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.

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.

Aspects correlates with Scandinavian Stroke Scale for predicting early neurological impairment

Objective: To investigate the correlation between the Alberta Program Early CT Score (ASPECTS) and the Scandinavian Stroke Scale (SSS) for the evaluation of neurological impairment in patients with acute stroke. Method: 59 patients with a first acute ischemic stroke were evaluated. The ASPECTS were evaluated by 2 neurologists at admission and by another neurologist after 48 hours. The NIHSS and SSS was applied to determinate stroke severity. Correlations and agreements were analysed statistically by Spearman and Kappa tests. Results: ASPECTS was correlated with National Institute of Health Stroke Scale (NIHSS) at admission (r = -0.52; p < 0.001) and SSS (r = 0.50; p < 0.001). The ASPECTS and SSS items were most correlated with arm (r = 0.52; p < 0.001) and hand (r = 0.49; p < 0.001) motor power, and speech (r = 0.51; p < 0.001). The SSS of 25.5 shows sensitivity (68%) and specificity (72%) when associated with ASPECTS <= 7. Conclusion: The SSS can predict worst neurological impairment when associated with lower values of ASPECTS.

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.

Validation of the Scandinavian stroke scale in a multicultural population in Brazil

Background: The objective of this study was to evaluate the consistency, coherence, and interobserver reliability of the Portuguese version of the Scandinavian Stroke Scale (SSS) in a multicultural population of stroke. Methods: The SSS was translated, culturally adapted, and applied by two independent investigators. This was a randomized transverse study involving two groups: group 1 included 20 patients in the acute phase and group 2 included 20 patients in the subacute phase after stroke was confirmed by computed tomography with a pre-stroke modified Rankin Scale score of 0. Each patient also underwent National Institutes of Health Stroke Scale (NIHSS) evaluation at hospital entry and at the time of the SSS evaluation for correlation with our current standard hospital practice. Consistency and coherence were analyzed by Cronbach’s α and interobserver reliability by ĸ. Results: Forty patients were evaluated with 0.88 consistency and coherence in both stroke phases. Mean interobserver ĸ was 0.76, with reliability considered excellent and good for most scale items, and moderate for only the facial palsy item. Conclusion: The SSS is adequate and validated to study post-stroke patients in a multicultural Brazilian population and in the Portuguese language.

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."

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.