Research ethics
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The new boundaries of academic integrityThis book extends and completes the construction of the sciences of integrity begun in 2021, and continued at the 2nd IRAFPA International Colloquium in Coimbra, Portugal, 16-18 June 2022. Eleven most accomplished contributions attempt to answer the question of what these new frontiers of integrity are in a changing academic world. If we were to define a unity of tone between them, it would be that of frankness; a unity of analysis, that of rigour; a unity of vision, that of academic rigour; and a unity of character, that of lucid optimism. It is this optimism that allows us to believe that the integrity sciences movement, capable of addressing the personal, relational and systemic levels, is well and truly underway. The ground assumption of the editors is that multidisciplinarity is central and necessary. It is mainly through multidisciplinarity that intellectual propositions can be fully validated, through the subtle variations of disciplinary perspectives and levels of analysis. In order to ethically remain in our own zone of discomfort, we all need this cross-validation, which ensures that everyone,author and reader alike come to a same ground of understanding.
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Academic integrity : a call to research and actionThe urgency of doing complements the urgency of knowing. Urgency here is not the inconsequential injunction of irrational immediacy. It arises in various contexts for good reasons, when there is a threat to the human existence and harms to others. Today, our knowledge based civilization is at risk both by new production models of knowledge and by the shamelessness of knowledge delinquents, exposing the greatest number to important risks. Swiftly, the editors respond to the diagnostic by setting up a reference tool for academic integrity. Across multiple dialogues between the twenty-five chapters and five major themes, the ethical response shapes pragmatic horizons for action, on a range of disciplinary competencies: from science to international diplomacy. An interdisciplinary work indispensable for teachers, students and university researchers and administrators.
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Ambivalence comme pari créatif : réflexions sur un modèle d’édition académique lié au développementLe rôle d’un éditeur de travaux académiques n’est pas simple. Il l’est encore moins lorsque l’aide au développement des pays du Sud devient une condition habituelle de cette activité. Devenant un engagement éditorial ambivalent, car orienté vers deux objectifs distincts : la qualité académique et l’aide au développement, l’éditeur espère tirer le meilleur parti d’outils et de réseaux en ligne pour répondre au défi. Si certains travaux universitaires échouent à être édités, qu’ils ne reçoivent pas toujours l’attention nécessaire, et posent la question si notre époque ne vit pas une crise du mentorat, cela ne veut pas dire qu’il n’y a pas de solution. L’éditeur ne peut pas entièrement compenser la faiblesse d’un travail de recherche qui lui est proposé, mais il devrait chercher à faire un investissement créatif dans l’œuvre. Nous montrons les succès et limites de cet engagement.
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Academic plagiarism : understanding it to take responsible actionWith the proliferation of the Internet, overcoming plagiarism seems insurmountable for students, teachers and researchers, who tend to find little choice between academia and the law in this regard. With a multidisciplinary approach and twenty years of expertise and research on this topic, Prof. Bergadaà proposes a concrete methodology for addressing this issue, both for the plagiarised and plagiariser, as well as for the institutions and associations. Researchers, students, directors of journals and institutions, as well as other actors in the scientific arena such as policy makers and lawyers are all concerned with preserving the value of integrity at the core of research ethics.
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Effective strategies for research integrity training - a meta-analysisThis article reviews educational efforts to promote a responsible conduct of research (RCR) that were reported in scientific publications between 1990 and early 2020. Unlike previous reviews that were exploratory in nature, this review aimed to test eleven hypotheses on effective training strategies. The achievement of different learning outcomes was analyzed independently using moderator analysis and meta-regression, whereby 75 effect sizes from 30 studies were considered. The analysis shows that the achievement of different learning outcomes ought to be investigated separately. The attainment of knowledge strongly benefited from individualized learning, as well as from the discussion and practical application of ethical standards. Contrarily, not covering ethical standards tended to be a feature of successful courses, when looking at other learning outcomes. Overall, experiential learning approaches where learners were emotionally involved in thinking about how to deal with problems were most effective. Primarily intellectual deliberation about ethical problems, often considered the “gold standard” of ethics education, was significantly less effective. Several findings from previous reviews, e.g., the preferability of mono-disciplinary groups, could not be replicated with multivariate analysis. Several avenues for future research efforts are suggested to advance knowledge on the effectiveness of research integrity training.
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The Future of Theological Ethics: Response to Robin Lovin and Nigel BiggarThis paper argues that the theological ethics of the future will be both more authentically Christian and more public, and briefly illustrates that claim in relation to the polity and to the academy. It argues, first, that Christian political reasoning should not be preoccupied with liberal anxieties about epistemic criteria for public reasoning, but rather turn its attention to the institutional telos of the polity, the political common good; and be prepared to speak in an openly Christian voice where appropriate. It argues, second, that scholarly reasoning offered by theological ethicists to the academy will be more effective the better it understands the complementary roles fulfilled by theology and other academic disciplines, such as the social sciences. Theological ethicists should not view theology as queen of the sciences but instead critically appropriate the findings of the social sciences and also work to offer it healthier, theologically-informed concepts.
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The Value of Nurses’ Codes: European nurses’ viewsNurses are responsible for the well-being and quality of life of many people, and therefore must meet high standards of technical and ethical competence. The most common form of ethical guidance is a code of ethics/professional practice; however, little research on how codes are viewed or used in practice has been undertaken. This study, carried out in six European countries, explored nurses’ opinions of the content and function of codes and their use in nursing practice. A total of 49 focus groups involving 311 nurses were held. Purposive sampling ensured a mix of participants from a range of specialisms. Qualitative analysis enabled emerging themes to be identified on both national and comparative bases. Most participants had a poor understanding of their codes. They were unfamiliar with the content and believed they have little practical value because of extensive barriers to their effective use. In many countries nursing codes appear to be ‘paper tigers’ with little or no impact; changes are needed in the way they are developed and written, introduced in nurse education, and reinforced/implemented in clinical practice.
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Controversias sobre la revisión ética de la investigación en ciencias humanas y sociales por el Sistema CEP/ Conep [Controversies on the ethical review of research in the Humanities and Social Sciences by System CEP/Conep]"The Ethics Committee must review all researches involving human subjects conducted in Brazil, which has caused controversies about the ethical review of research in the humanities and social sciences. The purpose of this article is to discuss the controversies of the ethical review of research in these areas in System CEP/ Conep. The controversies are the biocentrism, the punctual improvements in Resolution 466/2012, the emergence of a parallel system of ethical review for theses areas or the constitution of supplementary resolution in the system CEP/Conep. These controversies relate to functional limitations of the ethical committees: high demand of projects, few committees, limitations of the Brazil platform and the need for members training. The System CEP/Conep should continue as the only system of ethical review in Brazilian research; but it requires that the resolutions are continually revised in order to include the specificities of the researches in the humanities and create more committees with better training."
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La comprensión y la legibilidad del consentimiento informado en investigaciones clínicas [Comprehension and readability of the informed consent form in clinical research]"Este artículo es una revisión integradora de la literatura cuyo objetivo fue analizar la comprensión y la legibilidad de los consentimientos informados de los participantes de las investigaciones con seres humanos; y comprobar cuáles son los factores que influyen en su comprensión y legibilidad. Por lo tanto, se buscó identificar los factores asociados con el problema de la obtención del consentimiento válido. Forman parte de la muestra de esta revisión once artículos seleccionados, nacionales e internacionales, de los cuales cuatro eran en portugués (36, 36%), uno en español (9,10%) y seis en inglés (54,54%). Se concluyó que la mayoría de los estudios analizados confirma la hipótesis de que los participantes no entienden lo que leen en el consentimiento informado. Así, los factores deducidos como responsables de la dificultad para la lectura y la comprensión de los consentimientos informados fueron el nivel educativo de los participantes y el lenguaje usado en los términos."
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The experience of the research ethics committee at a public university in the state of Minas Gerais, Brazil"The article reports the experience of the Research Ethics Committee at the State University of Montes Claros, MG, Brazil, in the period from 2000 to 2009. Desk research, case study method were employd, and the significance level was set at p < 0.05. Of 1,751 projects, 95.8% were approved. Problems in preparing the statement of informed consent were among reasons for disapproval. The health sciences area of knowledge stood out at 60.8%. The average time between submission and ethical review was 11 days. The area of knowledge influenced the average time between submission and ethical assessment (p < 0.05), but did not affect the time to approval of the research project. Conclusion: the local committee followed the standards for ethical assessment in accordance with Resolution 466/2012, in view of the fact that it rejected projects with shortcomings in the statement of informed consent, thus protecting the subjects of the research."
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Experiencia del comité de ética en investigación de una universidad pública de Minas Gerais, Brasil [The experience of the research ethics committee at a public university in the state of Minas Gerais, Brazil]"El artículo informa sobre la experiencia del Comité de Ética de Investigación de la Universidad Estadual de Montes Claros, MG, Brasil, en el período del 2000 a 2009, con base en investigación documental, en la modalidad de estudio del caso, con un nivel de significación p < 0,05. De los 1.751 proyectos, 95,8% fueron aprobados y, entre las razones de la desaprobación, están los problemas en la elaboración del Término de Consentimiento Informado. El área de conocimiento más destacada fue el de las ciencias de la salud (60,8%). El tiempo promedio entre la presentación y la evaluación ética fue de 11 días. El área de conocimiento influyó en el tiempo pasado entre la presentación y la valoración ética (p < 0,05), pero no en la aprobación del proyecto. Se concluyó que el comité local sigue las normas para la consideración ética para cumplir con la Resolución 466/2012, una vez que reprobó proyectos con fallas en el Término de Consentimiento Informado, protegiendo a los sujetos"
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Integridad científica y investigación en salud en el Brasil [Scientific integrity and research in health in Brazil]"El Brasil es un país con ciencia emergente, en rápida expansión, con aumento significativo de investimentos destinados a investigación y capacitación de investigadores. Así, es importante verificar la calidad y confiabilidad de los conocimientos producidos, considerándose la adherencia a los requisitos de integridad y buenas prácticas científicas. Se buscó el objetivo de esbozar un panorama sobre el tema de la integridad científica en el Brasil a través del análisis de reflexiones e investigaciones publicadas en revistas científicas. Se realizó una revisión sistemática en bases de datos electrónicas: SciELO, PuBMed, LILACS/IBECS, Scopus y Web of Science, utilizándose palabras-clave para encontrar los artículos. Después de la aplicación de criterios de inclusión y exclusión fueron seleccionadas 19 publicaciones, agrupadas en seis categorías previamente definidas. El debate sobre la integridad científica es aún incipiente en este país. Los temas más discutidos fueron plagio y conflictos de intereses sobre autoría. Es necesario el acercamiento precoz a ese conocimiento en el proceso de formación académica de investigadores y jóvenes cientistas. "
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Scientific integrity and research in health in Brazil"Brazil is a country with an emerging and rapidly expanding body of scientific research, and is correspondingly experiencing a significant increase in investment in research and researcher training. It is important to verify the quality and reliability of the knowledge arising from such research, in terms of integrity and adherence to good scientific practices. The aim of this study was to provide an overview scientific integrity in Brazil through an analysis of studies published in scientific journals. A systematic review of the SciELO, PuBMed, LILACS/ IBECS and Web of Science electronic databases was performed, using keywords to select the relevant studies. Following application of inclusion and exclusion criteria, 19 publications were selected and classified into six previously defined categories. However, discussion of scientific integrity remains incipient in Brazil. The subjects discussed were plagiarism and conflicts of interest regarding authorship. Early adherence to principles of integrity are important in the academic training of researchers and young scientists."
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Characterization of risks in search of an ethics committee in research protocols"A descriptive study in order to learn how researchers described risks and protective/preventive measures of their researches submitted to analyzes by an ethics committee in research. 175 research protocols submitted to a research ethics committee were included. As a result, only 38 (24.7%) described the risks in the forms and 36 (23.5%) in the informed consent. However, 110 (62.9%) described preventive measures in the forms and 143 (93.5%) in the informed consent. It was concluded that, although researchers have identified preventive measures, they have not described the risks to which the measures were targeted. It is possible that they find it hard to describe risks since they relate them to injuries."
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Controversies on the ethical review of research in the Humanities and Social Sciences by System CEP/Conep"The Ethics Committee must review all researches involving human subjects conducted in Brazil, which has caused controversies about the ethical review of research in the humanities and social sciences. The purpose of this article is to discuss the controversies of the ethical review of research in these areas in System CEP/ Conep. The controversies are the biocentrism, the punctual improvements in Resolution 466/2012, the emergence of a parallel system of ethical review for theses areas or the constitution of supplementary resolution in the system CEP/Conep. These controversies relate to functional limitations of the ethical committees: high demand of projects, few committees, limitations of the Brazil platform and the need for members training. The System CEP/Conep should continue as the only system of ethical review in Brazilian research; but it requires that the resolutions are continually revised in order to include the specificities of the researches in the humanities and create more committees with better training."
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Scientific research and patent law"Scientific research and patent law belong to two very different worlds, which made dificult that there are points of contact. While the underlying principles that authorize the granting of a patent (existence of a patentable invention, novelty, a inventive improve in the object or capacity in question and there industrial application) envisioned no conflicts were observed. The changes in patent law as a result of increasing market pressure has led to a transformation that disturbs the free movement of knowledge and scientific research itself; ethical issues of undoubted interest. The most significant notes of this process are described in this work as well as the most important conflicts that arose."
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For a research ethics founded on Human Rights"This study aims to demonstrate that human rights should be the fundamental ethical framework of research ethics. We have divided the approach of the interrelationship between human rights framework and research ethics in three phases, the first marked by the introduction of the principles of Nüremberg, the second by the hegemony of the Declaration of Helsinki, and the third is characterized by the increase in international research, the decline of the Helsinki Declaration and the adoption of the Universal Declaration on Bioethics and Human Rights. Based on the tripartite methodology employed, we have concluded that, despite the unquestionable relevance of the Declaration of Helsinki for building a culture of respect and protection of the research subject, we can verify its loss of legitimacy, so, it must be understood that the Universal Declaration on Bioethics and Human Rights and the International Law of Human Rights should be the new parameters of the research ethics worldwide and in Brazil."
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Conflicts of interests in the medical and pharmacological research"The clinical medical pharmacological research corresponds to the experimental application of specific drug in human beings. Such application aims to protect them from unacceptable adverse effects and its inefficiency when comparing with other possibilities, more efficient. Partnerships between the pharmaceutical industry and external researchers establish potential conflict of interest. Literature use for this work indicates that researches performed under the sponsorship of pharmaceutical industry have a high rate of favorable results, and the conflicts of interest represent gaps which may interfere the result. There are studies that compare the efficiency of different drugs, whereas others compare their costs. All results should be published, even when negative. The present work concludes that the private sector must sponsor the science in order to improve human beings, especially to avoid diseases. However, it must keep its engagement in sponsoring the research with any influence on its methods, results and application, for a respectful understanding of the dignity of a person. "