Notificações emitidas pelo Conselho Regional de Enfermagem do Paraná / Notifications issued by the Paraná Regional Nursing Council / Notificaciones emitidas por el Consejo Regional de Enfermería de Paraná

Objetivo: Levantar e caracterizar as notificações de irregularidades e ilegalidades emitidas pelo Conselho Regional de Enfermagem do Paraná (COREN-PR) entre os anos de 2018 a 2022. Método:Pesquisa documental, com abordagem quantitativa, tendo o COREN-PR como cenário de pesquisa. Foram coletados dados de fonte primária e de domínio público do COREN-PR referentes aos relatórios de fiscalização em que constam os quantitativos de notificações por irregularidades e ilegalidades emitidas entre os anos de 2018 a 2022. Os dados foram analisados mediante análise estatística simples. Resultados:Verificou-se prevalência das notificações de inexistência ou inadequação de documentos relacionados ao gerenciamento dos processos de trabalho do serviço de Enfermagem, inexistência de anotação de responsabilidade técnica do serviço de enfermagem, profissionais de Enfermagem que não registram o processo de Enfermagem contemplando as cinco etapas preconizadas, inexistência ou inadequação dos registros relativos à assistência de enfermagem, inexistência ou ausência de enfermeiro onde são desenvolvidas as atividades de enfermagem e exercício irregular da enfermagem. Conclusão:Conhecer o perfil das notificações emitidas pelo Conselho de Classe representa um norteador para os profissionais de enfermagem direcionarem a sua atuação, em consonância com a legislação de enfermagem vigente, com vistas a um cuidado de enfermagem seguro, ético e qualificado.

Objective:To survey and characterize the notifications of irregularities and illegalities issued by the Paraná Regional Nursing Council (COREN-PR) between the years 2018 to 2022. Method:Documentary research, with a quantitative approach, with COREN-PR as the research scenario. Data were collected from a primary source and from the public domain of COREN-PR regarding inspection reports containing the number of notifications for irregularities and illegalities issued between the years 2018 to 2022. The data were analyzed using simple statistical analysis. Results:There was a prevalence of notifications of non-existence or inadequacy of documents related to the management of work processes in the Nursing service, lack of notes on the technical responsibility of the nursing service, Nursing professionals who do not register the Nursing process contemplating the five recommended steps, non-existence or inadequacy of records related to nursing care, non-existence or absence of a nurse where nursing activities are carried out and irregular nursing practice. Conclusion:Knowing the profile of notifications issued by the Class Council represents a guide for nursing professionals to direct their actions, in line with current nursing legislation, with a view to safe, ethical and qualified nursing care.

Objetivo:Relevar y caracterizar las notificaciones de irregularidades e ilegalidades emitidas por el Consejo Regional de Enfermería de Paraná (COREN-PR) entre los años 2018 a 2022. Método:Investigación documental, con enfoque cuantitativo, teniendo como escenariode investigación el COREN-PR. Los datos fueron recopilados de fuente primaria y del dominio público de COREN-PR sobre informes de inspección que contienen el número de notificaciones de irregularidades e ilegalidades emitidas entre los años 2018 a 2022. Los datos fueron analizados mediante análisis estadístico simple. Resultados:Hubo predominio de notificaciones de inexistencia o insuficiencia de documentos relacionados con la gestión de procesos de trabajo en el servicio de Enfermería, falta de notas de responsabilidad técnica para el servicio de enfermería, Profesionales de enfermería que no registran el proceso de Enfermería contemplando los cinco pasos recomendados, inexistencia o insuficiencia de registros relacionados con los cuidados de enfermería, inexistencia o ausencia de enfermero en el lugar donde se desarrollan las actividades de enfermería y práctica irregular de enfermería. Conclusión:Conocer el perfil de las notificaciones emitidas por el Consejo de Clase representa una guía para que los profesionales de enfermería orienten sus acciones, de acuerdo con la legislación de enfermería vigente, con miras a una atención de enfermería segura, ética y calificada.

A proibição dos cigarros eletrônicos no Brasil: sucesso ou fracasso? / The ban of eletronic cigarettes in Brazil: success or failure?

Resumo O Brasil foi um dos primeiros países do mundo a proibir os Dispositivos Eletrônicos de Fumar (DEFs), tal proibição foi motivada pela inexistência de evidências relativas às alegadas propriedades terapêuticas e da inocuidade destes produtos. Por conta de tal proibição, A Anvisa foi criticada, especialmente de grupos de usuários. Estes grupos argumentam que tal ação proibiu um produto que auxiliaria a cessação ao tabagismo e seria menos tóxico que os cigarros comuns. Assim sendo, surge o questionamento se esta decisão foi acertada ou não. Os dados disponíveis mostram que os DEFs possuem formulações diversas e algumas substâncias tóxicas são liberadas durante sua utilização em níveis significativos. Estudos em animais e em humanos demonstraram potencial efeito tóxico. Os DEFs também demostraram que podem afetar a saúde de fumantes passivos. Quanto a seu uso como ferramenta de cessação, os estudos ainda não são conclusivos. Observou-se também um alto grau de uso entre adolescentes em países que seu uso foi autorizado. Desta forma o Brasil ao proibir estes produtos, impediu que a população consumisse um produto sem comprovação que auxiliasse no tratamento do tabagismo, com indícios de significativa toxidade e altamente atrativo aos jovens.

Abstract Brazil was one of the first countries in the world to ban Electronic Smoking Devices (ESDs). This ban was motivated by the lack of evidence regarding the alleged therapeutic properties and harmlessness of these products. Anvisa was criticized for this move, especially by electronic cigarette's users groups. These groups argue that prohibition prevented people's access to a product that would aid smoking cessation and be less toxic than ordinary cigarettes. Thus, the question arises as to whether this decision was successful. Available data show that ESDs have diverse formulations and some toxic substances are released at significant levels during use. Studies in animals and humans have shown a potential toxic effect, also affecting the health of passive smokers. Studies are still inconclusive regarding its use as a cessation tool. A high level of use among adolescents was observed in countries whose use was authorized. Thus, Brazil's ban prevented the population from consuming a product that has not been proven effective toward smoking cessation, with indications of significant toxicity and highly attractive to young people.

Oversight on the Bioethical Compliance of National R&D Projects or Research Personnel

BACKGROUND: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. METHODS: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. RESULTS: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. CONCLUSION: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.

Controle da corrupção e burocracia da linha de frente: regras, discricionariedade e reformas no Brasil / Controlling corruption in frontline civil service: rules, discretionary power, and reforms in Brazil / Contrôle de la corruption et bureaucratie en première ligne: règles, pouvoir discrétionnaire et réformes au Brésil

This article analyzes the relationship between the development of new public administration and the perception of corruption in Brazil under democratic rule. We contend that the reason for the persistently widespread perception of corruption in Brazil is that despite important changes in the institutions with oversight of the Brazilian state, such administrative reforms have assigned limited priority to frontline civil servants. Organizational progress in the new public administration has focused on upper-level public employees, with little impact on the middle and lower echelons, so that practices like graft and bribery between public employees and ordinary citizens are still commonplace. Thus, the management changes have failed to produce a perception of improvement in accountability, and corruption is still seen as common, even within a context of administrative changes.

Dans cet article, on examine le rapport entre l'expansion de la nouvelle gestion publique et la perception de la corruption dans le Brésil démocratique. On avance que, si l'idée de la corruption persiste, malgré les changements importants dans les institutions de contrôle de l'État brésilien, c'est parce que les réformes administratives n'ont pas bénéficié aux fonctionnaires de première ligne. Malgré les progrès, en matière de gestion, de la nouvelle administration, qui favorisent les hauts fonctionnaires, les changements institutionnels n'ont pratiquement pas changé la conduite des employés de bureau en contact avec l'usager, de telle sorte que la pratique de la concussion et du bakchich reste fréquente dans les rapports entre fonctionnaires et citoyens. Ainsi les modifications dans la gestion ne correspondent pas, chez ces derniers, à un sentiment d'amélioration de la redevabilité du service public, ce qui préserve donc la sensation de corruption malgré ce cadre de transformations.

Research Ethics, Governance, Oversight And Public Interest

A better educated public has started to challenge the way decisions are made in medical research activities. Although Institutional and National Guidelines on Research are in place, there are fears that Institutional Review Boards (IRBs) and funding agencies are only fairly active in scientific and ethical reviews of research proposals but not on oversight of projects after their initiation. These issues are integral to good research governance and researchers and custodians of research ethics must ensure that public interest is not compromised. Medical progress is based on research including human experimentation carried out according to guiding principles as enunciated in the Declaration of Helsinki (2000), but the quality of compliance with the Declaration is an important issue. Better choice and appropriate training of members of IRBs to improve the quality of decision making and governance processes are urgently needed. Competency in evaluation of proposals requires not only the appropriate scientific knowledge but also access to relevant preclinical and other data. Unfortunately, the completeness and quality of such data may not be adequate. Public interest demands that injury to trial subjects in clinical trials is minimized if not avoided completely. Unfortunately this is not always possible with trials where novel biological modes of action are tested. A more robust evaluation mechanism for project approval may minimize but not completely avoid injury to subjects; thus insurance cover to provide care and compensation to subjects must be compulsory. The decision to approve or reject a project must be based on the balance of potential risks and benefits, taking into consideration justifiable distributive risks to target communities and populations. Economic considerations should never be the primary focus, especially when there are real concerns that the migration of early phase clinical trials including vaccine trials to developing countries is based on the perceived less stringent ethical requirements and oversight there.

Discutindo o Significado de Cidadania a Partir dos Direitos dos Usuários da Saúde / Discutindo el Significado de Ciudadanía a Partir de los Derechos de los Usuarios de la Salud / Discussing the Meaning of Citizenship from the Standpoint of Health Users' Rights

O objetivo do estudo foi ampliar informações, estimulando o espírito crítico/reflexivo dos usuários do Sistema Único de Saúde (SUS) sobre o significado de cidadania construído a partir da Carta dos Direitos dos Usuários da Saúde e do conceito de participação popular. Trata-se de pesquisa participante construtivista, realizada em hospital universitário do sul do Brasil, entre junho e outubro de 2007. Os dados foram submetidas à análise de conteúdo. Resultados: nós críticos constituídos pelas categorias - gestão/organização do SUS; formação de recursos humanos; modelo de assistência e controle social. Cabe aos profissionais da saúde informar e orientar os usuários, sem usar de manipulação, levando-os a participar das decisões sobre o cuidado/assistência à sua saúde e respeitando seus direitos à dignidade, privacidade e liberdade. Afinal, o SUS é o sistema de saúde vigente e fazer com que ela funcione é responsabilidade de todos e de cada um.

Aim: To improve the information level in order to stimulate thinking and criticism among users of Brazil’s national health system (SUS) as regards the meaning of citizenship as based on the Charter of Health Users’ Rights and the concept of popular participation. Methods: constructivist participatory research at a university hospital in southern Brazil, from June to October 2007. Data was analyzed using Bardin’s methodology. Results: critical nodes constituted by the categories: SUS management/organization; training; and model of care and social oversight. Conclusion: it is incumbent on health workers to inform and guide SUS users, without manipulation, so as to enable them to participate in decisions on their health care and related procedures, while preserving their rights to dignity, freedom and privacy. After all, the SUS is the current health system and it is everyone’s responsibility to make it work appropriately.

El objetivo del estudio fue ampliar las informaciones, fomentando el espíritu crítico/reflexivo de los usuarios del Sistema Único de Salud (SUS) sobre el significado de la ciudadanía constituido a partir de la Carta de los Derechos de los Usuarios de la Salud y del concepto de participación popular. Se trata de investigación constructivista, realizada en hospital universitario del sur de Brasil, en los meses de junio a octubre de 2007. Los datos fueron sometidos al análisis de contenido. Resultados: nudos críticos constituidos por las categorías - gestión y organización del SUS; formación de recursos humanos; modelo de asistencia y de control social. Cabe a los profesionales de la salud informar y orientar los usuarios, sin usar la manipulación, que los lleva a participar en las decisiones sobre el cuidado/asistencia a su salud y respetando sus derechos a la dignidad, la privacidad y la libertad. El SUS es el actual sistema de salud y garantizar que todo esté bien es responsabilidad de todos y de cada uno.