Evolution and importance of the Research Ethics Committee, CEP, in higher education institutions: a study in a western Amazonian institution between 2018 to 2022

The Research Ethics Committee (CEP) has become an essential mechanism for social control in Brazilian research involving human subjects, contributing to the development of studies guided by ethical standards and to the protection of research participants. This article analyzes the performance of CEP in Western Amazonian institution, its history, operating conditions, trends, and different aspects between 2018 to 2022. The theoretical framework addresses the history of research involving human subjects, the origins and evolution of bioethics in the international context, bioethics in Brazil, and regulations on the ethical analysis of research. The data were collected through the Brazil Platform and reports from the institution's CEP. The CEP evaluated 865 research protocols, most of which were from Health Sciences. Additionally, it was observed that during 2018 to 2022 the covid-19 pandemic had a negative impact on the number of projects submitted for evaluation to the CEP. The 57% drop in the number of projects registered during 2020/2022 reveals the negative impact of this event on the execution of projects with human participants.

El Comité de Ética en Investigación (CEP) se ha convertido en un mecanismo esencial para el control social en la investigación brasileña con seres humanos, contribuyendo al desarrollo de estudios guiados por normas éticas y a la protección de los participantes en la investigación. Este artículo analiza el desempeño del CEP en la institución amazónica occidental, su historia, condiciones de funcionamiento, tendencias y diferentes aspectos entre 2018 y 2022. El marco teórico aborda la historia de la investigación con seres humanos, los orígenes y la evolución de la bioética en el contexto internacional, la bioética en Brasil y la normativa sobre el análisis ético de la investigación. Los datos se recogieron a través de la Plataforma Brasil y de informes del CEP de la institución. El CEP evaluó 865 protocolos de investigación, la mayoría de los cuales eran de Ciencias de la Salud. Además, se observó que durante 2018 a 2022 la pandemia de covid-19 tuvo un impacto negativo en el número de proyectos presentados para evaluación al CEP. La caída del 57% en el número de proyectos registrados durante 2020/2022 revela el impacto negativo de este evento en la ejecución de proyectos con participantes humanos.

Os Comitês de Ética em Pesquisa (CEPs) tornaram-se um mecanismo essencial para o controle social em pesquisas brasileiras envolvendo sujeitos humanos, contribuindo para o desenvolvimento de estudos regido por padrões éticos e para a proteção de participantes de pesquisas. Esse artigo analisa o desempenho de CEP em instituição da Amazonia Ocidental, sua história, condições operativas, tendências e diferentes aspectos entre 2018 e 2022. O enquadre teórico visa a história da pesquisa envolvendo sujeitos humanos, as origens e evolução da bioética no contexto internacional, bioética no Brasil e regulamentos de análise ética de pesquisa. Os dados foram coletados através da Plataforma Brasil e relatórios do CEP da instituição. O CEP avaliou 865 protocolos de pesquisa, a maioria deles de Ciências da Saúde. Adicionalmente, foi observado que de 2018 a 2022 a pandemia da covid-19 teve um impacto negativo no número de projetos submetidos para avaliação do CEP. A queda de 57% no número de projetos registrados em 2020/2022 revela o impacto negativo desse evento na execução de projetos com participantes humanos.

Engajando crianças em pesquisas científicas: o termo de assentimento no formato de história em quadrinhos / Engaging children in scientific research: the term of assent in the format of comic / Instando a niños en investigaciones científicas: el término de asentimiento en el formato de cómics

O assentimento infantil é uma exigência ética em pesquisas com crianças, porém sua comunicação eficaz tem sido um desafio. Neste relato, descrevemos a construção teórica e metodológica de um termo de assentimento infantil em formato de história em quadrinhos. A experiência foi realizada em uma escola municipal de Teresina, Piauí, com 32 crianças entre oito e dez anos. As etapas consistiram no estudo das questões éticas envolvidas, na construção da arte sequencial, na observação participante, em ajustes na história em quadrinhos e na aplicação e assinatura do termo de assentimento. A experiência resultou em um termo com legibilidade de Flesch de 91,81 sobre as questões éticas na pesquisa com crianças. O assentimento infantil em formato de história em quadrinhos apresentou linguagem acessível, lúdica e legibilidade adequada para comunicar pesquisa com crianças.

Child assent is an ethical requirement in research with children, however effective communication has been a challenge. In this report we describe the theoretical and methodological construction of a child assent term in comic book format. The experience was carried out in a municipal school of Teresina-Piaui with 32 children between eight and ten years old. The steps consisted of the study of ethical issues, the construction of sequential art, in participant observation, in adjustments to the comic strip and in the application and signature of the assent term. The experience resulted in a term with Flesch readability of 91.81 on ethical issues in research with kids. The childish nod in comic book format presented accessible, playful language and adequate legibility to communicate research with children.

El asentimiento infantil es una exigencia ética en investigaciones con niños. Sin embargo, la comunicación eficaz ha sido un desafío. En este relato describimos la construcción teórica y metodológica de un término de asentimiento infantil en formato de cómics. La experiencia ha sido realizada en una escuela municipal de Teresina, Piauí, con 32 niños entre ocho y diez años. Las etapas consistieron en el estudio de las cuestiones éticas, en la construcción del arte secuencial, en la observación participante, en ajustes en los cómics y en la aplicación y firma del término de asentimiento. La experiencia resultó en un término con legibilidad de Flesch de 91,81 sobre las cuestiones éticas en la investigación con niños. El asentimiento infantil en formato de cómics presentó lenguaje accesible, lúdica y legibilidad adecuada para comunicar investigación con niños.

Implementation of an Ethics Committee in a University Mental Health Clinic.

Mental disorders in university students are very frequent, therefore higher education institutions have established in-campus mental healthcare centres. These clinics have particular characteristics that differ from other mental health centres, as they report to and represent an educational institution, while at the same time looking after the interests and well-being of patients requesting assistance, thus generating unique bioethical conflicts. Ethics Committees are useful tools to offer support to mental health professionals in making ethical decisions. In order to respond to these issues, it was decided that an Ethics Committee would be created in the mental health clinic of a private university in Mexico City. This article describes the implementation process for this Committee, its duties and scope, as well as the case work and review methodology. A list of the most frequent ethical conflicts is attached, jointly with the ethical analysis of the cases treated throughout the year and a half or work by the Committee.

Reporting of conflict of interests, source of funding, and ethics committee approval in randomized trials of three clinical specialties published in Spanish language

Background: Confidence in the results reported by randomized clinical trials (RCTs) depends mainly on the internal validity of the trial and its conduct, but also on other aspects related to health research such as the complete reporting of conflicts of interest (COI), funding sources and approval by ethics committees. Bias in the study results may arise from any one of these elements. Prior studies have explored the reporting of these items in the medical literature, but there are no reports on RCTs published in Spanish and Latin American journals. This study aimed to evaluate the reporting of COIs, funding sources, and approval by ethics committees of RCTs published in Spanish and Latin American journals in dentistry, geriatrics and neurology. Methods: We did a systematic retrospective survey of all RCTs published from 1990 to 2018 in dentistry, neurology, and geriatrics journals published in Spain and Latin America and included in the BADERI database (Iberoamerican journals and trials database by its initials in Spanish). We completed with hand searching. We included RCTs with a recoverable full text published between 1990 and 2018. We extracted data on sources of funding, COI statements, and ethics reviews. The extraction of these items in the RCTs included was done independently by two pairs of reviewers and in parallel for each article, with a third independent reviewer resolving discrepancies. We analysed compliance for each item. Results: We identified RCTs in 69 journals from Spain and Latin American countries. Dentistry accounted for 75% (n = 52) of the journals, neurology 20.6% (n = 14), and geriatrics 4.4% (n = 3). Of the total number of RCTs included in this study (n = 392), only 102 (26%) reported the presence or absence of a COI, 103 (26%) studies reported funding, and 43 (36%) included the ethics committee approval. Conclusions: RCTs published in the Spanish language in dentistry, neurology, and geriatrics had poor compliance with the reporting of a COI, source of funding, and ethics committee approval. Future research should evaluate the accuracy and completeness of COI statements and their relationship to the funding source and direction of the results.

Política de medicamentos de alto costo en un hospital público pediátrico: Análisis de utilización y costos / High-cost medication policy at a public pediatric hospital: utilization and cost analysis

Objetivos. Analizar el circuito de utilización de los medicamentos de alto costo (MAC) y los resultados clínicos obtenidos en un hospital de pediatría público de alta complejidad de Argentina y presentar una estrategia de selección replicable para otras instituciones de similares características de la región. Métodos: Estudio prospectivo, descriptivo, aleatorizado, conducido en el Hospital de Pediatría Juan P. Garrahan de la Ciudad Autónoma de Buenos Aires en el período entre el 1 de setiembre de 2018 y el 31 de marzo de 2019. Se evaluaron dos unidades de estudio, la unidad paciente y la unidad MAC. Resultados: Los MAC consumen 7.921.200 dólares estadounidenses (USD) anuales y representan el 41% del costo de los medicamentos del hospital de alta complejidad. El 50% del costo de los MAC estuvo representado por la gammaglobulina (medicamento utilizado en diferentes enfermedades). Los pacientes proceden de toda la Argentina y otros países y un 44% tiene cobertura de salud. Los diagnósticos para los que se prescribieron MAC con mayor frecuencia fueron los relacionados con patología oncológica (leucemia linfoide aguda, leucemia mieloblástica aguda). El 54% de los pacientes presentó mejoría atribuible directamente a la administración de los MAC, 39% no presentó cambios y el 7% empeoró. Conclusiones: La efectividad en los resultados clínicos y el análisis de los circuitos de aprobación indican que, además de la aprobación por las entidades nacional e internacionales, la evaluación responsable por parte de las instituciones efectoras, mediante la discusión interdisciplinaria basada en la mejor evidencia, contribuye a optimizar la utilización de los MAC y la seguridad de los pacientes (AU)

Objectives. To analyze the utilization circuit of high-cost medications (HCM) and the clinical results obtained in a tertiarycare public pediatric hospital in Argentina and to present a selection strategy that may be disseminated to other institutions of similar characteristics in the region. Methods: A prospective, descriptive, randomized study was conducted at Hospital de Pediatría Juan P. Garrahan in Buenos Aires between September 1, 2018 and March 31, 2019. Two study units were evaluated, the patient and the HCM. Results: HCMs account for 7,921,200 US dollars (USD) per year and represent 41% of the cost of drugs in this tertiary-care hospital. Gamma globulin (a drug used for different diseases) accounted for 50% of the cost of HCMs. Patients came from Argentina and other countries and 44% had a health insurance. Cancer (acute lymphoid leukemia, acute myeloblastic leukemia) was the diagnosis for which HCMs were most frequently prescribed. Fifty-four percent of patients showed improvement directly attributable to the administration of HCMs, 39% showed no change, and 7% worsened. Conclusions: The effectiveness in clinical outcomes and the analysis of approval circuits show that, in addition to approval by national and international entities, responsible evaluation by the effector institutions through interdisciplinary discussion based on the best evidence contributes to optimizing the use of HCMs and patient safety (AU)

Assessment of an electronic system for research ethics committees document management: An observational study.

Since 1 January 2020, the Central Research Ethics Committee of the Health Ministry implemented PRIISA.BA, an in-house developed electronic system for online submission of health research applications to the 63 public and private research ethics committees (RECs) of Buenos Aires City, Argentina. This study though to compare the times to first review and the time to approval among applications submitted prior to PRIISA.BA and thereafter, across public RECs. All public RECs of the city were invited to participate. Overall, 453 applications from 10 RECs (242 pre- and 211 post-PRIISA.BA) were available for the analyses. There was a decrease in the time to first review and an increase in the time to approval after PRIISA.BA implementation. The increase in time to approval was transient and limited to the first three months. The results were consistent with analyses limited to non-COVID applications. Our results show an increase in the times to approval after the implementation of an electronic system for online submission of health research applications that, although transient, was significant. These data could be relevant to other RECs implementing this technology since it emphasizes the need of monitoring potential unnecessary delays in reviews during the critical initial period.

Variability in Ethics Review for Multicenter Protocols in Buenos Aires, Argentina. An Observational Study.

It has been reported that significant variability in the ethics review process affects multisite studies. We analyzed 1,305 applications for multicenter studies (409 unique protocols), from 1st January 2020 to 20th September 2021. We examined the variability in the times to approval and the first observation and the variation in the level of risk assigned. The median [IQR] variabilities were 42.19 [15.23-82.36] days and 8.00 [3.12-16.68] days, for the times to approval and to the first observation, respectively. There was disagreement in the level of risk assigned by the Research Ethics Committee (REC) in 24.0% of cases. Independent predictors of variability included the number of REC members. In our study, we found substantial variability in the ethics review process among health research protocols. Also, we describe methods to readily measure the delays and the variations in the ethics review process.

Accreditation of research ethics committees in Paraguay: An ethical imperative.

In the last decade, Paraguay has made progress in the development of health-related research involving human subjects. This entails the obligation of the State to ensure that research is conducted ethically: protecting the dignity, rights and welfare of the participants, scientific integrity and adherence to international ethical guidelines. Research Ethics Committees are the main instance or resource to guarantee the aforementioned obligation. In view of the above and the context lacking adequate regulation in which research is currently carried out in the country, this article will defend the ethical imperative of establishing an accreditation system for research ethics committees. To this end, its necessity will be presented and justified and some objections related to the ethical imperative defended will be answered, such as the per se value of the accreditation of research ethics committees in the protection of participants, the investment of time and bureaucracy involved in the accreditation processes and the incipient regulatory framework for research on human beings in Paraguay. Finally, it will be proposed to strengthen the governance of research ethics in the country, as the main means to establish, implement and supervise an accreditation system for research ethics committees.

Resumen: En la última década, el Paraguay ha presentado avances en el desarrollo de la investigación relacionada con la salud con seres humanos. Sin embargo, existe una obligación estatal de asegurar que las investigaciones sean realizadas éticamente: protegiendo la dignidad, los derechos y el bienestar de los participantes, la integridad científica y la adherencia a pautas éticas locales e internacionales. Los comités de ética de la investigación institucionales constituyen la instancia o recurso principal para garantizar la mencionada obligación. Ante lo expuesto y el contexto carente de adecuada regulación en el cual actualmente se desarrollan las investigaciones en el país, en el presente artículo defenderemos el imperativo ético de establecer un sistema de acreditación de los comités de ética de la investigación. Para ello, expondremos y justificaremos su necesidad y buscaremos responder algunas objeciones relativas al imperativo ético defendido, como, por ejemplo, el valor per se de la acreditación de los comités de ética en investigación en la protección de los participantes, la inversión de tiempo y burocracia que implican los procesos de acreditación y el marco regulatorio incipiente para las investigaciones en seres humanos en el Paraguay. Finalmente, propondremos el fortalecimiento de la gobernanza de la ética de la investigación en el país, como medio principal para establecer, implementar y supervisar un sistema de acreditación de los comités de ética de la investigación. Palabras clave: comité de ética en investigación; acreditación de los comités de ética de la investigación; investigación relacionada con la salud con seres humanos; protección de los sujetos de estudio en las investigaciones; pautas éticas internacionales; gobernanza de la ética de la investigación. Resum: A l'última dècada, el Paraguai ha presentat avenços en el desenvolupament de la recerca relacionada amb la salut amb éssers humans. Tot i això, hi ha una obligació estatal d'assegurar que les investigacions siguin realitzades èticament: protegint la dignitat, els drets i el benestar dels participants, la integritat científica i l'adherència a pautes ètiques locals i internacionals. Els comitès d'ètica de la investigació institucionals constitueixen la instància o el recurs principal per garantir l'obligació esmentada. Davant del que s'ha exposat i el context sense regulació adequada en el qual actualment es desenvolupen les investigacions al país, en aquest article defensarem l'imperatiu ètic d'establir un sistema d'acreditació dels comitès d'ètica de la investigació. Per això, exposarem i justificarem la seva necessitat i buscarem respondre algunes objeccions relatives a l'imperatiu ètic defensat, com, per exemple, el valor perseguit de l'acreditació dels comitès d'ètica en recerca en la protecció dels participants, la inversió de temps i burocràcia que impliquen els processos d'acreditació i el marc regulador incipient per a les investigacions en éssers humans al Paraguai. Finalment, proposarem l'enfortiment de la governança de l'ètica de la investigació al país com a mitjà principal per establir, implementar i supervisar un sistema d'acreditació dels comitès d'ètica de la investigació. Paraules clau: comitè d'ètica en investigació; acreditació dels comitès d'ètica de la investigació; investigació relacionada amb la salut amb éssers humans; protecció dels subjectes d'estudi a les investigacions; pautes ètiques internacionals; governança de l'ètica de la investigació.

Professional and academic profile of the Brazilian research ethics committees.

BACKGROUND: Brazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics (CONEP) and 779 Research Ethics Committees (RECs), in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities (SSH) researches must respect Resolution 510/16. There are Brazilian RECs that review SSH and clinical trials. This study aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC's Chairs to compose their membership. METHODS: All 779 Brazilian RECs' chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. RESULTS: The results showed a predominance of members from the biomedical area (57%), while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were (45.2%) PhD and (27.9%) masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees. CONCLUSION: The RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC's specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols.

Aspectos éticos y recomendaciones para investigación en seres humanos en la era genómica / Ethical aspects and recommendations for human research in the genomic age

Este artículo revisa los principales desafíos éticos que plantea la investigación vinculada al genoma humano a la luz de la bibliografía internacional y entrega recomendaciones sobre su abordaje basada en nuestra experiencia en el Comité de Ética para la Investigación en Seres Humanos de la Facultad de Medicina, Universidad de Chile, incluyendo las regulaciones legales nacionales. Los estándares éticos de la investigación en seres humanos deben extremarse para proteger adecuadamente a los participantes en estudios involucrados con la genómica. Especialmente relevantes en este contexto son: la protección de la confidencialidad y anonimato; la política de entrega de resultados y la posibilidad de retirarse del estudio. Compartir datos resultantes de investigaciones genéticas permite optimizar recursos, otorga mayor transparencia y replicabilidad de los análisis y permite descubrir alteraciones genéticas responsables de enfermedades raras y genes involucrados en enfermedades hereditarias multifactoriales, además de contribuir al diseño de medicina de precisión y de nuevas estrategias terapéuticas. Sin embargo, plantea grandes desafíos: proteger la privacidad y evitar la re-identificación de los voluntarios, la entrega de resultados con asesoría pre y post estudio. Estos aspectos requieren la elaboración de un cuidadoso proceso de consentimiento informado para investigaciones genómicas cuyos componentes principales se analizan en este artículo.

This article reviews the main ethical challenges posed by human genome research in the light of the international literature and provides recommendations on how to approach them based on our experience in the Ethics Committee for Research on Human Subjects of the Faculty of Medicine, University of Chile, including national legal regulations. Ethical standards in human research must be extreme, in order to adequately protect participants in studies involving genomics. Particularly relevant in this context are the protection of confidentiality and anonymity; the policy of delivery of results and the possibility of withdrawing from the study. Sharing data resulting from genetic research optimizes resources, provides greater transparency, and replicability of the analyses and makes it possible to discover genetic alterations responsible for rare diseases and genes involved in multi-factorial hereditary diseases, as well as contributing to the design of precision medicine and new therapeutic strategies. However, it poses great challenges: protecting privacy and avoiding re-identification of volunteers, delivery of results with pre- and post-study counseling. These aspects require the elaboration of a careful informed consent process for genomic research, the main components of which are discussed in this article.

Operation of research ethics committees in Colombia, Costa Rica, Guatemala, and Mexico: Mesoamerican Project / Funcionamiento de los comités de ética en investigación en Colombia, Costa Rica, Guatemala y México: Proyecto Mesoamericano

Abstract: Objective: To attain a better understanding of the structure and processes of Research Ethics Committees (REC) in the low-and middle-income countries of the Mesoamerican region. The objectives are knowing the operational practices of the RECs regarding project evaluation, training needs, and infrastructure. Materials and methods: The REC training and needs assessment involved an online survey of all the RECs (n=55) identified in Colombia (n=11), Costa Rica (n=5), Guatemala (n=5), and Mexico (n=34). Results: Participants reported inadequate infrastructure for its proper operation (only 49.1 %, or 27/55, have an exclusive office to safeguard files); insufficient administrative staff (47.3%, 26/55), or financial resources to conduct active site monitoring (85.6%, 47/55) to ensure the protection of rights and welfare of study participants. Conclusions: Investments in REC member training and infrastructure are needed to ensure compliance of REC evaluations with the standards for ethical conduct of research.

Resumen: Objetivo: Comprender la estructura y procesos de los Comités de Ética en Investigación (CEI) en países mesoamericanos de ingresos bajos y medios. Conocer las prácticas operativas en evaluación de proyectos, necesidades de capacitación e infraestructura. Material y métodos: Encuesta en línea para evaluar necesidades de capacitación de los CEI (n=55) identificados en Colombia (n=11), Costa Rica (n=5), Guatemala (n=5) y México (n=34). Resultados: Los participantes reportaron una infraestructura inadecuada para su correcto funcionamiento (oficina exclusiva para archivos 49.1%, 27/55); personal administrativo insuficiente (47.3%, 26/55), recursos financieros insuficientes para monitoreo del sitio (85.6%, 47/55), para garantizar protección de derechos y bienestar de los participantes. Conclusiones: Se necesita invertir en capacitación de los miembros e infraestructura del CEI, para garantizar la conducción ética de la investigación.

Jornadas de Bioética de Arica y Parinacota: siete años de crecimiento / Bioethics Conference in Arica and Parinacota: seven years of growth

Desde el año 2015 se realizan anualmente las Jornadas de Bioética de Arica y Parinacota, en la ciudad más extremo norte de Chile. Esta actividad ha permitido el conocimiento y desarrollo de la bioética en el ámbito hospitalario y académico en la XV región, y ha sido promotora de la creación del Comité Ético Científico de la Universidad de Tarapacá (CEC UTA) y de la revista Journal of Health and Medical Sciences (JOHMASC). Durante siete años han participado en forma activa, e ininterrumpida, exponentes locales y destacados invitados nacionales, quienes han contribuido a la enseñanza y difusión de esta interdisciplina en la ciudad de Arica, incluyendo la realización de las Jornadas Nacionales de la Sociedad Chilena de Bioética el año 2018.

Since 2015, the Arica and Parinacota Bioethics Sessions have been held annually, in the northernmost city of Chile. This activity has allowed the knowledge and development of bioethics in the hospital and academic field in the XV region, and has promoted the creation of the Scientific Ethics Committee of the University of Tarapacá (CEC UTA) and the Journal of Health and Medical Sciences (JOHMASC). For seven years, local exponents and prominent national guests have participated actively and uninterruptedly, contributing to the teaching and dissemination of this interdiscipline in the city of Arica, including holding the National Conference of the Chilean Society of Bioethics on year 2018.

Marco ético y jurídico en la investigación científica en chile: acreditación de comités ético científicos / Ethical and legal framework in scientific research from Chile: functioning of accredited scientific ethics committees

RESUMEN: La investigación científica en seres humanos es fundamental para el desarrollo y avance en la ciencia de la salud y para el bienestar de la sociedad. La necesidad de contar con principios éticos explícitos y un marco regulatorio, permitió en el año 2001 la aprobación de la Norma sobre Regulación de Ensayos Clínicos en Seres Humanos. La ley 20.120 (2006), norma la investigación científica en el ser humano, describe aspectos centrales para el desarrollo de la investigación, dando sustento legal a la creación de los Comités Éticos Científicos (CEC), entidades colegiadas que tienen por objeto velar por la protección de la vulneración de derechos y libertades de los participantes, pudiendo aprobar o rechazar los protocolos de los proyectos. En Chile al año 2021 se registran 62 CEC acreditados. La región Metropolitana concentra el 58,2 %, la zona Norte un 11,2 % y en el sur del país un 30,6 %, de ellos solo el 12,9 % están acreditados para evaluar ensayos clínicos aleatorizados (ECA). Los criterios éticos internacionales más utilizados son la Declaración de Helsinki, pautas éticas sobre la salud, bienestar y los derechos de los pacientes; El Consejo Internacional de Ciencias Médicas (CIOMS) que protege en entornos vulnerables de escasos recursos; y el Informe Belmont en la protección de los sujetos de investigación. Se concluye que las guías éticas nacionales e internacionales son pautas que guardan relación con la adecuada protección jurídica de los participantes, velando por el respeto a la autonomía, la justicia y la selección justa de los participantes, a través del consentimiento informado voluntario. El desarrollo de una cultura de conducta ética en la investigación se debe basar en tres dimensiones generales; el ambiente humano, ambiente político y mecanismos de la sociedad civil.

SUMMARY: Scientific research in human beings is essential for the development and advancement of health science and for the well-being of society. The need to have explicit ethical principles and a regulatory framework allowed in 2001 the approval of the Standard on the Regulation of Clinical Trials in Human Beings. Law 20,120 (2006), regulates scientific research in human beings and describes central aspects for the development of research, giving legal support to the creation of Scientific Ethics Committees (SEC), collegiate entities whose purpose is to ensure the protection of the vulnerability of rights and freedoms of the participants, being able to approve or reject the protocols of the projects. In Chile by 2021, 62 accredited CECs are registered. The Metropolitan region concentrates 58.2 %, the North zone 11.2 % and in the south of the country 30.6 %, of which only 12.9 % are accredited to evaluate randomized clinical trials (RCTs). The most widely used international ethical criteria are the Helsinki Declaration, ethical guidelines on health, well-being and the rights of patients; The International Council of Medical Sciences (CIOMS) that protects in vulnerability low-resource settings; and the Belmont Report on the protection of research subjects. It is concluded that the national and international ethical guidelines are appropriate legal ethical guidelines and risk-benefit ratio that protect the participants, ensuring respect for the autonomy, justice and fair selection of the participants, through voluntary informed consent. The development of a culture of ethical conduct in research must be based on three general dimensions; the human environment, political environment and mechanisms of civil society.

Fundamentos para resolução de problemas morais e/ou éticos nos comitês de ética em pesquisa / Fundamentals for solving moral and/or ethical problems in research ethics committees / Fundamentos para la resolución de problemas morales y / o éticos en los comités de ética en investigación

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)

Caracterização de membros de Comitês de Ética em Pesquisa de uma capital do Nordeste brasileiro / Characterization of members of research ethics committees in a capital of northeastern Brazil / Caracterización de los miembros de los comités de ética que investigan una capital en el noreste de Brasil

Objetivo: caracterizar membros de comitês de ética em pesquisa implantados em instituições de ensino superior e em hospitais de uma capital do Nordeste brasileiro. Método: estudo descritivo, por meio de questionário online, aplicado na plataforma Google Forms, tendo como participantes 39 membros efetivos que atuavam em comitês de ética em pesquisa implantados em instituições de ensino superior e em hospitais. Resultados: dos participantes que responderam,59,0% pertenciam ao gênero feminino, 51,2% eram pardos, 54,0% mestres, 49,0% casados, 38,4% pertencem à categoria profissional professor (a), 54,0% dos participantes disseram não haver treinamento inicial, 51% disseram haver formação continuada, 79,5% relataram atuar em comitês de ética em pesquisa na instituição na qual trabalham. Conclusão: os membros dos comitês de ética de uma capital no nordeste brasileiro possuem caraterísticas necessárias para atuarem nesses colegiados, mas há necessidade de redimensionamento em alguns aspectos para que de fato possa haver proteção e garantia aos direitos e interesses dos participantes da pesquisa. (AU)

Objective: To characterize members of research ethics committees located in institutions of higher education and in hospitals in a capital of Northeastern Brazil. Methods: A descriptive study, using an online questionnaire, applied on the Google Forms platform, with 39 effective members who worked on research ethics committees in higher education institutions and hospitals as participants. Results: Of the participants who responded, 59.0% were female, 51.2% were brown, 54.0% masters, 49.0% married, 38.4% belong to the professional category teacher (a), 54, 0% of participants said there was no initial training, 51% said there was continuing training, 79.5% reported working on research ethics committees at the institution where they work. Conclusion: The members of the ethics committees of a capital city in northeastern Brazil have the necessary characteristics to act in these collegiate bodies, but there is a need to resize in some aspects so that in fact there can be protection and guarantee to the rights and interests of the research participants. (AU)

Objetivo: Caracterizar a los miembros de los comités de ética en investigación ubicados en instituciones de educación superior y en hospitales de una capital del noreste de Brasil. Métodos: Estudio descriptivo, mediante cuestionario online, aplicado en la plataforma Google Forms, con 39 miembros efectivos que trabajaron en comités de ética en investigación en instituciones de educación superior y hospitales como participantes. Resultados: De los participantes que respondieron, 59,0% eran mujeres, 51,2% morenos, 54,0% maestros, 49,0% casados, 38,4% pertenecen a la categoría profesional docente (a), 54,0% de los participantes dijeron que no había formación inicial, El 51% dijo que había formación continua, el 79,5% informó que trabaja en comités de ética en investigación en la institución donde trabaja. Conclusión: Los miembros de los comités de ética de una ciudad capital en el noreste de Brasil tienen las características necesarias para actuar en estos órganos colegiados, pero es necesario redimensionar en algunos aspectos para que de hecho pueda haber protección y garantía a los derechos y intereses de los participantes en la investigación. (AU)

Reflexiones en torno al papel de enfermería en los comités de bioética

Propósito/Contexto. En este artículo expondremos los diferentes tipos de comités de bioética y realizaremos un recorrido por su historia para luego adentrarnos en el rol de enfermería dentro de estos espacios. Metodología/Enfoque. Los comités de bioética son organismos que abordan aspectos dilemáticos de orden moral que se presentan en las ciencias de la salud, las ciencias biológicas y las políticas de salud innovadoras. Si bien la conformación debería ser multidisciplinar, con el objetivo de tener un enfoque amplio frente a las situaciones que se presentan, en la práctica no siempre sucede esto. Nos enfocaremos en analizar cómo es la experiencia de estos profesionales dentro de los comités y cuáles son las barreras que se encuentran al querer formar parte de estos equipos. Resultados/Hallazgos. Entre los hallazgos se encuentran las dificultades para la participación de los enfermeros en los comités por falta de tiempo, reconocimiento y apoyo institucional, de los compañeros y de los superiores, falta de formación específica y confusión entre problemas éticos y legales. También se encontró dispersión en la legislación argentina sobre el tema. Discusión/Conclusiones/Contribuciones. Es necesario ganar un mayor reconocimiento y apoyo por parte de las instituciones y de los colegas y superiores para que la participación de los profesionales en enfermería pueda ser efectiva.

Purpose/Context. This article presents different types of bioethics committees, looks through their history, and delves into the role of nursing in these settings. Methodology/Approach. Bioethics committees deal with moral dilemmas arising in health sciences, biological sciences, and innovative health policies. While their structure should be multidisciplinary for a broad approach to emerging situations, it does not always happen in practice. We will focus on analyzing what nurses' experience is like within committees and the barriers they face when joining these teams. Results/Findings. We found difficulties in the participation of nurses in committees due to a lack of time, recognition, and support by institutions, colleagues, and superiors, no specific training, and confusion between ethical and legal issues. A dispersion was also detected in Argentine legislation on the subject. Discussion/Conclusions/Contributions. Greater recognition and support from institutions, colleagues, and superiors is necessary for the participation of nursing professionals to be effective.

Objetivo/contexto. Neste artigo exporemos os diferentes tipos de comitês de bioética e realizaremos um percurso por sua história para logo adentrar-nos no rol de enfermagem dentro destes espaços. Metodologia/Abordagem. Os comitês de bioética são organismos que abordam aspectos dilemáticos de ordem moral que se apresentam nas ciências da saúde, nas ciências biológicas e nas políticas de saúde inovadoras. Embora a conformação deveria ser multidisciplinar, com o objetivo de ter uma abordagem ampla diante das situações que se apresentam, na prática nem sempre isso acontece. Vamos nos concentrar em analisar como é a experiência destes profissionais dentro dos comitês e quais são as barreiras diante das que se encontram ao querer fazer parte destas equipes. Resultados/Descobertas. Entre as descobertas encontram-se as dificuldades para a participação dos enfermeiros nos comitês por falta de tempo, reconhecimento e apoio institucional, dos companheiros e dos superiores, falta de formação específica e confusão entre problemas éticos e legais. Também encontrou se dispersão na legislação argentina sobre o tema. Discussão/Conclusões/Contribuições. É necessário ganhar um maior reconhecimento e apoio por parte das instituições e dos colegas e superiores para que a participação dos profissionais de enfermagem possa ser efetiva.

Safety and bioactive potential of nanoparticles containing Cantaloupe melon (Cucumis melo L.) carotenoids in an experimental model of chronic inflammation.

The safety and bioactive potential of crude carotenoid extract from Cantaloupe melon nanoencapsulated in porcine gelatin (EPG) were evaluated in a chronic inflammatory experimental model. Animals were fed a high glycemic index and high glycemic load (HGLI) diet for 17 weeks and treated for ten days with 1) HGLI diet, 2) standard diet, 3) HGLI diet + crude carotenoid extract (CE) (12.5 mg/kg), and 4) HGLI diet + EPG (50 mg/kg). General toxicity signals were investigated, considering body weight, food intake, hematological, biochemical parameters, relative weight, morphology, and histopathology of organs. The biochemical parameters indicated the low toxicity of EPG. Acute hepatitis was observed in animals' livers, but CE and EPG groups presented improved tissue appearance. Chronic enteritis was observed in animals, with villi and intestinal glands preservation in the EPG group. The results suggest the safety and the bioactive effect of EPG, possibly related to its anti-inflammatory potential.

Consulta do Registo de Saúde Eletrónico ­ Análise ética de um caso clínico / Electronic Health Registry Query - Ethical Case Study / Consulta electrónica de registros de salud - Estudio de caso ético

Introducción: La bioética surgió de la necesidad de regular un código de conducta ética que evitara las prácticas médicas abusivas llevadas a cabo durante varios siglos. El Procedimiento Deliberativo (PD), aplicado a la medicina, ayuda a tomar decisiones éticas de forma objetiva (equilibrada, podenrada) y justa. Con la presentación de este caso clínico se pretende, como ejemplo, demostrar la importancia de aplicar el PD en la práctica clínica en medicina general y familiar (MGF). Caso clínico: Un hombre de 58 años que, después de un antígeno prostático específico alterado, fue derivado a una consulta de urología. Un mes después de la biopsia de próstata, asiste a la consulta de MGF con la confianza de que el resultado sería negativo. Sin su autorización, el médico de familia (MF) accedió al registro electrónico de salud y descubrió que el paciente tenía un adenocarcinoma de próstata, aunque no habia sido re-evaluado por Urologia. Se eligió el problema ético más importante y se definió el curso de acción óptimo que cumplía los criterios de legalidad, publicidad y temporalidad. Conclusión: La decisión del médico siempre debe beneficiar el paciente. El PD permite tomar decisiones estructuradas, por lo cual debe aplicarse en el contexto de la MGF frente a problemas éticos

Introduction: Bioethics emerged from the need to implement an ethical code of conduct that would avoid abusive clinical practice carried for centuries. The Deliberative Procedure (DP) applied to medicine helps in making ethical decisions in a well-reasoned and fair manner. This clinical case report is intended to exemplify the importance of applying the deliberative process in clinical practice in general practice/family medicine (GP/FM). Clinical case: Male, 58 years old referenced to urology office visit after positive Prostate-Specific Antigen (PSA) test. A month after prostatic biopsy he went to the medical consultation with his Family Doctor, believing the result was negative. His family doctor assessed his health electronic record without his authorization, and verified the result of the biopsy was a prostatic adenocarcinoma, without new urology appointment. It was elected the most important ethic problem and defined the action curse that accomplish the legality, publicity and temporary criteria. Conclusions: Whatever the physician decides, it should always be for the benefit of the wearer. DP allows structured decision making so it should be applied in the context of GP/FM in the face of ethical problems.

Introdução: A bioética surgiu da necessidade de regulamentar um código de conduta ética que evitasse as práticas médicas abusivas realizadas durante vários séculos. O Procedimento Deliberativo (PD) aplicado à medicina, ajuda na tomada de decisões éticas de forma ponderada e justa. Com a apresentação deste caso clínico pretende-se exemplificar a importância da aplicação do PD na prática clínica em Medicina Geral e Familiar (MGF). Apresentação do caso: Homem de 58 anos que no seguimento de um antígeno específico da próstata (PSA) alterado foi referenciado à consulta de urologia. Um mês após biópsia prostática recorre à consulta de MGF confiante de que o resultado seria negativo. Sem a sua autorização, o Médico de Família (MF) acedeu ao Registo de Saúde Eletrónico e verificou que o doente apresentava um adenocarcinoma da próstata, embora não tivesse ainda consulta de reavaliação de urologia. Foi eleito o problema ético mais importante e definido o curso de ação ótimo que cumpria os critérios de legalidade, publicidade e temporalidade. Conclusões: Qualquer que seja a decisão do médico, deve ser sempre em benefício da pessoa. O PD permite uma tomada de decisão estruturada pelo que deve ser aplicado no contexto de MGF perante a ocorrência de problemas éticos.

Challenges and Opportunities in Clinical Ethics with the Implementation of Korea's End-of-Life Act / Desafíos y oportunidades en ética clínica con la implementación de la Ley de fin de vida de Corea / Desafios e oportunidades em ética clínica com a implementação do Ato de Fim-da-Vida na Córeia

Abstract: This paper examines the possible impacts of the Act on Decisions on Life-Sustaining Treatment for Patients in Hospice and Palliative Care or at the End of Life in Korea (Korea's end-of-life act), legislated in 2016, on the development of hospital ethics committees and clinical ethics consultation services in South Korea. Clinical ethics in Korea has not made much progress in comparison to other subdisciplines of biomedical ethics. While the enactment of this law may give rise to beneficial clinical ethics services, it is possible that customary practices and traditional authorities in Korean society will come into conflict with the norms of clinical ethics. This paper examines how the three main agents of Korean society—family, government, and medical professionals—may clash with end-of-life stage norms in clinical ethics, thus posing obstacles to the development of hospital committees and consultation services. A brief outline of what lies ahead for the progress of clinical ethics practice is explored.

Resumen: Este documento examina los posibles impactos de la Ley de decisiones sobre el tratamiento de soporte vital para pacientes en hospicios y cuidados paliativos, o al final de la vida en Corea (Ley de Corea del Final de la Vida), legislada en 2016, sobre el desarrollo de comités de ética hospitalaria y servicios de consulta de ética clínica en Corea del Sur. La ética clínica en Corea no ha avanzado mucho en comparación con otras subdisciplinas de la ética biomédica. Si bien la promulgación de esta ley puede dar lugar a servicios de ética clínica beneficiosos, es posible que las prácticas tradicionales y las autoridades tradicionales en la sociedad coreana entren en conflicto con las normas de ética clínica. Este documento examina cómo los tres agentes principales de la sociedad coreana —familia, gobierno y profesionales médicos— pueden chocar con las normas de ética clínica al final de la vida, lo que plantea obstáculos para el desarrollo de comités hospitalarios y servicios de consulta. Se explora un breve resumen de lo que queda por delante para el progreso de la práctica de la ética clínica.

Resumo: Este artigo examina os possíveis impactos que o Ato sobre Decisões Relacionadas a Tratamento de Manutenção da Vida para Pacientes em Casas de Idosos e de Cuidados Paliativos ou ao Fim da Vida na Coréia (ato de fim da vida da Coréia), aprovado pelo legislativo em 2016, sobre o desenvolvimento de comitês de ética de hospitais e serviços de consulta sobre ética clínica na Coréia do Sul. Ética clínica na Coréia não sofreu muito progresso em comparação com outras subdisciplinas da ética biomédica. Enquanto a promulgação desta lei pode dar origem a serviços de ética clínica proveitosos, é possível que práticas usuais e autoridades tradicionais na sociedade coreana entrarão em conflito com as normas da ética clínica. Este artigo examina como os três principais agentes da sociedade coreana - família, governo e profissionais médicos - podem se chocar com normas de estágios de fim da vida em ética clínica, colocando assim obstáculos para o desenvolvimento de comitês hospitalares e serviços de consulta. Um breve esboço do que vem pela frente para o progresso da prática de ética clínica é explorado.

III. THE ROLE OF THE RESEARCH ETHICS COMMITTEES IN THE REGULATION OF PHARMA-SPONSORED STUDIES.

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects' first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.