Construction of ethics in clinical research - Clinical trials registration

Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong conclusions) led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE), supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO) created the International Clinical Trial Registry Platform (ICTRP), which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

Progress in animal experimentation ethics. A case study from a brazilian medical school and from the international medical literature

PURPOSE: This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. METHODS: The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. RESULTS: The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). CONCLUSIONS: The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.

Progress in animal experimentation ethics: a case study from a Brazilian medical school and from the international medical literature

PURPOSE: This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. METHODS: The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. RESULTS: The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). CONCLUSIONS: The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.

Why Most Biomedical Findings Echoed by Newspapers Turn Out to be False: The Case of Attention Deficit Hyperactivity Disorder

Context: Because positive biomedical observations are more often published than those reporting no effect, initial observations are often refuted or attenuated by subsequent studies. Objective: To determine whether newspapers preferentially report on initial findings and whether they also report on subsequent studies. Methods: We focused on attention deficit hyperactivity disorder (ADHD). Using Factiva and PubMed databases, we identified 47 scientific publications on ADHD published in the 1990s and soon echoed by 347 newspapers articles. We selected the ten most echoed publications and collected all their relevant subsequent studies until 2011. We checked whether findings reported in each ‘‘top 10’’ publication were consistent with previous and subsequent observations. We also compared the newspaper coverage of the ‘‘top 10’’ publications to that of their related scientific studies. Results: Seven of the ‘‘top 10’’ publications were initial studies and the conclusions in six of them were either refuted or strongly attenuated subsequently. The seventh was not confirmed or refuted, but its main conclusion appears unlikely. Among the three ‘‘top 10’’ that were not initial studies, two were confirmed subsequently and the third was attenuated. The newspaper coverage of the ‘‘top 10’’ publications (223 articles) was much larger than that of the 67 related studies (57 articles). Moreover, only one of the latter newspaper articles reported that the corresponding ‘‘top 10’’ finding had been attenuated. The average impact factor of the scientific journals publishing studies echoed by newspapers (17.1 n = 56) was higher (p,0.0001) than that corresponding to related publications that were not echoed (6.4 n = 56). Conclusion: Because newspapers preferentially echo initial ADHD findings appearing in prominent journals, they report on uncertain findings that are often refuted or attenuated by subsequent studies. If this media reporting bias generalizes to health sciences, it represents a major cause of distortion in health science communication.

Proposal for bioethics education in Animal Ethics

This study proposes the continuous bioethics education in university health and biology courses. A field study was conducted with matriculating students at a university in southern Brazil about the ethics and legal questions regarding the use of animals in research and teaching. It was found that almost half of the students were unaware of important animal ethics issues, showing that these themes are merely incipient in the education provided within this particular university. Considering this reality, the inclusion of bioethics only as a discipline and isolated from the formal curriculum has not been effective and that bioethics education, incorporating polemic subjects such as animal ethics, should be included in an all-encompassing and constant approach throughout the training of students in biomedical fields.

IT professionals' experience of ethics and its implications for IT education

This study investigates variation in IT professionals' experience of ethics with a view to enhancing their formation and support. This is explored through an examination of the experience of IT, IT professional ethics and IT professional ethics education. The study's principal contribution is the empirical study and description of IT professionals' experience of ethics. The empirical phase is preceded by a review of conceptions of IT and followed by an application of the findings to IT education. The study's empirical findings are based on 30 semi-structured interviews with IT professionals who represent a wide demographic, experience and IT sub-discipline range. Their experience of ethics is depicted as five citizenships: Citizenship of my world, Citizenship of the corporate world, Citizenship of a shared world, Citizenship of the client's world and Citizenship of the wider world. These signify an expanding awareness, which progressively accords rights to others and defines responsibility in terms of others. The empirical findings inform a Model of Ethical IT. This maps an IT professional space increasingly oriented towards others. Such a model provides a conceptual tool, available to prompt discussion and reflection, and which may be employed in pursuing formation aimed at experiential change. Its usefulness for the education of IT professionals with respect to ethics is explored. The research approach employed in this study is phenomenography. This method seeks to elicit and represent variation of experience. It understands experience as a relationship between a subject (IT professionals) and an object (ethics), and describes this relationship in terms of its foci and boundaries. The study's findings culminate in three observations, that change is indicated in the formation and support of IT professionals in: 1. IT professionals' experience of their discipline, moving towards a focus on information users; 2. IT professionals' experience of professional ethics, moving towards the adoption of other-centred attitudes; and 3. IT professionals' experience of professional development, moving towards an emphasis on a change in lived experience. Based on these results, employers, educators and professional bodies may want to evaluate how they approach professional formation and support, if they aim to promote a comprehensive awareness of ethics in IT professionals.

Being ethical : how process drama assists pre-service drama teachers to reflect on professional ethics

This research thesis focuses on the experiences of pre-service drama teachers and considers how process drama may assist them to reflect on key aspects of professional ethics such as mandatory codes or standards, principled moral reasoning, moral character, moral agency, and moral literacy. Research from higher education provides evidence that current pedagogical approaches used to prepare pre –professionals for practice in medicine, engineering, accountancy, business, psychology, counselling, nursing and education, rarely address the more holistic or affective dimensions of professional ethics such as moral character. Process drama, a form of educational drama, is a complex improvisational group experience that invites participants to create and assume roles, and select and manage symbols in order to create a fictional world exploring human experience. Many practitioners claim that process drama offers an aesthetic space to develop a deeper understanding of self and situations, expanding the participant’s consciousness and ways of knowing. However, little research has been conducted into the potential efficacy of process drama in professional ethics education for pre-professionals. This study utilizes practitioner research and case study to explore how process drama may contribute to the development of professional ethics education and pedagogy.