Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 61
Filter
1.
Chinese Acupuncture & Moxibustion ; (12): 1273-1275, 2021.
Article in Chinese | WPRIM | ID: wpr-921044

ABSTRACT

The elements of ethical review related to clinical research of acupuncture and moxibustion is discussed to provide ideas for various institutions to carry out relevant ethical review. It is believed that the ethical review of clinical research of acupuncture and moxibustion needs to focus on the specificity of acupuncture and moxibustion. Starting from the basic theory of traditional Chinese medicine, the theory of meridians and acupoints and the theory of syndrome differentiation along meridians, the key contents of ethical review such as intervention methods, grouping design and placebo control should be considered, so as to standardize the clinical research of acupuncture and moxibustion and protect the health and rights and interests of participants.


Subject(s)
Acupuncture Points , Acupuncture Therapy , Biomedical Research , Ethical Review , Humans , Meridians , Moxibustion
2.
Article in Chinese | WPRIM | ID: wpr-879081

ABSTRACT

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Subject(s)
Biomedical Research , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal , Ethical Review , Humans , Medicine, Chinese Traditional , Multicenter Studies as Topic , Pharmaceutical Preparations
3.
Rev. baiana enferm ; 35: e45319, 2021. tab
Article in Portuguese | LILACS, BDENF | ID: biblio-1351615

ABSTRACT

Objetivo caracterizar o perfil dos Comitês de Ética em Pesquisa de um município baiano. Método estudo de abordagem quantitativa, com análise descritiva dos resultados, realizado em cinco Comitês de Ética em Pesquisa. A coleta de dados deu-se por questionário autoaplicado na Plataforma Google Forms. Resultados evidenciou-se maioria de membros do gênero masculino, com curso de pós-graduação stricto sensu, ingresso por convite e capacitação prévia para atuarem nos Comitês. Foram implantados há mais de 8 anos; composição varia de 8 a 25 membros efetivos; predomina a utilização da página eletrônica no processo comunicativo. Os projetos avaliados são multidisciplinares, distribuídos para apreciação considerando a área de formação, perfil e expertise do membro. Conclusão os Comitês de Ética em Pesquisa estudados atuavam há mais de oito anos, o que demonstra experiência consolidada em pesquisa. A recondução do mandato contribui para o aprofundamento das discussões, capacitação de novos membros e fortalecimento do sistema CEP/CONEP


Objetivo caracterizar el perfil de los Comités de Ética en Investigación de un municipio de Bahía. Método estudio de aproximación cuantitativa, con análisis descriptivo de los resultados, realizado en cinco Comités de Ética en Investigación. La recolección de datos se basó en un cuestionario autoadministrado en Google Forms Platform. Resultados se evidenció la mayoría de los miembros varones, con curso de posgrado stricto sensu, admisión por invitación y capacitación previa para trabajar en los Comités. Fueron implantados hace más de 8 años; la composición oscila entre 8 y 25 miembros de pleno derecho; predomina el uso del sitio web en el proceso comunicativo. Los proyectos evaluados son multidisciplinarios, distribuidos para su consideración considerando el área de capacitación, perfil y experiencia del miembro. Conclusión los Comités de Ética en Investigación estudiados llevaban más de ocho años activos, lo que demuestra una experiencia consolidada en investigación. La renovación del mandato contribuye a la profundización de los debates, la capacitación de nuevos miembros y el fortalecimiento del sistema (CEP/CONEP en Portugués).


Objective to characterize the profile of the Research Ethics Committees of a municipality of Bahia. Method quantitative approach study, with descriptive analysis of the results, conducted in five Research Ethics Committees. Data collection was based on a self-administered questionnaire on the Google Forms Platform. Results a majority of male members were evidenced, with stricto sensu graduate course, invitation admission and prior training to work in the Committees. They were implanted more than 8 years ago; composition ranges from 8 to 25 full members; the use of the website in the communicative process predominates. The projects evaluated are multidisciplinary, distributed for consideration considering the area of training, profile, and expertise of the member. Conclusion the Research Ethics Committees studied had been active for more than eight years, which demonstrates consolidated experience in research. The renewal of the mandate contributes to the deepening of discussions, training of new members and strengthening of the system (CEP/CONEP in Portuguese).


Subject(s)
Humans , Male , Female , Research/trends , Bioethics , Ethical Review , Ethics Committees, Research
4.
Rev. argent. salud publica ; 12(Suplemento Covid-19): 1-4, 23 de Julio 2020.
Article in Spanish | LILACS, BINACIS, ARGMSAL | ID: biblio-1104046

ABSTRACT

Realizar investigaciones para dar respuestas a la pandemia de COVID-19 es un deber moral. Con el objetivo de acelerar la evaluación de las investigaciones y asegurar su rigurosidad científica y ética, el Ministerio de Salud aprobó un documento de pautas éticas y operativas. El documento aborda los aspectos a los cuales se debe prestar especial atención durante la pandemia y brinda orientación a los Comités de Ética en Investigación para la elaboración de procedimientos operativos que acorten los plazos de la evaluación. Este artículo describe los puntos clave del documento


Subject(s)
Coronavirus Infections , Ethical Review , Ethics Committees, Research , Ethics, Research , Health Research Policy
5.
Rev. argent. salud publica ; 12(Suplemento Covid-19): 1-7, 23 de Julio 2020.
Article in Spanish | LILACS, BINACIS, ARGMSAL | ID: biblio-1129278

ABSTRACT

INTRODUCCIÓN: un sistema de evaluación ética de las investigaciones en seres humanos es esencial para proteger los derechos de los participantes. Los desafíos impuestos por la pandemia de la COVID-19 para conducir investigaciones éticas que produzcan resultados con rapidez demuestran la necesidad de fortalecerlo. El objetivo de este estudio fue describir el estado de situación de los sistemas de evaluación ética de las provincias de Argentina y las adaptaciones realizadas por la pandemia. MÉTODOS: se realizó una encuesta a los comités provinciales de ética en investigación o áreas similares de los ministerios de Salud que ejercen la vigilancia sobre la evaluación ética de las investigaciones de su jurisdicción. RESULTADOS: respondieron 16 de las 17 provincias encuestadas. El 93,7% de los comités provinciales evalúa investigaciones en seres humanos y tiene procedimientos operativos estandarizados (POE). El 68,7% lleva un registro de los comités de ética en investigación (CEI) de su jurisdicción. Un 75% acredita a los CEI y un 68,7% los supervisa. El 100% tiene un registro de las investigaciones en salud; en 56,2% de los casos este registro es público. Del total, 81,2% realizan actividades de capacitación. El 100% adaptó los POE para evaluar estudios sobre la COVID-19. DISCUSIÓN: los resultados muestran sistemas provinciales consolidados. Se requiere fortalecer la transparencia en la investigación mediante el registro público de las investigaciones. Se identificaron posibilidades de mejora para proponer acciones a futuro


Subject(s)
Argentina , Ethical Review , Ethics Committees, Research , Health Research Policy , Betacoronavirus
6.
Rev. Esc. Enferm. USP ; 54: e03548, 2020. tab, graf
Article in English | LILACS, BDENF | ID: biblio-1091963

ABSTRACT

Abstract Objective: To know the positions and practices adopted by nursing students in scientific initiation programs about the principles of scientific integrity in the different stages of the process of doing science. Method: An exploratory study of a quantitative nature, in which nursing student participants of the Scientific Initiation Program from the Federal District were interviewed. Results: Fifty (50) nursing students participated in the study. Most of the interviewed participants presented good notions about the process of conducting research in its different stages. Nevertheless, it was found that even though they were familiar with good scientific practices, students did not always behave in the most responsible manner. It was observed that the knowledge on topics related to the ethics of the scientific process was predominantly obtained through formal education, consisting of classes and courses. Nonetheless, the importance of complementary spaces such as research and research groups is recognized. Conclusion: Research experiences are important educational and vocational training spaces for students. Therefore, good research practices need to be included early in the academic curriculum.


Resumen Objetivo: Conocer planteamientos y prácticas adoptados por alumnos de enfermería incluidos en programas de iniciación científica acerca de los principios de integridad científica en las distintas etapas del proceso de hacer ciencia. Método: Estudio exploratorio, de naturaleza cuantitativa, en que fueron entrevistados estudiantes de enfermería del Distrito Federal, participantes en el Programa de Iniciación Científica. Resultados: Participaron en el estudio 50 estudiantes de enfermería. La mayoría de los entrevistados presentaron buenas nociones acerca del proceso de conducción de la investigación, en sus distintas etapas. Pese a ello, se verificó que, aun teniendo familiaridad con buenas prácticas científicas, no siempre los estudiantes se portaban de modo más responsable. Se observó que los conocimientos acerca de los temas relacionados con la etnicidad del proceso científico fueron obtenidos predominantemente mediante enseñanza formal, constituida de clases y asignaturas. Sin embargo, se reconoce la importancia de espacios complementarios, como la investigación y los grupos de investigación. Conclusión: Las experiencias en investigación son importantes espacios educativos y de formación profesional para los estudiantes. Por lo que las buenas prácticas en investigación necesitan incluirse precozmente en el currículo académico.


Resumo Objetivo: Conhecer posicionamentos e práticas adotados por alunos de enfermagem inseridos em programas de iniciação científica acerca dos princípios de integridade científica nas diferentes etapas do processo de fazer ciência. Método: Estudo exploratório, de natureza quantitativa, em que foram entrevistados estudantes de enfermagem do Distrito Federal, participantes do Programa de Iniciação Científica. Resultados: Participaram do estudo 50 estudantes de enfermagem. A maioria dos entrevistados apresentou boas noções sobre o processo de condução de pesquisa, em suas diferentes etapas. Apesar disso, verificou-se que, mesmo possuindo familiaridade com boas práticas científicas, nem sempre os estudantes se comportavam de maneira mais responsável. Observou-se que os conhecimentos sobre temas relacionados à eticidade do processo científico foram obtidos predominantemente por meio de ensino formal, constituído por aulas e disciplinas. Apesar disso, reconhece-se a importância de espaços complementares, como a pesquisa e grupos de pesquisa. Conclusão: As experiências em pesquisa são importantes espaços educativos e de formação profissional para os estudantes. Por isso, boas práticas em pesquisa precisam ser incluídas precocemente no currículo acadêmico.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Students, Nursing , Scientific Misconduct , Ethics, Research , Ethical Review , Morals
7.
Article in Chinese | WPRIM | ID: wpr-827952

ABSTRACT

High-quality clinical study on traditional Chinese medicine is of great significance to effectively control new public health emergencies represented by outbreaks of infectious diseases and ensure people's health and safety, but it still faces a series of ethical issues. Based on the seven core values of equity, good deeds, effectiveness, respect for individuals, freedom, reciprocity, and solida-rity proposed in the Guidelines for Management of Ethical Issues in Outbreaks of Infectious Diseases, this article emphasizes the characteristics and laws of clinical studies on traditional Chinese medicine. Main points of ethical review of traditional Chinese medicine were summarized in the aspects of overall concept, syndrome differentiation and treatment, prevention before disease onset, cultural value, and clinical basis. Based on the outbreak of coronavirus disease 2019(COVID-19), we collected relevant registered Chinese medicine clinical studies, summarized the core issues of the ethics review for COVID-19, and further improved the traditional Chinese medicine ethics review system and resources, so as to better serve ethical review and scientific studies in public health emergencies.


Subject(s)
Betacoronavirus , Coronavirus Infections , Emergencies , Ethical Review , Humans , Medicine, Chinese Traditional , Pandemics , Pneumonia, Viral , Public Health
8.
Geriatr., Gerontol. Aging (Impr.) ; 13(4): 223-229, out-.dez.2019. ilus
Article in English, Portuguese | LILACS | ID: biblio-1097141

ABSTRACT

A revisão por pares (peer review) é parte essencial e indissociável do processo editorial e de publicação acadêmica, contribuindo para a validação dos textos submetidos para revistas biomédicas. Boas revisões melhoram sobremaneira a qualidade dos manuscritos publicados e, por conseguinte, a reputação, o valor e a relevância da revista para os leitores. Este artigo especial incluiu as principais recomendações do Conselho Editorial da revista Geriatrics, Gerontology and Aging aos seus atuais e futuros revisores, almejando a contínua evolução dos padrões de qualidade do processo de revisão por pares adotado pelo periódico. Além de discorrer sobre a importância e tipos de processos de revisão, como se dão o fluxo editorial e a seleção dos revisores, apresentamos recomendações gerais e específicas para a condução de um bom parecer.


Peer review is an essential and integral part of the editorial and academic publication process that contributes to validate manuscripts submitted to biomedical journals. A good review can greatly improve the quality of published manuscripts, thereby improving the journal's reputation, value, and relevance to the reader. This special article includes the main recommendations of the editorial board of Geriatrics, Gerontology and Aging to its current and future reviewers, aiming at a continuous improvement of quality standards in the peer review process used by the journal. In addition, the importance and types of review processes are discussed, as well as the editorial flow and selection of reviewers, and general and specific recommendations are presented for carrying out good reviews.


Subject(s)
Peer Review/trends , Ethical Review/standards , Periodical , Peer Review, Research , Scientific Publication Ethics
10.
Rev. bras. cir. plást ; 33(4): 453-462, out.-dez. 2018. ilus
Article in English, Portuguese | LILACS | ID: biblio-979963

ABSTRACT

Introdução: O trabalho descreve 14 anos em reconstrução mamária com o retalho miocutâneo do grande dorsal (RGD) e implantes mamários. O objetivo é delinear experiência com o RGD e implantes mamários, programações das ilhas de pele e detalhes da dissecção, transposição de retalho e colocação do implante sob dupla camada muscular, estratégias para minimizar os danos na área doadora, estratégias de simetrização mamária e reconstrução do complexo areolopapilar, associado a avaliação do questionário Breast-Q. Métodos: Foi realizada revisão de prontuários entre abril de 2003 a junho de 2017. Resultados: No período 76 pacientes foram reconstruídas com o RGD, com idade média de 50,09 anos, sendo 11 bilaterais, 34 mama direita e 31 mama esquerda. 41 imediatas, 22 tardias e 13 de resgate. A média de satisfação foi 72,36% por meio do Breast-Q. Conclusão: Concluímos e comprovamos com o questionário do Breast-Q que a indicação precisa aliada a técnica de reconstrução proposta com plano duplo subpeitoral associada a cobertura do RDG, propicia uma loja mais segura, diminuído o índice de rippling.


Introduction: The paper describes a 14-year experience with breast reconstruction using a latissimus dorsi myocutaneous flap (LDMF) and breast implants. The objective was to delineate the experience with LDMF and breast implants, skin island schedules and dissection details, flap transposition and placement of the implant under a double layer, strategies to minimize damage in the donor area, and strategies of breast symmetry and reconstruction of the nipple-areola complex, in association with evaluation using the Breast-Q questionnaire. Methods: A review of medical records was performed between April 2003 and June 2017. Results: In the period, 76 patients with a mean age of 50.09 years underwent reconstruction with a LDMF, which was bilateral in 11, for the right breast in 34, for the left breast in 31, immediate in 41, late in 22, and for rescue in 13. Conclusion: We conclude and verified with the Breast-Q questionnaire that with a precise indication, the proposed reconstruction technique with a double subpectoral plane and coverage with a LDMF is safer with a lower complication rate.


Subject(s)
Humans , Female , Middle Aged , Surgical Flaps/surgery , Breast/surgery , Mammaplasty/methods , Reconstructive Surgical Procedures/adverse effects , Reconstructive Surgical Procedures/methods , Surveys and Questionnaires , Patient Satisfaction , Breast Implants , Ethical Review
11.
Pers. bioet ; 22(2): 303-318, jul.-dic. 2018. tab, graf
Article in Spanish | LILACS, BDENF, COLNAL | ID: biblio-990224

ABSTRACT

Resumen En las últimas décadas, los ensayos clínicos controlados patrocinados por la industria farmacéutica han aumentado de manera considerable, lo cual ha llevado a que sea necesario un mayor control y acompañamiento por parte de las entidades reguladoras, y de los comités de ética, para garantizar el adecuado cumplimiento de las normas éticas establecidas y de las buenas prácticas clínicas en general. En Colombia, el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), la entidad reguladora en el país, reglamenta y vigila el funcionamiento de la investigación clínica con medicamentos. En el 2008, esta entidad emitió la Resolución 2378, normatividad bajo la cual se establecen y regulan los diferentes actores de la investigación en Colombia, incluidos los comités de ética. Después de varios años de vigencia de esta norma, es necesario conocer si los comités de ética en investigación en Colombia funcionan de acuerdo con esta normativa, y determinar el estado de la implementación de lo solicitado en la regulación. Con este objetivo se diseñó una encuesta para ser respondida en forma voluntaria y se obtuvo respuesta de 25 de los 69 comités certificados en Colombia. El análisis fue posible en 22 de ellos cuya información estaba completa. En comparación con estudios anteriores, se observaron cambios favorables en el desarrollo y la organización de acuerdo con la norma actual propuesta.


Abstract In the last decades, controlled clinical trials sponsored by the pharmaceutical industry have increased considerably. This has led to the need for greater control and assistance by regulators and ethics committees to ensure appropriate compliance with established ethical standards and good clinical practices in general. In Colombia, the National Food and Drug Surveillance Institute (INVIMA), the regulator in the country, controls and monitors the operation of clinical research with drugs. In 2008, this entity issued Resolution 2378, which provides and regulates research actors in Colombia, including ethics committees. After being in force for several years, it is necessary to know whether research ethics committees in Colombia operate in accordance with this regulation and to determine the status of implementation of the requirements therein. For this purpose, a survey was designed to be voluntarily answered and a response was obtained from 25 of the 69 certified committees in Colombia. Twenty-two of them could be analyzed because their information was complete. Compared with previous studies, favorable changes in development and organization were observed in accordance with the current proposed regulation.


Resumo Nas últimas décadas, os ensaios clínicos controlados patrocinados pela indústria farmacêutica aumentaram consideravelmente, o que levou à necessidade de um maior controle e acompanhamento por entidades reguladoras e comitês de ética, para garantir o cumprimento adequado de normas éticas estabelecidas e boas práticas clínicas em geral. Na Colômbia, o Instituto Nacional de Vigilância de Medicamentos e Alimentos (Invima, na sigla em espanhol), órgão regulador no país, regulamenta e monitora o funcionamento da pesquisa clínica com medicamentos. Em 2008, essa entidade emitiu a Resolução 2378, que estabelece e regulamenta os diferentes atores da pesquisa na Colômbia, incluindo os comitês de ética. Depois de vários anos de vigência dessa norma, é necessário saber se os comitês de ética em pesquisa da Colômbia trabalham de acordo com este regulamento e determinar o estado da implementação do que é solicitado no regulamento. Com esse objetivo, uma pesquisa foi elaborada para ser respondida voluntariamente e uma resposta foi obtida de 25 dos 69 comitês certificados na Colômbia. A análise foi possível em 22 deles, cuja informação estava completa. Em comparação com estudos anteriores, mudanças favoráveis no desenvolvimento e organização foram observadas de acordo com a norma atual proposta.


Subject(s)
Humans , Research , Clinical Protocols , Ethical Review , Ethics Committees, Research , Information
13.
Rev. bioét. (Impr.) ; 25(3): 630-635, out.-dez. 2017. tab, graf
Article in Portuguese | LILACS | ID: biblio-897705

ABSTRACT

Resumo O estabelecimento de comissões de ética no uso de animais em ensino e pesquisa concretiza nova ética nas relações com animais não humanos. Realizou-se estudo estatístico sobre dados de 390 protocolos de pesquisa avaliados durante oito anos por uma comissão em uma universidade brasileira, buscando determinar se essa atuação foi capaz de reduzir o sofrimento e diminuiu proporcionalmente a prática de eutanásia. Empregou-se extensão do teste de Wilcoxon para verificar a tendência de procedimentos de proteção como melhor previsão de estresse e dor nos protocolos, uso mais frequente de anestesia e sedativos e redução de eutanásias executadas. Os resultados mostraram significância estatística em todos os três itens, sugerindo efeito concreto na proteção animal. O método utilizado é proposto ainda como forma de avaliar o uso desses procedimentos pelas comissões.


Abstract The creation of animal ethics committees in teaching and research establishes a new ethics in relations with non-human animals. The present article carried out a statistical study of data from 390 research protocols evaluated over eight years by a commission at one Brazilian university, to determine if its actions brought about a reduction in suffering and a proportional decrease in the practice of euthanasia. A statistical significance study was carried out using an extension of the Wilcoxon test, seeking to verify a long-term trend of protection procedures, such as lower predicted levels of stress and pain in protocols, more frequent use of anesthesia and sedatives and a reduction in euthanasia. The results were statistically significant for all three of these items, suggesting a concrete effect of animal protection. The method used is proposed as a form of evaluating the use of these procedures by commissions.


Resumen El establecimiento de comisiones de ética en el uso de animales en enseñanza e investigación concreta una nueva ética en las relaciones con los animales no humanos. Se realizó un estudio estadístico a partir de los datos de 390 protocolos de investigación evaluados durante ocho años por una comisión en una universidad brasileña, buscando determinar si esa actuación fue capaz de reducir el sufrimiento y de disminuir proporcionalmente la práctica de la eutanasia. Se empleó una extensión del test de Wilcoxon para verificar la tendencia de procedimientos de protección, como una mejor previsión de estrés y dolor en los protocolos, el uso más frecuente de anestesia y sedantes, y la reducción en la realización de eutanasia. Los resultados mostraron una significancia estadística en estos tres ítems, sugiriendo un efecto concreto en la protección animal. El método utilizado se propone, también, como una forma de evaluar el uso de estos procedimientos por parte de las comisiones.


Subject(s)
Humans , Animals , Male , Female , Bioethics , Ethical Review , Euthanasia, Animal , Animal Experimentation , Schools, Veterinary
14.
Rev. argent. salud publica ; 8(31): 45-48, jun. 2017. mapas
Article in Spanish | LILACS | ID: biblio-883110

ABSTRACT

El fortalecimiento y armonización de los criterios de evaluación de los comités de ética en investigación del país son objetivos de la Dirección de Investigación para la Salud y del Comité Nacional Asesor de Ética en Investigación. El presente artículo se propone describir las fortalezas y debilidades que han sido identificadas en el sistema de revisión ética de las provincias y que ayudarán a definir las próximas estrategias en la materia.


Subject(s)
Ethical Review , Ethics Committees, Research , Health , Research Design
15.
Rev. bioét. (Impr.) ; 25(1): 61-71, jan.-abr. 2017. tab
Article in Portuguese | LILACS | ID: biblio-843332

ABSTRACT

Resumo Este estudo buscou caracterizar perfil e operacionalização de Comitês de Ética em Pesquisa. Foi enviado questionário eletrônico aos 645 comitês existentes à época e respondido por 129 coordenadores. As respostas foram categorizadas por frequência e média e passaram por teste estatístico. Os resultados obtidos indicaram que a maioria dos coordenadores concluíra mestrado ou doutorado em Ciências Biológicas e da Saúde. Os comitês funcionavam há mais de nove anos em instituições de ensino superior com apoio institucional insuficiente. Os membros eram capacitados por meio da leitura das regulamentações e orientações do Comitê. A distribuição de protocolos era feita por afinidade temática, e a decisão grupal se dava por consenso ou votação. Conclui-se que os comitês estão consolidados e cumprem a regulamentação ética, mas necessitam dialogar mais com pesquisadores e a Comissão Nacional de Ética em Pesquisa.


Abstract This study aimed to characterize the Research Ethics Committees in their profile and operationalization. An electronic questionnaire was sent to the 645 existing committees at the time and answered by 129 coordinators. The answers were categorized by frequency and mean of the answers and passed by a statistical test. The results indicated that most of the coordinators had a degree in Biological and Health Sciences, at Masters and PhD levels. The committees had been operating for more than nine years in higher education institutions, with insufficient institutional support. Members were empowered by readings of the Committee';s regulations and guidelines. The distribution of protocols was done by subject affinity and the group decision was given by consensus or vote. It is concluded that the committees are consolidated, comply with ethical regulations, but they need to dialogue more with researchers and with the National Commission of Ethics in Research.


Resumen Este estudio tuvo como objetivo caracterizar el perfil y la operatividad de los Comités de Ética de la Investigación. Se les envió un cuestionario electrónico a los 645 comités existentes a la fecha y fue respondido por 129 coordinadores. Las respuestas se clasificaron por la frecuencia y el promedio y se sometieron a una prueba estadística. Los resultados obtenidos indicaron que la mayoría de los coordinadores finalizaron su magíster o doctorado en Ciencias Biológicas y de la Salud. Los comités funcionaban hace más de nueve años en instituciones de educación superior, con apoyo institucional insuficiente. Se capacitaba a los miembros por medio de la lectura de las normas y directrices del Comité. La distribución de los protocolos se realizó por afinidad temática y la decisión grupal se estableció por consenso o por votación. Se concluyó que los comités están consolidados y cumplen con las normas éticas, pero necesitan dialogar más con los investigadores y con la Comisión Nacional de Ética de la Investigación.


Subject(s)
Humans , Male , Female , Bioethics , Ethical Review , Ethics Committees, Research , Ethics, Research , Research/standards , Human Experimentation , Humanities
16.
Rev. méd. Chile ; 145(3): 386-392, Mar. 2017. tab
Article in Spanish | LILACS | ID: biblio-845552

ABSTRACT

Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.


Subject(s)
Humans , Ethical Review , Ethics Committees, Research/standards , Biomedical Research/ethics , Chile , Ethics Committees, Research/legislation & jurisprudence , Accreditation
17.
Article in Korean | WPRIM | ID: wpr-195016

ABSTRACT

PURPOSE: There are many forest and outdoor programs being offered but systematic reviews of effects are lacking. This study was done to identify content, format, and strategies of forest therapy programs for elementary school students. METHODS: Literature search using keywords in English and Korean was performed using 6 electronic databases in December 2016. Search participants were elementary school students and interventions conducted in the forest. Seventeen forest therapy studies were selected for evaluation. Risk of Bias Assessment tool for non-randomized study was used for quality assessment. RESULTS: All studies were quasi-experimental designs. Forest therapy programs included various activities in forests such as experience of five senses, meditation in the forest, walking in the forest, ecological play, observation of animals and insects. All studies used psychosocial health variables and forest healing programs had positive effects on sociality, depression, anxiety, self-esteem, stress, aggression, anger, and school adjustment. Limitations of these studies were vague reporting of the study, lack of ethical review and rigorous research designs. CONCLUSION: Forest therapy for elementary school child can be an effective way to improve psychosocial health. Future studies with rigorous study designs are needed to assess long-term effects of forest therapy on physical and psychosocial health.


Subject(s)
Aggression , Anger , Animals , Anxiety , Bias , Child , Depression , Ethical Review , Forests , Humans , Insecta , Meditation , Research Design , Walking
18.
Article in Korean | WPRIM | ID: wpr-7571

ABSTRACT

BACKGROUND: Artificial insemination by donor (AID) is important to chance the pregnancy in male infertile couples by requiring appropriate medical, legal and ethical reviews. The purpose of this study was to investigate the perception changes of AID to collect the basic information for establishing the sperm donation, cryopreservation and artificial insemination management system. METHODS: We evaluated the people's thought of sperm donation, cryopreservation, and artificial insemination by donor by means of national inquiry survey from 247 infertile couples for 4 weeks from October 2016. The questionnaires were composed of 4 areas, and each questionnaire consisted of 15 items. Changes in the perception of AID by year were investigated after review of domestic journals. RESULTS: 67.6% of respondents knew the growth of couples with difficulty getting pregnant due to male infertility. 82.2% of respondents replied the necessary of sperm bank as a treatment option for infertility and 40.5% knew the donation and receipt system of sperm. In the survey of change perception of AID according to year, 37.5% and 39.5% of respondents were got information about AID from doctor in 2003 and 2004, but 49.6% from broadcasting in 2016. As a child grows up, 4.0% (2003), 9.0% (2014), and 42.8% (2016) of respondents answered to tell the child about AID. CONCLUSIONS: Infertile couple's thought of AID about the extension of opportunities for male infertility treatment is changed. In conclusion, it is necessary to establish institutional system of sperm donation, cryopreservation and artificial insemination prior to public sperm bank operation.


Subject(s)
Child , Cryopreservation , Ethical Review , Family Characteristics , Humans , Infertility , Infertility, Male , Insemination, Artificial , Male , Pregnancy , Sperm Banks , Spermatozoa , Surveys and Questionnaires , Tissue Donors
19.
Rev. argent. salud publica ; 7(28): 43-45, sept. 2016.
Article in English | LILACS | ID: biblio-869573

ABSTRACT

En las investigaciones donde participan seres humanos, la exposición a riesgos obliga a contar con herramientas que permitan al Estado garantizar la protección de derechos de esos participantes. El Comité Nacional Asesor de Ética en Investigación asesorará al Ministerio de Salud y proporcionará directrices para establecer las pautas éticas en investigación, como parte fundamental de un Sistema Nacional de investigaciones para la Salud.


Subject(s)
Humans , Ethical Review , Ethics Committees, Research , Ethics, Research , Health , Research
SELECTION OF CITATIONS
SEARCH DETAIL