106 resultados para Human Research Ethics Committee
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Pós-graduação em Enfermagem - FMB
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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.
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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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This paper presents an assessment with simulated activities with the aim of analyzing the perception of ease/difficulty of the use of faucets (taps) handles by 180 Brazilian adults. Five different handles faucets were activated for subsequent collection of perceptual data. The procedures were based on main recommendations for biomedical ethics and human research. The results indicate that handles with levers are significantly (p <= 0.05) easier to use. The most difficult are characterized by not having support points for the rotation (levers) or more points of pressure concentration in the hand.
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OBJECTIVE: To describe the clinical presentation of hydatidiform molar pregnancy in women under the age of 20 years. In addition, we sought to understand if this adolescent population manifests differences in clinical factors compared to an adult population that may affect outcome.STUDY DESIGN: We used a database from the New England Trophoblastic Disease Center to analyze clinical data from all women followed for molar pregnancy between 1970 and 2009 with complete follow-up information. This population was stratified by age and clinical parameters including presenting signs, molar histology and development of gestational trophoblastic neoplasia (GTN). Univariable and multivariable logistic regression was employed to discern clinical factors that associated with adolescent age. The Partners Human Research Committee approved this study.RESULTS: We identified 1,494 women diagnosed with hydatidiform mole (HM), of which 220 (14.7%) were adolescents defined as age <20 years. The most common presenting clinical signs were vaginal bleeding and an enlarged uterus compared to dates. Median gestational age at diagnosis was 13.4 weeks, not different from that in the adult population. Similarly, no difference in presenting human chorionic gonadotropin was observed between the adult and adolescent populations. Adolescents presented with a significant overrepresentation of complete mole (86% vs. 75%, p < 0.001) compared to adults. Complete mole was associated with a heightened risk of developing GTN (OR 2.6, 95% CI 1.9-3.5), and despite the association of complete mole with young maternal age, univariable analysis showed no difference in the rate of GTN observed between adolescents and adults (24% vs. 30%, p = 0.08). Multivariable analysis controlling for molar histology demonstrated that adolescent age was associated with a decreased risk of GTN (hazard ratio 0.67, 95% CI 0.48 0.93).CONCLUSION: Adolescents account for a substantial proportion of the population with HM. They commonly present with vaginal bleeding. Though this population develops a complete mole with a higher frequency than adults, adolescents appear to have a significantly decreased risk of developing GTN. (J Reprod Med 2012; 57:225-230)
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This study investigated the effect of low-level laser therapy (LLLT) on the masticatory performance (MP), pressure pain threshold (PPT), and pain intensity in patients with myofascial pain. Twenty-one subjects, with myofascial pain according to Research Diagnostic Criteria/temporomandibular dysfunction, were divided into laser group (n = 12) and placebo group (n = 9) to receive laser therapy (active or placebo) two times per week for 4 weeks. The measured variables were: (1) MP by analysis of the geometric mean diameter (GMD) of the chewed particles using Optocal test material, (2) PPT by a pressure algometer, and (3) pain intensity by the visual analog scale (VAS). Measurements of MP and PPT were obtained at three time points: baseline, at the end of treatment with low-level laser and 30 days after (follow-up). VAS was measured at the same times as above and weekly throughout the laser therapy. The Friedman test was used at a significance level of 5 % for data analysis. The study was approved by the Ethics Committee of the Federal University of Sergipe (CAAE: 0025.0.107.000-10). A reduction in the GMD of crushed particles (p < 0.01) and an increase in PPT (p < 0.05) were seen only in the laser group when comparing the baseline and end-of-treatment values. Both groups showed a decrease in pain intensity at the end of treatment. LLLT promoted an improvement in MP and PPT of the masticatory muscles. © 2012 Springer-Verlag London.
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Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB
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Pós-graduação em Enfermagem (mestrado profissional) - FMB
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Pós-graduação em Psicologia do Desenvolvimento e Aprendizagem - FC
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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Pós-graduação em Ciências da Motricidade - IBRC