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1.
Cambios rev. méd ; 21(1): 746, 30 Junio 2022.
Article in Spanish | LILACS | ID: biblio-1392775

ABSTRACT

INTRODUCCIÓN. Los Comités de Ética de Investigación en Seres Humanos deben proteger la dignidad, los derechos, el bienestar y la seguridad de los sujetos investigados; evalúan aspectos éticos, metodológicos y jurídicos de los protocolos de investigación, competencia otorgada por el ente sanitario del país que ameritó observar si se cumplió. OBJETIVO. Evaluar la situación de los Comités de Ética de Investigación en Seres Humanos, basados en la percepción del cursillista, la normativa, las repercusiones y consecuencias para mantener su condición activa y su trascendencia. MATERIALES Y MÉTODOS. Estudio descriptivo, transversal y ambispectivo con un universo de 1 327 profesionales del área de la salud y una muestra de 385 encuestados que expresaron su percepción sobre trece Comités de Ética de Investigación en Seres Humanos a nivel nacional, con revisión bibliográfica nacional e internacional, se excluyeron los suspendidos. Se aplicó encuesta validada online, período abril a octubre de 2019. Data analizada en Excel y SPSS versión 23. RESULTADOS. El 76,92% Comités de Ética de Investigación en Seres Humanos fueron de la ciudad de Quito. Los cursillistas percibieron que el 64,16%, no trascendieron en su labor; desconocieron que: la Dirección Nacional de Inteligencia de la Salud, cuestionó el nombramiento de algún miembro un 97,14%; el cuestionamiento estuvo basado en la norma vigente un 79,48%; sobre la aprobación del plan anual de capacitación en investigación, 2019, un 95,06%; el plan anual de capacitación específico un 77,40%, y no recibieron directrices ni retroalimentación en temas de capacitación en calidad de investigador, un 90,39%. Además, percibieron que los Comités fueron responsables de capacitar otros Comités de ética de Investigación en Seres Humanos, un 81,82% y a los investigadores, un 85,71%; que deben elaborar el plan anual de educación específica para los miembros del comité, un 89,35%. CONCLUSIÓN. Se identificó entre los problemas que los investigadores casi no los conocen y hay necesidad de actualizar la norma que afectó el funcionamiento. Los justificativos para mantener la condición activa no se cumplieron, se evidenció la necesidad de asesoría para los comités por parte de las autoridades competentes, sin lograr conformación consolidada con actores y repercutió en su trascendencia.


INTRODUCTION. The Research Ethics Committees on Human Beings must protect the dignity, rights, well-being and safety of the research subjects; evaluate ethical, methodological and legal aspects of the research protocols, a competence granted by the health entity of the country that merited see if it is done. OBJECTIVE. Evaluate the situation of the Ethics Committees for Research in Human Beings, based on the perception of the trainee, the regulations, the repercussions and consequences to maintain their active condition and their transcendence. MATERIALS AND METHODS. Descriptive, cross-sectional and ambispective study with a universe of 1,327 professionals in the health area and a sample of 385 respondents who expressed their perception of thirteen Research Ethics Committees on Human Beings at the national level, with national and international bibliographic review. those suspended were excluded. An online validated survey was applied, from April to October 2019. Data analyzed in Excel and SPSS version 23. RESULTS. 76.92% Human Research Ethics Committees were from the city of Quito. The trainees perceived that 64,16%, did not transcend in their work; they did not know that: the National Directorate of Health Intelligence, questioned the appointment of a member 97,14%; the questioning was based on the current norm 79,48%; on the approval of the annual research training plan, 2019, 95,06%; the specific annual training plan 77,40%, and did not receive guidelines or feedback on training issues as a researcher, 90,39%. In addition, they perceived that the Committees were responsible for training other Human Beings Research Ethics Committees, 81,82% and the researchers, 85,71%; that they must prepare the annual specific education plan for the members of the committee, 89,35%. CONCLUSION. It was identified among the problems that the researchers hardly know them and there is a need to update the norm that affected the operation. The justifications to maintain the active condition were not fulfilled, the need for advice for the committees by the competent authorities was evidenced, without achieving a consolidated conformation with actors and had repercussions on its importance. hardly know them and there is a need to update the norm that affected the operation. The justifications to maintain the active condition were not fulfilled, the need for advice for the committees by the competent authorities was evidenced, without achieving a consolidated conformation with actors and had repercussions on its importance.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Young Adult , Research Design , Bioethics , Ethical Review/standards , Ethics Committees, Research , Principle-Based Ethics , Ethics, Research , Research Personnel , Clinical Protocols , Guidelines as Topic , Ethicists , Directive Counseling , Research Subjects , Ecuador , Advisory Committees , Ethics, Institutional , Legislation, Medical
2.
Saúde Soc ; 31(2): e210140es, 2022. tab, graf
Article in Spanish | LILACS | ID: biblio-1377346

ABSTRACT

Resumen Los procesos de atención y cuidado de la salud-enfermedad en los hospitales se configuran en torno a diferentes dimensiones relacionales entre los actores implicados. En las sociedades occidentales se han naturalizado a estas instituciones como espacios que suponen una estructura vertical, dominada por la racionalidad biomédica. Este artículo se basa en la revisión de la bibliografía y muestra que las prácticas de atención y cuidado involucran distintos vínculos, saberes y emociones que configuran aspectos por fuera de lo normado desde la institución. El objetivo consiste en indagar en los procesos de atención y cuidado desarrollados en los hospitales de Latinoamérica, colocando el foco en las tensiones entre la racionalidad que impone la norma y las emociones que emergen en el proceso de trabajo. Para ello se realizó una metaetnografía, que permitió sintetizar investigaciones cualitativas y producir una nueva interpretación del problema estudiado. De este modo, se conformó un corpus de 36 artículos científicos a partir de las búsquedas en las bases de la Biblioteca Virtual en Salud (BVS), PubMed, SciELO y Scopus. Los resultados muestran que las racionalidades y las emociones intervienen como dimensiones estructurales de los procesos de atención y cuidado en los hospitales.


Abstract Healthcare process that take place in hospitals are shaped around different relational dimensions between the actors involved. Western societies have naturalized these institutions as spaces of presumed vertical structure, ruled by biomedical rationality. This literature review shows that care practices entail different relations, knowledge and emotions, which configure aspects found outside the institution's standards. It investigates the healthcare processes developed in Latin America hospitals, focusing on the tensions between the rationality imposed by the norm and the emotions that emerge in the work process. For this purpose, a metaethnography was carried out to summarize qualitative research and produce new interpretations on the topic. A total 36 scientific papers was obtained by searching the BVS, PubMed, SciELO and Scopus databases. Results show that rationalities and emotions function as structural dimensions of healthcare processes in hospitals.


Subject(s)
Humans , Male , Female , Health Knowledge, Attitudes, Practice , Delivery of Health Care , Emotions , Hospital Care , Ethics , Hospitals , Ethical Review , Qualitative Research
3.
Enferm. foco (Brasília) ; 13: 1-7, 2022. tab
Article in Portuguese | LILACS, BDENF | ID: biblio-1393505

ABSTRACT

Objetivo: Analisar os fundamentos utilizados por membros de Comitês de Ética em Pesquisa, na resolução dos problemas éticos e/ou morais vivenciados durante suas atividades nestes Comitês. Métodos: Estudo qualitativo, com uso de questionário online autoaplicado na Plataforma Google Forms, que envolveu 39 membros efetivos de 10 Comitês de Ética em Pesquisa, de Salvador, Bahia, Brasil. Dados analisados a partir da Configuração Triádica, Humanista, Existencialista, Personalista. Resultados: Entre os fundamentos utilizados por membros dos Comitês de Ética em Pesquisa para resolução de problemas morais e/ou éticos vivenciados, estão as instruções e documentos normativos no âmbito da pesquisa envolvendo seres humanos, bioética, princípios e valores. Conclusão: Os membros dos Comitês de Ética utilizam normativas e princípios bióticos para solução de problemas morais e/ou éticos vivenciados em suas atividades, tendo em vista o desenvolvimento de Pesquisas em consonância com os aspectos éticos e científicos adequados. (AU)


Objective: To analyze the fundamentals used by members of Research Ethics Committees in solving ethical and/or moral problems experienced during their activities in these Committees. Methods: Qualitative study, using a self-administered online questionnaire on the Google Forms Platform, which involved 39 effective members of 10 Research Ethics Committees, from Salvador, Bahia, Brazil. Data analyzed from the Triadic, Humanist, Existentialist, Personalist Configuration. Results: Among the foundations used by members of the Research Ethics Committees to solve moral and/or ethical problems experienced are the instructions and normative documents within the scope of research involving human beings, bioethics, principles and values. Conclusion: The members of the Ethics Committees use norms and bioethics principles to solve moral and/or ethical problems experienced in their activities, with a view to developing research in line with the appropriate ethical and scientific aspects. (AU)


Objetivo: Analizar los fundamentos utilizados por los miembros de los Comités de Ética en Investigación en la resolución de problemas éticos y / o morales experimentados durante su actuación en estos Comités. Métodos: Estudio cualitativo, utilizando un cuestionario en línea autoadministrado en la plataforma Google Forms, que involucró a 39 miembros efectivos de 10 Comités de Ética en Investigación, de Salvador, Bahía, Brasil. Datos analizados desde la Configuración Triádica, Humanista, Existencialista, Personalista. Resultados: Entre los fundamentos que utilizan los miembros de los Comités de Ética en Investigación para resolver los problemas morales y / o éticos vividos se encuentran las instrucciones y documentos normativos en el ámbito de la investigación con seres humanos, bioética, principios y valores. Conclusión: Los miembros de los Comités de Ética utilizan normas y principios bióticos para resolver problemas morales y/o éticos vividos en sus actividades, con miras a desarrollar la investigación en línea con los aspectos éticos y científicos adecuados (AU)


Subject(s)
Bioethics , Problem Solving , Ethical Review , Ethics Committees, Research , Ethics, Research , Committee Membership
4.
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
5.
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)
Humans , Acupuncture Points , Acupuncture Therapy , Biomedical Research , Ethical Review , Meridians , Moxibustion
6.
China Journal of Chinese Materia Medica ; (24): 1696-1700, 2021.
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)
Humans , Biomedical Research , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal , Ethical Review , Medicine, Chinese Traditional , Multicenter Studies as Topic , Pharmaceutical Preparations
7.
Rev. argent. salud publica ; 12(Suplemento Covid-19): 1-4, 23 de Julio 2020.
Article in Spanish | BINACIS, ARGMSAL, LILACS | 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
8.
Rev. argent. salud publica ; 12(Suplemento Covid-19): 1-7, 23 de Julio 2020.
Article in Spanish | LILACS, ARGMSAL, BINACIS, BRISA | 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


INTRODUCTION: a research ethics system is essential to protect the rights of research participants. The challenges posed by the COVID-19 pandemic to conduct research ethically to produce rapid results have demonstrated the need to strengthen this system. The objective of this study was to describe the state of the research ethics system of the Provinces of Argentina and the adaptations made due to the pandemic. METHOD: a survey was conducted with provincial research ethics committees or similar areas within the Ministries of Health of the provinces responsible for the oversight of research ethics review under their jurisdiction. RESULTS: sixteen of the 17 provinces surveyed responded. 93.7% of the provincial committees review human research and have standard operating procedures (SOPs). 68.7% register the research ethics committees (REC) in their jurisdiction. Seventy-five percent accredit RECs and 68.7% supervise them. 100% have a registry of health research in the jurisdiction, only 56.2% have public access. 81.2% carry out training activities. 100% adapted the SOPs to evaluate studies on COVID-19. DISCUSSION: the results show consolidated provincial systems. Transparency in research needs to be strengthened through public registration of research. Possibilities for improvement were identified to propose future actions.


Subject(s)
Argentina , Ethical Review , Ethics Committees, Research , Health Research Policy , Betacoronavirus
10.
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
11.
China Journal of Chinese Materia Medica ; (24): 2287-2290, 2020.
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)
Humans , Betacoronavirus , Coronavirus Infections , Emergencies , Ethical Review , Medicine, Chinese Traditional , Pandemics , Pneumonia, Viral , Public Health
12.
Geriatr., Gerontol. Aging (Online) ; 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
13.
Journal of Korean Medical Science ; : e41-2019.
Article in English | WPRIM | ID: wpr-765141

ABSTRACT

No abstract available.


Subject(s)
Ethical Review
14.
Pers. bioet ; 22(2): 303-318, jul.-dic. 2018. tab, graf
Article in Spanish | LILACS, 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
15.
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 , Plastic Surgery Procedures/adverse effects , Plastic Surgery Procedures/methods , Surveys and Questionnaires , Patient Satisfaction , Breast Implants , Ethical Review
17.
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
18.
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
19.
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
20.
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
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