Cases Analysis and Countermeasures Discussion on Ethical Review of Clinical Trial Protocol Violation / 中国医学伦理学

To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.

Percepción de los profesionales interventores de organismos colaboradores del Servicio Mejor Niñez sobre la vulneración de los derechos de niños, niñas y adolescentes en comuna centro-sur de Chile: una mirada desde el contexto de pandemia / Perception of professional officers involved with the Childhood Improvement Service Regarding the infringement of the rights of children and adolescents in a commune in the central-south of Chile. A view from the pandemic context

Resumen El Servicio Mejor Niñez es un organismo público que tiene como objetivo garantizar la protección de derechos de niños, niñas y adolescentes al amparo de la Ley N.º 21302. En los últimos años, se ha visto cuestionado tanto por la opinión pública como por organismos internacionales, por incumplimiento de las funciones para la cual se creó. En esta línea, el objetivo de esta investigación se centró en la percepción de los profesionales interventores sobre la vulneración de derechos sobre niños, niñas y adolescentes en la zona centro-sur de Chile. Estas personas son profesionales en Psicología y Trabajo Social que durante años han trabajado en programas de protección de vulneración de derechos, y han desempeñado un rol protector en cuanto a la protección de estos derechos. Para ello, se utilizó un método cualitativo basado en un enfoque fenomenológico, a partir de entrevistas que permitieron conocer los significados y percepciones sobre su ejercicio profesional. Los resultados destacan la visión opuesta y extrema de los profesionales sobre el proceso de intervención (satisfactoria y frustrante), así como la diversidad de modelos o enfoques utilizados en el proceso, lo que parece indicar que no existe una sistematización teórica en cuanto a la intervención que cada programa utiliza. Se estableció una reflexión importante sobre la ejecución de políticas en infancia y adolescencia que buscan promover el desarrollo integral en el marco postpandemia por COVID-19, considerando que muchas personas menores de edad se vieron nuevamente expuestas a vulneraciones de derechos durante el proceso de pandemia.

Abstract The Childhood Improvement Service is a public agency whose objective is to guarantee protection of the rights of children and adolescents with respect to the enactment of Law No. 21302. This has been questioned in recent years by both public opinion and international organizations, in relation to a failure to fulfill the functions for which it was created. In this sense, the objective of this research focused on the perception of professionals involved in children's and adolescents' rights in the central-south zone of Chile. The professionals are psychologists and social workers who have worked to protect the rights circumscribing the different types of interventions and multidisciplinary approaches carried out. For this purpose, a qualitative method was used in phase with a phenomenological approach, based on interviews that allowed ascertaining the meanings and perceptions regarding their professional practice. The results highlight the opposed and extreme views of the professionals in the intervention process (satisfactory versus frustrating), as well as the diversity of models or approaches used in the process, which seems to indicate that there is no theoretical systematization regarding the intervention applied by each program. Establishing an important reflection on the implementation of policies in childhood and adolescence that seek to promote integral development in the post-Covid-19 Pandemic framework.

Masacre estudiantil de 1975 en El Salvador: memorias, silencios y activaciones políticas

(analítico) Se presenta un estudio de caso sobre la masacre de estudiantes de 1975 en El Salvador como expresión del fracaso del proceso de paz; en tanto la justicia transicional se redujo a leyes de amnistía que dejaron heridas abiertas por ausencia de verdad, reparación y justicia. Se presenta un breve contexto sobre los acontecimientos, un diálogo con la entrevistada y unas reflexiones finales en relación con las memorias, los silencios y las activaciones políticas. Para ello, se recurrió a una entrevista en profundidad desarrollada entre 2018 y 2019.

(analytical) This article is a case study that views the 1975 student massacre in El Salvador as an expression of the failure of the peace process, given that transitional justice was reduced to amnesty laws that left open wounds as a result of the absence of truth, reparations and justice. The article contains a brief contextualization of the events, dialogue with the interviewee and some final reflections regarding memory, silences and political activation. An indepth interview conducted between 2018 and 2019 was used for this purpose.

(analítico) Este artigo é um estudo de caso sobre a massacre de estudantes do ano 1975 em El Salvador como expressão do fracasso do processo de paz, uma vez que a justiça de transição foi reduzida a leis de amnistia que deixaram feridas abertas na ausência de verdade, reparação e justiça. São apresentados um breve contexto dos acontecimentos, um diálogo com a entrevistado e algumas reflexões finais sobre memórias, silêncios e ativações políticas. Para este efeito, foi realizada uma entrevista aprofundada entre 2018 e 2019.

Analysis on Protocol Violation in Pediatric Clinical Trials and Its Countermeasures / 中国医学伦理学

By collecting 475 protocol violation reports of pediatric clinical trials accepted by the ethics committee of a grade A tertiary hospital from January 2016 to December 2022, and conducting classification statistics of the responsible body, types of violation, and natures of violation, this paper analyzed and discussed the specific reasons and response measures for protocol violation. The results showed that the most common types of protocol violation included missed medication and incorrect medication dosage for pediatric research participants, missed laboratory inspection, over-windowed follow-up, and non-compliance with inclusion/exclusion criteria. And the responsibility bodies were pediatric research participants and/or their guardians, followed by the researchers. Besides, the sponsor, clinical trial coordinator, and other factors also contributed to protocol violation. Establishing awareness of responsible body, emphasizing subject management, building sound quality control system, and strengthening ethical supervision are the main countermeasures to prevent and reduce protocol violation in pediatric clinical trials, which helps to protect the safety and rights of pediatric research participants and promote standardized research in pediatric clinical trials.

Responsabilização ou Punição: Violações de Direitos na Medida Socioeducativa de Internação / Liability or Punishment: Violations of Rights in Socio-Educative Measure of Confinement / Responsabilizacion o Castigo: Violaciones de Derechos en la Medida Socioeducativa de Internacion

Este artigo tem como objetivo analisar as violações de direitos na vida de jovens em cumprimento de medidas socioeducativas de internação. Foi realizada uma pesquisa com dez jovens que cumpriam medida socioeducativa de internação em uma cidade do estado da Paraíba. Utilizou-se uma entrevista aberta individual abordando o cotidiano dos jovens na unidade de internação. Os dados foram analisados a partir da Análise Temática de Conteúdo, organizados na classe temática Violações de direitos durante o cumprimento da medida socioeducativa, com as respectivas categorias: Violência física e psicológica, Enclausuramento, Superlotação, Negligência, Consequências da medida disciplinar e Revista íntima vexatória. Conclui-se que o cumprimento da medida socioeducativa de internação se caracteriza pela permanência da cultura punitiva, evidenciando a necessidade de um projeto pedagógico que norteie as ações nas unidades e as atividades de todos os profissionais que atuam nas instituições de medidas socioeducativas, e que efetive a garantia de direitos dos jovens.

This article aims to analyze violations of rights in the lives of young people in fulfillment with socio-educative measures of confinement. A survey was conducted with ten young people who fulfilled socio-educational measures of confinement in a city in the state of Paraíba. An individual unstructured interview addressing the daily life of young people in the confinement unit was used. The data were analyzed from the Thematic Content Analysis, organized in the thematic class Violations of rights during the fulfillment of the socio-educational measure, with the respective categories: Physical and psychological violence, Enclosure, Overcrowding, Neglect, Consequences of disciplinary action and Vexatious intimate search. It was concluded that fulfillment with the socio-educative measure of confinement has been characterized by the permanence of punitive culture related to the absence of activities based on the pedagogical dimension, evidencing the need for a pedagogical project that guides the actions in the units and the activities of all professionals who work in the institutions of socio-educational measures, and that effectively guarantees the rights of young people.

Este artículo tiene como objetivo analizar las violaciones de los derechos en la vida de los jóvenes en cumplimiento de las medidas socioeducativas de internación. Se realizó una encuesta con diez jóvenes que cumplen medida socioeducativa de internación en una ciudad del estado de Paraíba. Se utilizó una entrevista individual abierta para abordar la vida cotidiana de los jóvenes en la unidad de internación. Los datos se analizaron a partir del Análisis de contenido temático, organizados en la clase temática Violaciones de derechos durante el cumplimiento de la medida socioeducativa, con las respectivas categorías: violencia física y psicológica, encierro, enclaustramiento, negligencia, consecuencias de la medida disciplinaria y revista vejatoria íntima. Se concluye que el cumplimiento de la medida socioeducativa de internación se ha caracterizado por la permanencia de la cultura punitiva, evidenciando la necesidad de un proyecto pedagógico que oriente las acciones en las unidades y las actividades de todos los profesionales que trabajan en las instituciones de medidas socioeducativas, y para garantizar los derechos de los jóvenes.

Cases Analysis and Countermeasures Discussion on Ethical Review of Clinical Trial Protocol Violation / 中国医学伦理学

To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.

Efectividad de la política criminal colombiana hacia la prevención del delito / The Colombian Criminal Policy's Effectiveness Preventing Crime / Eficácia da política criminal colombiana para a prevenção do crime

Resumen El presente artículo desarrolla un análisis descriptivo cuantitativo sobre el desempeño del sistema a través del cual el Gobierno Colombiano implementa su política pública criminal: sistema judicial, penal y penitenciario. Este estudio no se realiza desde el punto de vista del derecho, sino desde la perspectiva de la evaluación de su efectividad, entendiendo la criminalidad como un problema social. El impacto de este artículo radica en la posibilidad de entender y abordar el fenómeno de la criminalidad desde un enfoque preventivo. Esto, al identificar un desequilibrio dinámico de los componentes del sistema que refuerza el problema, evidenciando deficiencias en la finalidad de la política criminal como política pública debería propender por la prevención del crimen y por el contrario refuerza un ciclo vicioso que incrementa impunidad. Este ciclo ha desgastado operativamente al Estado y ha generado un alto costo como resultado de los altos índices de criminalidad.

Abstract This article performs a descriptive, quantitative analysis of the performance of the system through which the Colombian Government implements its criminal public policy: judicial, criminal justice and penitentiary systems. This study is not performed from the point of view of law, but from a perspective evaluating its effectiveness, considering crime a social issue. This article impacts the possibility of understanding and facing the phenomenon of crime from a preventive approach. This, upon identifying a dynamic imbalance of the system's components, which strengthens the problem, shows deficiencies in the purpose of criminal policy as a public policy that promotes prevention and emphasizes a vicious cycle that increases impunity. This cycle has operationally worn-out the Government and has generated high costs as a result of high crime indices.

Resumo Este artigo desenvolve uma análise descritiva quantitativa sobre o desempenho do sistema por meio do qual o Governo colombiano implementa sua política pública criminal: sistema judicial, penal e penitenciário. Este estudo não é realizado do ponto de vista do direito, mas da perspectiva de avaliar sua eficácia, entendendo o crime como problema social. O impacto deste artigo reside na possibilidade de compreender e abordar o fenómeno do crime a partir de uma abordagem preventiva. Isto, ao identificar um desequilíbrio dinâmico dos componentes do sistema que reforça o problema, mostra deficiências na finalidade da política criminal como política pública que visa à prevenção e acentua um ciclo vicioso que aumenta a impunidade. Este ciclo desgastou operacionalmente o Estado e gerou um custo elevado em decorrência dos altos índices de criminalidade.

Crashes and Traffic Signal Violations Caused by Commercial Motorcycle Couriers

BACKGROUND: Motorcycles are one of the important members of commercial transportation because of the convenient use during congested traffic conditions and the ease of parking in narrow streets. This study investigates the characteristics of crashes and traffic signal violations caused by motorcycle couriers. METHODS: From the national compensation data, this study analyzed the traffic crashes caused by 671 motorcycle couriers. RESULTS: Among 671 injured couriers, 50.6% were aged less than 40 years, 49.2% run in a small business of < 5 employees, and 47.2% had work experience of < 6 months. Motorcycle crashes occurred mainly due to “rider overturned alone” (67.5%), in the daytime (73.5%), or on cloudy or clear days (77.2%). However, the violation rate caused by motorcycle couriers was high in couriers in a small business of < 5 employees (13.9%), with work experience of < 6 months (13.9%), on cloudy or clear days (12.4%), on an intersection (29.8%), in the type of “crash with a vehicle” (31.2%), or in a death accident (35.7%). CONCLUSION: The findings of this study can be used as a baseline in devising policies for preventing crashes of motorcycle couriers.

Visão de jovens pais e mães sobre medidas de acolhimento institucional de seus filhos / Vision of young fathers and mothers on measures of institutional sheltering of their children

Reflete-se aqui sobre condições de vida e de consciência de jovens com filhos em acolhimento institucional, cujas medidas judiciais visaram preservar direitos ameaçados ou violados destas crianças. A pesquisa procurou identificar os elementos fundamentais que interferiram na reprodução social da família e que comprometeram a proteção e os cuidados para com os filhos destes jovens. Verificou-se que estas situações denunciam uma expressiva falta de condições de vida para si e para seus filhos.

It reflects here on living conditions and awareness of young people with children in institutional sheltering, whose judicial measures aimed at preserving the threatened or violated rights of these children. The research sought to identify the fundamental elements that interfered in the social reproduction of the family and which compromised the protection and care for the children of these young people. It was found that these situations denounce a total lack of living conditions for themselves and their children.

O fazer profissional no CREAS: ilhas, travessias e descaminhos possíveis / The professional make in CREAS: islands, crossings and misplacements possible / El hacer profesional en el CREAS: islas, travesías y descaninos posibles

O artigo problematiza o fazer cotidiano dos profissionais no Centro de Referência Especializado de Assistência Social (CREAS), além de discutir o trabalho ofertado por este serviço e a sua interação com as demais políticas sociais, bem como as repercussões da atual conjuntura socioeconômica no atendimento à violação de direitos, no contexto do Sistema Único de Assistência Social (SUAS). Para tal discussão, além de uma revisão teórica sobre a Política de Assistência Social, são construídas narrativas dos autores a partir de suas experiências profissionais no CREAS. O debate realizado pelos profissionais aponta para um trabalho que se caracteriza pela fragmentação e por serviços configurados em "ilhas". Nesse sentido, reflete-se sobre possibilidades de construção de aproximações, a partir de pontes e descaminhos que estabeleçam a comunicação entre os diversos serviços, resultando na qualificação das intervenções e proteção social aos usuários. (AU)

The article discusses the daily practice of professionals in Centro de Referência Especializado de Assistência Social (CREAS), besides discussing the work offered by this service and its interaction with other social policies, as well as the repercussions of the current socioeconomic situation in relation to the violation of rights, in the context of Sistema Único de Assistência Social (SUAS). For this discussion, in addition to a theoretical revision on Social Assistance Policy, narratives of the authors are constructed based on their professional experiences in CREAS. The debate carried out by professionals points to a work characterized by fragmentation and services configured in "islands". In this sense, it is reflected on possibilities of construction of approximations, from bridges and misplacements that establish communication between the various services, resulting in the qualification of interventions and social protection to users. (AU)

El artículo problematiza el hacer cotidiano de los profesionales en el Centro de Referência Especializado de Assistência Social (CREAS), además de discutir el trabajo ofrecido por este servicio y su interacción con las demás políticas sociales, así como las repercusiones de la actual coyuntura socioeconómica en la atención a la violación de derechos, en el contexto del Sistema Único de Assistência Social (SUAS). Para tal discusión, además de una revisión teórica sobre la Política de Asistencia Social, se construyen narrativas de los autores a partir de sus experiencias profesionales en el CREAS. El debate realizado por los profesionales apunta a un trabajo que se caracteriza por la fragmentación y por servicios configurados en "islas". En este sentido, se reflexiona sobre posibilidades de construcción de aproximaciones, a partir de puentes y descaminos que establezcan la comunicación entre los diversos servicios, resultando en la calificación de las intervenciones y protección social a los usuarios. (AU)

De quem é este bebê? Movimento social de proteção do direito de mães e bebês juntos, com vida digna! / Whose baby is this?: Social movement to protect rights of mothers and babies together, with worthy life!

Em Belo Horizonte filhos de mulheres na maioria negras e pobres, com histórico de uso de álcool e outras drogas, trajetória de rua, sofrimento mental, estão sendo separados de suas mães, ainda na maternidade. Os serviços de saúde, pressionados pelas recomendações 5 e 6 de 2014 da 23ª Promotoria de Justiça da Infância e Juventude Cível do Ministério Público passaram a avaliar a aptidão/inaptidão da mãe para o cuidado com o filho, ainda na maternidade. As mães se viram obrigadas a provar sua inocência e capacidade de cuidar do filho, em um contexto em que seu passado pesa desproporcionalmente sobre sua possibilidade de futuro. O movimento "De quem é este bebê?" traz visibilidade e concretiza ações de enfrentamento às situações de violação de direitos de mães, bebês e famílias de permanecerem juntos, tendo em vista o registro de aumento expressivo do número de bebês retidos nas maternidades e de bebês abrigados em BH, além da aceleração dos processos de adoção, segundo a Defensoria Pública de MG. Este movimento envolve diversas entidades comprometidos com a defesa dos direitos das populações em situação de maior vulnerabilidade e defesa da ética profissional em saúde. Atua em defesa dos direitos da mulher à maternidade segura, com assistência digna e livre de qualquer discriminação, das crianças ao nascimento respeitoso, incentivo à convivência com a sua família e contra o afastamento compulsório de suas mães na maternidade antes de esgotados todas as possibilidades e deveres do Estado de proteção social e de cuidado em saúde. (AU)

In Belo Horizonte (BH) children of social excluded mothers, mostly black and poor, history of alcohol and other drugs use, street living trajectory or mental suffering, are being separated from their mothers, right aGer birth, still in the maternity ward. Health professionals, under pressure from the 5th and 6th recommendations 2014 of the 23rd Public Prosecutor's Office for Children and Youth, began to evaluate the aptitude or inability of the mothers to care for the child within in the maternity hospital. Mothers have been forced to prove their innocence and ability to care for their child, in a context in which their past weighs disproportionately on their future possibility. The movement "Whose baby is this?" Brings visibility and concrete actions to face situations of violation of the rights of mothers, babies and families to stay together, according to the significant increase in number of newborns retained in maternity wards and babies sheltered in BH and, as publicized by the Public Defenders of MG, acceleration of the adoption processes. This movement involves actors from various entities and citizens, committed to defend the rights of vulnerable populations and defend professional ethics in health. The movement uncovers actions of abuse of power of judicial authority through hygienic health interventions as a contemporary example of biopower, to the detriment of full citizenship rights. It acts in defense of the rights of women to safe motherhood, with dignity and respecVul care, free from any kind of discrimination, the r ight of children to respec Vul birth, encouragement of family coexistence and against compulsory shelter before achieving all possibilities and duties of social protection by the State.(AU)

Graves vulneraciones de derechos en la infancia y adolescencia: variables de funcionamiento familiar / Serious Violations of Rights in Children and Adolescents: Variables of Family Functioning

Resumen La presente investigación tiene por objetivo determinar las características y problemáticas que se presentan en el funcionamiento familiar de 389 niños, niñas y adolescentes víctimas de graves vulneraciones de derechos en Chile, mediante la aplicación de la Escala deEvaluación Familiar de Carolina del Norte (NCFAS-G). Sus resultados identifican problemáticas centrales en esta muestra, tales como una moderada vulnerabilidad socioeconómica, dificultades en las interacciones entre sus miembros y con su entorno (familia, vecindario), así como debilitamiento de las competencias parentales.Se concluye que las variables de dinámica relacional de la familia y la pareja, los vínculos afectivos, la parentalidad y la autonomía familiar requieren ser abordadas mediante una intervención integral, sistémica, coordinada y oportuna.

Abstract The present research aims to determine the characteristics and problems that occur in the family functioning of 389 children and adolescents victims of serious violations of rights in Chile, through the implementation of the North Carolina Family Assessment Scale (NCFAS-G). The results identify central problems in this sample, such as a moderate socio-economic vulnerability, difficulties in the interactions between their members and their environment (family, neighbourhood), as well as weakening of parental competences. The conclusion is that the variables of relational dynamics of the family and the couple, affective bonds, parenthood and family autonomy need to be addressed through an integral, systemic, coordinated and timely intervention.

Intervenciones de niños, niñas y adolescentes con vulneración de derechos: Evaluación de funciones ejecutivas y habilidades parentales / Interventions for infringement on rights of children and adolescents: Executive functions and parental skills evaluation

La interacción con los padres o adultos significativos (P/AS) en los primeros años de vida, afecta el desarrollo de las funciones ejecutivas (FE), y éstas a su vez, en el rendimiento escolar de niños y niñas (NN). El maltrato se asocia a trastornos en el desarrollo de las FE. En Chile, 173000 NN se encuentran judicializados por algún tipo de maltrato y han sido derivados al SENAME. Pruebas estandarizadas miden FE y Habilidades Parentales (HP). Se busca explorar las FE en NN judicializados (NNj) y las HP de sus P/AS. Objetivo. Medición de FE en NNj y de HP en sus P/AS y establecer la relación entre sus resultados y compararlas con un grupo control. Metodología: NN de 2° ciclo escolar básico y uno de sus P/AS: Estudio 25 NNM (promedio 10,3 años) del Programa de Prevención Focalizada San José de Peñalolén; Control 24 NN no judicializados (NNn) (10,6 años) de dos colegios (de Ñuñoa y Peñalolén). Consentimiento informado firmado de cada participante. El estudio ingresó al Comité de ética de la Pontificia Universidad Católica de Chile (PUC). Enero-Julio/2017, se aplicó el Test ENFEN© a los NN (mide FE) y la Prueba E2P© (mide HP) a sus P/AS. Se calcula promedio ± DE a cada prueba y se realiza prueba t y de Levene para comparar grupos. Resultados: (NNM; NNn) ENFEN 3.09 ±1.66; 6.45 ±0.75; IC: [-4,1- -2,1] α: 0,005. E2P©: 76.3 ±12.06; 81.8±5. IC [-10,1- -0,06] α 0,001. Discusión: Los resultados demuestran que existe relación entre HP y FE en el contexto del maltrato.

Summary. Introduction. Interaction with parents or significant adults (P/AS) in early childhood affects the development of executive functions (FE), and these in turn, in school performance of boys and girls (NN). Child abuse is associated with disorders in the development of the FE. In Chile, there are 173000 NN involved in legal cases prosecuted for child abuse, who have been referred to SENAME. There are standardized tests that measure FE and parental skills (HP). This study seeks to explore the FE in these NN (NNM) and the HP of their P/AS. Goal. Measurement of FE in NNM and HP on their P/AS to establish a relationship between its results and compared to a control group. Methodology: NN of 2nd cycle basic school and one of their P/AS: study of 25 NNM (average 10.3 years) of the Focused Prevention Program San Jose of Peñalolén; control group are 24 NN not involved in child abuse cases (NNn) from two schools (in Ñuñoa and Peñalolén) (10.6 years). A signed informed consent of each participant was obtained. The study was approved by the Ethics Committee of PUC. From January to July / 2017, the Test ENFEN © was applied to NN (measured on FE) and the E2P © test (measures HP) to their P/AS. The average ±SD to each test, t and Levene tests were calculated to compare the groups. Results: (NNM; NNn) ENFEN 3.09 ±1. 66; 6.45 ±0. 75; CI: [- 4.1-2.1] Α: 0.005. E2P ©: 76.3 ±12. 06; 81. 8±5. IC [- 10.1-0.06] Α 0.001. Discussion: The results show that there is a relationship between HP and FE in the context of child abuse.

Violation of Human Rights of Leprosy Afflicted Persons: Some Real Life Experiences

In the present study an attempt has been made to understand the observance of marginalization and social exclusion of leprosy patients in their family and community and their violation of human rights. A total of forty (40) leprosy Afflicted Persons (LAPs), 20 without deformities and 20 having deformities were selected through stratified random sampling method from 'The Leprosy Mission Hospital (TLM)' of Allahabad district of Uttar Pradesh (India). Narratives of lived experiences of LAPs, supplement with observations, were used for data collection to observe the interaction patterns of LAPs with their family, neighbors and community members. The content analysis of data indicates that some of the LAPs experienced isolation and discrimination in their family, community and economic life. Some of the medical personnel also showed their hesitance in providing health services to them. It is also found that socio-economic problems became more in case of LAPs with visible deformities in comparison to LAPs who did not have deformities. Traditional cultural beliefs of the disease like the 'sin of previous birth', 'punishment of God', and 'fear of infection by germs', appear to be contributing to social, cultural, economic isolation of these patients. On the contrary lack of awareness about the ailment and also modern medical belief system like disease is not infectious and curable are may be helping in promoting their integration into their family and community, however, these aspects need to be studied in depth in current scenario. As present study is just based on some examples from a select group, it can not be considered as representative of all LAPs across the country which, however, should not be ignored at person level specially from the perspective of human rights. Health education programmes should be better implemented to prevent the physical disabilities, to reduce the traditional cultural beliefs and values associated with leprosy.

Ethics Committee' s Management of Noncompliance/Violation or Protocol Deviation Report in Clinical Research / 中国医学伦理学

With the promulgation of a series of laws and regulations in our country, the requirement for stand-ardized management of clinical research process are gradually clear, and higher requirements on the following-up review management of ethics committee also are put forward. Through concluding and summarizing 128 noncompli-ance/violation or protocol deviation reports accepted by a hospital in recent two years, this paper analyzed four main problems including that the researchers at management level failed to report or report timely; the researchers reported in irregular filling;the same type of violation/deviation program happened repeatedly and the rectification to the review opinions of ethics committee was ineffective, and also put forward the corresponding suggestions, in order to strengthen and perfect the standard management of noncompliance/violation or protocol deviation report.

Sexual Boundary Violation between Psychiatrist and Patient / 신경정신의학

Recently, the Korean Neuropsychiatric Association expelled one of its members on grounds of multiple ethical violations, which included a sexual boundary violation between doctor-patient relationships. However, the lack of understanding of why this is an ethical issue was found among the general population as well as psychiatric professionals. In this review article, we introduce the basic concepts of psychotherapy and psychiatrist-patient relationships, including therapeutic structure and transference/countertransference, and elaborate the reasons why boundary violations, and especially sexual boundary violations, are unethical and potentially harmful to the patient and to the psychiatric community.

Medical Litigations Associated with Cataract Surgery in Korea

BACKGROUND: To analyze the results of court rulings about medical litigations related to cataract surgery in Korea. METHODS: We collected 50 anonymized judgements regarding cataract surgery between 2000 and 2016 and analyzed the reasons for the medical litigations, the court rulings, the reasons for compensation, and the amount claimed and finally awarded. RESULTS: Forty-eight litigations (96%) resulted from errors in treatment, and the reasons were as follows: endophthalmitis, dissatisfaction of visual outcome or ocular discomfort, bullous keratopathy or corneal opacity, retinal detachment, glaucoma or vitreous hemorrhage due to the progression of an underlying diabetic retinopathy, and others in order. Two litigations (4%) arose due to errors in diagnosis. Among the 50 final cases, 21 litigations (42%) were decided in favor of the plaintiff, and 29 litigations (58%) were decided against the plaintiff and dismissed. Ten cases awarded damages to the plaintiffs because of a violation of duty of care, and 11 cases awarded damages due to a violation of informed consent. When comparing cases with errors in diagnosis to cases with errors in treatment, there was no significant difference in the relative risk of a defendant's verdict (P = 0.503). The total amount of awarded damages was KRW 439,124,496 (USD 399,204), and the average amount was KRW 20,910,690 (USD 19,010). CONCLUSION: Nearly half of the cases were decided in favor of the plaintiff due to the violation of informed consent. This study's results will be helpful in understanding the results of medical litigations regarding cataract surgery and reducing future lawsuits.

Practice and cogitation of ethical review of medical research involving human subjects / 中华医学科研管理杂志

Objective To enhance the recognition of the ethical principles and provide reference for the ethical review in medical research involving human subjects.Methods By summarizing the ethical review of the projects involving human subjects in past three years,analyzing common issues identified,and proposing the corresponding solutions.Results Conducting ethical review for research involving human subject according to ethical principles,is helpful for the protection of human subject,and also for the internationalization of medical research in China.Conclusions For the development of medical research in long term,the ethical review is necessary.All investigators need to improve their understandings and execute the ethical principles well in their research practice.

La vida posible de poblaciones expuestas a sustancias tóxicas: desafíos para una cultura de paz

La dignidad humana se reconoce como el principio ético básico que fundamenta la forma de gobierno democrática adoptada constitucionalmente en Paraguay. Este principio se entiende como autonomía o como posibilidad de diseñar un plan vital y de determinarse según características propias, requiere de ciertas condiciones materiales concretas de existencia y exige protección de la integridad física e integridad moral. Desde esta perspectiva, se reflexiona, a partir del análisis de estudios sobre poblaciones expuestas a sustancias tóxicas en diferentes contextos, acerca de la vida posible de dichas poblaciones, condicionada por la vulneración de derechos básicos, situación que plantea desafíos para promover una educación para la paz desde dichas realidades.

Human dignity is recognized as the basic ethical principle that underlies the form of democratic government constitutionally adopted in Paraguay. This principle is understood as autonomy or as the possibility to design a life plan and to determine one's own choices according to one's own characteristics. It requires certain basic material conditions of existence, which include the protection of an individual's physical and moral integrity. Based on this perspective, we reflect about the possible life of populations exposed to toxic substances, using analyses of overpopulation studies exposed to toxic substances in different contexts, conditioned by the violation of basic human rights, a reality that poses challenges in the promotion of education towards a peaceful existence.

Violação de direitos de crianças e adolescentes: elementos para uma reflexão metodológica na pesquisa social / Violación de derechos de niños y adolescentes: elementos para una reflexión metodológica en la investigación social / Violation of rights of children and adolescents: elements for a methodological reflection in social inquiry

Este artigo tem por objetivo problematizar alguns elementos de caráter epistemológico e metodológico na produção de conhecimento na pesquisa social, tomando por objeto de discussão um conjunto de dados de pesquisa desenvolvida no Programa SOS Criança, do estado do Rio Grande do Norte. A partir de breve contextualização das condições históricas que contribuíram para o surgimento e consolidação do modo de produção capitalista e do modelo de ciência que lhe deu suporte, o positivismo, esboça-se uma crítica da perspectiva gnosiológica do conhecimento. Aponta-se a necessidade de um saber que considere a gênese e o desenvolvimento dos fenômenos sociais, ou seja ontológico, portanto, lançando mão de categorias dialéticas como totalidade e essência. Toma-se por campo para essa discussão a análise dos dados sobre violação de direitos de crianças e adolescentes, em que as mães aparecem ao mesmo tempo como principais cuidadoras e violadoras.(AU)

Este artículo tiene para el objetivo a problematizar algunos elementos del carácter epistemológicos y metodológicos en la producción del conocimiento en la investigación social, tomando para el objeto de la discusión un sistema de datos de investigación desarrolladas en el Programa Infantil SOS del Rio Grande do Norte. Desde breve reseña de las condiciones históricas que contribuyeron a la aparición y consolidación del modo de producción capitalista y el modelo de la ciencia que le dio el apoyo, el positivismo, esquemas es una crítica de la perspectiva epistemológica del conocimiento. Apunta a la necesidad de conocer a considerar la génesis y el desarrollo de los fenómenos sociales, que es ontológica, por lo tanto, recurrir a las categorías dialécticas en su conjunto y la esencia. Si de el que está para el campo para esta discusión para analizar los datos en violación de los derechos de niños y adolescentes, donde aparecen las madres al mismo tiempo que los principales cuidadores y violadores.(AU)

This article aims to discuss some elements epistemological and methodological of character in in the knowledge production in the social inquiry, taking as a subject of discussion a set of inquiry fact developed in the SOS Child Program of the Rio Grande do Norte state. From brief background of the historical conditions that contributed to the emergence and consolidation of the capitalist mode of production and the model of science that gave him support, positivism, outlines is a critique of the epistemological perspective of knowledge. Points to the need to know to consider the genesis and development of social phenomena, that is ontological, therefore resorting to dialectical categories as a whole and essence. It is taken for field for this discussion to analyze the data on violation of rights of children and adolescents, in which mothers appear at the same time as primary caregivers and violators.(AU)