106 resultados para Human Research Ethics Committee


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Animal models are an important tool in scientific research. It is known that this practice must be based on bioethical principles in order to impose limits about pain and suffering, or for inspecting proceedings and research site. This study has as aim to evaluate and present current legislation ruling animal research in Brazil, comparing it with other countries, as well as fostering bioethical reflection about this issue. For this, we present current Brazilian legislation and we have carried out international literature review and discussion. The articles were searched in PubMed data base, using the key words "bioethics" and "animal welfare". Nineteen articles from 1997 to 2013 were included. It was concluded the evident contribution of animal research for scientific research in several fields. It is morally relevant for humans, as rational beings, to secure humane treatment to animals contributing to research. The safest way to follow this path is establishing clear norms and studies well designed, involving society for assigning ethical norms. Thus, animal welfare would be guarantee.

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Pós-graduação em Enfermagem - FMB

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Introduction: The frequency of surgical procedures has increased steadily in recent decades, including the myocardial revascularization.Objectives: To demonstrate the importance of physiotherapy in the preoperative period of cardiac surgery in relation to the reduction of hospital stay, changes in lung volumes and respiratory muscle strength.Methods: We conducted a prospective study with patients undergoing myocardial revascularization, the Hospital das Clinicas da Universidade Estadual Paulista (UNESP)/Botucatu - SP. We evaluated 70 patients of both genders, aged between 40 and 75 years, subdivided into two groups: group I - 35 patients of both genders, who received a written protocol guidance, breathing exercises and respiratory muscle training in the preoperative period and group II - 35 patients of both genders, who received only orientation of the ward on the day of surgery. This study was approved by the Ethics Committee of UNESP /Botucatu - SP.Results: Maximal inspiratory pressure in third postoperative day and fifth postoperative day and significant difference between groups, being better for the intervention group. Expiratory pressure was significant in fifth postoperative day in the intervention group compared to controls. The difference of length of hospital stay in the postoperative was found between the groups with shorter hospital stay in the group receiving preoperative therapy.Conclusion: Physical therapy plays an important role in the preoperative period, so that individuals in the intervention group more readily restored the parameters evaluated before surgery, in addition, there was a decrease in the time of the postoperative hospital stay. Thus, it is thought the cost-effectiveness of a program of preoperative physiotherapy.

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Pós-graduação em Enfermagem (mestrado profissional) - FMB

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Background and Aims Bone metabolism involves understanding many factors, especially during puberty, when bone turnover is significant and the bone mass peak must be achieved as a protective factor of future bone health. The objective was to evaluate the behavior of formation and resorption bone biomarkers (BB) in function of biological maturation in female adolescents.Methods Evaluation of formation and resorption BB, osteocalcin (OC), bone alkaline phosphatase (BAP) and carboxyterminal telopeptide (S-CTx) by correlating them with bone mineralization, bone age and pubertal development in healthy female adolescents. Seventy-two volunteers were subdivided into groups according to chronological age/bone age (BA): 10 11 years (n=12), 12 13 years (n=16), 14 15 years (n=15) and 16 19 years (n=29). The following were evaluated: weight (kg), height (m), BMI (kg/m2), calcium intake (3-day 24h food recalls (mg/day), puberty events (Tanner stages), serum OC (ng/mL), BAP (U/L), S-CTx (ng/mL) and bone mineral density (BMD) as calculated by DXA (g/cm2) in the spine (L1-L4), proximal femur and whole body. The project was approved by the UNESP Ethics Committee.Results BB showed similar behaviors, with higher mean values for 10 12 years and when adolescents were in the B2-B3 Pubertal Maturation Stage (B2: BAP=110.16 U/L, OC=33.81ng/mL, S-CTx=1.66 ng/mL and B3: BAP=136.50 U/L, OC=39.15ng/mL and S-CTx=1.88 ng/mL; p<0.001). Mean BB values decreased with advancing BA and pubertal maturity.Conclusions BB values showed parallelism with peak height velocity and significant negative correlation with BMD in the different evaluated sites, with chronological and BA ; higher BMD values correlated with lower bone biomarker values.

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In Brazil, research involving human beings must obey to ethical norms foresaw by the 196/96 National Health Council Resolution of the Ministry of Health. This paper gives account of a knowledge evaluation about some concepts and rules established by the resolution by Dental post degree students. It is concluded that in spite of the spreading and importance of the resolution most students do not know about it. In the same situation are those who work in research.

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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.

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OBJETIVO: Estudar as normas relativas à ética da pesquisa em seres humanos contidas nas Instruções aos Autores de revistas científicas brasileiras. MATERIAL E MÉTODOS: As Instruções aos Autores de 139 revistas científicas brasileiras das áreas de medicina, biomedicina, enfermagem, odontologia e ciências gerais foram analisadas com relação às suas recomendações sobre os aspectos éticos. RESULTADOS: Das 139 revistas estudadas, 110 (79,1%) não fazem referências aos aspectos éticos; 17 (12,2%) exigem aprovação prévia pela Comissão de Ética; três (2,1%) fazem referência à Declaração de Helsinque; uma (0,7%) recomenda adotar o consentimento esclarecido; cinco (3,5%) seguem orientações dos requisitos uniformes para manuscritos submetidos a revistas biomédicas e três (2,1%) seguem princípios, normas e padrões éticos não especificados. Nas 29 revistas que fazem referências à ética, as exigências são solicitadas sob as seguintes formas: 15 (51,7%) exigem a inclusão da informação no texto do artigo; duas (6,8%) pedem carta assinada pelos autores; uma (3,4%) solicita cópia da autorização da Comissão de Ética; uma (3,4%) afirma supor que o autor cumpriu as exigências e dez (34,4%) não fazem qualquer referência específica. CONCLUSÕES: Os resultados do estudo indicam que na maioria das revistas científicas brasileiras há pouca preocupação em relação aos aspectos éticos da pesquisa em seres humanos, contidas nas Instruções aos Autores. Nas revistas que fazem referência aos aspectos éticos, as exigências são muito variáveis.

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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OBJETIVO: Traçar o perfil das publicações científicas de fase I e procurar saber se a publicação oferece dados da fase pré-clínica com ênfase nos aspectos bioéticos. MÉTODOS: Foram analisados 61 artigos científicos publicados no ano de 2007, que relatam pesquisas envolvendo seres humanos com novos fármacos, medicamentos ou vacinas em fase I. Foi elaborado um roteiro para coleta de dados, com o qual fosse possível analisar e avaliar os artigos científicos. O roteiro contempla itens referentes à fase pré-clínica (associados à fase clínica) e itens referentes às características da amostra. RESULTADOS: Nos artigos analisados, a maioria das pesquisas foi realizada nos EUA. Devido ao grande número de publicações destinadas às doenças oncológicas a maioria delas foi realizada com voluntários doentes. Quanto às informações sobre a fase pré-clínica presente nas publicações de fase I observamos que são pobres ou inexistentes. Mesmo que os autores julguem a pesquisa fase I como promissora e sugiram estudos futuros de fase II, ao leitor não é possível este mesmo julgamento pela escassez de informações da fase pré-clínica. CONCLUSÃO: O perfil das publicações levanta dados que merecem reflexão e análise para melhor avaliação do que está ocorrendo com as publicações de fase I.

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This paper reports the ongoing project (since 2002) of developing a wordnet for Brazilian Portuguese (Wordnet.Br) from scratch. In particular, it describes the process of constructing the Wordnet.Br core database, which has 44,000 words organized in 18,500 synsets Accordingly, it briefly sketches the project overall methodology, its lexical resourses, the synset compilation process, and the Wordnet.Br editor, a GUI (graphical user interface) which aids the linguist in the compilation and maintenance of the Wordnet.Br. It concludes with the planned further work.

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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.