifest a high degree of phenotypic plasticity, whereby morphology is of limited value for species identification and taxonomy. By using molecular data, the aim was to genetically characterize the species of Crassostrea occurring along the Brazilian coast, and phylogenetically relate these to other Crassostrea from different parts of the world. Sequencing of the partial cytochrome oxidase c subunit I gene (COI), revealed a total of three species of Crassostrea at 16 locations along the Brazilian coast. C. gasar was found from Curuca (Para state) to Santos (Sao Paulo state), and C. rhizophorae from Fortim (Ceara state) to Florianopolis (Santa Catarina state), although small individuals of the latter species were also found at Ajuruteua beach (municipality of Braganca, Para state). An unidentified Crassostrea species was found only on Canela Island, Braganca. Crassostrea gasar and C. rhizophorae grouped with C. virginica, thereby forming a monophyletic Atlantic group, whereas Crassostrea sp. from Canela Island was shown to be more similar to Indo-Pacific oysters, and either arrived in the Atlantic Ocean before the convergence of the Isthmus of Panama or was accidentally brought to Brazil by ship