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.

Committees for ethics in research involving human subjects

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Towards an integrative approach to sustainability: exploring potential synergies between gender and environment

Includes bibliography.

Library Classifications Criticism: Universality, Poststructuralism and Ethics

We study library classifications criticisms from a poststructuralist and pragmatist point of view that rejects the idea of universality in knowledge organization systems. From this perspective, we analize the seminal texts on library classifications criticisms and conclude that the seek of neutrality in some of these texts is not only an impossible goal but also a contradiction in the representation of different cultures. Therefore, we suggest the commitment with the goals and the recognition of bias in library classifications as an important device for achieving a transcultural ethics in knowledge organization and representation.

Improving business innovation and research through the application of neuromarketing with ethics: a framework

The objective of this paper is to analyse and to discuss the ethical issues in the field of research known as neuromarketing, a tool used to improve innovation in companies. It uses techniques available to neuroscientists, both newer and more sophisticated ones along with traditional ones, but now for new purposes. From the beginning, this new area has evoked discussions about ethical aspects related to the results presented. Despite the unrestricted controversy surrounding the theme, few studies have discussed ethical issues involved in this line of research in a pragmatic manner. In this sense, this paper seeks to analyse and discuss ethical issues in neuromarketing research through a literature review and the proposal for a framework of ethical mapping. This framework revealed the ethical implications that would be most prominent in certain research situations: the purpose of utilising neuromarketing techniques, organisational type, and industrial sector, among others.

South Carolina Federal Feminist Credit Union Records - Accession 106 - M45 (60)

The South Carolina Federal Feminist Credit Union Records consists of a charter, newspaper clippings, photographs, statements, minutes, correspondence, memoranda and brochures relating to the creation and early history of the Credit Union, the first of its kind in the Southeast and the tenth one established in the nation. The Credit Union dissolved on September 1, 1977.

The Ethics of Implementation: Institutional Remedies and the Lawyer's Role

The issue addressed in this article is whether and to what extent a lawyer has an ethical responsibility to pursue implementation of the remedy in institutional reform litigation. Institutional reform litigation refers to cases in which an individual or class of individuals sues a large organization in order to vindicate constitutional or statutory rights. The types of cases with which this article is concerned are the "public law" type, such as school desegregation, prisoners' rights and patients' rights cases, although included under the rubric of institutional reform can be, inter alia, antitrust, reapportionment and bankruptcy cases. The implementation stage of institutional reform litigation arises after an individual or class of individuals prevails at the liability stage, or pursuant to a settlement, and a court orders the defendant organization to change in order to vindicate the plaintiffs' rights. At that point, the defendant organization, whether it be a prison, mental hospital or school district, usually has the burden of implementing the order. One conclusion drawn is that the ethical duty of the lawyer must always be consistent with the lawyer's "special responsibility for the quality of justice."

Literacy Research: Issues of Authority, Ownership, and Representation

With the “social turn” of language in the past decade within English studies, ethnographic and teacher research methods increasingly have acquired legitimacy as a means of studying student literacy. And with this legitimacy, graduate students specializing in literacy and composition studies increasingly are being encouraged to use ethnographic and teacher research methods to study student literacy within classrooms. Yet few of the narratives produced from these studies discuss the problems that frequently arise when participant observers enter the classroom. Recently, some researchers have begun to interrogate the extent to which ethnographic and teacher research methods are able to construct and disseminate knowledge in empowering ways (Anderson & Irvine, 1993; Bishop, 1993; Fine, 1994; Fleischer. 1994; McLaren, 1992). While ethnographic and teacher research methods have oftentimes been touted as being more democratic and nonhierarchical than quantitative methods—-which oftentimes erase individuals lived experiences with numbers and statistical formulas—-researchers are just beginning to probe the ways that ethnographic and teacher research models can also be silencing, unreflective, and oppressive. Those who have begun to question the ethics of conducting, writing about, and disseminating knowledge in education have coined the term “critical” research, a rather vague and loose term that proposes a position of reflexivity and self-critique for all research methods, not just ethnography or teacher research. Drawing upon theories of feminist consciousness-raising, liberatory praxis, and community-action research, theories of critical research aim to involve researchers and participants in a highly participatory framework for constructing knowledge, an inquiry that seeks to question, disrupt, or intervene in the conditions under study for some socially transformative end. While critical research methods are always contingent upon the context being studied, in general they are undergirded by principles of non-hierarchical relations, participatory collaboration, problem-posing, dialogic inquiry, and multiple and multi-voiced interpretations. In distinguishing between critical and traditional ethnographic processes, for instance, Peter McLaren says that critical ethnography asks questions such as “[u]nder what conditions and to what ends do we. as educational researchers, enter into relations of cooperation. mutuality, and reciprocity with those who we research?” (p. 78) and “what social effects do you want your evaluations and understandings to have?” (p. 83). In»the same vein, Michelle Fine suggests that critical researchers must move beyond notions of the etic/emic dichotomy of researcher positionality in order to “probe how we are in relation with the contexts we study and with our informants, understanding that we are all multiple in those relations” (p. 72). Researchers in composition and literacy stud¬ies who endorse critical research methods, then, aim to enact some sort of positive transformative change in keeping with the needs and interests of the participants with whom they work.

No more than Conjectures: Popper and the Ethics of Scientific Enterprise

Karl Popper dealt with both problems Yurevich (Integrative Psychological and Behavioral Science, 43(2), 2009, doi:10.1007/s12124-008-9082-7) deals: the crisis in Psychology and in the discourse about the nature of science. Although he failed to provide a complete response for both problems, his proposals can yet be fruitful to the reflection on these matters in the context of the present discussion. He offers some tentative answers to what could be considered a healthy epistemic activity, something Yurevich does not provide. More interestingly, some of the Popper proposals seem to fit, and in some extent correct, the quest for ""collaborative work"" proposed by Zittoun et al. (Integrative Psychological and Behavioral Science, 43(2), 2009, doi:10.1007/s12124-008-9082-7) as a way of transforming crisis in development.

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.

Il ruolo della Narrative in Medical Ethics, Medical Practice e Medical Education. Elementi di ricerca

La mia tesi di dottorato ha ad oggetto lo studio e l’analisi del ruolo della Narrative all’interno di tre ambiti, quali Medical Ethics, Clinical Practice e Medical Education. La tesi è strutturata in 4 capitoli: i primi tre vanno a comporre la parte teorica mentre nel quarto capitolo viene riportata una ricerca sul campo da me svolta negli Stati Uniti. Nel primo capitolo, analizzo il ruolo della narrative all’interno della Medical Ethics specificando che cosa si intenda con etica narrativa, quali sono le motivazione alla base del suo sviluppo e chi sono i suoi principali esponenti. In questo capitolo, inoltre, esamino i problemi che l’etica narrativa solleva suggerendo un nuovo modo in cui essa si integra alla riflessione bioetica. Il secondo capitolo è dedicato al contributo della narrative nella Medical Practice investigando sia le modalità attraverso le quali il paziente può avvalersi della narrazione per analizzare la sua esperienza di malattia sia la cosiddetta Medicina Narrativa. Il terzo capitolo è dedicato all'analisi delle Medical Humanities, ossia di quelle discipline che all’interno della Medical Education si stanno rivelando strumenti efficaci per una formazione più equilibrata e completa dei professionisti della salute. Il quarto capitolo, invece, è dedicato alla descrizione di una ricerca svolta presso l’University of California – Irvine . Durante questa esperienza ho frequentato i corsi del Program in Medical Humanities and Arts diretto dalla Prof.ssa J. Shapiro, (programma in vigore da 13 anni e implementato allo scopo di migliorare alcune competenze nei futuri medici quali: l'empatia, l’altruismo, la compassione e la predisposizione alla cura verso i pazienti, oltre che per affinare le comunicazione clinica e la capacità di osservazione) e intervistato gli studenti che hanno preso parte a queste lezioni.