Base de dados : MEDLINE
Pesquisa : K01.752.566.479.173 [Categoria DeCS]
Referências encontradas : 6285 [refinar]
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[PMID]:29371211
[Au] Autor:Hey SP; Weijer C; Taljaard M; Kesselheim AS
[Ad] Endereço:Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, USA shey@bwh.harvard.edu.
[Ti] Título:Research ethics for emerging trial designs: does equipoise need to adapt?
[So] Source:BMJ;360:k226, 2018 01 25.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Ensaios Clínicos como Assunto/ética
Projetos de Pesquisa
Equipolência Terapêutica
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto/métodos
Ética em Pesquisa
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180127
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.k226


  2 / 6285 MEDLINE  
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[PMID]:29284666
[Au] Autor:Hey SP; London AJ; Weijer C; Rid A; Miller F
[Ad] Endereço:Harvard Center for Bioethics, Boston, MA, USA shey@bwh.harvard.edu annette.rid@kcl.ac.uk.
[Ti] Título:Is the concept of clinical equipoise still relevant to research?
[So] Source:BMJ;359:j5787, 2017 12 28.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Qualidade da Assistência à Saúde/normas
Projetos de Pesquisa/normas
[Mh] Termos MeSH secundário: Ética em Pesquisa
Seres Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto/ética
Projetos de Pesquisa/tendências
Valores Sociais
Incerteza
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171230
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.j5787


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[PMID]:29466147
[Au] Autor:Gelinas L; Largent EA; Cohen IG; Kornetsky S; Bierer BE; Fernandez Lynch H
[Ad] Endereço:From the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge (L.G., I.G.C., H.F.L.), and Harvard Catalyst-Harvard Clinical and Translational Science Center, Harvard Medical School (L.G., I.G.C., B.E.B., H.F.L.), Boston Children's Hospital (S.K.), the
[Ti] Título:A Framework for Ethical Payment to Research Participants.
[So] Source:N Engl J Med;378(8):766-771, 2018 02 22.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Ética em Pesquisa
Motivação
Seleção de Pacientes/ética
Sujeitos da Pesquisa
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto/ética
Coerção
Regulamentação Governamental
Voluntários Saudáveis
Seres Humanos
Sujeitos da Pesquisa/legislação & jurisprudência
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180222
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMsb1710591


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[PMID]:29326254
[Au] Autor:Cohen J
[Ti] Título:How a horror story haunts science.
[So] Source:Science;359(6372):148-150, 2018 Jan 12.
[Is] ISSN:1095-9203
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Pesquisa Biomédica
Literatura Moderna
Editoração
Ciência na Literatura
[Mh] Termos MeSH secundário: Pesquisa Biomédica/ética
Ética em Pesquisa
História do Século XIX
Literatura Moderna/história
Ciência na Literatura/história
Biologia Sintética
[Pt] Tipo de publicação:HISTORICAL ARTICLE; JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180207
[Lr] Data última revisão:
180207
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180113
[St] Status:MEDLINE
[do] DOI:10.1126/science.359.6372.148


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[PMID]:29241881
[Au] Autor:Santos J; Palumbo F; Molsen-David E; Willke RJ; Binder L; Drummond M; Ho A; Marder WD; Parmenter L; Sandhu G; Shafie AA; Thompson D
[Ad] Endereço:Global Compliance and Quality Director, Kantar Health, Cambridge, Wales, UK.
[Ti] Título:ISPOR Code of Ethics 2017 (4th Edition).
[So] Source:Value Health;20(10):1227-1242, 2017 12.
[Is] ISSN:1524-4733
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 - Introduction; 2 - Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 - Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 - Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 - Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 - Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 - Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 - Publication and Dissemination; and 9 - Conclusion and Limitations.
[Mh] Termos MeSH primário: Códigos de Ética
Ética em Pesquisa
Avaliação de Resultados (Cuidados de Saúde)/ética
[Mh] Termos MeSH secundário: Guias como Assunto
Seres Humanos
Internacionalidade
Projetos de Pesquisa
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180202
[Lr] Data última revisão:
180202
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171216
[St] Status:MEDLINE


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[PMID]:29274270
[Au] Autor:Johnstone MJ
[Ti] Título:HONESTY AND INTEGRITY IN AUTHORSHIP ATTRIBUTION.
[So] Source:Aust Nurs Midwifery J;24(10):30, 2017 May.
[Is] ISSN:2202-7114
[Cp] País de publicação:Australia
[La] Idioma:eng
[Ab] Resumo:The publication of peer reviewed journal articles, book chapters, and books have become an important hallmark of the professional, academic, social and scientific credibility of the nursing profession.
[Mh] Termos MeSH primário: Autoria
Ética em Enfermagem
Ética em Pesquisa
Editoração
[Mh] Termos MeSH secundário: Seres Humanos
Revisão da Pesquisa por Pares
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180118
[Lr] Data última revisão:
180118
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:171224
[St] Status:MEDLINE


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[PMID]:29243472
[Au] Autor:Siipi H
[Ti] Título:Preliminary ethical appraisal of a trial - what's it all about?
[So] Source:Duodecim;133(6):582-6, 2017.
[Is] ISSN:0012-7183
[Cp] País de publicação:Finland
[La] Idioma:eng
[Ab] Resumo:Preliminary ethical appraisal of medical trials is often based on the following four principles: respect for autonomy, beneficence, non-maleficence, and justice. Preliminary ethical appraisal should, however, not be understood solely as application of these four principles to practice. Ethical committees will inevitably interpret the principles and make decisions about their reciprocal importance in connection with each trial. Reasoning does not always proceed from above towards practical recommendations of action, but can instead also be based on a moral rule or practice relating to a certain action. A good preliminary ethical appraisal will also take into account everyday standards of morality, law and shared moral values of the society.
[Mh] Termos MeSH primário: Ensaios Clínicos como Assunto/ética
Ética em Pesquisa
[Mh] Termos MeSH secundário: Beneficência
Comissão de Ética
Seres Humanos
Princípios Morais
Autonomia Pessoal
Justiça Social
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180115
[Lr] Data última revisão:
180115
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171216
[St] Status:MEDLINE


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[PMID]:29243475
[Au] Autor:Keränen T; Pasternack A; Halkoaho A
[Ti] Título:Hope for better treatment in participating clinical drug trials.
[So] Source:Duodecim;133(6):587-91, 2017.
[Is] ISSN:0012-7183
[Cp] País de publicação:Finland
[La] Idioma:eng
[Ab] Resumo:An informed consent is a prerequisite for participating in medical trials, whereby the person asked to take part in the trial shall understand what he is committing himself to, and that the consent is given voluntarily. Voluntariness can be undermined by so-called therapeutic optimism, i.e. belief in personal benefit brought about by the trial, as well as the difficulty of understanding how conventional treatment and the trial differ from each other, i.e. the so-called therapeutic misconception. The investigator, especially if he is also the attending physician, may influence the development of therapeutic misconception, because the participant may assume that the physician works as an investigator for the best benefit of the patients. It is important to recognize unrealistic optimism and therapeutic misconception of the trial, because for the participant they may result in disappointment and loss of confidence during the trial.
[Mh] Termos MeSH primário: Ensaios Clínicos como Assunto/ética
Tratamento Farmacológico
Ética em Pesquisa
Consentimento Livre e Esclarecido
Mal-Entendido Terapêutico
[Mh] Termos MeSH secundário: Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180115
[Lr] Data última revisão:
180115
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171216
[St] Status:MEDLINE


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[PMID]:27770794
[Au] Autor:Barchi F; Little MT
[Ad] Endereço:Edward J. Bloustein School of Planning and Public Policy, Rutgers University-New Brunswick, 33 Livingston Street, New Brunswick, NJ, 08901, USA. francis.barchi@rutgers.edu.
[Ti] Título:National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.
[So] Source:BMC Med Ethics;17(1):64, 2016 10 22.
[Is] ISSN:1472-6939
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. METHODS: An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens. RESULTS: Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS. CONCLUSIONS: Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise.
[Mh] Termos MeSH primário: Bancos de Espécimes Biológicos/ética
Pesquisa Biomédica/ética
Regulamentação Governamental
[Mh] Termos MeSH secundário: África ao Sul do Saara
Ética em Pesquisa
Seres Humanos
Consentimento Livre e Esclarecido
Propriedade
Manejo de Espécimes
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171228
[Lr] Data última revisão:
171228
[Sb] Subgrupo de revista:E; IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE


  10 / 6285 MEDLINE  
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[PMID]:27770780
[Au] Autor:Fitzpatrick EF; Martiniuk AL; D'Antoine H; Oscar J; Carter M; Elliott EJ
[Ad] Endereço:Discipline of Paediatrics and Child Health, Sydney Medical School, University of Sydney, Sydney, Australia. emilyfitzp@gmail.com.
[Ti] Título:Seeking consent for research with indigenous communities: a systematic review.
[So] Source:BMC Med Ethics;17(1):65, 2016 10 22.
[Is] ISSN:1472-6939
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. METHODS: A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review. RESULTS: Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and included. Articles were categorised into original research that evaluated the consent process (n = 5) or publications detailing the process of seeking consent (n = 13) and guidelines for ethical research (n = 38). Guidelines were categorised into international (n = 8); national (n = 20) and state/regional/local guidelines (n = 10). In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and "plain language" forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the 'Grey literature' concerns about the consent process are identified but no solutions are offered. CONCLUSION: Consultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process.
[Mh] Termos MeSH primário: Ética em Pesquisa
Índios Norte-Americanos
Consentimento Livre e Esclarecido/ética
Grupo com Ancestrais Oceânicos
Pesquisa
Distribuição Espacial da População
[Mh] Termos MeSH secundário: Austrália
Canadá
Cultura
Seres Humanos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171228
[Lr] Data última revisão:
171228
[Sb] Subgrupo de revista:E; IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE



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