Problemas morais e/ou éticos em comitês de ética em pesquisa / Moral and/or ethical issues in research ethics committees / Problemas morales y/o éticos en los comités de ética de investigación

Resumo O objetivo do estudo é analisar problemas morais e/ou éticos vivenciados por membros de comitês de ética em pesquisa durante suas atividades e as estratégias utilizadas para solucionar esses problemas. Trata-se de pesquisa de abordagem qualitativa, com participação de 39 membros que atuavam em comitês em Salvador/BA, Brasil. Os dados foram coletados em outubro de 2020 por questionário on-line autoaplicado na plataforma Google Forms. Os resultados evidenciaram: vivências de conflitos de interesses e de valores, bem como dilemas; e utilização de trocas de experiências e compartilhamento de ideias e opiniões como estratégias para solucionar esses problemas. Conclui-se que os membros desses comitês vivenciam problemas morais e/ou éticos e buscam solucioná-los por meio de estratégias que favorecem o desenvolvimento de pesquisas conforme critérios éticos e metodológicos adequados.

Abstract The objective of the study is to analyze moral and/or ethical issues experienced by members of research ethics committees when performing their activities and the strategies used to deal with those issues. This is a qualitative study with 39 individuals that participated in committees in Salvador, Bahia, Brazil. Data were collected in October 2020 using a self-administered online questionnaire developed using Google Forms. Results showed that participants underwent conflicts of interests and values, and also faced dilemmas, and the strategies used to deal with those issues were exchanging of experiences and sharing of ideas and opinions. It is concluded that members of such committees experience moral and/or ethical issues and seek to deal with them via strategies that favor the development of research according to appropriate ethical and methodological criteria.

Resumen El objetivo del estudio es analizar los problemas morales o éticos experimentados por los miembros de los comités de ética de investigación durante sus actividades y las estrategias que utilizan para resolver dichos problemas. Se trata de una investigación de enfoque cualitativo, con la participación de 39 miembros que actuaban en comités en Salvador, Bahía, Brasil. Los datos se recopilaron en octubre del 2020 por medio de un cuestionario en línea autoadministrado en la plataforma Google Forms. Los resultados mostraron experiencias de conflictos de intereses y valores, así como dilemas; y el intercambio de experiencias, ideas y opiniones como estrategias para solucionar dichos problemas. Se concluye que los miembros de estos comités experimentan problemas morales o éticos y tratan de solucionarlos mediante estrategias que favorezcan el desarrollo de investigaciones de acuerdo con criterios éticos y metodológicos adecuados.

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)

Research Using Big Data in Gastroenterology: Based on the Outcomes from Big Data Research Group of the Korean Society of Gastroenterology / 대한소화기학회지

The Big Data Research Committee of the Korean Society of Gastroenterology conducted activities and researches with three goals. First, it provides the basis for proper and cost-effective treatment of digestive diseases in Korea. Second, it carries out population-level global research by establishing a system of big data analysis related to gastroenterology. Third, it provides the members of the Korean Society of Gastroenterology with the opportunity to plan and assess the public interest related to big data. The studies published by the committee members in this paper were carried out under these objectives, and the findings are believed to have achieved the public interest goals that may be helpful in the current medical and health policy. The construction of the big data infrastructure for digestive drugs is also underway, and we expect to see meaningful results pertaining to important digestive drugs. Research using public health medical big data, such as the National Health Insurance Corporation data base, should ultimately provide a basis for reflecting public messages and policies for the public. To this end, it is necessary for Korean researchers to lead efforts to lower the barriers and to approach relevant information and opportunities using big data research.

La Nominación de Humberto Fernández-Morán al Premio Nobel en Fisiología o Medicina de 1968 / The nomination of Humberto Fernandez-Moran to the Nobel Prize in Physiology or Medicine 1968

En 1968 Humberto Fernández-Morán fue nominado por dos personas para el Premio Nobel en Fisiología o Medicina por sus contribuciones al estudio de la ultraestructura celular por medio del uso del microscopio electrónico, con especial mención al desarrollo de la cuchilla de diamante. Sin embargo, en ese año no fue seleccionado para su ulterior consideración para el premio.

Views of South African biomedical research ethics committee members on their own ethics review outcomes

Background. Current research ethics guidelines and legislation provide research ethics committees (RECs) with the prerogative to review and approve the ethical acceptability of human research before commencement. However, individual REC members' views on the ethical issues identified behind closed doors remain largely empirically unexplored. Objective. To investigate the views and perceptions of South African biomedical REC members on their own aggregated ethics review outcomes. Methods. Semi-structured interviews were conducted with nine REC members from two different institutions in South Africa. Results. All respondents concurred with the prioritisation of informed consent in the review outcomes, emphasising the importance of the use of simple and understandable language for participants. Respondents also discussed lack of scientific validity as a common problem when reviewing proposals. Interestingly, while the majority of respondents reiterated the common view that scientifically invalid research is unethical, some REC members believed that there was an overemphasis on evaluation of scientific validity, and that it was not within the remit of RECs to review the scientific quality of proposed studies. The REC members felt that HIV and tuberculosis research had high social value, because it addresses national and regional public health priorities. For this reason, there was no concern expressed that a high proportion of research proposals involved HIV and TB. Conclusion. Although most respondents found the aggregated results unsurprising, there was some disagreement with the ranked review outcomes, with a minority of respondents arguing that scientific validity was overemphasised. These findings have potential training and practice implications for RECs and researchers. The study findings call for further studies to validate such findings in other RECs

Delphi study to evaluate the emergency medical system operation fund support projects

OBJECTIVE: This study aimed to achieve expert consensus for the evaluation of Emergency medical system operation fund (EMSOF) support projects using the Delphi method in Korea. METHODS: The Delphi study was performed in June 2018. Experts who are members of the policy committee of the Korean Society of Emergency Medicine (KSEM) participated in the study. Respondents were asked to express their level of agreement of appropriateness for the following 6 categories for 21 projects: project contents, amount of support, indicators, performance, overall evaluation, and need to maintain. With a possible score of 9 points, the project categories were classified into 3 groups, inappropriate, moderate and appropriate, based on the median score of the respondents' ratings in each question. RESULTS: Sixteen of the 18 policy committee members participated in the survey. Their average professional work years were 8.2 years. All 21 projects were evaluated as appropriate for content. Amount of support and indicators were evaluated as moderate. Only 5 out of the 21 projects were evaluated as having appropriate indicators. No projects were evaluated as ineffective. Comprehensive evaluation of the projects was evaluated as moderate, and no project was evaluated as inappropriate in fund support. CONCLUSION: Overall, the contents of the EMSOF assistance project were rated high; however, there was a disagreement on the amount of support and evaluation indicators for each project. The results of this study are expected to be used as basic data to improve the use of EMSOF.

Practice guidelines for management of ovarian cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement / 부인종양

Since after 2006 when the first edition of practice guidelines for gynecologic oncologic cancer treatment was released, the Korean Society of Gynecologic Oncology (KSGO) has published the following editions on a regular basis to suggest the best possible standard care considering updated scientific evidence as well as medical environment including insurance coverage. The Guidelines Revision Committee was summoned to revise the second edition of KSGO practice guidelines, which was published in July 2010, and develop the third edition. The current guidelines cover strategies for diagnosis and treatment of primary and recurrent ovarian cancer. In this edition, we introduced an advanced format based on evidence-based medicine, collecting up-to-date data mainly from MEDLINE, EMBASE, and Cochrane Library CENTRAL, and conducting a meta-analysis with systematic review. Eight key questions were raised by the committee members. For every key question, recommendations were developed by the consensus meetings and provided with evidence level and strength of the recommendation.

Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement / 부인종양

Clinical practice guidelines for gynecologic cancers have been developed by many organizations. Although these guidelines have much in common in terms of the practice of standard of care for uterine corpus cancer, practice guidelines that reflect the characteristics of patients and healthcare and insurance systems are needed for each country. The Korean Society of Gynecologic Oncology (KSGO) published the first edition of practice guidelines for gynecologic cancer treatment in late 2006; the second edition was released in July 2010 as an evidence-based recommendation. The Guidelines Revision Committee was established in 2015 and decided to produce the third edition of the guidelines as an advanced form based on evidence-based medicine, considering up-to-date clinical trials and abundant qualified Korean data. These guidelines cover screening, surgery, adjuvant treatment, and advanced and recurrent disease with respect to endometrial carcinoma and uterine sarcoma. The committee members and many gynecologic oncologists derived key questions from the discussion, and a number of relevant scientific literatures were reviewed in advance. Recommendations for each specific question were developed by the consensus conference, and they are summarized here, together with other details. The objective of these practice guidelines is to establish standard policies on issues in clinical areas related to the management of uterine corpus cancer based on the findings in published papers to date and the consensus of experts as a KSGO Consensus Statement.

Practice guidelines for management of cervical cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement / 부인종양

Clinical practice guidelines for gynecologic cancers have been developed by academic society from several countries. Each guideline reflected their own insurance system and unique medical environment, based on the published evidence. The Korean Society of Gynecologic Oncology (KSGO) published the first edition of practice guidelines for gynecologic cancer treatment in late 2006; the second edition was released in July 2010 as an evidence-based recommendation. The Guidelines Revision Committee was established in 2015 and decided to develop the third edition of the guidelines in an advanced format based on evidence-based medicine, embracing up-to-date clinical trials and qualified Korean data. These guidelines cover strategies for diagnosis and treatment of primary and recurrent cervical cancer. The committee members and many gynecologic oncologists derived key questions through discussions, and a number of relevant scientific literature were reviewed in advance. Recommendations for each specific question were developed by the consensus conference, and they are summarized here, along with the details. The objective of these practice guidelines is to establish standard policies on issues in clinical practice related to the management in cervical cancer based on the results in published papers to date and the consensus of experts as a KSGO Consensus Statement.

Análise da atuação do comitê nacional de educação popular em saúde no período de 2009 a 2013

A contribuição do Comitê Nacional de Educação Popular em Saúde, no período2009-2013, para o avanço da Educação Popular em Saúde é o objeto deste estudo. Para analisar em que medida o Comitê contribuiu para a Educação Popular em Saúde nesse período, foi realizada uma revisão bibliográfica para a definição dos conceitos de Educação Popular e Educação Popular em Saúde.Em seguida caracterizou-se o CNEPS com base nas portarias do Ministério da Saúde. Após a análise documental e a sistematização das pautas e dos encaminhamentos foi realizada uma avaliação normativa, verificando-se se os objetivos instituídos formam alcançados ou não.

The contribution of the National Popular Education in Health Committee in theperiod 2009-2013, for the advancement of Popular Education in Health is theobject of this study. To analyze the extent to which the Committee contributedto the Popular Education in Health from 2009 to 2013, was carried out aliterature review to define the concepts of Popular Education and PopularEducation in Health. Then characterized the CNEPS based on ordinances ofthe Ministry of Health. After the document analysis and the systematization ofguidelines and referrals a normative evaluation was performed, verifying if theestablished objectives form achieved or not.

Survey of Endoscope Reprocessing in Korea

BACKGROUND/AIMS: There is a growing emphasis on quality management in endoscope reprocessing. Previous surveys conducted in 2002 and 2004 were not practitioner-oriented. Therefore, this survey is significant for being the first to target actual participants in endoscope reprocessing in Korea. METHODS: This survey comprised 33 self-filled questions, and was personally delivered to nurses and nursing auxiliaries in the endoscopy departments of eight hospitals belonging to the society. The anonymous responses were collected after 1 week either by post or in person by committee members. RESULTS: The survey included 100 participants. In the questionnaire addressing compliance rates with the reprocessing guideline, the majority (98.9%) had a high compliance rate compared to 27% of respondents in 2002 and 50% in 2004. The lowest rate of compliance with a reprocessing procedure was reported for transporting the contaminated endoscope in a sealed container. Automated endoscope reprocessors were available in all hospitals. Regarding reprocessing time, more than half of the subjects replied that reprocessing took more than 15 minutes (63.2%). CONCLUSIONS: The quality management of endoscope reprocessing has improved as since the previous survey. A national survey expanded to include primary clinics is required to determine the true current status of endoscope reprocessing.

Use of Thiopurines in Inflammatory Bowel Disease: A Consensus Statement by the Korean Association for the Study of Intestinal Diseases (KASID)

BACKGROUND/AIMS: For decades, thiopurines have been the mainstay of inflammatory bowel disease (IBD) treatment and will play an important role in the future. However, complex metabolism and various side effects limit the use of these potent drugs in clinical practice. The Korean Association for the Study of Intestinal Diseases developed a set of consensus statements with the aim of guiding clinicians on the appropriate use of thiopurines in the management of IBD. METHODS: Sixteen statements were initially drafted by five committee members. The quality of evidence and classification of recommendation were assessed according to the Grading of Recommendations Assessment, Development and Evaluation system. The statements were then circulated to IBD experts in Korea for review, feedback, and then finalized and accepted by voting at the consensus meeting. RESULTS: The consensus statements comprised four parts: (1) pre-treatment evaluation and management strategy, including value of thiopurine S-methyltransferase screening, dosing schedule, and novel biomarkers for predicting thiopurine-induced leukopenia; (2) treatment with thiopurines with regards to optimal duration of thiopurine treatment and long-term outcomes of combination therapy with anti-tumor necrosis factors; (3) safety of thiopurines, especially during pregnancy and lactation; and (4) monitoring side effects or efficacy of therapy using biomarkers. CONCLUSIONS: Thiopurines are an effective treatment option for patients with IBD. Management decisions should be individualized according to the risk of relapse and adverse events.