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Ethical Committee (ethical + committee)

Distribution by Scientific Domains

Medical Sciences	40%
Humanities and Social Sciences	40%

Selected Abstracts

Anti-gingivitis effect of a dentifrice containing bioactive glass (NovaMin®) particulate

JOURNAL OF CLINICAL PERIODONTOLOGY, Issue 2 2006
Bao Jun Tai
Abstract Background: The objective of this pilot clinical trial was to evaluate the anti-gingivitis and anti-plaque effects of a dentifrice containing bioactive glass (NovaMin®) compared with a placebo control dentifrice in a 6 weeks clinical study. Methods: The study design was a randomized, double-blinded, controlled clinical trial. One hundred volunteers took part in the study and were matched for plaque index (PLI), gingival bleeding index (GBI), age and gender. The protocol was reviewed and approved by the Ethical Committee of the University. The subjects received a supragingival prophylaxis to remove all plaque, calculus and extrinsic stain. Following the baseline examination, subjects were instructed to brush with their assigned dentifrice and toothbrush. The PLI and GBI were determined for the baseline and 6 weeks. The data were analysed using a repeated-measures anova conducted on the two dependent measures to compare the effect between the test and control group. Results: Ninety-five subjects finished the study. The results showed that the PLI (baseline=1.54, 6 weeks=1.29) and GBI (baseline=1.14, 6 weeks=0.47) were significantly reduced, respectively, over the 6 weeks period in the test group (p<0.001 for each measure). There was a 58.8% reduction in gingival bleeding and a 16.4% reduction in plaque growth. There was no difference of the PLI (baseline=1.60, 6 weeks=1.57) and GBI (baseline=1.18, 6-week=1.02) over the 6 week period in the control group. Conclusion: This study demonstrated that a dentifrice containing NovaMin® significantly improves oral health as measured by a reduction in gingival bleeding and reduction in supragingival plaque compared with a negative dentifrice over the 6 weeks study period. [source]

Age-related changes in the human thymus studied with scanning electron microscopy

MICROSCOPY RESEARCH AND TECHNIQUE, Issue 8 2008
Carlo Cavallotti
Abstract This investigation describes some morphological, age-related changes in different compartments and cells of the human thymus. Scanning electron microscopic observations were done on human thymus samples obtained from four young and eight elderly patients during thoracic surgery and/or diagnostic biopsy of the thymus, after receiving authorization from the Ethical Committee of our university. The morphological data were submitted to quantitative image analysis so as to obtain quantitative results. Subsequently, the related values were used for statistical analysis. Our findings demonstrate that (1) all thymus compartments (subcapsular spaces, cortical, medullar, thymus microenvironment) contain numerous thymocytes even after the thymus has aged. (2) In older humans, residual thymus lymphoid islets contain, in addition to fatty cells and/or fibrous cells, also the same types of resident and nonresident cells (permanent and moving cells) that are found in young and adult subjects. (3) Endothelial cells of thymus microvessels contain numerous gaps. These gaps are tight in young subjects and become loose with age. (4) Thymocytes, in older subjects, are always found near these loose endothelial gaps of thymus microvessels. (5) While thymus cortical microvessels are provided with pericytes and/or periarteriolar spaces, microvessels of the thymus medullar are free of such spaces. Our morphological and quantitative results lead us to consider the possibility that the thymus fraction of resident and permanent cells (including thymocytes and reticular epithelial cells) is larger in younger subjects compared with older ones. The endothelial loose gaps of thymus microvessels, in older subjects, can allow the bidirectional transit of thymocytes through the wall of the said microvessels. Microsc. Res. Tech., 2008. © 2008 Wiley-Liss, Inc. [source]

Extremely low frequency-modulated static magnetic fields to treat cancer: A pilot study on patients with advanced neoplasm to assess safety and acute toxicity

BIOELECTROMAGNETICS, Issue 8 2004
Flavio Ronchetto
Abstract Results of a toxicity pilot human study approved by the competent ethical Committee are reported. Eleven patients with heavily pre-treated advanced cancer were enrolled in a pilot study with different schedules of time exposure to static magnetic fields (MF), amplitude modulated by ELF. An area including the neck, thoracic and abdomen was MF exposed daily, 5 days/week for 4 weeks according to two different schedules: 20 min daily (4 patients) and 70 min daily (7 patients). ECOG performance status was 1 (2 patients), 2 (8 patients), 3 (1 patient). Toxicity was assessed according to WHO criteria. ECG, Chest X-ray, physical examination, blood cell count and complete blood chemistry were performed before and at the end of the treatment. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevation (grade 2 toxicity) in 1 patient and microscopic urinary abnormalities in 5 patients were the only negative effects observed. We conclude that MF can be safely administrated according to the MF exposure schedules. Bioelectromagnetics 25:563,571, 2004. © 2004 Wiley-Liss, Inc. [source]

HARMONIZING REGULATIONS FOR BIOMEDICAL RESEARCH: A CRITICAL ANALYSIS OF THE US AND VENEZUELAN SYSTEMS

DEVELOPING WORLD BIOETHICS, Issue 3 2008
DANNIE DI TILLIO-GONZALEZ
ABSTRACT This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze , as an example , the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. [source]

ETHICAL REVIEW ISSUES IN COLLABORATIVE RESEARCH BETWEEN US AND LOW , MIDDLE INCOME COUNTRY PARTNERS: A CASE EXAMPLE

BIOETHICS, Issue 8 2008
SCOTT MCINTOSH
ABSTRACT The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country. [source]