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Pesquisa : K01.752.566.479.147 [Categoria DeCS]
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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


  2 / 3612 MEDLINE  
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[PMID]:29202968
[Au] Autor:Ethics Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Ethics Committee of the American Society for Reproductive Medicine
[Ti] Título:Child-rearing ability and the provision of fertility services: an Ethics Committee opinion.
[So] Source:Fertil Steril;108(6):944-947, 2017 Dec.
[Is] ISSN:1556-5653
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Fertility programs may withhold services from prospective patients on the basis of well-grounded reasons that those patients will be unable to provide minimally adequate or safe care for offspring. This document was reviewed and updated; this version replaces the previous version of this document, last published July 2013 (Fertil Steril 2013;100:50-53).
[Mh] Termos MeSH primário: Educação Infantil
Bem-Estar da Criança
Comissão de Ética/normas
Infertilidade/terapia
Poder Familiar
Pais
Recusa do Médico a Tratar
Medicina Reprodutiva/normas
Técnicas de Reprodução Assistida/normas
[Mh] Termos MeSH secundário: Criança
Educação Infantil/psicologia
Bem-Estar da Criança/psicologia
Fertilidade
Seres Humanos
Infertilidade/diagnóstico
Infertilidade/fisiopatologia
Infertilidade/psicologia
Poder Familiar/psicologia
Pais/psicologia
Direitos do Paciente/normas
Recusa do Médico a Tratar/ética
Medicina Reprodutiva/ética
Técnicas de Reprodução Assistida/ética
Medição de Risco
Fatores de Risco
[Pt] Tipo de publicação:JOURNAL ARTICLE; PRACTICE GUIDELINE
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171215
[Lr] Data última revisão:
171215
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171206
[St] Status:MEDLINE


  3 / 3612 MEDLINE  
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[PMID]:29073658
[Au] Autor:Ballantyne A; Style R
[Ad] Endereço:Department of Primary Health Care and General Practice, University of Otago, Wellington.
[Ti] Título:Health data research in New Zealand: updating the ethical governance framework.
[So] Source:N Z Med J;130(1464):64-71, 2017 Oct 27.
[Is] ISSN:1175-8716
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:Demand for health data for secondary research is increasing, both in New Zealand and worldwide. The New Zealand government has established a large research database, the Integrated Data Infrastructure (IDI), which facilitates research, and an independent ministerial advisory group, the Data Futures Partnership (DFP), to engage with citizens, the private sector and non-government organisations (NGOs) to facilitate trusted data use and strengthen the data ecosystem in New Zealand. We commend these steps but argue that key strategies for effective health-data governance remain absent in New Zealand. In particular, we argue in favour of the establishment of: (1) a specialist Health and Disability Ethics Committee (HDEC) to review applications for secondary-use data research; (2) a public registry of approved secondary-use research projects (similar to a clinical trials registry); and (3) detailed guidelines for the review and approval of secondary-use data research. We present an ethical framework based on the values of public interest, trust and transparency to justify these innovations.
[Mh] Termos MeSH primário: Pesquisa Biomédica/ética
Conjuntos de Dados como Assunto/ética
Comissão de Ética/organização & administração
[Mh] Termos MeSH secundário: Pesquisa Biomédica/legislação & jurisprudência
Conjuntos de Dados como Assunto/legislação & jurisprudência
Guias como Assunto
Seres Humanos
Nova Zelândia
Sistema de Registros
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171027
[St] Status:MEDLINE


  4 / 3612 MEDLINE  
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[PMID]:28390420
[Au] Autor:Mamzer MF; Duchange N; Darquy S; Marvanne P; Rambaud C; Marsico G; Cerisey C; Scotté F; Burgun A; Badoual C; Laurent-Puig P; Hervé C
[Ad] Endereço:Laboratoire d'Ethique Médicale et Médecine Légale EA4569, Faculté de Médecine, Université Paris Descartes, 45 rue des Saints-Pères, 75006, Paris, France. marie-france.mamzer@parisdescartes.fr.
[Ti] Título:Partnering with patients in translational oncology research: ethical approach.
[So] Source:J Transl Med;15(1):74, 2017 Apr 08.
[Is] ISSN:1479-5876
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations. METHODS: Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders. RESULTS: The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications. CONCLUSIONS: Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses the concept of translational ethics as a way to handle the main remaining gap between combining care and research activities in the medical pathway and the existing framework.
[Mh] Termos MeSH primário: Oncologia/ética
Pesquisa Médica Translacional/ética
[Mh] Termos MeSH secundário: Comunicação
Termos de Consentimento
Comissão de Ética
Guias como Assunto
Seres Humanos
Bases de Conhecimento
Mutação/genética
Neoplasias/genética
Medicina de Precisão
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170410
[St] Status:MEDLINE
[do] DOI:10.1186/s12967-017-1177-9


  5 / 3612 MEDLINE  
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[PMID]:28144901
[Au] Autor:Camporesi S; Vaccarella M; Davis M
[Ad] Endereço:Bioethics and Society, Department of Global Health and Social Medicine, King's College London, WC2R 2LS, London, UK. silvia.camporesi@kcl.ac.uk.
[Ti] Título:Investigating Public trust in Expert Knowledge: Narrative, Ethics, and Engagement.
[So] Source:J Bioeth Inq;14(1):23-30, 2017 Mar.
[Is] ISSN:1176-7529
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:"Public Trust in Expert Knowledge: Narrative, Ethics, and Engagement" examines the social, cultural, and ethical ramifications of changing public trust in the expert biomedical knowledge systems of emergent and complex global societies. This symposium was conceived as an interdisciplinary project, drawing on bioethics, the social sciences, and the medical humanities. We settled on public trust as a topic for our work together because its problematization cuts across our fields and substantive research interests. For us, trust is simultaneously a matter of ethics, social relations, and the cultural organization of meaning. We share a commitment to narrative inquiry across our fields of expertise in the bioethics of transformative health technologies, public communications on health threats, and narrative medicine. The contributions to this symposium have applied, in different ways and with different effects, this interdisciplinary mode of inquiry, supplying new reflections on public trust, expertise, and biomedical knowledge.
[Mh] Termos MeSH primário: Bioética
Comissão de Ética
Prova Pericial/ética
Competência Profissional/normas
Opinião Pública
Valores Sociais
[Mh] Termos MeSH secundário: Congressos como Assunto
Tomada de Decisões
Ética Médica
Seres Humanos
Comunicação Interdisciplinar
Princípios Morais
Narração
Confiança
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171105
[Lr] Data última revisão:
171105
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170202
[St] Status:MEDLINE
[do] DOI:10.1007/s11673-016-9767-4


  6 / 3612 MEDLINE  
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[PMID]:28127067
[Au] Autor:Tanum G
[Ti] Título:[Ethics in the Norwegian Medical Association's Council for Medical Ethics?].
[Ti] Título:Etikk i Legeforeningens etiske råd?.
[So] Source:Tidsskr Nor Laegeforen;137(2):88, 2017 01.
[Is] ISSN:0807-7096
[Cp] País de publicação:Norway
[La] Idioma:nor
[Mh] Termos MeSH primário: Emigração e Imigração
Comissão de Ética/ética
Médicos/ética
[Mh] Termos MeSH secundário: Seres Humanos
Noruega
[Pt] Tipo de publicação:LETTER
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170128
[St] Status:MEDLINE
[do] DOI:10.4045/tidsskr.16.1038


  7 / 3612 MEDLINE  
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[PMID]:28035436
[Au] Autor:Montanaro N; Melis M; Proni S; Chiabrando G; Motola D
[Ad] Endereço:University of Bologna, University Hospital St. Orsola-Malpighi,, Via Albertoni 15, 40138, Bologna, Italy. nicola.montanaro@unibo.it.
[Ti] Título:Six-year activity on approval of compassionate use of medicines by the Ethics Committee of the University Hospital of Bologna (Italy): time to update rules and recommendations.
[So] Source:Eur J Clin Pharmacol;73(4):479-485, 2017 Apr.
[Is] ISSN:1432-1041
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Compassionate use of forthcoming drugs has become an increasing pathway through which patients can take advantage of promising medicines. We aimed to analyse the main features of the requests of compassionate use submitted to the Independent Ethics Committee (IEC) of the University Hospital of Bologna in the period 2010-2015. METHODS: The present analysis concerns the requests of compassionate use received by the IEC in the period 2010-2015. For each requested drug, we paired the date of the first request to our IEC with the date(s) of (a) submission to EMA, (b) CHMP positive opinion, and (c) European marketing authorization (if issued). RESULTS: In the period 2010-2015, our IEC received compassionate use requests for 610 patients. Most of the requests concerned patients suffering from solid or haematological cancers not responsive to first or second line of treatment. Sixty-five couples of medicine/clinical condition (corresponding to 56 individual medicines) were submitted to our IEC, and 62 of them regarded products following the centralised procedure at the EMA. Twenty-one out of the latter (34%) had already obtained CHMP positive opinion. CONCLUSIONS: Our results indicate that compassionate use of forthcoming medicines represents a not negligible portion of the therapies utilized in hospital care. The observed large resort to medicines still on trial may suggest that doctors are more aware with the potential benefits of the new drugs. However, this trend may also indicate an increasing marketing activity of the pharmaceutical industry, addressing to get the clinicians used to the upcoming medicines.
[Mh] Termos MeSH primário: Ensaios de Uso Compassivo
Indústria Farmacêutica
Comissão de Ética
[Mh] Termos MeSH secundário: Seres Humanos
Itália
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170920
[Lr] Data última revisão:
170920
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161231
[St] Status:MEDLINE
[do] DOI:10.1007/s00228-016-2186-y


  8 / 3612 MEDLINE  
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[PMID]:26208721
[Au] Autor:Harte JD; Homer CS; Sheehan A; Leap N; Foureur M
[Ad] Endereço:University of Technology, Sydney, Australia.
[Ti] Título:Using video in childbirth research.
[So] Source:Nurs Ethics;24(2):177-189, 2017 Mar.
[Is] ISSN:1477-0989
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Conducting video-research in birth settings raises challenges for ethics review boards to view birthing women and research-midwives as capable, autonomous decision-makers. AIM: This study aimed to gain an understanding of how the ethical approval process was experienced and to chronicle the perceived risks and benefits. RESEARCH DESIGN: The Birth Unit Design project was a 2012 Australian ethnographic study that used video recording to investigate the physical design features in the hospital birthing space that might influence both verbal and non-verbal communication and the experiences of childbearing women, midwives and supporters. Participants and research context: Six women, 11 midwives and 11 childbirth supporters were filmed during the women's labours in hospital birth units and interviewed 6 weeks later. Ethical considerations: The study was approved by an Australian Health Research Ethics Committee after a protracted process of negotiation. FINDINGS: The ethics committee was influenced by a traditional view of research as based on scientific experiments resulting in a poor understanding of video-ethnographic research, a paradigmatic view of the politics and practicalities of modern childbirth processes, a desire to protect institutions from litigation, and what we perceived as a paternalistic approach towards protecting participants, one that was at odds with our aim to facilitate situations in which women could make flexible, autonomous decisions about how they might engage with the research process. DISCUSSION: The perceived need for protection was overly burdensome and against the wishes of the participants themselves; ultimately, this limited the capacity of the study to improve care for women and babies. CONCLUSION: Recommendations are offered for those involved in ethical approval processes for qualitative research in childbirth settings. The complexity of issues within childbirth settings, as in most modern healthcare settings, should be analysed using a variety of research approaches, beyond efficacy-style randomised controlled trials, to expand and improve practice-based results.
[Mh] Termos MeSH primário: Trabalho de Parto
Parto
Projetos de Pesquisa
Gravação em Vídeo/ética
[Mh] Termos MeSH secundário: Austrália
Tomada de Decisões
Doulas
Comissão de Ética
Feminino
Seres Humanos
Consentimento Livre e Esclarecido
Entrevistas como Assunto
Tocologia
Gravidez
Privacidade
Gravação em Vídeo/legislação & jurisprudência
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170720
[Lr] Data última revisão:
170720
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:150726
[St] Status:MEDLINE
[do] DOI:10.1177/0969733015591073


  9 / 3612 MEDLINE  
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[PMID]:28937729
[Au] Autor:Hernandez E; Weissler MC
[Ti] Título:Ethics Committee Town Hall on industry representatives in the OR highlights issues outlined in ACS statement.
[So] Source:Bull Am Coll Surg;101(10):84-5, 2016 10.
[Is] ISSN:0002-8045
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Comércio
Comissão de Ética
Setor de Assistência à Saúde/normas
Salas Cirúrgicas
[Mh] Termos MeSH secundário: Confidencialidade
Seres Humanos
Sociedades Médicas
Estados Unidos
[Pt] Tipo de publicação:NEWS
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171016
[Lr] Data última revisão:
171016
[Sb] Subgrupo de revista:H
[Da] Data de entrada para processamento:170925
[St] Status:MEDLINE


  10 / 3612 MEDLINE  
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[PMID]:28533498
[Au] Autor:Schmidt H; Schwartz JL
[Ti] Título:The Missions of National Commissions: Mapping the Forms and Functions of Bioethics Advisory Bodies.
[So] Source:Kennedy Inst Ethics J;26(4):431-456, 2016.
[Is] ISSN:1054-6863
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The findings, conclusions, and recommendations of national ethics commissions (NECs) have received considerable attention throughout the 40-year history of these groups in the United States and worldwide. However, the procedures or types of argument by which these bodies arrive at their decisions have received far less scrutiny. This paper explores how the diversity of ethical principles, concepts, or theories is featured in publications or decisions of these bodies, with particular emphasis on the need for NECs to be inclusive of pluralist positions that typically exist in contemporary democracies. The discussion is centered on the extent to which NECs may focus on providing focal frameworks, primarily framing the ethical issues at stake, or normative frameworks, additionally providing transparent justifications for any conclusions and recommendations that are made. The structure allows for assessments of the relative merits and drawbacks of different approaches in both theory and practice.
[Mh] Termos MeSH primário: Comitês Consultivos/organização & administração
Temas Bioéticos
Comissão de Ética/organização & administração
[Mh] Termos MeSH secundário: Consenso
Processos Grupais
Seres Humanos
Objetivos Organizacionais
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170619
[Lr] Data última revisão:
170619
[Sb] Subgrupo de revista:E; IM
[Da] Data de entrada para processamento:170524
[St] Status:MEDLINE
[do] DOI:10.1353/ken.2016.0037



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