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[PMID]:29020586
[Au] Autor:Asch DA; Ziolek TA; Mehta SJ
[Ad] Endereço:From the Center for Health Care Innovation (D.A.A., S.J.M.) and the Institutional Review Board (T.A.Z.), University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center (D.A.A.) - all in Philadelphia.
[Ti] Título:Misdirections in Informed Consent - Impediments to Health Care Innovation.
[So] Source:N Engl J Med;377(15):1412-1414, 2017 Oct 12.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Comitês de Ética em Pesquisa
Regulamentação Governamental
Consentimento Livre e Esclarecido
Melhoria de Qualidade/ética
Ensaios Clínicos Controlados Aleatórios como Assunto/ética
[Mh] Termos MeSH secundário: Seres Humanos
Consentimento Livre e Esclarecido/legislação & jurisprudência
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171019
[Lr] Data última revisão:
171019
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171012
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMp1707991


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[PMID]:28949918
[Au] Autor:Packenham JP; Rosselli RT; Ramsey SK; Taylor HA; Fothergill A; Slutsman J; Miller A
[Ad] Endereço:Clinical Research Branch, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) , Research Triangle Park, North Carolina, USA.
[Ti] Título:Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research.
[So] Source:Environ Health Perspect;125(9):094503, 2017 Sep 25.
[Is] ISSN:1552-9924
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:SUMMARY: Research involving human subjects after public health emergencies and disasters may pose ethical challenges. These challenges may include concerns about the vulnerability of prospective disaster research participants, increased research burden among disaster survivors approached by multiple research teams, and potentially reduced standards in the ethical review of research by institutional review boards (IRBs) due to the rush to enter the disaster field. The NIEHS Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Research was formed to identify and address ethical and regulatory challenges associated with the review of disaster research. The working group consists of a diverse collection of disaster research stakeholders across a broad spectrum of disciplines. The working group convened in July 2016 to identify recommendations that are instrumental in preparing IRBs to review protocols related to public health emergencies and disasters. The meeting included formative didactic presentations and facilitated breakout discussions using disaster-related case studies. Major thematic elements from these discussions were collected and documented into 15 working group recommendations, summarized in this article, that address topics such as IRB disaster preparedness activities, informed consent, vulnerable populations, confidentiality, participant burden, disaster research response integration and training, IRB roles/responsibilities, community engagement, and dissemination of disaster research results. https://doi.org/10.1289/EHP2378.
[Mh] Termos MeSH primário: Desastres
National Institute of Environmental Health Sciences (U.S.)
[Mh] Termos MeSH secundário: Emergências
Comitês de Ética em Pesquisa
Seres Humanos
Estudos Prospectivos
Saúde Pública
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171027
[Lr] Data última revisão:
171027
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170927
[St] Status:MEDLINE
[do] DOI:10.1289/EHP2378


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[PMID]:28877014
[Au] Autor:Choudhry NK
[Ad] Endereço:From the Center for Healthcare Delivery Sciences and Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston.
[Ti] Título:Randomized, Controlled Trials in Health Insurance Systems.
[So] Source:N Engl J Med;377(10):957-964, 2017 Sep 07.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Seguradoras
Seguro Saúde
Ensaios Clínicos Controlados Aleatórios como Assunto
[Mh] Termos MeSH secundário: Comitês de Ética em Pesquisa
Seres Humanos
Revisão da Utilização de Seguros
Avaliação de Resultados (Cuidados de Saúde)
Ensaios Clínicos Controlados Aleatórios como Assunto/ética
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
Ensaios Clínicos Controlados Aleatórios como Assunto/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170918
[Lr] Data última revisão:
170918
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170907
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMra1510058


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Texto completo SciELO Brasil
[PMID]:28724033
[Au] Autor:Paumgartten FJR
[Ad] Endereço:MD, PhD, National School of Public Health, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.
[Ti] Título:Ethical issues on the "synthetic" phosphoethanolamine clinical trial.
[So] Source:Rev Assoc Med Bras (1992);63(5):388-392, 2017 May.
[Is] ISSN:1806-9282
[Cp] País de publicação:Brazil
[La] Idioma:eng
[Ab] Resumo:Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho. Preclinical safety studies of syn-phospho were also insufficient to support a trial of this investigational drug in cancer patients. Moreover, the ethical approval decision apparently overlooked two previous findings that suggested a possible enhancement of mammary carcinoma cell proliferation by phosphoethanolamine, and an apparent increase in lung metastases (rat implanted tumor assay) by syn-phospho. The syn-phospho risk-benefit ratio is clearly unfavorable and, thus, this trial in cancer patients does not fulfill a key requirement to make a clinical research ethical. There are also concerns regarding whether the study design is robust enough (scientific validity), and the social value of the trial of syn-phospho in cancer patients is questionable.
[Mh] Termos MeSH primário: Antineoplásicos/uso terapêutico
Ensaios Clínicos como Assunto/ética
Drogas em Investigação/uso terapêutico
Etanolaminas/uso terapêutico
[Mh] Termos MeSH secundário: Brasil
Avaliação Pré-Clínica de Medicamentos/ética
Comitês de Ética em Pesquisa
Seres Humanos
Medição de Risco
Experimentação Humana Terapêutica/ética
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Drugs, Investigational); 0 (Ethanolamines); 78A2BX7AEU (phosphorylethanolamine)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170929
[Lr] Data última revisão:
170929
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170721
[St] Status:MEDLINE


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[PMID]:28698010
[Au] Autor:Moulton LJ; Michener CM; Levinson K; Cobb L; Tseng J; Jernigan A
[Ad] Endereço:Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic Foundation, 9500 Avenue, Desk A81, Cleveland, OH 44195, USA. Electronic address: moultol@ccf.org.
[Ti] Título:Compliance with research standards within gynecologic oncology fellowship: A Gynecologic Oncology Fellowship Research Network (GOFRN) study.
[So] Source:Gynecol Oncol;146(3):647-652, 2017 Sep.
[Is] ISSN:1095-6859
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: Participation in clinical and basic science research is emphasized in gynecologic oncology training. We sought to identify trends in adherence to expected research practices and reasons for non-adherence among gynecologic oncology fellows. METHODS: An anonymous 31-question online survey assessing academic behaviors, including IRB compliance, authorship assignment, data sharing, and potential barriers to non-adherence was distributed to all SGO gynecologic oncology fellow members in July 2016. Descriptive statistics and univariate analyses were performed. RESULTS: Of 190 members, 35.3% (n=67) responded. 73% (n=49) of respondents reported personal non-compliance and 79.1% (n=53) reported having witnessed others being non-complaint with at least one expected research practice. Areas of compliance failure included changing a research question without appropriate IRB amendment (20%; n=14), conducting research under a nonspecific IRB (13.9%; n=9), and performing research without IRB approval (6.1%; n=4). Longer institutional time for IRB approval was significantly associated with IRB non-adherence (p<0.05). First year fellows were more likely to use a nonspecific IRB (p=0.04) or expand a question without amending the IRB (p=0.04). When asked about storage of protected health information (PHI) for research, 53% reported non-secure storage with 17.1% (n=6) having done so for >1000 patients. Thirty respondents (45.5%) assigned authorship to someone who failed to meet ICMJE criteria and twelve (18.5%) accepted authorship without meeting ICMJE criteria. Most commonly cited reasons for non-adherence were: cumbersome IRB processes (80.3%), pressure from senior authors (78.8%), fear of someone else publishing first, (74.2%) and lack of support navigating appropriate research practices (71.2%). CONCLUSIONS: Fellow non-compliance with expected research practices is high, particularly with regards to secure storage of PHI and appropriate authorship assignment. Time-consuming and cumbersome IRB procedures, perceived pressure from senior authors, and lack of research support contribute to non-adherence. Further support and education of gynecologic oncology fellows is needed in order to help address these barriers.
[Mh] Termos MeSH primário: Pesquisa Biomédica/normas
Confidencialidade/normas
Bolsas de Estudo/estatística & dados numéricos
Fidelidade a Diretrizes/estatística & dados numéricos
Ginecologia
Oncologia
[Mh] Termos MeSH secundário: Autoria/normas
Pesquisa Biomédica/ética
Comitês de Ética em Pesquisa/normas
Feminino
Guias como Assunto
Seres Humanos
Disseminação de Informação
Masculino
Registros Médicos
Inquéritos e Questionários
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170919
[Lr] Data última revisão:
170919
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170713
[St] Status:MEDLINE


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[PMID]:28562269
[Au] Autor:Rose CD
[Ad] Endereço:Division of Rheumatology, Nemours Alfred I. duPont Hospital for Children, Thomas Jefferson University, Wilmington, Delaware; and Chair, Nemours Wilmington Institutional Review Board, Nemours Office of Human Research Protection, Wilmington, Delaware crose@nemours.org.
[Ti] Título:Ethical Conduct of Research in Children: Pediatricians and Their IRB (Part 2 of 2).
[So] Source:Pediatrics;139(6), 2017 Jun.
[Is] ISSN:1098-4275
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:In part 1 of this series, we discussed the historical, ethical, and legal background that provides justification for the current system of protection of subjects of human experimentation. We also discussed briefly the implementation of those principles in institutional review board (IRB) operations. In part 2, we focus on legislation dealing with pediatric research, the rules and ethics of assent, and then turn our attention to minimal-risk studies. To that end, we discuss the minimal-risk threshold and the process of balancing benefit and risk in IRB decisions for pediatric studies. We define the notion of consent waiver as well as the procedures for expedited review, management of adverse events, and amendments to approved protocol. Finally, we mention some miscellaneous issues, including central and commercial IRB, reliance agreements, biobanks, and sample shipping regulations.
[Mh] Termos MeSH primário: Pesquisa Biomédica/ética
Comitês de Ética em Pesquisa/ética
Ética em Pesquisa
Consentimento Livre e Esclarecido/legislação & jurisprudência
[Mh] Termos MeSH secundário: Criança
Seres Humanos
Pediatras
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170907
[Lr] Data última revisão:
170907
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170601
[St] Status:MEDLINE


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[PMID]:28557746
[Au] Autor:Rose CD
[Ad] Endereço:Division of Rheumatology, Nemours Alfred I. duPont Hospital for Children, Thomas Jefferson University, Wilmingtom, Delaware; and Chair, Nemours Wilmington Institutional Review Board, Nemours Office of Human Research Protection, Wilmington, Delaware crose@nemours.org.
[Ti] Título:Ethical Conduct of Research in Children: Pediatricians and Their IRB (Part 1 of 2).
[So] Source:Pediatrics;139(5), 2017 May.
[Is] ISSN:1098-4275
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:As human experimentation continues to grow into an ever more complex and sophisticated endeavor, the relevant ethical and regulatory structures become more intricate. When pediatricians and general practitioners are invited by pharmaceutical companies to enroll their offices in a clinical trial or a multicenter observational study or when they develop their own research questions, they frequently find themselves at a loss in the human research environment. The legal and regulatory complexity may have an unintended deterring effect at a time when office-based high quality pediatric research is urgently needed to support evidence-based medicine. Unfortunately, in many instances, unaware practitioners become involved in low-risk research activities without knowing it and become entangled in legal, auditing, and compliance procedures. This paper, written in 2 parts, aims at providing a general guidance on the principles that regulate human research with a focus on pediatrics. Part 1 discusses the history, the legal framework, and the consent process and highlights some practical aspects of initial protocol submission, continued review, and institutional review board determinations with the main focus on multicenter clinical trials (industry-sponsored research). Part 2 focuses on pediatric research regulation, also known as subpart-D, and minimal risk research, which encompasses many research activities aimed at addressing questions that may emerge in pediatricians' practices (investigator-initiated research).
[Mh] Termos MeSH primário: Pesquisa Biomédica/ética
Comitês de Ética em Pesquisa
Pediatras/ética
[Mh] Termos MeSH secundário: Pesquisa Biomédica/história
Pesquisa Biomédica/legislação & jurisprudência
Criança
Ensaios Clínicos como Assunto/ética
Descoberta de Drogas/ética
História do Século XX
Experimentação Humana/ética
Experimentação Humana/história
Experimentação Humana/legislação & jurisprudência
Seres Humanos
Consentimento Informado por Menores/ética
Estudos Multicêntricos como Assunto/ética
Estados Unidos
[Pt] Tipo de publicação:HISTORICAL ARTICLE; JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170810
[Lr] Data última revisão:
170810
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170531
[St] Status:MEDLINE


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Texto completo SciELO Chile
[PMID]:28548197
[Au] Autor:Portales MB; Michaud P; Salas SP; Beca JP
[Ad] Endereço:Centro de Bioética, Facultad de Medicina, Universidad del Desarrollo, Santiago, Chile.
[Ti] Título:[Differentiated review of biomedical research projects by ethics committees].
[Ti] Título:Formas de Revisión Ética de Proyectos de Investigación Biomédica..
[So] Source:Rev Med Chil;145(3):386-392, 2017 Mar.
[Is] ISSN:0717-6163
[Cp] País de publicação:Chile
[La] Idioma:spa
[Ab] Resumo:Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.
[Mh] Termos MeSH primário: Pesquisa Biomédica/ética
Revisão Ética
Comitês de Ética em Pesquisa/normas
[Mh] Termos MeSH secundário: Acreditação
Chile
Comitês de Ética em Pesquisa/legislação & jurisprudência
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170808
[Lr] Data última revisão:
170808
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170527
[St] Status:MEDLINE


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[PMID]:28445582
[Au] Autor:Klitzman R; Pivovarova E; Lidz CW
[Ad] Endereço:Columbia University, New York, New York.
[Ti] Título:Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy.
[So] Source:JAMA;317(20):2061-2062, 2017 05 23.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Comitês de Ética em Pesquisa/normas
Estudos Multicêntricos como Assunto/ética
National Institutes of Health (U.S.)
[Mh] Termos MeSH secundário: Ética em Pesquisa
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170713
[Lr] Data última revisão:
170713
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170427
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.4624


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[PMID]:28421889
[Au] Autor:Abdulrahman M; Nair SC
[Ad] Endereço:1 Department of Medical Education, Dubai Health Authority, United Arab Emirates.
[Ti] Título:Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates.
[So] Source:J Empir Res Hum Res Ethics;12(2):71-78, 2017 Apr.
[Is] ISSN:1556-2654
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.
[Mh] Termos MeSH primário: Pesquisa Biomédica/ética
Comitês de Ética em Pesquisa/normas
[Mh] Termos MeSH secundário: Ética em Pesquisa
Fidelidade a Diretrizes
Recursos em Saúde
Experimentação Humana/ética
Seres Humanos
Pesquisadores
Emirados Árabes Unidos
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171003
[Lr] Data última revisão:
171003
[Sb] Subgrupo de revista:E; IM
[Da] Data de entrada para processamento:170420
[St] Status:MEDLINE
[do] DOI:10.1177/1556264617697522



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