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1.
Mayo Clin Proc ; 96(1): 165-173, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33413815

RESUMO

Biospecimen research is a prominent investigative strategy that aims to provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials, and develop effective, life-saving treatments. However, COVID-19 biospecimen research raises accompanying ethical concerns and practical challenges for investigators and participants. In this special article, we discuss the ethical issues that are associated with autonomy, beneficence, and justice in COVID-19 biospecimen research and describe strategies to manage the practical challenges, with an emphasis on protecting the rights and welfare of human research participants during a pandemic response. Appropriate institutional review board oversight and bioethics guidance for COVID-19 biospecimen research must maintain their focus on protecting the rights and welfare of research participants, despite the urgent need for more knowledge about the virus and the threat it poses to communities and nations.


Assuntos
Pesquisa Biomédica/ética , Eticistas , Comitês de Ética em Pesquisa , Ética em Pesquisa , Bancos de Espécimes Biológicos , Humanos , Pandemias
2.
Trials ; 22(1): 90, 2021 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-33494785

RESUMO

BACKGROUND: New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. MAIN TEXT: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. CONCLUSION: Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.


Assuntos
Aspirina/administração & dosagem , Aterosclerose/prevenção & controle , Comitês de Ética em Pesquisa/normas , Projetos de Pesquisa/normas , Prevenção Secundária/métodos , Adulto , Aspirina/efeitos adversos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Feminino , Humanos , Consentimento Livre e Esclarecido/normas , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto/ética , Estudos Multicêntricos como Assunto/normas , Participação do Paciente , Ensaios Clínicos Pragmáticos como Assunto/ética , Ensaios Clínicos Pragmáticos como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Medição de Risco/normas , Resultado do Tratamento
3.
Vaccine ; 39(4): 633-640, 2021 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-33341309

RESUMO

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.


Assuntos
Pesquisa Biomédica/ética , /prevenção & controle , Experimentação Humana/ética , Consentimento Livre e Esclarecido/ética , /patogenicidade , Antivirais/administração & dosagem , /imunologia , Comitês de Ética em Pesquisa/organização & administração , Voluntários Saudáveis , Experimentação Humana/legislação & jurisprudência , Humanos , Seleção de Pacientes/ética , Vacinação/ética , Organização Mundial da Saúde
4.
Recurso na Internet em Português | LIS - Localizador de Informação em Saúde | ID: lis-47998

RESUMO

A Plataforma Brasil é uma base nacional e unificada de registros de pesquisas envolvendo seres humanos para todo o sistema CEP/Conep. Ela permite que as pesquisas sejam acompanhadas em seus diferentes estágios - desde sua submissão até a aprovação final pelo CEP e pela Conep, quando necessário - possibilitando inclusive o acompanhamento da fase de campo, o envio de relatórios parciais e dos relatórios finais das pesquisas (quando concluídas).O sistema permite, ainda, a apresentação de documentos também em meio digital, propiciando ainda à sociedade o acesso aos dados públicos de todas as pesquisas aprovadas. Pela Internet é possível a todos os envolvidos o acesso, por meio de um ambiente compartilhado, às informações em conjunto, diminuindo de forma significativa o tempo de trâmite dos projetos em todo o sistema CEP/CONEP.


Assuntos
Gestão da Informação em Saúde/organização & administração , Comitês de Ética em Pesquisa/organização & administração
5.
PLoS One ; 15(12): e0241783, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33382683

RESUMO

BACKGROUND: Biomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies. METHODS: An online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined. RESULTS: Seventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants' rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study's scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19]. CONCLUSIONS: An understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.


Assuntos
Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa/ética , Pesquisadores/psicologia , Percepção Social/psicologia , Adulto , Ética em Pesquisa , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Singapura , Inquéritos e Questionários
6.
Rev Esp Salud Publica ; 942020 Nov 03.
Artigo em Espanhol | MEDLINE | ID: mdl-33140740

RESUMO

OBJECTIVE: The health crisis caused by COVID-19 required the prompt launch of research in order to generate scientific evidence pertaining to the new disease oriented to control its devastating effects and continuous spread. Therefore, it was essential to adapt the work flow of Research Ethics Committees, to prioritize and to accelerate the evaluation of projects related to this disease. METHODS: This work analyses the evaluation conducted by our Regional Ethics Committees during the initial period of the health emergency (between 13th March and 28th May 2020). RESULTS: 81 research projects were evaluated, 73 of them of regional scope (62 single-centre), 4 national and 4 international. 57 projects obtained a favourable opinion, 4 were withdrawn by the sponsors, 6 did not require ethics approval and 14 did not respond to the clarifications requested up to the date of the study's closure. CONCLUSIONS: The most important research procedures to be analysed in this context are those related to the methodology and informed consent process. It is also essential to address aspects related to the privacy of personal data, and to take into account the workload of the researchers. As an improvement proposal, we think that greater collaboration between the different research teams should be encourage to obtain more robust results.


Assuntos
Infecções por Coronavirus/epidemiologia , Comitês de Ética em Pesquisa , Pneumonia Viral/epidemiologia , Projetos de Pesquisa/normas , Fluxo de Trabalho , Betacoronavirus , Humanos , Consentimento Livre e Esclarecido , Pandemias , Espanha
7.
Gastroenterol. hepatol. (Ed. impr.) ; 43(9): 540-550, nov. 2020.
Artigo em Espanhol | IBECS | ID: ibc-ET2-7602

RESUMO

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


Assuntos
Humanos , Pesquisadores/normas , Publicações/normas , Ciência , Guias como Assunto/normas , Mentores , Comitês de Ética em Pesquisa/organização & administração , Comitês de Ética em Pesquisa/normas , Conhecimento , Motivação
9.
J Med Internet Res ; 22(11): e22302, 2020 11 19.
Artigo em Inglês | MEDLINE | ID: mdl-33112758

RESUMO

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.


Assuntos
Infecções por Coronavirus , Comitês de Ética em Pesquisa/estatística & dados numéricos , Hospitais Universitários , Internet , Pandemias , Pneumonia Viral , Inquéritos e Questionários , Comunicação por Videoconferência/estatística & dados numéricos , Infecções por Coronavirus/epidemiologia , Comitês de Ética em Pesquisa/organização & administração , Humanos , Japão/epidemiologia , Pneumonia Viral/epidemiologia , Comunicação por Videoconferência/organização & administração
10.
J Korean Med Sci ; 35(36): e329, 2020 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-32924344

RESUMO

BACKGROUND: The number of clinical trials conducted in Korea continues to increase and an increasing proportion focus on severe and rare incurable diseases. After the start of the severe acute respiratory syndrome, coronavirus disease 2019 (COVID-19), Korea Centers for Disease Control and Prevention (KCDC) developed guidelines to prevent the spread of infection. This study evaluated the impact of COVID-19 and the KCDC guideline on the conduct of clinical research in Korea. The purpose was to develop recommendations on how to minimize the risk of infection while enabling subjects to take part in the trials if no better alternative treatment options were available. METHODS: The impact on subject's scheduled visits and major milestones of clinical trials in Korea were measured by conducting a survey among clinical project manager (CPMs) working at global clinical research organization. The policy on monitor's access to hospital and site initiation meetings was investigated through correspondence with clinical trial center of 39 hospitals. The Top 25 pharmaceutical companies' official press and public clinical trial registry database were used to analyze companies' trial strategy during the pandemic and COVID-19 clinical research status, respectively. RESULTS: Of 85 CPMs, 12% reported that trial subjects' scheduled visits had been affected in their project. Monitors' access to hospital for source data verification was restricted at all sites in February 2020. Accordingly, 43% of 105 CPMs reported that the COVID-19 epidemic had an effect on study major milestones and data cleaning and database lock accounted for > 60% of milestones affected. In addition, 87% sites advised not to have site initiation meetings and 52% pharmaceutical companies suspended recruitment or new study start-up due to the pandemic. On the other hands, the number of COVID-19 related clinical trials increased rapidly in Korea and worldwide, with investigator-initiated trials accounting for 47% and 63% of all trials locally and globally, respectively. Most trials were phase 2 and were in the recruitment stage. CONCLUSION: The COVID-19 and the KCDC guideline influenced all parties involved in clinical trials in Korea. In order to ensure the safety and well-being of trial subjects during the pandemic, new approaches are required for clinical trials to respond to the impact actively. Method of non-contact is developed to replace and supplement the face-to-face contact and alternatives to reduce the travel is introduced to decrease the risk of infection for all trial participants in whole trial process. The relevant regulations should be developed and the guidelines for foreign countries need to be adopted in accordance with the situation in Korea. COVID-19 trial is rapidly increasing worldwide and continuous support of health authorities, regulation, and facilities is required for developing the treatments with protecting all trial participants.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Continuidade da Assistência ao Paciente , Infecções por Coronavirus/epidemiologia , Indústria Farmacêutica , Comitês de Ética em Pesquisa , Fidelidade a Diretrizes , Humanos , Controle de Infecções , Consentimento Livre e Esclarecido , Estudos Multicêntricos como Assunto , Pneumonia Viral/epidemiologia , Guias de Prática Clínica como Assunto , República da Coreia/epidemiologia , Projetos de Pesquisa , Pesquisadores , Viagem
11.
PLoS One ; 15(7): e0236079, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32735597

RESUMO

In this preregistered study, we investigated whether the statistical power of a study is higher when researchers are asked to make a formal power analysis before collecting data. We compared the sample size descriptions from two sources: (i) a sample of pre-registrations created according to the guidelines for the Center for Open Science Preregistration Challenge (PCRs) and a sample of institutional review board (IRB) proposals from Tilburg School of Behavior and Social Sciences, which both include a recommendation to do a formal power analysis, and (ii) a sample of pre-registrations created according to the guidelines for Open Science Framework Standard Pre-Data Collection Registrations (SPRs) in which no guidance on sample size planning is given. We found that PCRs and IRBs (72%) more often included sample size decisions based on power analyses than the SPRs (45%). However, this did not result in larger planned sample sizes. The determined sample size of the PCRs and IRB proposals (Md = 90.50) was not higher than the determined sample size of the SPRs (Md = 126.00; W = 3389.5, p = 0.936). Typically, power analyses in the registrations were conducted with G*power, assuming a medium effect size, α = .05 and a power of .80. Only 20% of the power analyses contained enough information to fully reproduce the results and only 62% of these power analyses pertained to the main hypothesis test in the pre-registration. Therefore, we see ample room for improvements in the quality of the registrations and we offer several recommendations to do so.


Assuntos
Comitês de Ética em Pesquisa , Tamanho da Amostra , Estatística como Assunto/métodos
12.
PLoS One ; 15(8): e0235618, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32756563

RESUMO

BACKGROUND: This is a multi-method, in-depth, three part qualitative study exploring the regulation and practice of secondary research with tissue and data in a high-income country. We explore and compare the perspectives of researchers, research ethics committees (RECs) and other relevant professionals (e.g. pathologists and clinicians). We focus on points of contention because they demonstrate misalignment between the expectations, values and assumptions of these stakeholders. METHODS: This is a multi-method study using observational research, focus groups and interviews with 42 participants (conducted 2016-2017) and analyzed using thematic analysis. RESULTS: Results are arranged under the following themes: consent; balancing the social value of the research with consent requirements; and harm. Our findings demonstrate different perspectives on the review process, styles of ethical reasoning and issues of concern. First, researchers and RECs disagreed about whether the cost of re-consenting patients satisfied the criterion of impracticability for consent waivers. Second, most researchers were skeptical that secondary research with already collected tissue and data could harm patients. Researchers often pointed to the harm arising from a failure to use existing material for research. RECs were concerned about the potential for secondary research to stigmatize communities. Third, researchers adopted a more consequentialist approach to decision-making, including some willingness to trade off the benefit of the research against the cost of getting consent; whereas RECs were more deontological and typically considered research benefit only after it had been established that re-consent was impractical. CONCLUSION: This research highlights ways in which RECs and researchers may be talking past each other, resulting in confusion and frustration. These finding provide a platform for realignment of the expectations of RECs and researchers, which could contribute to making research ethics review more effective.


Assuntos
Comitês de Ética em Pesquisa , Consentimento Livre e Esclarecido/ética , Comitês de Ética em Pesquisa/ética , Ética em Pesquisa , Grupos Focais , Humanos , Pesquisa Qualitativa , Projetos de Pesquisa , Pesquisadores/ética , Bancos de Tecidos/ética
17.
Rev. argent. salud publica ; 12(Suplemento Covid-19): 1-4, 23 de Julio 2020.
Artigo em Espanhol | LILACS, BINACIS, ARGMSAL | ID: biblio-1104046

RESUMO

Realizar investigaciones para dar respuestas a la pandemia de COVID-19 es un deber moral. Con el objetivo de acelerar la evaluación de las investigaciones y asegurar su rigurosidad científica y ética, el Ministerio de Salud aprobó un documento de pautas éticas y operativas. El documento aborda los aspectos a los cuales se debe prestar especial atención durante la pandemia y brinda orientación a los Comités de Ética en Investigación para la elaboración de procedimientos operativos que acorten los plazos de la evaluación. Este artículo describe los puntos clave del documento


Assuntos
Infecções por Coronavirus , Revisão Ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Política de Pesquisa em Saúde
18.
Rev. argent. salud publica ; 12(Suplemento Covid-19): 1-7, 23 de Julio 2020.
Artigo em Espanhol | LILACS, BINACIS, ARGMSAL | ID: biblio-1129278

RESUMO

INTRODUCCIÓN: un sistema de evaluación ética de las investigaciones en seres humanos es esencial para proteger los derechos de los participantes. Los desafíos impuestos por la pandemia de la COVID-19 para conducir investigaciones éticas que produzcan resultados con rapidez demuestran la necesidad de fortalecerlo. El objetivo de este estudio fue describir el estado de situación de los sistemas de evaluación ética de las provincias de Argentina y las adaptaciones realizadas por la pandemia. MÉTODOS: se realizó una encuesta a los comités provinciales de ética en investigación o áreas similares de los ministerios de Salud que ejercen la vigilancia sobre la evaluación ética de las investigaciones de su jurisdicción. RESULTADOS: respondieron 16 de las 17 provincias encuestadas. El 93,7% de los comités provinciales evalúa investigaciones en seres humanos y tiene procedimientos operativos estandarizados (POE). El 68,7% lleva un registro de los comités de ética en investigación (CEI) de su jurisdicción. Un 75% acredita a los CEI y un 68,7% los supervisa. El 100% tiene un registro de las investigaciones en salud; en 56,2% de los casos este registro es público. Del total, 81,2% realizan actividades de capacitación. El 100% adaptó los POE para evaluar estudios sobre la COVID-19. DISCUSIÓN: los resultados muestran sistemas provinciales consolidados. Se requiere fortalecer la transparencia en la investigación mediante el registro público de las investigaciones. Se identificaron posibilidades de mejora para proponer acciones a futuro


Assuntos
Argentina , Revisão Ética , Comitês de Ética em Pesquisa , Política de Pesquisa em Saúde , Betacoronavirus
19.
Recurso na Internet em Português | LIS - Localizador de Informação em Saúde | ID: lis-47637

RESUMO

Durante a pandemia das síndromes da angústia respiratória aguda grave e a Doença por COVID-19, o isolamento social é a medida mais eficaz no enfrentamento do agravo (NUSSBAUMER-STREIT et al., 2020). Desde que a World Health Organization (WHO) declarou estado de pandemia (WHO, 2020), esforços mundiais vêm sendo envidados em busca de vacina e de tratamento eficaz para a doença (YI et al., 2020; WHO, 2020). É crescente a necessidade de realizar pesquisas com seres humanos para se obter respostas clínicas, epidemiológicas, farmacológicas e sociais. Estratégias de obtenção de assinaturas em documentos obrigatórios, que compõe o protocolo de pesquisa a ser submetido ao Sistema CEP (Comitê de Ética em Pesquisa) /CONEP (Comissão Nacional de Ética em Pesquisa), representam um desafio, devido a vulnerabilidade do participante de pesquisa.(AU)


Assuntos
Ética em Pesquisa , Pesquisa sobre Serviços de Saúde , Comitês de Ética em Pesquisa , Quarentena , Documentação
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