917 resultados para Human Research Ethics Committee
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The present study aims to analyze the nurse s work process at Family Health Strategy, considering its basic elements and dynamic, and searching to identify aspects that may constitute strengths and weaknesses in its development. This is an analytical case study, with qualitative approach and theoretical-conceptual mark grounded in Dialectic Hermeneutics. Empirical research fields were the Family Health Units of Natal, RN, Brazil. The subjects are nurses working in this Strategy. Data collection was conducted through semi-structured individual interviews combined with field observation. The research was initiated after approval by the Ethics Committee of Universidade Federal do Rio Grande do Norte, according to the guidelines and rules for research involving humans (Resolution 466/12), ensuring proper ethical precepts. The project was approved by register number 398.929, CAAE 19588813.7.0000.5537. From the 9 interviewed nurses, 8 were female and 1 male, average age of 52 years, average graduation time of 27 years and average time they stayed at the same Family Health territory of 7 years. It was found that it is up to the professional nurse in the Family Health care the important role of taking care of human beings in their life, family and community contexts, producing conditions to meet their needs through therapeutic act in health, using for such purpose both materials and immaterial instruments. It was possible to relate aspects that characterize strengths and weaknesses in the work process of nurses in the ESF, according to the speech of the interviewed workers, including the meanings and contradictions. Among the potentialities observed, it was possible to highlight the wide role of the nurse at Family Health; the perception of nurses about teamwork; the relative autonomy of nurses; the commitment of professionals to work; Humanization as a technology; the presence of other agents at work, such as directors and officers at the primary health units; the professional s experience time and contract type in the case studied. As weaknesses in the work process of nurses at Family Health Strategy, were highlighted the limited skills of the workforce; the difficulty in 10 identifying specific limits of the work of nurses in this scenario; the disturbances that occur in the process, the existing gaps in multiprofessional teams; Structural deficits of the units in the studied case, the low coverage of the Family Health in the county, and the political vulnerability of the work conditions. It is considered necessary to understand the dilemmas experienced in everyday life of nurses at Family Health Strategy as part of multiprofessional teams, facing actual achievement of changes in work processes necessary for the reorientation of health care in Brazil. In accordance, it is necessary to promote proper working conditions and welfare of labor agents which are protagonists the work at the United Health System
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The aim of this study was to determine the prevalence of enamel white spots and the quality of oral hygiene in children up to 36 months old, in municipalities with different fluoride levels in the water supply, analyzing the contribution of several variables. After approval of the Ethics Committee, the parents signed an informed consent form and were interviewed about their educational level, economic classification of the family, nursing habits, use of toothpaste, access to dental service and other information. The children were clinically examined using the same codes and criteria established by the WHO (World Health Organization) and ADA (American Dental Association). The data were processed and analyzed with the Epi-info software program, version 3.2, and Microsoft Excel. Fisher's exact test (p<0.05) was applied to assess the association among the variables. The enamel white spot prevalence was 30.8% and the age group, duration of the bedtime milk feeding habit, age of initial practice of oral hygiene and presence of caries lesions with cavitation were considered statistically significant with regard to enamel white spot prevalence (p < 0.05). No association was found between oral hygiene quality and the study variables. © 2009 Sociedade Brasileira de Pesquisa Odontológica.
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Background: Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted.Methods/design: This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution.Discussion: The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil. Clinical trials registration number: ClinicalTrials.gov: NCT00971165. © 2011 Fuchs et al; licensee BioMed Central Ltd.
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Pós-graduação em Desenvolvimento Humano e Tecnologias - IBRC
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Objective: To assess the attitudes and knowledge about hepatitis by scholars and dental practitioners from Recife and its metropolitan region. Method: The research protocol was submitted and approved by the Ethics and Human Research Committee of the Federal University of Pernambuco. There were included 230 undergraduate students in dentistry and 104 dentists who exercise their professional activity in Recife and its Metropolitan Region. They signed a consent form and answered a questionnaire, the evaluative instrument, with objective questions about biosafety, transmission of hepatitis and sexually transmitted diseases. Results: About the types of hepatitis 133 (57.8%) students and 61 (58.7%) professionals claimed to know the types A, B and C. Concerning transmission 31 (13.5%) students and 25 (24.0%) professionals said that the main route of transmission were sexual and bloodstream respectively. Relating to imunization 221 (96.1%) students and 99 (95.2%) professionals reported that have been vaccinated against hepatitis B, however, only 126 (54.8%) students and 55 (52.9%) professionals have followed the immunization’s schema. Regarding the cleaning of the office equipment, 18.7% of the students replied that they do not know who does it. 56.7% of professionals said that it was performed with alcohol 70 ° GL.Conclusions: The findings indicate that there is a concern for biosafety but the knowledge about the forms of hepatitis transmission and biosecurity measures need to be better settled.
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Pós-graduação em Desenvolvimento Humano e Tecnologias - IBRC
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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.
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Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors' groups, respectively. 54 patients answered the questionnaire through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Conclusions Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil.
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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.
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Modification of proteins by reactive ethanol metabolites has been known for some time to occur in the liver, the main site of ethanol metabolism. In more recent studies of laboratory animals, similar modifications have been detected in organs with lesser ability to metabolize ethanol, such as skeletal and cardiac muscle and brain. Such modification may alter protein function or form a neoantigen, making it a target for immune attack. We now report an analysis of protein modification derived from ethanol metabolites in human brain tissue by ELISA using adduct-specific antibodies. We obtained autopsy cerebellum samples from 10 alcoholic cerebellar degeneration cases and 10 matched controls under informed written consent from the next of kin and clearance from the UQ Human Ethics Committee. Elevated levels of protein modifications derived from acetaldehyde (unreduced-acetaldehyde and acetaldehyde-advanced glycation end-product adducts), from malondialdehyde (malondialdehyde adducts) and from combined adducts (malondialdehydeacetaldehyde (MAA) adducts) were detected in alcoholic cerebellar degeneration samples when compared to controls. Other adduct types found in liver samples, such as reduced-acetaldehyde and those derived from hydroxyethyl radicals, were not detected in brain samples. This may reflect the different routes of ethanol metabolism in the two tissues. This is the first report of elevated protein modification in alcoholic cerebellar degeneration, and suggests that such modification may play a role in the pathogenesis of brain injury. Supported by NIAAA under grant NIH AA12404 and the NHMRC (Australia) under grant #981723.
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Este estudo apresenta uma relação entre o trabalho agrícola familiar e a saúde humana e ambiental em um cenário insular com características rurais, tendo-se como objetivo geral, analisar a sustentabilidade da relação socioambiental do trabalho de agricultores moradores da Ilha dos Marinheiros. Os objetivos específicos foram: Caracterizar a sustentabilidade do trabalho agrícola familiar na Ilha dos Marinheiros; Identificar como os trabalhadores agricultores da Ilha dos Marinheiros significam a sua saúde e atuam para mantê-la; Compreender como os trabalhadores agricultores identificam os impactos positivos e negativos do trabalho agrícola familiar desencadeados no ambiente e a conservação da saúde ambiental. Trata-se de uma pesquisa exploratória, descritiva, transversal com desenho de método misto com estruturação [QUAL + quan]. Foi realizada na Ilha dos Marinheiros, Rio Grande, Brasil, com 129 trabalhadores agricultores entre março a outubro de 2013, utilizando-se entrevista com aplicação individual de um questionário semiestruturado, gravado, previamente elaborado e testado. Também foram utilizados dados secundários referentes à constituição geográfica, cultural e econômica da Ilha. A organização dos dados qualitativos ocorreu a partir da transcrição dos dados oriundos das entrevistas no Microsoft Word, seguido da Análise de Conteúdo por temas com auxílio do Software Nvivo10. Para ambos os processos de análise utilizou-se o apoio teórico na racionalidade cultural de Enrique Leff. A organização dos dados quantitativos se fez pela codificação dos dados e digitação no software Statistical Package for the Social Sciences, 21.0, seguido da análise estatística descritiva e Teste Qui-quadrado de Pearson, com o p-valor <0,05 como significância estatística. Foram asseguradas as exigências éticas e científicas preconizadas nas pesquisas com seres humanos, mediante Resolução 466/2012 e aprovação do macroprojeto pelo Comitê de Ética da Universidade Federal do Rio Grande sob parecer 026/2013. Teve-se 78 trabalhadores agricultores do sexo masculino com idade média de (55,33±14,27), e 51 do sexo feminino, com idade média de (54,68±11,08). Predominou a descendência portuguesa 106 (84,8%), a maioria 100 (77,52%) com ensino fundamental incompleto, média de 2,53 integrantes no domicílio e renda familiar média de (1.648,39±947,72) para uma média de 2,58 dependentes desta. Os participantes atuavam em média há 40,56 anos, por (8,51± 3,10) horas diárias de trabalho em suas propriedades com média de 12,49 hectares. A atividade que mais exerciam e que eram mais auxiliados foi colher os produtos agrícolas, predominando o sexo masculino nesta função. O desenvolvimento do trabalho era conduzido mais pelos homens e de forma diária 83 (64,34%), seguido dos filhos 33 (25,58%) também diariamente 24 (18,60%). Quanto à saúde humana, esta foi concebida como boa, regular e ruim, com ações que convergem à continuidade do exercício laboral e adesão aos serviços de saúde mínima anualmente. Já os impactos positivos do trabalho no ambiente incidiram na conservação do trabalho como uma riqueza, o que exige atenção quanto ao uso dos agrotóxicos frente aos impactos negativos desencadeados ao ambiente em uma perspectiva sustentável à vida humana e não humana. O estudo fornece subsídios 6 contributivos à prática argumentativa do Enfermeiro à saúde ocupacional na agricultura familiar sob uma perspectiva sustentável ao ambiente.
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Universidade Estadual de Campinas . Faculdade de Educação Física
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Universidade Estadual de Campinas. Faculdade de Educação Física
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Background: Universities worldwide are seeking objective measures for the assessment of their faculties` research products to evaluate them and to attain prestige. Despite concerns, the impact factors (IF) of journals where faculties publish have been adopted. Research objective: The study aims to explore conditions created within five countries as a result of policies requiring or not requiring faculty to publish in high IF journals, and the extent to which these facilitated or hindered the development of nursing science. Design: The design was a multiple case study of Brazil, Taiwan, Thailand (with IF policies, Group A), United Kingdom and the United States (no IF policies, Group B). Key informants from each country were identified to assist in subject recruitment. Methods: A questionnaire was developed for data collection. The study was approved by a human subject review committee. Five faculty members of senior rank from each country participated. All communication occurred electronically. Findings: Groups A and B countries differed on who used the policy and the purposes for which it was used. There were both similarities and differences across the five countries with respect to hurdles, scholar behaviour, publishing locally vs. internationally, views of their science, steps taken to internationalize their journals. Conclusions: In group A countries, Taiwan seemed most successful in developing its scholarship. Group B countries have continued their scientific progress without such policies. IF policies were not necessary motivators of scholarship; factors such as qualified nurse scientists, the resource base in the country, may be critical factors in supporting science development.
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Background: Blood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage. Methods: This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution. Discussion: The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe in a population-based perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil.