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1.
Rom J Morphol Embryol ; 61(1): 277-281, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32747923

RESUMO

PURPOSE: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014∕536, the Directive 2001∕20∕EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field. BACKGROUND: The Directive 2001∕20∕EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. CONTENT: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework. CONCLUSIONS: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.


Assuntos
Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/legislação & jurisprudência , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Revisão Ética , Ética em Pesquisa , Política de Saúde , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Comissão de Ética , União Europeia , Humanos , Consentimento Livre e Esclarecido , Pandemias , Segurança do Paciente , Saúde Pública , Projetos de Pesquisa
2.
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
3.
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
4.
Zhongguo Zhong Yao Za Zhi ; 45(10): 2287-2290, 2020 May.
Artigo em Chinês | MEDLINE | ID: mdl-32495581

RESUMO

High-quality clinical study on traditional Chinese medicine is of great significance to effectively control new public health emergencies represented by outbreaks of infectious diseases and ensure people's health and safety, but it still faces a series of ethical issues. Based on the seven core values of equity, good deeds, effectiveness, respect for individuals, freedom, reciprocity, and solida-rity proposed in the Guidelines for Management of Ethical Issues in Outbreaks of Infectious Diseases, this article emphasizes the characteristics and laws of clinical studies on traditional Chinese medicine. Main points of ethical review of traditional Chinese medicine were summarized in the aspects of overall concept, syndrome differentiation and treatment, prevention before disease onset, cultural value, and clinical basis. Based on the outbreak of coronavirus disease 2019(COVID-19), we collected relevant registered Chinese medicine clinical studies, summarized the core issues of the ethics review for COVID-19, and further improved the traditional Chinese medicine ethics review system and resources, so as to better serve ethical review and scientific studies in public health emergencies.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Revisão Ética , Medicina Tradicional Chinesa , Pandemias , Pneumonia Viral , Emergências , Humanos , Saúde Pública
5.
J Med Ethics ; 46(8): 502-504, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32461245

RESUMO

Global fatalities related to COVID-19 are expected to be high in 2020-2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods-that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made.


Assuntos
Pesquisa Biomédica/ética , Infecções por Coronavirus/prevenção & controle , Guias como Assunto , Experimentação Humana/ética , Pandemias/ética , Pneumonia Viral/prevenção & controle , Projetos de Pesquisa , Vacinas Virais , Betacoronavirus , Pesquisa Biomédica/métodos , Infecções por Coronavirus/virologia , Análise Ética , Revisão Ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido , Intenção , Pandemias/prevenção & controle , Pneumonia Viral/virologia , Pesquisadores , Sujeitos da Pesquisa , Vacinação , Voluntários
7.
Clin Trials ; 17(4): 461-462, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32429698

Assuntos
Revisão Ética
8.
Am J Bioeth ; 20(1): 31-39, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31896328

RESUMO

Comparative effectiveness studies, referred to here as "usual-care" trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains "unusual" care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects' safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.


Assuntos
Protocolos de Ensaio Clínico como Assunto , Ensaios Clínicos como Assunto/ética , Revisão Ética/normas , Projetos de Pesquisa/normas , Erro Experimental/ética , Padrão de Cuidado , Comitês de Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido , Sujeitos da Pesquisa
9.
Rev. Esc. Enferm. USP ; 54: e03548, 2020. tab, graf
Artigo em Inglês | LILACS, BDENF - Enfermagem | ID: biblio-1091963

RESUMO

Abstract Objective: To know the positions and practices adopted by nursing students in scientific initiation programs about the principles of scientific integrity in the different stages of the process of doing science. Method: An exploratory study of a quantitative nature, in which nursing student participants of the Scientific Initiation Program from the Federal District were interviewed. Results: Fifty (50) nursing students participated in the study. Most of the interviewed participants presented good notions about the process of conducting research in its different stages. Nevertheless, it was found that even though they were familiar with good scientific practices, students did not always behave in the most responsible manner. It was observed that the knowledge on topics related to the ethics of the scientific process was predominantly obtained through formal education, consisting of classes and courses. Nonetheless, the importance of complementary spaces such as research and research groups is recognized. Conclusion: Research experiences are important educational and vocational training spaces for students. Therefore, good research practices need to be included early in the academic curriculum.


Resumen Objetivo: Conocer planteamientos y prácticas adoptados por alumnos de enfermería incluidos en programas de iniciación científica acerca de los principios de integridad científica en las distintas etapas del proceso de hacer ciencia. Método: Estudio exploratorio, de naturaleza cuantitativa, en que fueron entrevistados estudiantes de enfermería del Distrito Federal, participantes en el Programa de Iniciación Científica. Resultados: Participaron en el estudio 50 estudiantes de enfermería. La mayoría de los entrevistados presentaron buenas nociones acerca del proceso de conducción de la investigación, en sus distintas etapas. Pese a ello, se verificó que, aun teniendo familiaridad con buenas prácticas científicas, no siempre los estudiantes se portaban de modo más responsable. Se observó que los conocimientos acerca de los temas relacionados con la etnicidad del proceso científico fueron obtenidos predominantemente mediante enseñanza formal, constituida de clases y asignaturas. Sin embargo, se reconoce la importancia de espacios complementarios, como la investigación y los grupos de investigación. Conclusión: Las experiencias en investigación son importantes espacios educativos y de formación profesional para los estudiantes. Por lo que las buenas prácticas en investigación necesitan incluirse precozmente en el currículo académico.


Resumo Objetivo: Conhecer posicionamentos e práticas adotados por alunos de enfermagem inseridos em programas de iniciação científica acerca dos princípios de integridade científica nas diferentes etapas do processo de fazer ciência. Método: Estudo exploratório, de natureza quantitativa, em que foram entrevistados estudantes de enfermagem do Distrito Federal, participantes do Programa de Iniciação Científica. Resultados: Participaram do estudo 50 estudantes de enfermagem. A maioria dos entrevistados apresentou boas noções sobre o processo de condução de pesquisa, em suas diferentes etapas. Apesar disso, verificou-se que, mesmo possuindo familiaridade com boas práticas científicas, nem sempre os estudantes se comportavam de maneira mais responsável. Observou-se que os conhecimentos sobre temas relacionados à eticidade do processo científico foram obtidos predominantemente por meio de ensino formal, constituído por aulas e disciplinas. Apesar disso, reconhece-se a importância de espaços complementares, como a pesquisa e grupos de pesquisa. Conclusão: As experiências em pesquisa são importantes espaços educativos e de formação profissional para os estudantes. Por isso, boas práticas em pesquisa precisam ser incluídas precocemente no currículo acadêmico.


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Estudantes de Enfermagem , Má Conduta Científica , Ética em Pesquisa , Revisão Ética , Princípios Morais
10.
Clin Trials ; 16(6): 580-588, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31818147

RESUMO

BACKGROUND: All studies classified as research involving human participants require research ethics review. Most regulation and guidance on ethical oversight of research involving human participants was written for pharmacotherapy interventions. Interpretation of such guidance for cluster-randomized trials and stepped-wedge trials, which commonly evaluate complex non-therapeutic interventions such as knowledge translation, public health, or health service delivery interventions, can pose challenges to researchers and regulators. CURRENT GUIDANCE: The Ottawa Statement on the Ethical Design and Conduct of Cluster-Randomized Trials provides guidance on the ethical oversight and consent procedures for cluster-randomized trials, and while not explicit, this includes stepped-wedge trials. Yet, stepped-wedge trials have unique characteristics that differentiate them from standard cluster-randomized trials. In particular, they can be used to evaluate knowledge translation interventions within the context of a routine health system rollout; they may have a non-randomized design; and the decision to implement the intervention is not always made by the researcher. Many stepped-wedge trials do not undergo ethical review and do not report trial registration. This suggests that those undertaking these studies and research ethics committees perceive them as non-research activities. RECOMMENDATIONS: Through an ethical analysis of two case studies, we argue that stepped-wedge trials, like parallel arm cluster trials, are systematic investigations designed to produce generalizable knowledge. We contend that stepped-wedge trials usually include human research participants, which may be patients, health care providers, or both. Stepped-wedge trials are therefore research involving human participants for the purpose of ethical review. Nevertheless, the use of a waiver or alteration of consent may be appropriate in many stepped-wedge trials due to the infeasibility of obtaining informed consent and the low-risk nature of the interventions. To ensure that traditional ethical principles such as respect for persons are upheld, these studies must undergo research ethics review.


Assuntos
Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/métodos , Assistência à Saúde , Revisão Ética , Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido , Melhoria de Qualidade , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Pesquisadores
11.
CRISPR J ; 2(5): 299-303, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31599678

RESUMO

Since its advent in 2012, CRISPR has spawned a cottage industry of bioethics literature. One principal criticism of the technology is its virtually instant widespread adoption prior to deliberative bodies conducting a meaningful ethical review of its harms and benefits-a violation, to some, of bioethics' "precautionary principle." This view poorly considers, however, the role that the law can play-and does, in fact, play-in policing the introduction of ethically problematic uses of the technology. This Perspective recounts these legal regimes, including regulatory agencies and premarket approval, tort law and deterrence, patents and ethical licenses, funding agencies and review boards, as well as local politics. Identifying these legal regimes and connecting them to the precautionary principle should be instructive for bioethicists and policy makers who wish to conduct ethical reviews of new applications of CRISPR prior to their introduction.


Assuntos
Revisão Ética/legislação & jurisprudência , Engenharia Genética/ética , Engenharia Genética/legislação & jurisprudência , Animais , Bioética/tendências , Sistemas CRISPR-Cas , Tomada de Decisões/ética , Regulamentação Governamental , Humanos , Princípios Morais , Política
12.
Nagoya J Med Sci ; 81(3): 501-509, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31579340

RESUMO

The survey involves examining the applications from 142 institutions that have consented to make available all certification applications from 2015 and 2016 to a research project for building a certification system for an ethics committee run by the Agency for Medical Research and Development. The number of certified institutions is 20 (14.1%). In the applications from uncertified institutions, there are cases in which requirements of ethics guidelines are unmet, and there is insufficient information provided on regulation and procedure. An analysis of the committee members who can contribute as members of the general public (general public committee members) has indicated that the number of committee members who do not belong to an institution in which an ethics committee is instituted (external committee members) is 41 (95.7%) among the certified institutions and 224 (84.5%) among the uncertified institutions. The proportion of general public committee members drawn internally from institutions tends to be higher among uncertified institutions. While a separate committee examined conflicts of interest in research in 19 certified institutions (95.0%), such conflicts were found in 41 uncertified institutions (33.9%) by the ethics committee. The survey confirms that the challenge lies in increasing the number of external committee members and in further improving the system to manage conflicts of interest, and the education and training regime.


Assuntos
Comitês Consultivos/estatística & dados numéricos , Comitês de Ética em Pesquisa/estatística & dados numéricos , Pesquisa Biomédica/ética , Revisão Ética , Humanos , Japão
14.
J Empir Res Hum Res Ethics ; 14(4): 307-317, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31378129

RESUMO

There is limited literature on the opinions and perspectives of researchers on the ethical issues in biobank research in South Africa. This study aimed to explore researchers' perspectives on informed consent and ethical review of biobank research in South Africa. An online survey was conducted among researchers and scientists at Stellenbosch University and the University of Kwazulu-Natal. The majority of researchers opined that broad consent is appropriate for biobank research. However, there was no consensus on the necessity for re-consent. Researchers were also in agreement that issues concerning informed consent and future use of samples require thorough discussions during the ethical review process. Overall, the attitude of researchers on informed consent and ethical review of biobank research was positive and ethically informed.


Assuntos
Bancos de Espécimes Biológicos , Pesquisa Biomédica , Revisão Ética , Consentimento Livre e Esclarecido , Pesquisadores , Estudos Transversais , Comitês de Ética em Pesquisa , Feminino , Humanos , Masculino , Sujeitos da Pesquisa , África do Sul , Inquéritos e Questionários
15.
J Empir Res Hum Res Ethics ; 14(4): 383-394, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31291798

RESUMO

Researchers and research ethics committees share a common goal of conducting ethically sound research. However, little is known of researchers' experiences in obtaining ethics approval for suicide-related studies. This study aimed to investigate what concerns researchers have received on suicide-related ethics applications and how they dealt with it. Thirty-four respondents, recruited through the International Association for Suicide Prevention, filled out an online survey. The study found that researchers have received important concerns regarding potential harm and researchers' responsibilities to participants. Researchers modified their application and/or consulted their research ethics committee in response to the concerns, which had a positive/neutral impact on their given study. Anticipating concerns and improved collaboration between researchers and research ethics committees should protect the quality of suicide prevention research.


Assuntos
Revisão Ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Suicídio , Feminino , Humanos , Masculino , Inquéritos e Questionários
16.
J Law Med Ethics ; 47(2): 247-253, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31298095

RESUMO

Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are "designed to develop or contribute to generalizable knowledge." However, the "generalizable knowledge" standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some individuals are exposed to greater-than-minimal risks for the potential benefit of others, at least when the activity in question is conducted or supported by federal agencies. Under such an approach, the fact that an activity constitutes research would be neither necessary nor sufficient to trigger prospective ethical oversight.


Assuntos
Revisão Ética/normas , Comitês de Ética em Pesquisa , Experimentação Humana/legislação & jurisprudência , Pesquisa/legislação & jurisprudência , Humanos , Conhecimento , Medição de Risco
18.
J Law Med Ethics ; 47(2): 232-237, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31298106

RESUMO

For the first time, the revised Common Rule specifies that public health surveillance activities are not research. This article reviews the historical development of the public health surveillance exclusion and implications for other foundational public health practices.


Assuntos
Vigilância em Saúde Pública , Pesquisa/classificação , Pesquisa/legislação & jurisprudência , Coleta de Dados , Revisão Ética/legislação & jurisprudência , Comitês de Ética em Pesquisa/legislação & jurisprudência , História do Século XX , História do Século XXI , Humanos , Saúde Pública/história , Saúde Pública/legislação & jurisprudência
19.
BMC Med Ethics ; 20(1): 39, 2019 06 03.
Artigo em Inglês | MEDLINE | ID: mdl-31159853

RESUMO

BACKGROUND: Ethical approval (EA) must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. METHODS: Sixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. RESULTS: N = 8/16 of the NCs could apply at one single national ethical committee (EC), while the others had to apply to various regional ECs and/or individual hospital institutional research boards (IRBs). The time between applying for EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were (very) unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. DISCUSSION: Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. CONCLUSION: Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries.


Assuntos
Revisão Ética , Estudos Observacionais como Assunto/ética , Comitês de Ética em Pesquisa/organização & administração , Comitês de Ética em Pesquisa/estatística & dados numéricos , Europa (Continente) , Humanos , Consentimento Livre e Esclarecido/ética , Inquéritos e Questionários , Fatores de Tempo
20.
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