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2.
mBio ; 11(4)2020 08 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769091

RESUMO

Proponents of the use of gain-of-function (GOF) experiments with pathogens with pandemic potential (PPP) have argued that such experiments are necessary because they reveal important facets of pathogenesis and can be performed safely. Opponents of GOF experiments with PPP have argued that the risks outweigh the knowledge gained. The COVID-19 pandemic demonstrates the vulnerability of human societies to a new PPP, while also validating some arguments of both camps, questioning others, and suggesting the need to rethink how we approach this class of experiments.


Assuntos
Betacoronavirus/genética , Infecções por Coronavirus/virologia , Mutação com Ganho de Função , Pneumonia Viral/virologia , Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Bioterrorismo , Contenção de Riscos Biológicos/ética , Contenção de Riscos Biológicos/normas , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Humanos , Virus da Influenza A Subtipo H5N1/genética , Influenza Humana/epidemiologia , Influenza Humana/virologia , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle
5.
OMICS ; 24(9): 515-517, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32603205

RESUMO

After the initial emergency responses deployed to control the coronavirus disease 2019 (COVID-19) pandemic in the first half of 2020, we should now start thinking about long-term strategies and concepts for pandemic and disaster governance such as resilience. In this context, COVID-19 health care and education are especially important because they are essential public goods that determine what kind of a society we live in, during the pandemic and afterward. So for, the focus has been a tactical efficiency perspective that prioritized instrumental, logistical, or pragmatic aspects in planetary health and university education, with much less attention paid to social justice, history of inequity, and power asymmetries that affect the pandemic impacts in society. For a resilient COVID-19 response, we need to address not only medical, technical, and logistical challenges, but also the social disparities that are inherited from the prepandemic world that are negatively affecting the current pandemic outcomes.


Assuntos
Betacoronavirus/patogenicidade , Infecções por Coronavirus/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Saúde Pública/ética , Justiça Social/ética , Acesso à Informação/ética , Pesquisa Biomédica/ética , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/patologia , Disparidades em Assistência à Saúde/ética , Humanos , Cooperação Internacional , Pneumonia Viral/diagnóstico , Pneumonia Viral/patologia , Saúde Pública/educação , Saúde Pública/métodos
6.
PLoS One ; 15(7): e0234962, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32609747

RESUMO

The All of Us Research Program (All of Us) is a national effort to accelerate health research by exploring the relationship between lifestyle, environment, and genetics. It is set to become one of the largest research efforts in U.S. history, aiming to build a national resource of data from at least one million participants. All of Us aims to address the need for more diversity in research and set the stage for that diversity to be leveraged in precision medicine research to come. This paper describes how the program assessed demographic characteristics of participants who have enrolled in other U.S. biomedical research cohorts to better understand which groups are traditionally represented or underrepresented in biomedical research. We 1) reviewed the enrollment characteristics of national cohort studies like All of Us, and 2) surveyed the literature, focusing on key diversity categories essential to the program's enrollment aims. Based on these efforts, All of Us emphasizes enrollment of racial and ethnic minorities, and has formally designated the following additional groups as historically underrepresented: individuals-with inadequate access to medical care; under the age of 18 or over 65; with an annual household income at or below 200% of the federal poverty level; who have a cognitive or physical disability; have less than a high school education or equivalent; are intersex; identify as a sexual or gender minority; or live in rural or non-metropolitan areas. Research accounting for wider demographic variability is critical. Only by ensuring diversity and by addressing the very barriers that limit it, can we position All of Us to better understand and tackle health disparities.


Assuntos
Pesquisa Biomédica/métodos , Diversidade Cultural , Demografia/métodos , Pesquisa Biomédica/ética , Estudos de Coortes , Grupos de Populações Continentais , Grupos Étnicos , Feminino , Humanos , Masculino , Grupos Minoritários , Saúde da População , Medicina de Precisão/métodos , Estados Unidos
9.
mSphere ; 5(4)2020 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-32669462

RESUMO

Human infection challenge studies involving the intentional infection of research participants with a disease-causing agent have recently been suggested as a means to speed up the search for a vaccine for the ongoing coronavirus disease 2019 (COVID-19) outbreak. Calls for challenge studies, however, rely on the expected social value of these studies. This value represents more than the simple possibility that a successful study will lead to the rapid development and dissemination of vaccines but also some expectation that this will actually occur. I show how this expectation may not be realistic in the current political moment and offer potential ways to make sure that any challenge trials that arise actually achieve their goals.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/métodos , Ensaios Clínicos como Assunto/ética , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/prevenção & controle , Betacoronavirus , Ética em Pesquisa , Humanos , Valores Sociais , Vacinas Virais/uso terapêutico
11.
BMC Med ; 18(1): 209, 2020 07 07.
Artigo em Inglês | MEDLINE | ID: mdl-32635912

RESUMO

Rapid development of an effective vaccine for SARSCoV2 is a global priority. A controlled human infection model (CHIM) would accelerate the efficacy assessment of candidate vaccines. This strategy would require deliberate exposure of volunteers to SARSCoV2 with no currently available treatment and a small but definite risk of serious illness or death. This raises complex questions about the social and ethical acceptability of risk to individuals, given the potential benefit to the wider population, and as such, a study cannot be done without public involvement. We conducted a structured public consultation with 57 individuals aged 20-40 years to understand public attitudes to a CHIM, and pre-requisites for enrolment. The overall response to this strategy was positive, and many would volunteer altruistically. Carefully controlled infection is viewed as safer than natural exposure to wild virus. The prolonged social isolation required for the proposed CHIM is considered an obstacle but not insurmountable, with reasonable compensation and supportive care. Given the significant level of public interest, a CHIM should be done as open science with regular, controlled dissemination of information into the public domain. Importantly, there was a strong view that the final decision whether to conduct a CHIM should be in the hands of qualified and experienced clinician-scientists and the authorities.


Assuntos
Atitude Frente a Saúde , Pesquisa Biomédica/ética , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/uso terapêutico , Adulto , Betacoronavirus , Desenvolvimento de Medicamentos , Feminino , Grupos Focais , Humanos , Masculino , Seleção de Pacientes , Opinião Pública , Encaminhamento e Consulta , Reino Unido , Adulto Jovem
13.
Niger Postgrad Med J ; 27(3): 250-258, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32687128

RESUMO

Research misconduct policy (RMP) is a legal document that shows the definitions of the various types of misconduct, describes the inquiry and investigation of allegations, and the appropriate penalties that should be imposed. The presence of the adopted RMP on the website of a university or postgraduate college is an indication of the level of commitment to promote the proper handling of misconduct cases. Perusal of the websites of top universities in developing countries revealed that many do not have RMP on their websites. The probable starting point for combating research misconduct at the national or institutional level is by acquisition of RMP. The purpose of this article is to propose a modern, structured and cost-effective RMP for universities and postgraduate colleges in developing countries. The bibliographic database, PubMed, was searched using the terms 'research misconduct' and 'research misconduct policy'. All relevant articles from the search and some RMPs of universities, national agencies and global health organisations available on the Internet were carefully studied. A formulated RMP, based on the Final Rule of the United States, Public Health Services Policies on Research Misconduct of 2005 and the Regulations of the University Grants Commission of India of 2018, is hereby presented. In the proposed RMP, plagiarism was stratified into four levels in ascending order of severity so that imposed penalties are commensurate with the seriousness of misconduct. The zero tolerance for plagiarism in the core work areas was adopted. The proposed RMP was designed to act as a template. It should be modified as required based on the prevailing local circumstances and made fit for purpose. Universities, postgraduate colleges and journals should have RMP on the homepage of their websites.


Assuntos
Autoria/normas , Pesquisa Biomédica/ética , Plágio , Editoração/ética , Pesquisadores/ética , Má Conduta Científica/ética , Academias e Institutos , Países em Desenvolvimento , Ética em Pesquisa , Humanos , Revisão por Pares/normas , Editoração/normas , Universidades
14.
Rev. bioét. derecho ; (49): 173-189, jul. 2020.
Artigo em Espanhol | IBECS | ID: ibc-192101

RESUMO

El uso de animales para obtener conocimiento y desarrollar tratamientos para enfermedades humanas, se justifica argumentando que son similares a nosotros, pero, al mismo tiempo sus intereses se ignoran enfatizando que ellos son diferentes de nosotros, lo que se considera un doble estándar moral en la ciencia. Millones de animales son sometidos a dolor y sufrimiento cuando no siempre hay certeza de que se obtendrá un beneficio real, en ocasiones la extrapolación no es exitosa, los resultados no son aplicables o nunca se publican. ¿Qué tan éticos y válidos son los métodos que utilizamos para alcanzar nuestros objetivos? Los animales deberían ser considerados un grupo vulnerable a los que se extiendan algunos principios éticos establecidos en la Declaración de Helsinki


The use of animals to obtain knowledge and develop treatments for human diseases is justified by arguing that they are like us, yet their interests are ignored by emphasizing that they are not similar to us, which is considered a double moral standard in science. Millions of animals are subjected to pain and suffering, even when there is no certainty that a real benefit will be obtained. Sometimes extrapolation is not successful, results are invalid, not applicable or even never published. Then, how ethical and valid are the methods we use to achieve our goals? We propose animals should be considered as a vulnerable group and to extend them some of the ethical principles stated in the Declaration of Helsinki


L'ús d'animals per obtenir coneixement I desenvolupar tractaments per a malalties humanes es justifica argumentant que són similars a nosaltres, però, al mateix temps els seus interessos s'ignoren emfatitzant que ells són diferents de nosaltres, el que es considera un doble estàndard moral en la ciència. Milions d'animals són sotmesos a dolor I sofriment quan no sempre hi ha la certesa de que s'obtindrà un benefici real, de vegades l'extrapolació no és exitosa, els resultats no són aplicables o mai es publiquen. Què tan ètics I vàlids són els mètodes que utilitzem per assolir els nostres objectius? Els animals haurien de ser considerats un grup vulnerable als que afecten alguns principis ètics establerts en la Declaració d'Hèlsinki


Assuntos
Animais , Conhecimento , Pesquisa Biomédica/ética , Experimentação Animal/ética , Direitos dos Animais/legislação & jurisprudência , Pesquisa Biomédica/legislação & jurisprudência , Declaração de Helsinki , Direitos dos Animais/normas
15.
Account Res ; 27(6): 396-400, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32543229

RESUMO

The COVID-19 pandemic has accelerated the pace of research from its routine marathon to a sprint, and this can increase the risk of both human error (mistakes) as well as research misconduct. In an effort to save time, researchers can be tempted to "cut corners", discount ethical complexity, or use methods and approaches that fall outside of good research practice. Ethically, it is vital that research outputs during a pandemic be robust because clinical decision-making may reflect on these research results. Luxembourg, while a small European nation, is known for its well-ranked global research and innovation. Accordingly, Luxembourg's national organization for research integrity has taken several proactive measures to help researchers nationally and globally, foster robust research. This paper reports on these measures and encourages other nations to similarly assist the research community.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Betacoronavirus , Humanos , Luxemburgo , Pandemias , Reprodutibilidade dos Testes
17.
Cancer Radiother ; 24(4): 306-315, 2020 Jul.
Artigo em Francês | MEDLINE | ID: mdl-32499188

RESUMO

French regulations about research ethics are based on the so-called Jardé law, which defines researches involving human beings. Researches involving human beings require the submission of research protocols to a committee for protection of persons with a precise list of documents to submit for a favourable opinion. This law describes different categories of researches and determines the ethical procedures to apply before setting up a research protocol. This issue of categorisation is central and must be taken into account by researchers from the beginning of the research process. Researches considered as not involving human beings also require a set of ethical precautions focused on patients' information and the collection of their non-opposition (due to the application of the General Data Protection Regulation adopted by the European Parliament). Thus, many regulations exist and they require a real work for researchers to meet these requirements in research ethics. This article aims to summarise French regulations. Selected examples are specifically taken into the field of radiation oncology research.


Assuntos
Ética em Pesquisa , Regulamentação Governamental , Radioterapia (Especialidade)/ética , Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , França , Humanos , Segurança do Paciente/legislação & jurisprudência , Radioterapia (Especialidade)/legislação & jurisprudência , Sujeitos da Pesquisa/legislação & jurisprudência
18.
PLoS One ; 15(6): e0233954, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32579547

RESUMO

The current paradigm for biomedical research and drug testing postulates that in vitro and in silico data inform animal studies that will subsequently inform human studies. Recent evidence points out that animal studies have made a poor contribution to current knowledge of Major Depressive Disorder, whereas the contribution of in vitro and in silico studies to animal studies- within this research area- is yet to be properly quantified. This quantification is important since biomedical research and drug discovery and development includes two steps of knowledge transferability and we need to evaluate the effectiveness of both in order to properly implement 3R principles (Replacement, Reduction and Refinement). Here, we used the citation tracking facility within Web of Science to locate citations of original research papers on in vitro and in silico related to MDD published identified in PubMed by relevant search terms. 67 publications describing target papers were located. Both in vitro and in silico papers are more cited by human medical papers than by animal papers. The results suggest that, at least concerning MDD research, the current two steps of knowledge transferability are not being followed, indicating a poor compliance with the 3R principles.


Assuntos
Experimentação Animal/ética , Pesquisa Biomédica/ética , Transtorno Depressivo Maior , Animais , Bibliometria , Simulação por Computador , Humanos , Técnicas In Vitro , Projetos de Pesquisa
19.
Vaccine ; 38(33): 5085-5088, 2020 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-32540271

RESUMO

While a human challenge study holds the prospect of accelerating the development of a vaccine for the coronavirus SARS-CoV-2, it may be opposed due to risks of harm to participants and researchers. Given the increasing number of human deaths and severe disruption to lives worldwide, we argue that a SARS-CoV-2 challenge study is ethically justifiable as its social value substantially outweighs the risks. Such a study should therefore be seriously considered as part of the global research response towards the COVID-19 pandemic. In this paper, we contribute to the debate by addressing the misperception that a challenge study for the coronavirus would lower scientific and ethical standards for vaccine research and development, and examine how it could be ethically conducted. We also set out information that needs to be disclosed to prospective participants to obtain their consent.


Assuntos
Pesquisa Biomédica/ética , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinação/ética , Vacinas Virais/uso terapêutico , Betacoronavirus , Humanos , Consentimento Livre e Esclarecido , Pandemias/ética , Risco , Vacinas Virais/administração & dosagem
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