RESUMO
BACKGROUND: Medical research in complementary and alternative medicine (CAM) has increased recently, raising ethical concerns about the moral status of CAM. Medical academic journals are responsible for conducting ethical review (ER) of manuscripts to protect the interests of human subjects and to make ethical results available before deciding to publish. However, there has been no systematic analysis of the ER in CAM journals. This study is aim to evaluate the current status of ethical requirements and compliance in CAM journals. METHODS: This is a cross-sectional study. We reviewed instructions for authors (IFAs) of CAM journals included in the Journal Citation Reports (2021) ( https://jcr.clarivate.com ) for general information and requirements for ER. We also browsed the manuscripts regarding randomized controlled trials published by CAM journals in Q1 and Q2 section from January to June, 2023, to check the actual situation of ethical requirement. Descriptive statistics and Fisher's exact test were used for statistical analysis. RESULTS: 27 journals and 68 manuscripts were ultimately included. 92.6% (25/27) IFAs included keywords of ER, indicating the presence of ethical considerations. However, no specific ER was required for CAM (n = 0). We categorized journals by Geographic origin, JCR section, Year of electronic JCR, Types of studies, % of OA Gold to explore the factors that could influence CAM journals to have certain ethical review policies. The results showed there was no statistical significance in certain ethical review policy in any classification of journals (p > 0.05). All RCT manuscripts included in the study generally met the requirements of the published journals for ethical review. CONCLUSIONS: All IFAs discussed ER, but the content was scattered, unfocused, and there were no specific ER requirements regarding CAM. Although the manuscripts basically met the requirements of the journal, it was not possible to get closer to the process of ER in the manuscript. To ensure full implementation of these policies in the future, CAM journals should require authors to provide more details, or to form a list of items necessary for CAM ethical review.
Assuntos
Terapias Complementares , Políticas Editoriais , Publicações Periódicas como Assunto , Terapias Complementares/ética , Estudos Transversais , Humanos , Publicações Periódicas como Assunto/ética , Revisão Ética , Autoria , Editoração/éticaRESUMO
BACKGROUND: The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). METHODS: We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. RESULTS: Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. CONCLUSIONS: There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.
Assuntos
COVID-19 , Emergências , Pandemias , Saúde Pública , SARS-CoV-2 , Humanos , COVID-19/epidemiologia , Saúde Pública/ética , África/epidemiologia , Revisão Ética , Betacoronavirus , Doença pelo Vírus Ebola/epidemiologia , Infecções por Coronavirus/epidemiologia , Ética em PesquisaRESUMO
Ethics committees ensure compliance with ethical principles in medical research. They are oriented towards clinical studies, but also review e. g., qualitative research. Using a semi-structured online survey, we collected data on experiences of qualitative researchers with the review by ethics committees and analysed them via content analysis. In July 2019, 73 researchers took part in the survey. Five main topics were derived from their statements regarding the ethics review of qualitative research: 1. relevance of qualitative research expertise; 2. cooperation between researchers and ethics committees; 3. transparency of review criteria; 4. dealing with formal review requirements; 5. evaluation of the review's significance for qualitative research. The results show the potential of ethics review for reflection on ethical questions in qualitative research. Prerequisites for this are the fit with the characteristics and quality criteria of qualitative research, the presence of qualitative research expertise in ethics committees, the transparency of the ethics review process as well as openness to different professional cultures and a constructive communication culture.
Assuntos
Pesquisa sobre Serviços de Saúde , Pesquisa Qualitativa , Pesquisa sobre Serviços de Saúde/ética , Alemanha , Inquéritos e Questionários , Humanos , Pesquisadores/ética , Revisão Ética , Comitês de Ética em PesquisaRESUMO
Brain-computer interface (BCI) technology is rapidly advancing in medical research and application. As an emerging biomedical engineering technology, it has garnered significant attention in the clinical research of brain disease diagnosis and treatment, neurological rehabilitation, and mental health. However, BCI also raises several challenges and ethical concerns in clinical research. In this article, the authors investigate and discuss three aspects of BCI in medicine and healthcare: the state of international ethical governance, multidimensional ethical challenges pertaining to BCI in clinical research, and suggestive concerns for ethical review. Despite the great potential of frontier BCI research and development in the field of medical care, the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI. To ensure "responsible innovation" in BCI research in healthcare and medicine, the creation of an ethical global governance framework and system, along with special guidelines for cutting-edge BCI research in medicine, is suggested.
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Interfaces Cérebro-Computador , Humanos , Pesquisa Biomédica/ética , Interfaces Cérebro-Computador/ética , Revisão ÉticaRESUMO
In 2021, we were designing a research study in Sweden in which we planned to use newspaper articles focusing on children and adolescents under the age of eighteen during the Covid-19 pandemic as empirical material. As we developed this study, an ethical question arose: do studies using journalistic articles that may contain health information about individuals as empirical material have to be approved by an ethics review committee? Sweden, in contrast to other countries, requires the approval of an ethics review committee for the use of publicly available material in research when such material might include sensitive personal data such as health-related information. This case study calls for harmonized laws and policies that support global research by clarifying what kinds of empirical material and what types of research must be assessed by national ethics review committees, including with consideration for children's safety and rights.
Assuntos
Revisão Ética , Comitês de Ética em Pesquisa , Criança , Adolescente , Humanos , Suécia , Pandemias , Menores de IdadeRESUMO
Ethics Review began a decade ago with a mission to identify ethical concerns that hold back innovation and to promote solutions that would move the field forward. Over this time, blood biomarkers for brain pathology and medications that treat that pathology promise to transform research and care. A central problem is that the evidence needed to guide test interpretation and practice is accumulating and there are unanswered questions. At the same time, people living with and at risk for dementia want access to their test results and involvement in their care. We promote dialog among diverse people across many institutions through collaboration with the Advisory Group on Risk Evidence Education for Dementia (AGREEDementia.org). Over the years Ethics Review continues to publish these dialogs and solutions to overcome the paralysis of indecision and ethical concerns.
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Demência , Humanos , Demência/prevenção & controle , Revisão ÉticaRESUMO
Many countries consider long-term implications for society.
Assuntos
Pesquisa Biomédica , Revisão Ética , Humanos , Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Cooperação InternacionalRESUMO
INTRODUCTION: In recent years, information technology and social media have experienced unprecedented growth, particularly in the Nordic countries. However, there is a noticeable lack of comprehensive understanding regarding the latest research findings on online health information seeking behaviour (OHISB) among young adults (18 to >30). There is a need to conduct an updated review to identify knowledge gaps in where young adults find health information and their user interface preferences and to provide research-based guidance and recommendations to governments, health organisations and social media platforms on how to facilitate this prominent pattern. The scoping review protocol outlines a study that will systematically map the existing literature on young adults' preferences for digital platforms and platform characteristics in relation to OHISB, enabling the identification of promising areas for further research and the development of more effective interventions to promote healthy and informed choices. Conducting a scoping review is imperative to gain a comprehensive understanding of young adults' OHISB and support the next generation of dissemination that promotes accurate and reliable digital health information. METHODS AND ANALYSIS: The scoping review will use Arksey and O'Malley's methodological framework (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR)) and employ the citation pearl method and the Sample, Phenomenon of Interest, Design, Evaluation, Research type model to design the search strategy. To identify relevant literature, three databases will undergo a search: Scopus, Web of Science and EMBASE. Additionally, a subsidiarily grey literature search will be conducted in Google Scholar. The data charting process will conform to the PRISMA-ScR standard and will be further structured with EndNote. Qualitative and quantitative analyses of the extracted data will be developed using EndNote and Excel. ETHICS AND DISSEMINATION: Conducting a scoping review involves secondary data analysis of publicly available sources and does not require an ethical review. The protocol will be published to ensure transparency. The scoping review results will be disseminated through open-access peer-reviewed publications, national and international conferences, social media platforms, newspapers and YouTube to service users and stakeholders.
Assuntos
Comportamentos Relacionados com a Saúde , Comportamento de Busca de Informação , Humanos , Adulto Jovem , Bases de Dados Factuais , Saúde Digital , Revisão Ética , Projetos de Pesquisa , Literatura de Revisão como AssuntoRESUMO
How research during a public health emergency is conducted is recognized as essential to the public health response to that emergency. Such research needs to undergo substantive and meaningful ethical review in a timely manner. Rapid ethical review may be accomplished through a number of mechanisms, including use of local rapid-response institutional review boards (IRBs). We describe use of such a model in the setting of the 2014 Ebola virus disease epidemic and the Rapid-Response IRB's subsequent transition to a multisite single IRB model during the current Covid-19 pandemic. The rapid-response review model is characterized by a small IRB with extensive use of alternate members with specific expertise and by close collaboration with the investigator in an iterative process.
Assuntos
COVID-19 , Emergências , Humanos , Pandemias , Saúde Pública , Revisão ÉticaRESUMO
The significance of the ethical review process in human-based research undertakings cannot be overemphasized as it is necessary to uphold ethical standards and protect participants. However, the review process per se can act as a bottleneck, potentially hindering research progress and leading to academic dishonesty. The present work explores the benefits and challenges of ethical review, emphasizing issues like intellectual theft, forced authorship, and the stifling of independent researchers. Proposed solutions include leveraging previously approved designs, empowering experienced professors for clearance, establishing panels of researchers, creating voluntary ethical approval offices, utilizing private consultancy offices, and establishing a transnational ethical clearance authority. In conclusion, this work stresses the importance of finding mechanisms to streamline the ethical review process while maintaining ethical standards to foster integrity in research and combat academic dishonesty.
Assuntos
Ética em Pesquisa , Pesquisadores , Humanos , Pesquisadores/ética , Autoria/normas , Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Revisão Ética , Má Conduta Científica/éticaRESUMO
All life science and medical research involving human subjects must be conducted in compliance with the Declaration of Helsinki and the relevant laws and guidelines. Additionally, its scientific and ethical suitability must be reviewed by a committee well versed in the nature and content of the research. Failure to comply with these requirements when conducting research involving human subjects is a serious violation of Japanese laws, guidelines, and local regulations, so several ethics committees and institutional review boards have been established within the Nippon Medical School (NMS) Foundation and its affiliated institutions. It is essential for investigators to keep up to date with the latest developments in the ethical review process and to ensure that any projects they propose to embark on are subjected to an appropriate ethical review before the research is initiated. To help researchers and other staff affiliated with the NMS Foundation keep abreast of these developments, this report outlines NMS's current ethical review processes for research involving human subjects.
Assuntos
Comitês de Ética em Pesquisa , Faculdades de Medicina , Humanos , Pesquisa Biomédica/ética , Revisão Ética , Ética em Pesquisa , Declaração de Helsinki , Experimentação Humana/ética , Experimentação Humana/legislação & jurisprudência , Japão , Faculdades de Medicina/éticaRESUMO
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)
Assuntos
Bioética , Resolução de Problemas , Revisão Ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Membro de ComitêRESUMO
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.
Assuntos
Humanos , Masculino , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Atenção à Saúde , Emoções , Assistência Hospitalar , Ética , Hospitais , Revisão Ética , Pesquisa QualitativaRESUMO
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.
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Adulto Jovem , Projetos de Pesquisa , Bioética , Revisão Ética/normas , Comitês de Ética em Pesquisa , Ética Baseada em Princípios , Ética em Pesquisa , Pesquisadores , Protocolos Clínicos , Guias como Assunto , Eticistas , Aconselhamento Diretivo , Sujeitos da Pesquisa , Equador , Comitês Consultivos , Ética Institucional , Legislação MédicaRESUMO
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).
Assuntos
Humanos , Masculino , Feminino , Pesquisa/tendências , Bioética , Revisão Ética , Comitês de Ética em PesquisaRESUMO
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.
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Estudantes de Enfermagem , Má Conduta Científica , Ética em Pesquisa , Revisão Ética , Princípios MoraisRESUMO
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
Assuntos
Infecções por Coronavirus , Revisão Ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Política de Pesquisa em SaúdeRESUMO
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.
Assuntos
Argentina , Revisão Ética , Comitês de Ética em Pesquisa , Política de Pesquisa em Saúde , BetacoronavirusRESUMO
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.