• O Consentimento Informado nos Comitês de Ética em Pesquisa e na Prática Médica [The Informed Consent in the Research Ethics Committees and in Medical Practice]

      Clotet, Joaquím (Conselho Federal de Medicina, 1995)
      "A prática ou a obtenção do consentimento informado no exercício da medicina e a pesquisa em seres humanos são próprias das últimas décadas e caracterizam o aperfeiçoamento da ética biomédica. O artigo focaliza três aspectos básicos do consentimento informado: conceituação, origens e atualidade. Estes três pontos são examinados com informações da história e princípios da Ética e do Direito. É destacada a valiosa contribuição das orientações e declarações de entidades internacionais. Encerra-se o trabalho com um apelo ao aprimoramento na teoria e na prática do consentimento informado nos Comitês de Ética em pesquisa e na relação médico-paciente em território nacional."
    • O consentimento livre e esclarecido e a vulnerabilidade do sujeito de pesquisa [Free and Informed consent and vulnerability of human research subjects]

      Lee dos Santos, Mary; Emmerich, Adauto (Conselho Federal de Medicina, 2011)
      "A Resolução CNS 196/96 normatiza a pesquisa envolvendo seres humanos e estabelece a proteção do voluntário com o termo de consentimento livre e esclarecido (TCLE). O trabalho investigou o perfil de sujeitos de pesquisas de uma instituição de ensino buscando estabelecer relação entre sua condição socioeconômica e o entendimento sobre a pesquisa. O CEP intermediou o contato entre pesquisadores, revelando apenas a identidade dos que aceitaram participar da investigação. Os voluntários mais frequentes são pacientes, trabalhadores dos serviços públicos de saúde, estudantes da instituição e grupos de idosos e residentes de instituições de longa permanência. Destes, 75% pertencem às classes D e E, e apesar da alta escolaridade de 49% dos voluntários, 60% não leram o TCLE. Os resultados apontam a necessidade de resgatar o valor do TCLE mediante ações de educação, tornando a comunicação mais eficiente entre pesquisador e voluntário, além de propiciar maior consideração à vulnerabilidade social."
    • O processo de consentiento livre e esclarecido nas pesquisas em doença falciforme [The process of informed consent in research on sickle cell disease]

      Siqueira Valêncio, Luis Felipe (Conselho Federal de Medicina, 2016)
      "Doença falciforme diz respeito a grupo de hemoglobinopatis associadas à presença da hemoglobina S. Sendo majoritária na população negra, e acometendo em sua maioria vulneráveis e vulnerados, a forma homozigota da doença – a anemia falciforme – é considerada relevante problema de saúde pública no Brasil. Entendendo a pesquisa cientíia como essencial para a promoção da saúde e para melhorar a qualidade de vida dos pacientes, o processo de consentiento livre e esclarecido deve ser aplicado para superar, na medida do pos- sível, vulnerabilidades a que as pessoas com doença falciforme estão expostas. Recursos lúdicos, transmissão coletia de informações, proteção conferida pelas associações de pacientes e a formação permanente em étia em pesquisa por parte dos profisionais que aplicam o consentiento são indicados como ferramentas para otiizar esse processo."
    • O termo de consentimento livre e esclarecido nas pesquisas com seres humanos [The free and clarified consent term in research with humans]

      Maluf, Fabiano; Garrafa, Volnei (Conselho Federal de Medicina, 2011)
      "A consolidação do sistema brasileiro de revisão ética das pesquisas com seres humanos é fruto da Resolução 196/96 do Conselho Nacional de Saúde, que contribuiu de forma significativa para a ampliação da bioética no Brasil. O presente estudo tem como objetivo verificar o uso do termo de consentimento livre e esclarecido (TCLE) nas dissertações e teses defendidas no programa de pós-graduação em Ciências da Saúde da Universidade de Brasília no período de agosto de 1996 a dezembro de 2006. Os resultados obtidos mostram um panorama de conscientização na formação dos pesquisadores quanto à aplicação efetiva dos pilares da bioética, mais especificamente o respeito ao princípio da autonomia dos sujeitos de pesquisa."
    • Objeciones planteadas por los comités éticos a las traducciones de los documentos de consentimiento informado en investigación clínica [Analysis of the objections raised by ethics committees in Spain to the translations of clinical research patient information sheets and informed consent forms]

      Gallego Borghini, Lorenzo (Observatori de Bioètica i Dret - Universitat de Barcelona, 2015)
      "En muchos ensayos clínicos internacionales, la versión en castellano de los documentos de consentimiento informado (CI) presenta deficiencias atribuibles a la traducción. Para conocer las objeciones que formulan los comités éticos de investigación clínica a las traducciones, como paso previo a la elaboración de un manual sobre la traducción de estos documentos, se analiza un corpus de 100 solicitudes de aclaración. El 67,63% de las peticiones hacen referencia al CI y de éstas, el 31,80% tienen alguna relevancia para la traducción. La mayoría de estas objeciones conciernen a la redacción general (43,62%); también son objeto de crítica la terminología (34,31%) y los aspectos culturales (22,05%). En este artículo se describen estas objeciones y se analiza qué implicaciones tienen para el trabajo del traductor" ["In many international clinical trials submitted for approval in Spain, the Spanish versions of the patient information sheets and informed consent forms (PIS/ICFs) have problems that may be attributed to the translation. A sample of 100 clarification letters from Spanish ethics committees has been analyzed to assess the objections posed by these ethics committees to the translation of PIS/ICFs, as a previous step for the preparation of a handbook on PIS/ICF translation. As many as 67.63% of all clarification requests relate to the PIS/ICF. Of these, 31.80% is somehow relevant to the translation. Most of these objections concern general style and writing (43.62%), whereas the other two points of attention are terminological issues (34.31%) and cultural issues (22.05%). Following the analysis of these objections, the implications for the work of translators are discussed"]
    • Objektorientierter Ansatz zum Schutz von Informationssystemen

      Identités et Différenciation de l'Environnement des Espaces et des Sociétés (IDEES); Université de Rouen Normandie (UNIROUEN); Normandie Université (NU)-Normandie Université (NU)-Université de Caen Normandie (UNICAEN); Normandie Université (NU)-Université Le Havre Normandie (ULH); Normandie Université (NU)-Institut de Recherche Interdisciplinaire Homme et Société (IRIHS); Université de Rouen Normandie (UNIROUEN); Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN); Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS); Colloc, Joël (HAL CCSD, 1991)
      International audience
    • Observation of dairy cattle to assess well-being

      Centre d'Elevage ; Partenaires INRAE; UR 1213 SUR LES HERBIVORES Unité de Recherches sur les Herbivores. Centre de recherche de Clermont-Ferrand-Theix ; Institut National de la Recherche Agronomique (INRA); Ecole Nationale Vétérinaire de Lyon (ENVL); Hetreau, Thierry; Mounier, Luc; bertholdy, Emilie (HAL CCSD, 2009)
      La demande d'une visite "bien-être" peut provenir d'une obligation pour l'éleveur de respecter des normes, être consécutive à une plainte ou à une baisse de productivité. Le bien-être est subjectif, mais il doit être évalué de manière la plus objective possible, à l'aide de critères comportementaux, physiologiques, zootechniques et sanitaires. Néanmoins, ils restent difficiles à évaluer et le moyen le plus simple est d'utiliser les cinq libertés du Farm Animal Welfare Council ou les douze besoins du projet européen Welfare Quality®
    • Observational Research on the Electronic Superhighway

      Rosenoer, Jonathan; Isaacs, Sandy; Macklin, Ruth; Silverman, Sam (2016-01-08)
    • Observational Research where it is most Needed

      D. Rathod, Sujit (Forum for Medical Ethics Society, 2012-01)
      "The importance of this sort of basic scientific investigation cannot be overstated. In the absence of evidence from randomised control trials, guidelines around cancer screening rely on data generated from observational studies. By determining the incidence and prevalence of women with carcinoma in situ, and identifying the features of dysplasia associated with progression to carcinoma in situ, this research could support health policy makers’ efforts to increase capacity and to precisely target the treatment of cervical cancer. The primary beneficiaries of the findings of this kind of research would be those populations most affected by cervical cancer - who happen to be women in developing countries. The burden of research participation should be borne by a sample drawn from populations expected to benefit from the results of the research findings. Thus it is just and appropriate that women in developing countries were enrolled in this study."(pg 57)
    • Obstacles to Researching the Researchers: A Case Study of the Ethical Challenges of Undertaking Methodological Research Investigating the Reporting of Randomised Controlled Trials

      McKenzie, Joanne E.; Herbison, G. Peter; Roth, Paul; Paul, Charlotte (2016-01-09)
      BACKGROUND: Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes. Bias resulting from selective reporting can impact on meta-analyses, influencing the conclusions of systematic reviews, and in turn, evidence based clinical practice guidelines.In 2006 we received funding to investigate if there was evidence of within-study selective reporting in a cohort of RCTs submitted to New Zealand Regional Ethics Committees in 1998/99. This research involved accessing ethics applications, their amendments and annual reports, and comparing these with corresponding publications. We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons. In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee. The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application. This initiated a seventeen month process to obtain ethical approval. This publication outlines what we planned to do, the issues we encountered, discusses the legal and ethical issues, and presents some potential solutions. DISCUSSION AND CONCLUSION: Methodological research such as this has the potential for public benefit and there is little or no harm for the participants (trialists) in undertaking it. Further, in New Zealand, there is freedom of information legislation, which in this circumstance, unambiguously provided rights of access and use of the information in the ethics applications. The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research. Methodological research, such as this, can be used to develop processes to improve quality in research reporting. Recognition of the potential benefit of this research in the broader research community, and those who sit on ethics committees, is perhaps needed. In addition, changes to the ethical review process which involve separation between those who review proposals to undertake methodological research using ethics applications, and those with responsibility for reviewing ethics applications for trials, should be considered. Finally, we contend that the research community could benefit from quality improvement approaches used in allied sectors.
    • Obtaining 'fresh' consent for genetic research with biological samples archived 10 years ago.

      Vermeulen, Eric; Schmidt, Marjanka K.; Aaronson, Neil K.; Kuenen, Marianne; van Leeuwen, Flora E. (2011-07-12)
      http://dx.doi.org/10.1016/j.ejca.2008.11.022
    • Obtaining 'fresh' consent for genetic research with biological samples archived 10 years ago.

      Vermeulen, Eric; Schmidt, Marjanka K.; Aaronson, Neil K.; Kuenen, Marianne; van Leeuwen, Flora E. (2011-07-12)
    • Obtaining archived pathological material for biomedical research

      Basu, S.; Martin, S.W.; Phillips, R.M.; Puri, R. (2011-07-12)
      letter
    • Obtaining archived pathological material for biomedical research

      Basu, S.; Martin, S.W.; Phillips, R.M.; Puri, R. (2011-07-12)
      letter
    • Obtaining consent for future research with induced pluripotent cells: opportunities and challenges.

      Aalto-Setälä, Katriina; Conklin, Bruce R.; Lo, Bernard (2011-07-12)
    • Obtaining consent for future research with induced pluripotent cells: opportunities and challenges.

      Aalto-Setälä, Katriina; Conklin, Bruce R.; Lo, Bernard (2011-07-12)
      http://dx.doi.org/10.1371/journal.pbio.1000042