915 resultados para Informed consent (Medical law)


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This article discusses the concept of right and its identification with the power to coerce, to show a reciprocity between the original contract and the right, as a manifestation of the reciprocity between moral law and freedom, as Kant states in its Second Critique. The demonstration of this view will allow a republican stance evident in the legal and political thought of Kant, since the right of a people can only exist while the town itself is unified to enact.

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In Marxist frameworks “distributive justice” depends on extracting value through a centralized state. Many new social movements—peer to peer economy, maker activism, community agriculture, queer ecology, etc.—take the opposite approach, keeping value in its unalienated form and allowing it to freely circulate from the bottom up. Unlike Marxism, there is no general theory for bottom-up, unalienated value circulation. This paper examines the concept of “generative justice” through an historical contrast between Marx’s writings and the indigenous cultures that he drew upon. Marx erroneously concluded that while indigenous cultures had unalienated forms of production, only centralized value extraction could allow the productivity needed for a high quality of life. To the contrary, indigenous cultures now provide a robust model for the “gift economy” that underpins open source technological production, agroecology, and restorative approaches to civil rights. Expanding Marx’s concept of unalienated labor value to include unalienated ecological (nonhuman) value, as well as the domain of freedom in speech, sexual orientation, spirituality and other forms of “expressive” value, we arrive at an historically informed perspective for generative justice. 

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Three-dimensional printing (“3DP”) is an additive manufacturing technology that starts with a virtual 3D model of the object to be printed, the so-called Computer-Aided-Design (“CAD”) file. This file, when sent to the printer, gives instructions to the device on how to build the object layer-by-layer. This paper explores whether design protection is available under the current European regulatory framework for designs that are computer-created by means of CAD software, and, if so, under what circumstances. The key point is whether the appearance of a product, embedded in a CAD file, could be regarded as a protectable element under existing legislation. To this end, it begins with an inquiry into the concepts of “design” and “product”, set forth in Article 3 of the Community Design Regulation No. 6/2002 (“CDR”). Then, it considers the EUIPO’s practice of accepting 3D digital representations of designs. The enquiry goes on to illustrate the implications that the making of a CAD file available online might have. It suggests that the act of uploading a CAD file onto a 3D printing platform may be tantamount to a disclosure for the purposes of triggering unregistered design protection, and for appraising the state of the prior art. It also argues that, when measuring the individual character requirement, the notion of “informed user” and “the designer’s degree of freedom” may need to be reconsidered in the future. The following part touches on the exceptions to design protection, with a special focus on the repairs clause set forth in Article 110 CDR. The concluding part explores different measures that may be implemented to prohibit the unauthorised creation and sharing of CAD files embedding design-protected products.

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This thesis is about a class of literate professionals that served as hereditary brehons, poets and doctors to the Gaelic aristocracy over a period from c.1250-c.1630. My investigation into these families brings together evidence from Gaelic and English sources to highlight the work these families did for their patrons, their status in society and their subsequent fall in the seventeenth century. Such a broad canvas allows us to observe the vibrancy of Gaelic literary culture as these families adapted to the changing political landscape to absorb new Anglo-Norman patrons and assimilated English and Continental ideas while maintaining their distinctive identity. I want to look beyond the ideology espoused by these families to look at the practical choices members of these families made to maintain their status and relevance in a changing social context. To do this I have chosen to focus on each of the three professions in individual chapters to highlight the continuities and changes within the professions and ultimately by comparing the three groups to gauge the success or failure of these professional families to adapt to the encroachment of the New English and the ultimate collapse of the Gaelic world. This thesis takes a holistic approach to these families by including branches of these families not engaged in the hereditary profession. It seeks to provide a broader picture of Gaelic society below the level of the aristocracy by looking at the geographic distribution of these families, their proximity to centres of power, and to land and sea routes that can indicate their involvement in alternative economic activities.

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In 2009 and 2010, the major drug regulatory bodies, the European Medicines Agency and the Food and Drug Administration in the USA, issued requests for the generation of information relating to the absorption, distribution, metabolism, excretion, efficacy and safety of investigational drugs in pregnant women prior to approval. In the wake of thalidomide, research involving pregnant women other than for obstetric or gynaecologic purposes became rare, and studies of investigational drugs practically unknown. Consequently, none of the legislation applicable in the UK and few of the guidelines introduced in the last 40 years properly addresses the conduct of clinical trials of investigational drugs in this population. This thesis questions whether the legal protection for the foetus is adequate in clinical trials. The answer appears to be a qualified “no”. Arguments persist regarding the moral standing of the foetus, particularly regarding abortion. That will not be the intent of such trials, and a moral case is made for the conduct of clinical trials in this population by analogy with the neonate, and the pregnant woman’s autonomy. Legally, we already recognise the foetus has ‘interests’ which crystallise upon live birth, and that compensation is recoverable for harm inflicted in utero manifesting as congenital injury. The essence of research is quite different from medical practice, and the extent to which this is understood by trial participants is unclear. The approvals processes contain a number of inadequacies which have the potential to expose the foetus to harm and affect the consent of the pregnant woman. The recovery of compensation in the event of children born injured following clinical trials during pregnancy in many ways may be more complex than other personal injury cases.. The conclusions of this thesis are that the existence of a foetus does merit recognition by the law in this setting and that morally such studies are justifiable. However, the present legislation and approval processes potentially expose the foetus to avoidable risk and may not be appropriate to enable the recovery of compensation, thereby creating potential to deter future trial participants. A proposal is made regarding an approach to simplify the process for recovery of compensation, and thereby strengthen the approval and consent processes.

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ANTECEDENTES.- Las infecciones de vías urinarias son causadas por bacterias, hongos y parásitos a nivel mundial.1Esta investigación se realizó en los habitantes de la comunidad de Sarapamba Yutuloma. OBJETIVO.- Determinar la prevalencia de infección de vías urinarias y sus factores asociados en los habitantes de la comunidad de Sarapamba Yutuloma Tambo. METODOLOGÍA.- La investigación fue de tipo descriptivo transversal, se trabajó con un universo de 280 habitantes de la comunidad. El tamaño de la muestra fue calculada con la fórmula finita con un nivel de confiabilidad del 95%.el resultado de la población a estudiar fue de 180 habitantes. Los participantes de esta investigación firmaron o colocaron su huella digital en el consentimiento informado en mayores o asentimiento para menores de edad, personas analfabetas o discapacitadas, llenaron una encuesta que han sido elaborados en base al modelo de Vigilancia STEPS de los factores de riesgo de enfermedades crónicas no transmisibles de la OMS 2010 aplicado en Suiza. Las muestras fueron recolectadas bajo normas de Bioseguridad, estas fueron procesadas en el Laboratorio del Centro de Diagnóstico de la Facultad de Ciencias Médicas de la Universidad de Cuenca. La información obtenida se registró en los programas, SPSS V 22 y Excel para hacer el análisis y las estadísticas. RESULTADOS.- El 16,1% de los habitantes de Sarapamba Yutuloma tiene infección del tracto urinario, el 86,2% son mujeres, el 13,8 son varones, 72,4% en edades comprendidas entre 22 y 53 años y el 89,9% al mantener actividad sexual.

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Antecedentes: La infección del tracto urinario es una de las patologías más comunes y forma parte de las principales causas de consulta médica y hospitalización. (1, 2) Es frecuente en mujeres, personas con vida sexual activa, mujeres embarazadas y diabéticos. El 10 al 20 % de mujeres entre los 18 y 40 años experimentan infección del tracto urinario, en hombres mayores a 50 años se asocia a problemas por hiperplasia prostática y en personas de la tercera edad la frecuencia es similar tanto en hombres como en mujeres. (1) Objetivo: Identificar infección de vías urinarias mediante el examen elemental y microscópico de orina en los habitantes de la comuna Sunicorral Tambo- Cañar 2015. Metodología: Estudio de tipo descriptivo transversal en habitantes la comuna Sunicorral, la muestra fue de 202 personas. Luego firmar del consentimiento y asentimiento informado, se llenó las encuesta con información relacionada a las variables de estudio, se recolectaron las muestras de orina y el análisis se realizó en el laboratorio del Centro de Diagnóstico de la Universidad de Cuenca, los datos obtenidos fueron analizado en el programa SPSS y Microsoft Excel y presentados en tablas y gráficos estadísticos. Resultados: De 202 muestras el 15% reportó infección del tracto urinario, el 87,1% fue mujer, el 25,8% correspondió a la edad de 10 a 19 años, el 64,6% realizó su higiene intima pasando uno o más días, el 62,0% tiene actividad sexual siendo un factor importante.

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Este proyecto se origina en el interés de analizar las estrategias actuales de promoción de productos farmacéuticos, en el marco del debate sobre el efecto persuasivo o informativo que la publicidad directa tiene sobre los consumidores. El objetivo es determinar el efecto de las estrategias de promoción directa para consumidores (Direct to Consumer Advertising [DTCA]) sobre el comportamiento de compra de pacientes y las prescripciones que formulan los médicos en el mercado de productos bajo receta en Estados Unidos. Para tal fin se propuso realizar una monografía que incluyera una revisión de literatura de carácter argumentativo, consultando información de nivel secundario en bases de datos científicas cuyos contenidos obedecieran a criterios metodológicos determinados por la naturaleza argumentativa del estudio. Adicionalmente, se analizó el debate sobre estos anuncios a la luz de dos estudios realizados a pacientes con cáncer de seno, próstata y colon, liderados por el Pennsylvania Cancer Registry con los productos biofarmacéuticos Avodart® y Flomax®. Finalmente, la investigación se fundamentó en la relación del mercado farmacéutico en Estados Unidos con cada uno de los agentes que interactúan en él; consumidores, médicos prescriptores y empresas farmacéuticas, así como el valor que estos comparten través de dichas interacciones. Se concluye que el comportamiento de compra de los consumidores está determinado por la naturaleza de la patología que padecen y el comportamiento de los profesionales que prescriben a sus pacientes se ve influenciado por los anuncios DTCA.

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In 2019, the Italian Supreme Court established that hemp, for non-medical use, cannot be commercialized for human use, when the “psychotropic effect” of the product or its “offensiveness” can be demonstrated. The first chapter of this work reports a review of the European and Italian legislation on hemp cultivation, as well as the hemp production chain and commercial activities. The second chapter reports the pharmacological aspects and the psychoactive effects of light cannabis, along with pharmacokinetics of the main Cannabis compounds: Δ9-tetrahydrocannabinol (Δ9-THC), Cannabidiol (CBD) and Cannabinol (CBN). The aim of the experimental study, reported in the third chapter, is to assess Δ9-THC and CBD blood concentrations after smoking “light cannabis”, and its effects on vigilance, cognitive and motor skills. Eighteen young adults consumed three light cannabis cigarettes with a percentage of 0.41% of Δ9-THC and of 12.41% of CBD. Blood samples were collected before the experiment (t0) and after pre-defined time-lapses. Five performance tasks and a subjective scale were employed for measuring cognitive and psychomotor performances the day before the experiment (TT0) and after the third cigarette (TT1). Mean (SD) concentrations (ng/ml) were between 1.0(0.8) in t1 and 0.3(0.3) in t5 for Δ9-THC; and 10.5(10.3) in t1 and 5.7(5.7) in t5 for CBD. No significant differences were observed between TT0 and TT1 for all performed psychomotor performance task. Δ9-THC and CBD concentrations showed a high inter-subject variability, and the average concentrations were lower than those previously reported. Toxicological results showed a decrease of Δ9-THC and CBD after the third light cannabis cigarette, and a Δ9-THC /CBD ratio always < 1 was observed. This value might be useful in discriminating light cannabis versus illegal/medical cannabis consumption. The lack of impairment observed in our participants can be interpreted as a consequence of the very low concentrations in the blood.

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This thesis studies how commercial practice is developing with artificial intelligence (AI) technologies and discusses some normative concepts in EU consumer law. The author analyses the phenomenon of 'algorithmic business', which defines the increasing use of data-driven AI in marketing organisations for the optimisation of a range of consumer-related tasks. The phenomenon is orienting business-consumer relations towards some general trends that influence power and behaviors of consumers. These developments are not taking place in a legal vacuum, but against the background of a normative system aimed at maintaining fairness and balance in market transactions. The author assesses current developments in commercial practices in the context of EU consumer law, which is specifically aimed at regulating commercial practices. The analysis is critical by design and without neglecting concrete practices tries to look at the big picture. The thesis consists of nine chapters divided in three thematic parts. The first part discusses the deployment of AI in marketing organisations, a brief history, the technical foundations, and their modes of integration in business organisations. In the second part, a selected number of socio-technical developments in commercial practice are analysed. The following are addressed: the monitoring and analysis of consumers’ behaviour based on data; the personalisation of commercial offers and customer experience; the use of information on consumers’ psychology and emotions, the mediation through marketing conversational applications. The third part assesses these developments in the context of EU consumer law and of the broader policy debate concerning consumer protection in the algorithmic society. In particular, two normative concepts underlying the EU fairness standard are analysed: manipulation, as a substantive regulatory standard that limits commercial behaviours in order to protect consumers’ informed and free choices and vulnerability, as a concept of social policy that portrays people who are more exposed to marketing practices.

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Law students internationally suffer from a high level of psychological distress compared with the general and student populations, and anecdotal evidence suggests that students developing skills without adequate support experience significant stress and anxiety. This article considers an initiative at one Australian law school to develop a degree-wide structured online skills development programme as a means to both improve student skills acquisition and reduce student stress. The project implements, through the use of learning technology, the principles proposed by McKinney for making small changes to law school teaching, informed by self-efficacy theory, which can have powerful results.

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The purpose of this research study is to discuss privacy and data protection-related regulatory and compliance challenges posed by digital transformation in healthcare in the wake of the COVID-19 pandemic. The public health crisis accelerated the development of patient-centred remote/hybrid healthcare delivery models that make increased use of telehealth services and related digital solutions. The large-scale uptake of IoT-enabled medical devices and wellness applications, and the offering of healthcare services via healthcare platforms (online doctor marketplaces) have catalysed these developments. However, the use of new enabling technologies (IoT, AI) and the platformisation of healthcare pose complex challenges to the protection of patient’s privacy and personal data. This happens at a time when the EU is drawing up a new regulatory landscape for the use of data and digital technologies. Against this background, the study presents an interdisciplinary (normative and technology-oriented) critical assessment on how the new regulatory framework may affect privacy and data protection requirements regarding the deployment and use of Internet of Health Things (hardware) devices and interconnected software (AI systems). The study also assesses key privacy and data protection challenges that affect healthcare platforms (online doctor marketplaces) in their offering of video API-enabled teleconsultation services and their (anticipated) integration into the European Health Data Space. The overall conclusion of the study is that regulatory deficiencies may create integrity risks for the protection of privacy and personal data in telehealth due to uncertainties about the proper interplay, legal effects and effectiveness of (existing and proposed) EU legislation. The proliferation of normative measures may increase compliance costs, hinder innovation and ultimately, deprive European patients from state-of-the-art digital health technologies, which is paradoxically, the opposite of what the EU plans to achieve.

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The project answers to the following central research question: ‘How would a moral duty of patients to transfer (health) data for the benefit of health care improvement, research, and public health in the eHealth sector sit within the existing confidentiality, privacy, and data protection legislations?’. The improvement of healthcare services, research, and public health relies on patient data, which is why one might raise the question concerning a potential moral responsibility of patients to transfer data concerning health. Such a responsibility logically would have subsequent consequences for care providers concerning the further transferring of health data with other healthcare providers or researchers and other organisations (who also possibly transfer the data further with others and other organisations). Otherwise, the purpose of the patients’ moral duty, i.e. to improve the care system and research, would be undermined. Albeit the arguments that may exist in favour of a moral responsibility of patients to share health-related data, there are also some moral hurdles that come with such a moral responsibility. Furthermore, the existing European and national confidentiality, privacy and data protection legislations appear to hamper such a possible moral duty, and they may need to be reconsidered to unlock the full use of data for healthcare and research.

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This research addresses the use of ex ante contracts to arbitrate tort claims in domestic settings using law and economics research methodologies. Potential economic benefits from using arbitration, particularly between informed and knowledgeable parties and in international business transactions, are not guaranteed in domestic disputes. Arbitration can potentially be used to manipulate the adjudication process. This research has several findings. There is a lack of information available concerning the use of arbitration to adjudicate tort claims. Proxy measurements concerning the demand for third party adjudication and other legal indicators are a poor substitute for the information hidden behind the veil of arbitration. There is the potential for the strategic use of ex ante contracts to arbitrate tort claims by repeat player tortfeasors to domestic tort claims, both individually and in concert with other repeat player firms. These strategic efforts aim to: manipulate enforcement errors for tort claims, avoid procedural rules which have the effect of lowering enforcement errors, enable a unique type of domestic forum arbitrage, shirk from taking due care, capture the economic benefit of using arbitration, manipulate the stock of precedents and production of public goods from courts, collude in these underlying efforts, restrain competition, indirectly fix prices, and other aims which increase the repeat player tortfeasor’s or their industries economic gains related to their underlying contracts and tort disputes. This research also demonstrates how this subject is appropriate for further academic research and why states should be cautious of giving carte blanche to arbitrate all domestic tort claims.

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To report on the use of chronic myeloid leukemia as a theme of basic clinical integration for first year medical students to motivate and enable in-depth understanding of the basic sciences of the future physician. During the past thirteen years we have reviewed and updated the curriculum of the medical school of the Universidade Estadual de Campinas. The main objective of the new curriculum is to teach the students how to learn to learn. Since then, a case of chronic myeloid leukemia has been introduced to first year medical students and discussed in horizontal integration with all themes taught during a molecular and cell biology course. Cell structure and components, protein, chromosomes, gene organization, proliferation, cell cycle, apoptosis, signaling and so on are all themes approached during this course. At the end of every topic approached, the students prepare in advance the corresponding topic of clinical cases chosen randomly during the class, which are then presented by them. During the final class, a paper regarding mutations in the abl gene that cause resistance to tyrosine kinase inhibitors is discussed. After each class, three tests are solved in an interactive evaluation. The course has been successful since its beginning, 13 years ago. Great motivation of those who participated in the course was observed. There were less than 20% absences in the classes. At least three (and as many as nine) students every year were interested in starting research training in the field of hematology. At the end of each class, an interactive evaluation was performed and more than 70% of the answers were correct in each evaluation. Moreover, for the final evaluation, the students summarized, in a written report, the molecular and therapeutic basis of chronic myeloid leukemia, with scores ranging from 0 to 10. Considering all 13 years, a median of 78% of the class scored above 5 (min 74%-max 85%), and a median of 67% scored above 7. Chronic myeloid leukemia is an excellent example of a disease that can be used for clinical basic integration as this disorder involves well known protein, cytogenetic and cell function abnormalities, has well-defined diagnostic strategies and a target oriented therapy.