Challenges and Lessons from Conducting a Community-Engaged Evaluation of a Community Advisory Board-A Case Study from Flint.

Community-engaged research often poses challenges due to exactly those qualities that make it desirable: it provides a new model of research that differs in many ways from top-down, university-led, prospectively designed approaches. While many have discussed the challenges to conducting community-engaged research, few have provided precise and generalizable lessons for how to surmount these challenges. Here we discuss the challenges experienced in a project that was community-engaged at three levels: 1) a research team consisting of an academic and a community partner as well as a community and academic research assistant, 2) the research team engaged with a Community Advisory Board called the CBOP-CERB (Community Based Organization Partners-Community Ethics Research Board) throughout the project, and 3) the research involved recruiting community participants from an area with a historical distrust of researchers and research: Flint Michigan. We also discuss administrative challenges that this multilevel community-engagement posed. Most important, we provide practical lessons in order for future community-engaged research to avoid or mitigate many of these challenges.

Evaluating the Impact and Effectiveness of Flint's Community Ethics Review Board (CBOP-CERB): A Pilot Study.

In recognition of the importance of evaluation for funding, research, and quality improvement, a longstanding Community Advisory Board in Flint Michigan embarked on a process to evaluate their impact. The Community-Based Organization Partners (CBOP)-Community Ethics Review Board (CERB) engaged a research team composed of an academic researcher (Solomon Cargill) and a community partner (Spencer) to obtain funding, design and implement an evaluation of the CBOP-CERB. This evaluation study yielded two evaluations of the CBOP-CERB, one with researchers who had engaged with the CBOP-CERB and the other with Flint area community residents. The results of these two evaluations can serve to show other Community Advisory Boards how to establish and expand their impact, establish their worth for future funding, and how to articulate, evaluate, and achieve their goals.

Ética en investigación: desafíos durante la pandemia / Research ethics: challenges during the pandemic

Durante la pandemia de Covid-19 los hospitales pediatricos se vieron menos afectados, debido a la menor infección en niños, y sus recursos fueron reasignados en distintas tareas.. El Comité de Ética en Investigación del Hospital General de Niños Pedro de Elizalde presenta los distintos procedimientos implementados en esta emergencia, para sostener diferentes investigaciones, y que les permitió una rápida respuesta a esta situación.

COVID-19, ¿un conflicto ético? / COVID-19, an ethical conflict?

Exposición sobre posibles dilemas éticos ante la pandemia Covid-19 desde los comité de ética en investigación, en relación a la validación de resultados y distribución de diferentes vacunas, y a los criterios objetivos en la toma de decisiones con respecto a las conductas médicas aprobadas y permitidas durante la pandemia; de modo tal de crear un protocolo especial para la utilización de las futuras generaciones en contextos similares.

Investigación en Pandemia: intervenciones del Comité Provincial de Bioética de Santa Fe / Pandemic research: Santa Fe Provincial Committee of Bioethics interventions

Se presenta brevemente la evaluación ética de los protocolos presentados durante la pandemia de Covid-19 al Comité Provincial de Bioética de Santa Fe, organismo que regula las investigaciones con seres humanos en esta provincia, articulando esta tarea con los 24 comités de ética acreditados a nivel provincial. Se describen especialmente dos protocolos que fueron observados y en uno de los casos rechazado por el Comité en base a aspectos éticos.

Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group.

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.

Pela vida das pessoas com doenças crônicas e patologias

O encontro virtual do Comitê do CNS de acompanhamento da Covid-19 será transmitido ao vivo na quarta-feira (22/7), às 17h, pelo Facebook e Youtube. A falta de medidas efetivas de proteção à saúde e planos de apoio às pessoas com doenças crônicas e outras patologias, durante a pandemia da Covid-19, serão temas da próxima live do Conselho Nacional de Saúde (CNS) na quarta-feira (22/7), às 17h, com transmissão pelo Facebook e Youtube. Desde o início da pandemia o CNS tem manifestado preocupação com a ausência de medidas protetivas para esta população. A infecção por Covid-19 em pessoas com doenças crônicas e patologias pode representar em torno de 25% a 50%, sendo que estes pacientes apresentam maiores taxas de mortalidade devido à dificuldade de recuperação dos sintomas graves. Para debater o assunto, participarão da live do CNS o diretor do Departamento de Doenças de Condições Crônicas e Infecções Sexualmente Transmissíveis (DCCI/SVS) do Ministério da Saúde, Gerson Pereira, a secretária de Articulação Política da Articulação Nacional de Luta contra a Aids (Anaids), Carla Almeida e a coordenadora da BioRede Brasil (Biored), Priscila Torres. O programa será mediado pelo conselheiro nacional de saúde Artur Custódio, que representa o Movimento de Reintegração das Pessoas Atingidas pela Hanseníase (Morhan) no CNS. O programa também terá representações dos segmentos de gestores, usuários e trabalhadores do SUS, com as participações de Maíra Botelho, diretora do Departamento de Atenção Especializada e Temática, da Secretaria de Atenção Especializada à Saúde do Ministério da Saúde, Eduardo Fróes, conselheiro nacional de saúde pela Associação Brasileira de Linfoma e Leucemia (Abrale) e Laís Souza, representante da Associação Brasileira de Ensino em Fisioterapia (Abenfisio) no CNS, respectivamente. Em abril, o Conselho solicitou ao Ministério da Saúde a apresentação de um plano de apoio para estas pessoas, com o objetivo de reduzir o risco de desenvolvimento de comorbidades e óbitos. O que se tem observado a cada dia são as dificuldades de acesso ao tratamento, baixo diagnóstico, falta de medicamentos e fechamento de atendimento ambulatorial de diferentes especialidades. Entre as medidas efetivas de proteção à saúde das pessoas com doenças crônicas e patologias, recomendadas ao Ministério da Saúde, estão: testagem prioritária, alternativas ao acesso de medicamentos com a estratégia de fornecimento ampliado (para dois ou três meses), enquanto durar o período de isolamento social e construção de protocolos específicos de atendimento a esta população. Essas estratégias devem ser voltadas às pessoas com HIV/Aids, câncer, celíacos, hanseníase, lúpus, doença falciforme, esclerose múltipla, doenças reumáticas, alzheimer, síndrome de down, Transtorno do Espectro Autista (TEA), diabetes, cardiopatas, transplantados, doenças raras, entre outras. Este é o 9º encontro virtual organizado pelo Comitê do CNS de acompanhamento da Covid-19 com transmissão ao vivo.

O controle social do SUS: em defesa dos participantes de pesquisas

Mudanças na legislação que protege participantes de pesquisa clínica no Brasil pode abrir espaço para um sistema vinculado ao governo e sem autonomia A proteção aos direitos dos participantes de pesquisa clínicas no Brasil será tema da próxima live do Conselho Nacional de Saúde (CNS), na quinta-feira 17/09, às 17h. O programa virtual será transmitido pelo Facebook e Youtube do CNS. Com a participação da deputada federal Margarida Salomão, da pesquisadora da Fundação Oswaldo Cruz (Fiocruz) Margareth Dalcolmo e do membro do Comitê de Ética e Pesquisa (CEP) de Porto Alegre Oscar Paniz, a live vai abordar o Projeto de Lei nº 7.082, que pode reduzir os diretos dos pacientes de pesquisas e fragilizar a independência da Comissão Nacional de Ética em Pesquisa (Conep) do CNS. O PL está em tramitação na Câmara dos Deputados e, se aprovado, altera uma característica exemplar e quase única do sistema brasileiro, que garante o acesso, pós estudo, dos produtos que se mostrarem eficazes e seguros para o participante de pesquisa pelo tempo que for necessário, sem custos. O projeto ainda desvincula a Conep do CNS ao instituir o Sistema Nacional de Ética em Pesquisa Clínica com Seres Humanos, sob coordenação da Secretaria de Ciência, Tecnologia e Insumos Estratégicos (SCTIE) do Ministério da Saúde, o que poderá representar a flexibilização de regras éticas para os laboratórios e patrocinadores de medicamentos, abrindo espaço para um sistema vinculado ao governo e sem autonomia. A live será moderada pelo coordenador da Conep, Jorge Venâncio, com a participação do infectologista e professor da Universidade Federal de Minas Gerais (UFMG) Dirceu Greco e dos conselheiros nacionais de saúde Aníbal Machado e Neilton Araújo, que também é membro da mesa diretora do CNS. O debate envolve uma discussão em torno da formulação de princípios universais dos direitos humanos e da bioética, que embasam os sistemas de regulação da ética em pesquisa em todo o mundo na garantia da proteção à vida.

Clinical Ethics Committees in Africa: lost in the shadow of RECs/IRBs?

BACKGROUND: Clinical Ethics Committees (CECs) are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services (CESs) on the continent. METHODS: A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists in Africa. Data were subjected to descriptive analysis and Fischer's exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. RESULTS: In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants' bioethics qualification or training and involvement in clinical ethics (p = 0.005). All participants were familiar with Research Ethics Committees (RECs), and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants (81.7%) were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. CONCLUSIONS: This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed.

Reglas y consejos para ser un investigador de éxito / Tips and guidelines for being a successful researcher

Este artículo tiene como objetivo compartir nuestra experiencia con los que se plantean dedicarse a investigar. Así, se enumeran las características, cualidades o competencias que, a nuestro criterio, un buen investigador debería cumplir, y por tanto las claves que pueden ayudarle a lograr una carrera investigadora exitosa. La intención del presente artículo no es enumerar sin más una serie de recomendaciones teóricas, sino compartir algunas sugerencias personales basadas en nuestra experiencia y, por tanto, de índole eminentemente práctica. Las cualidades fundamentales que se tratarán son: Ética y honestidad. Curiosidad, pasión, entusiasmo y motivación. Persistencia, dedicación y disciplina. Ambición y liderazgo. Compromiso y responsabilidad. Organización y planificación. Adquirir conocimientos sobre metodología de la investigación. Actitud crítica y positiva ante las dificultades y el fracaso. Priorización de objetivos y gestión del tiempo. La importancia de un buen mentor. Establecimiento de una red de colaboradores y trabajo en equipo. Mantener un equilibrio entre actividad clínica e investigadora. Combinar investigación pública y privada. Equilibrio entre la vida profesional y personal. Y, finalmente, humildad, generosidad y agradecimiento. La investigación representa un pilar fundamental de la actividad médica y es evidente que la mayor calidad asistencial surge de la integración de una práctica clínica y una actividad investigadora excelentes. Con la filosofía de que la mayoría de las cualidades para desarrollar una actividad investigadora de excelencia dependen de la actitud, y pueden aprenderse, desarrollarse y mejorarse, en el presente manuscrito compartimos con el lector una serie de recomendaciones que consideramos esenciales para ser un buen investigador

This article aims to share our experience with those who consider dedicating themselves to research. In this way, the characteristics, qualities or competences that, in our opinion, a good researcher should fulfill are listed, and therefore the keys that can help you achieve a successful research career. The intention of this article is not to simply list a series of theoretical recommendations but to share some personal suggestions based on our experience and, therefore, of an eminently practical nature. The fundamental qualities to be discussed are: Ethics and honesty. Curiosity, passion, enthusiasm and motivation. Persistence, dedication and discipline. Ambition and leadership. Compromise and responsibility. Organization and planning. Acquire knowledge of research methodology. Critical and positive attitude towards difficulties and failure. Prioritization of objectives and time management. The importance of a good mentor. Establishment of a network of collaborators and teamwork. Maintain a balance between clinical and research activity. Combine public and private investigation. Balance between professional and personal life. And, finally, humility, generosity and thanks. Research represents a fundamental pillar of medical activity and it is evident that the highest quality of care arises from the integration of excellent clinical practice and research activity. With the philosophy that most of the qualities to develop an excellent research activity depend on attitude, and can be learned, developed and improved, in this manuscript we share with the reader a series of recommendations that we consider essential to be a good researcher

Status of Institutional Review Board Meetings Conducted Through Web Conference Systems in Japanese National University Hospitals During the COVID-19 Pandemic: Questionnaire Study.

BACKGROUND: With the global proliferation of the novel COVID-19 disease, conventionally conducting institutional review board (IRB) meetings has become a difficult task. Amid concerns about the suspension of drug development due to delays within IRBs, it has been suggested that IRB meetings should be temporarily conducted via the internet. OBJECTIVE: This study aimed to elucidate the current status of IRB meetings conducted through web conference systems. METHODS: A survey on conducting IRB meetings through web conference systems was administered to Japanese national university hospitals. Respondents were in charge of operating IRB offices at different universities. This study was not a randomized controlled trial. RESULTS: The survey was performed at 42 facilities between the end of May and early June, 2020, immediately after the state of emergency was lifted in Japan. The survey yielded a response rate of 74% (31/42). Additionally, while 68% (21/31) of facilities introduced web conference systems for IRB meetings, 13% (4/31) of the surveyed facilities postponed IRB meetings. Therefore, we conducted a further survey of 21 facilities that implemented web conference systems for IRB meetings. According to 71% (15/21) of the respondents, there was no financial burden for implementing these systems, as they were free of charge. In 90% (19/21) of the facilities, IRB meetings through web conference systems were already being conducted with personal electronic devices. Furthermore, in 48% (10/21) of facilities, a web conference system was used in conjunction with face-to-face meetings. CONCLUSIONS: Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% (15/21) of the respondents who conducted IRB meetings through web conference systems, the cost of introducing such meetings was US $0, showing a negligible financial burden. Moreover, it was shown that online deliberations could be carried out in the same manner as face-to-face meetings, as 86% (18/21) of facilities stated that the number of comments made by board members did not change. To improve the quality of IRB meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members' screens during meetings. Further examination of all members who use web conference systems is required. Our measures for addressing the requests and problems identified in our study could potentially be considered protocols for future IRB meetings, when the COVID-19 pandemic has passed and face-to-face meetings are possible again. This study also highlights the importance of developing web conference systems for IRB meetings to respond to future unforeseen pandemics.

Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.

Leveraging Interdisciplinary Teams to Develop and Implement Secure Websites for Behavioral Research: Applied Tutorial.

Behavioral researchers are increasingly using interactive digital platforms, either as standalone or supplementary intervention tools, to facilitate positive changes in research participants' health habits. Research-oriented interactive websites optimally offer a variety of participatory mediums, such as blogs, user-driven content, or health activities. Owing to the multidirectional features of interactive websites, and a corresponding need to protect research participants' identity and data, it is paramount that researchers design ethical platforms that ensure privacy and minimize loss of anonymity and confidentiality. Authentication (ie, digital verification of one's identity) of interactive sites is one viable solution to these concerns. Although previous publications have addressed ethical requirements related to authenticated platforms, few applied guidelines in the literature facilitate adherence to ethical principles and legally compliant study protocols during all phases of research website creation (feasibility, design, implementation, and maintenance). Notably, to remain compliant with ethical standards and study protocols, behavioral researchers must collaborate with interdisciplinary teams to ensure that the authenticated site remains secure and usable in all stages of the project. In this tutorial, we present a case study conducted at a large research university. Through iterative and practical recommendations, we detail lessons learned from collaborations with the Institutional Review Board, legal experts, and information technology teams. Although the intricacies of our applied tutorial may require adaptations based on each institution's technological capacity, we are confident that the core takeaways are universal and thus useful to behavioral researchers creating ethically responsible and compliant interactive websites.

Challenges and strategies to research ethics in conducting COVID-19 research.

The number of research involving human subjects on coronavirus disease 2019 (COVID-19) is surging, bringing challenges to the ethical review committee (ERC) in terms of reviewing speed and special ethical considerations under the pandemic. However, the existing ethical review system and regulations have their limitations to meet the demand for a prompt and efficient epidemic control. Since the research under the public health emergency is different from that carried out in familiar situations to design and implementation, the strategy for a satisfactory ERC response should balance the duty of protecting individual participants as well as the special public needs derived from the disease control. It is suggested that the ethical review-related regulations need to be updated, and a unified supervision system to the overall ERC is required. ERC collaboration, capacity-improving and efficiency-improving measures need to be taken. With respect to the reviewing guidelines, it is suggested that the international norms should be explained with more consideration of the local condition and the exceptional circumstances in this public health emergency. A joint effort needs to be taken for better research conduction.

Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies.

OBJECTIVE: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. METHODS: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. RESULTS: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. CONCLUSION: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.