La regulación jurídica de la investigación farmacológica en personas menores de edad y el consentimiento informado a partir de un caso de irregularidades administrativas sancionadas por ANMAT

Introducción: El 28 de diciembre de 2011 el Juzgado Nacional en lo Penal Económico Nro. 2, en los autos "Glaxosmithkline Argentina S.A. — A. H. — T. M. s/infracción ley 16.463", denegó un planteo de nulidad deducido contra la Disposición N° 2626 dictada por la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) en virtud de la cual se había aplicado sanción de multa a Glaxosmithkline Argentina S.A., el Dr. H. A. y el Dr. M. T. por haber infringido diversos ítems de la Disposición ANMAT N° 5330/97 referida a Buenas Prácticas de investigación en Estudios de Farmacología Clínica. El fallo ha tenido amplia repercusión pública y en el presente comentario nos atendremos a su contenido en sentido estricto, sin considerar versiones periodísticas que no están reflejadas en la sentencia examinada y que resultaron desmentidas por un comunicado del ANMAT como veremos más adelante. Para el análisis de la sentencia, comenzamos por presentar la actualidad que presenta la cuestión ética en la investigación clínica. Luego, consideramos prudente ofrecer una pormenorizada narración de los hechos y las principales cuestiones que resultaron debatidas en la sentencia a partir de las investigaciones conducidas por ANMAT y los sucesivos descargos realizados por los sumariados. En este marco, el presente comentario se focaliza en dos grandes temas. Por un lado, los fundamentos normativos de la sentencia y la necesidad de legislar de manera expresa sobre esta materia. En segundo lugar, sobre la importancia del consentimiento informado y la particular situación de las personas menores de edad que participan de estas investigaciones. Concluimos con algunas reflexiones finales sobre la regulación jurídica de la investigación clínica

Ecological restoration of farmland: progress and prospects

Sustainable agricultural practices in conjunction with ecological restoration methods can reduce the detrimental effects of agriculture. The Society for Ecological Restoration International has produced generic guidelines for conceiving, organizing, conducting and assessing ecological restoration projects. Additionally, there are now good conceptual frameworks, guidelines and practical methods for developing ecological restoration programmes that are based on sound ecological principles and supported by empirical evidence and modelling approaches. Restoration methods must also be technically achievable and socially acceptable and spread over a range of locations. It is important to reconcile differences between methods that favour conservation and those that favour economic returns, to ensure that conservation efforts are beneficial for both landowners and biodiversity. One option for this type of mutual benefit is the use of agri-environmental schemes to provide financial incentives to landholders in exchange for providing conservation services and other benefits. However, further work is required to define and measure the effectiveness of agri-environmental schemes. The broader potential for ecological restoration to improve the sustainability of agricultural production while conserving biodiversity in farmscapes and reducing external costs is high, but there is still much to learn, particularly for the most efficient use of agri-environmental schemes to change land use practice

A review of evidence on the environmental impact of Ireland’s Rural Environment Protection Scheme (REPS)

peer-reviewedSince its inception in 1994, there has been strong demand for evidence of the environmental effectiveness of the Rural Environment Protection Scheme (REPS), which paid farmers in the Republic of Ireland over €3 billion by 2010. A variety of research projects have been undertaken that investigate the environmental effects of REPS through an examination of either specific environmental measures or specific geographical areas. A review of available publications confirmed the absence of a comprehensive, national-scale study of the environmental impacts of REPS. Because of this, there is insufficient evidence with which to judge the environmental effectiveness of the national-scale implementation of the whole scheme. For some specific measures, however, sufficient evidence is available to inform an objective assessment in some cases, and to help learn how to improve environmental effectiveness in most cases. The majority of the REPS payments are now dedicated toward biodiversity objectives. Thus, biodiversity measures and options should be a priority for any national-scale environmental assessment of the scheme. Such a study would help identify the environmental benefits of REPS, the specific elements of REPS that are performing adequately, and those elements that are in need of improvement. Given the considerable overlap between REPS measures and options and those included in the 2010 Agri-Environment Options Scheme (AEOS), assessment of REPS measures could also be used to inform the likely environmental performance of the AEOS

Self assessments of participants on enterprise training courses

This paper discusses research which was stimulated by the controversial question of the educability of entrepreneurial characteristics and the economic value of enterprise training. The research focuses on participants on enterprise training courses within the Irish Republic which aim to help people to set up and run businesses. An attempt was made to develop a technique, that is an adapted Osgood's Sematic Differential Technique, for use in the exploration of participants’ perceptions of entrepreneurial characteristics. This technique could represent a useful assessment technique for appraising participants’ attitudes to themselves as entrepreneurs and any changes over the duration of a training course in participants’ identification with entrepreneurial characteristic. Although, this technique would require self assessments, it could be used to establish the conditions for the development of entrepreneurial characteristics and explore questions of whether entrepreneurial characteristics may be developed. Despite methodological limitations, the reported study lends support to the thesis that many entrepreneurial characteristics may be developed over the duration of enterprise training courses in the view of participants