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[PMID]:28453700
[Au] Autor:Bleiberg H; Decoster G; de Gramont A; Rougier P; Sobrero A; Benson A; Chibaudel B; Douillard JY; Eng C; Fuchs C; Fujii M; Labianca R; Larsen AK; Mitchell E; Schmoll HJ; Sprumont D; Zalcberg J
[Ad] Endereço:Institut Jules Bordet, Brussels, Belgium.
[Ti] Título:A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.
[So] Source:Ann Oncol;28(5):922-930, 2017 05 01.
[Is] ISSN:1569-8041
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods: The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results: A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. Conclusions: This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.
[Mh] Termos MeSH primário: Termos de Consentimento
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Conhecimentos, Atitudes e Prática em Saúde
Seres Humanos
Consentimento Livre e Esclarecido
Participação do Paciente
Guias de Prática Clínica como Assunto
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1093/annonc/mdx050


  2 / 33901 MEDLINE  
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[PMID]:28453790
[Au] Autor:Manning JM
[Ad] Endereço:Faculty of Law, University of Auckland, Auckland, New Zealand.
[Ti] Título:Does the Law on Compensation for Research-Related Injury in the UK, Australia, and New Zealand Meet Ethical Requirements?
[So] Source:Med Law Rev;25(3):397-427, 2017 Aug 01.
[Is] ISSN:1464-3790
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Despite a consensus that society owes an ethical obligation to compensate for research-related injury, and that no-fault is the best ethical response, an assessment of the compensation arrangements in place in the UK, Australia and New Zealand shows that in general compensation arrangements fall below this ethical expectation. Most subjects rely on ex gratia payment or an unenforceable assurance of payment in the event of injury. It is also likely that, given significant deficiencies in participant information about compensation arrangements in place for trials recommended by the supervisory ethics agencies in each jurisdiction, subjects only find out about their financial exposure in the event of injury. Industry-drafted guidelines governing compensation in commercially sponsored trials do not protect subjects' interests, but operate primarily to protect the interests of industry. The article considers potential solutions to the ethical deficiency of the compensation arrangements, and argues that the ethical corollary of the fact that society is the ultimate beneficiary of its members' participation in clinical research, is that society as a whole should bear the cost of participant injuries, through establishment of a central no-fault compensation fund financed either by the state or those directly involved in biomedical research.
[Mh] Termos MeSH primário: Compensação e Reparação/ética
Sujeitos da Pesquisa
[Mh] Termos MeSH secundário: Austrália
Seres Humanos
Consentimento Livre e Esclarecido
Princípios Morais
Nova Zelândia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180302
[Lr] Data última revisão:
180302
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1093/medlaw/fwx019


  3 / 33901 MEDLINE  
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[PMID]:29198614
[Au] Autor:Zener R; Johnson P; Wiseman D; Pandey S; Mujoomdar A
[Ad] Endereço:Victoria Hospital, London Health Sciences Centre, Department of Medical Imaging, Western University, London, Ontario, Canada. Electronic address: rebeccazener@gmail.com.
[Ti] Título:Informed Consent for Radiation in Interventional Radiology Procedures.
[So] Source:Can Assoc Radiol J;69(1):30-37, 2018 Feb.
[Is] ISSN:1488-2361
[Cp] País de publicação:Canada
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To explore the patient perception on radiation-related cancer risk from interventional radiology (IR) procedures and whether informed radiation consent is warranted. METHODS: A multiple-choice survey was prospectively administered to 68 adults undergoing a body or neuro-IR procedure with ionizing radiation exposure. Subgroup analysis with chi-square or Fisher exact test was performed based on patient past IR history (P < .05). RESULTS: A total of 81% of patients wanted to be informed if there was a radiation-related 3% increased cancer risk over 5 years. Although 55% considered 3% a small risk, 28% wanted to further discuss the risks and alternate options, and 15% would have only proceeded if it were a life-saving procedure: 89%, 80%, and 67% of patients wanted to be informed with exposure risks of 1 in 100, 1 in 1000, and 1 in 10,000, respectively. Only 53% were aware they were going to be exposed to radiation, irrespective of past IR history (P = .15). Most patients believed radiation consent should include radiation-related cancer risks (85%). No past IR history was significantly associated with wanting consent to include cancer-related risk (100% vs 76%; P = .01) and deterministic risks (70% vs 41%; P = .04). A majority (69%) believed both the referring physician and the interventional radiologist were responsible for obtaining radiation consent, and 65% of patients wanted verbal consent followed by signed written consent, regardless of past IR history. CONCLUSIONS: Many patients want to discuss cancer-related radiation risks with both radiologists and physicians. Informed radiation consent should be considered for procedures with high anticipated radiation doses.
[Mh] Termos MeSH primário: Consentimento Livre e Esclarecido/estatística & dados numéricos
Participação do Paciente/estatística & dados numéricos
Radiologia Intervencionista
[Mh] Termos MeSH secundário: Feminino
Seres Humanos
Masculino
Meia-Idade
Estudos Prospectivos
Inquéritos e Questionários
[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:IM
[Da] Data de entrada para processamento:171205
[St] Status:MEDLINE


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[PMID]:29258637
[Au] Autor:Stilwell C
[Ti] Título:Mandibular Implant Overdentures: Treatment and Medico-Legal Considerations.
[So] Source:Prim Dent J;6(4):28-35, 2017 Dec 01.
[Is] ISSN:2050-1684
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:The concept of a two-implant overdenture as the minimum standard of care or first choice treatment for the edentulous mandible was first proposed in 2002 and has since been backed by an overwhelming body of evidence supporting greater patient satisfaction and improved quality of life. This article examines the implant overdenture concept and its various options and discusses best practice from both the patient's and a medico-legal standpoint.
[Mh] Termos MeSH primário: Prótese Dentária Fixada por Implante
Planejamento de Dentadura
Prótese Total Inferior
Revestimento de Dentadura
[Mh] Termos MeSH secundário: Retenção de Dentadura
Seres Humanos
Consentimento Livre e Esclarecido
Satisfação do Paciente
Seleção de Pacientes
Qualidade de Vida
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180227
[Lr] Data última revisão:
180227
[Sb] Subgrupo de revista:D
[Da] Data de entrada para processamento:171221
[St] Status:MEDLINE
[do] DOI:10.1308/205016817822230265


  5 / 33901 MEDLINE  
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[PMID]:29320637
[Au] Autor:Charo RA; Sipp D
[Ad] Endereço:From the University of Wisconsin Law School, Madison (R.A.C.); and the RIKEN Center for Developmental Biology, Kobe, and Keio University School of Medicine, Keio Global Research Institute, and the RIKEN Center for Advanced Intelligence Project, Tokyo - all in Japan (D.S.).
[Ti] Título:Rejuvenating Regenerative Medicine Regulation.
[So] Source:N Engl J Med;378(6):504-505, 2018 Feb 08.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Terapia Baseada em Transplante de Células e Tecidos
Regulamentação Governamental
Medicina Regenerativa/legislação & jurisprudência
Transplante de Células-Tronco/legislação & jurisprudência
United States Food and Drug Administration
[Mh] Termos MeSH secundário: Segurança de Produtos ao Consumidor/legislação & jurisprudência
Aprovação de Drogas
Seres Humanos
Consentimento Livre e Esclarecido
Marketing de Serviços de Saúde
Governo Estadual
Transplante Autólogo/legislação & jurisprudência
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180214
[Lr] Data última revisão:
180214
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMp1715736


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[PMID]:29336420
[Au] Autor:Paudel B; Shrestha GK
[Ad] Endereço:Department of Nursing, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre.
[Ti] Título:Perception on Informed Consent Regarding Nursing Care Practices in a Tertiary Care Center.
[So] Source:Kathmandu Univ Med J (KUMJ);14(56):328-331, 2016 Oct.-Dec..
[Is] ISSN:1812-2078
[Cp] País de publicação:Nepal
[La] Idioma:eng
[Ab] Resumo:Background Consent for care procedures is mandatory after receipt of adequate information. It maintains patient's rights and autonomy to make thoughtful decisions. Poor communication often leads to poor health quality. Objective To assess hospitalized patients' perception on informed consent regarding nursing care practices in a tertiary care center. Method This is a descriptive cross-sectional study among 113 admitted patients conducted in February 2012 at Dhulikhel Hospital, Nepal. Patients of various wards were selected using purposive non-probability sampling with at least 3 days of hospitalization. Close ended structured questionnaire was used to assess patients' perception on three different areas of informed consent (information giving, opportunity to make decision and taking prior consent). Result Among the participants 71.6% perceived positively regarding informed consent towards nursing care practices with a mean score of 3.32 ± 1.28. Patients' perception on various areas of informed consent viz. information giving, opportunities to make specific decision and taking prior consent were all positive with mean values of 3.43±1.12, 2.88±1.23, 3.65±1.49 respectively. Comparison of mean perception of informed consent with various variables revealed insignificant correlation (p-value >0.05) for age, educational level and previous hospitalization while it was significant (p-value < 0.05) for communication skills of nurses. Conclusion Majority of patients have positive perception on informed consent towards nursing care practices. Communication skills of nurses affect the perception of patients' regardless of age, education level and past experiences.
[Mh] Termos MeSH primário: Consentimento Livre e Esclarecido/psicologia
Cuidados de Enfermagem/psicologia
Percepção
Centros de Atenção Terciária/organização & administração
[Mh] Termos MeSH secundário: Adulto
Idoso
Estudos Transversais
Feminino
Hospitalização
Seres Humanos
Aprendizagem
Masculino
Meia-Idade
Nepal
Direitos do Paciente
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180129
[Lr] Data última revisão:
180129
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180117
[St] Status:MEDLINE


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[PMID]:28455296
[Au] Autor:Zannad F; Pfeffer MA; Bhatt DL; Bonds DE; Borer JS; Calvo-Rojas G; Fiore L; Lund LH; Madigan D; Maggioni AP; Meyers CM; Rosenberg Y; Simon T; Stough WG; Zalewski A; Zariffa N; Temple R
[Ad] Endereço:Clinical Investigation Center, Centre Hospitalier Universitaire de Nancy, Nancy, France.
[Ti] Título:Streamlining cardiovascular clinical trials to improve efficiency and generalisability.
[So] Source:Heart;103(15):1156-1162, 2017 08.
[Is] ISSN:1468-201X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease.
[Mh] Termos MeSH primário: Doenças Cardiovasculares/terapia
Ensaios Clínicos como Assunto/organização & administração
Consentimento Livre e Esclarecido
Sociedades Médicas
[Mh] Termos MeSH secundário: Bases de Dados Factuais
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1708
[Cu] Atualização por classe:180126
[Lr] Data última revisão:
180126
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170430
[St] Status:MEDLINE
[do] DOI:10.1136/heartjnl-2017-311191


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[PMID]:29257635
[Au] Autor:Hampton K; Newton J; Mazza D
[Ti] Título:ASSISTED FERTILITY TREATMENT AND THE QUALITY OF INFORMED CONSENT.
[So] Source:Aust Nurs Midwifery J;24(7):30-1, 2017 02.
[Is] ISSN:2202-7114
[Cp] País de publicação:Australia
[La] Idioma:eng
[Mh] Termos MeSH primário: Conhecimentos, Atitudes e Prática em Saúde
Consentimento Livre e Esclarecido
Técnicas de Reprodução Assistida
[Mh] Termos MeSH secundário: Austrália
Fertilidade
Alfabetização em Saúde
Seres Humanos
[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:171220
[St] Status:MEDLINE


  9 / 33901 MEDLINE  
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[PMID]:29251462
[Au] Autor:Starr L
[Ti] Título:THE IMPORTANCE OF A SPECIFIC CONSENT.
[So] Source:Aust Nurs Midwifery J;24(5):24, 2016 11.
[Is] ISSN:2202-7114
[Cp] País de publicação:Australia
[La] Idioma:eng
[Ab] Resumo:Healthcare practitioners are generally aware of the need to obtain a patient's consent before providing treatment to avoid legal liability. When practitioners fail to obtain a lawful consent it is possible that they could be subject to criminal and or civil proceedings.
[Mh] Termos MeSH primário: Consentimento Livre e Esclarecido/legislação & jurisprudência
Imperícia/legislação & jurisprudência
[Mh] Termos MeSH secundário: Adulto
Feminino
Seres Humanos
Laparoscopia
Responsabilidade Legal
Esterilização Tubária
[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:171219
[St] Status:MEDLINE


  10 / 33901 MEDLINE  
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[PMID]:28453709
[Au] Autor:Remon J; Ferté C
[Ad] Endereço:Department of Oncology, Hospital Vall d'Hebron, Barcelona, Spain.
[Ti] Título:A step towards the harmonization of clinical trials inform consent forms.
[So] Source:Ann Oncol;28(5):910-912, 2017 05 01.
[Is] ISSN:1569-8041
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Termos de Consentimento
Consentimento Livre e Esclarecido
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Seres Humanos
[Pt] Tipo de publicação:EDITORIAL; COMMENT
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180118
[Lr] Data última revisão:
180118
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1093/annonc/mdx082



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