Electrophysical agents (EPA) are a fundamental element of therapy practice and are vital for the treatment of a variety of conditions. Many of these agents employ some form of electromagnetic fields (EMF), in which radiofrequency (RF) is a major component. The therapeutic effects of RF are mainly linked to their effects on pain relief and potential effects on tissue repair. Although RF across various frequency ranges has been in use, reviews have shown that the frequency ranges currently used in therapy practice have narrowed to within 30 kHz-30,000 kHz (30 MHz). The most commonly used and hence the most commonly researched are shortwave therapies (SWT) that operate at 27.12 MHz, which is presently used predominantly in its pulsed form (PSWT). In addition to SWT, devices employing significantly lower RF ranges have also been used widely despite their lack of evidence. Capacitive Resistive Monopolar Radiofrequency (CRMRF) that operates at 448 kHz is one such RF. This programme of research was designed to investigate the physiological and clinical efficacy of CRMRF delivered using the 'Indiba Activ 902' device. The project also evaluated the scope and evidence for RF-based EPAs in therapy, through a comprehensive review of literature. A total of 120 relevant clinical studies on either acute (30 studies) or chronic (90 studies) conditions were reviewed. Notable evidence was identified for chronic OA knee and acute postoperative pain and wound healing. Some evidence also exists for chronic low back pain and healing of chronic wounds. Only eight studies reported devices that employed RF outside the shortwave frequency band. In a randomised crossover laboratory study on asymptomatic adults, the effects of contrasting doses of CRMRF on skin temperature (SKT), skin blood flow (SBF), nerve conduction velocity (NCV), deep blood flow and the extensibility of tissues were examined against a placebo dose and a control condition with no treatment. The study further compared CRMRF results with that of PSWT. The results showed that high (moderately thermal) and low (sub/minimally thermal) doses of CRMRF significantly enhanced and sustained SKT (p < 0.001), while only the high dose meaningfully increased SBF (p < 0.001). High dose PSWT increased SKT marginally (p < 0.001) but did not sustain it. Further, the high and low dose CRMRF significantly enhanced blood flow volume at depth (p=0.003), while PSWT failed to show any significant impact. None of the treatments significantly affected deep blood flow velocity, tissue extensibility or NCV. These results were reproduced on a cohort of patients affected by OA knee in a randomised controlled trial (RCT), and the effects appeared more pronounced in the patients than in the asymptomatic people. More importantly, the RCT showed that a four-week high dose CRMRF treatment (eight sessions) produced statistically and clinically significant gains in pain and function associated with OA knee in the short to medium term (p < 0.001), which was also significantly more pronounced than the gains produced by a placebo, or standard care (p=0.001for pain; p=0.031 for function). The findings of this study were considered promising. It is therefore suggested that CRMRF-based treatment can potentially be used as an adjunct to current therapeutic methods to enhance the clinical outcomes. However, further studies are needed to substantiate this, and the current results will provide credible baseline data for future research.

Thesis (MTech (Biomedical Technology))--Cape Technikon, Cape Town, 2004 / The need for radiobiological research was bom from the discovery that high doses of radiation could cause cancer and other health effects. However, recent developments in molecular biology uncovered the effects of low doses of radiation on different biological systems and as a result new techniques have been developed to measure these effects. The aim of this study was thus to validate biomarkers of initial DNA strand breaks, micronucleus formation, and the different pt ;ases of apoptosis as biological indicators of low-dose radiation damage. Furthermore, the difference in response of blood cells to different qualities and doses of radiation was investigated by irradiating cells with low- and high-LET radiation simultaneously. Blood from one donor was irradiated with doses between 0 and 4 Gy gamma- and neutron radiation. The alkaline single-cell gel electrophoresis (comet) assay was performed on different cell preparations directly after irradiation for the detection of initial DNA strand breaks. Radiation-induced cytogenetic damage was investigated using the cytokinesis-blocked micronucleus assay while different features of apoptosis were investigated by measuring caspase activation, enzymatic DNA fragmentation, and cellular morphology. The comet assay was sensitive enough to detect DNA strand breaks above 0.25 Gy and showed that the Iymphocyte isolation process induced some endogenous damage in cells, detected by the formation of highly damaged cells and hedgehogs in isolated cell preparations only.

The purpose of this study was to determine the effects of rapid weight loss on wrestlers' efficiency incorporating competitive aspects of the sport into the research procedures. Six subjects were selected from the North Texas State University Wrestling Club. Eight cardiovascular and neuromuscular measurements were taken and recorded before treatment and following treatment. Astrand's bicycle ergometer test was utilized to obtain exhaustive, heart rates. Data were analyzed by a one-tailed t test at the .05 level. Conclusion of the investigation was that following 6.25 per cent rapid loss of body weight, over a period of one week, no loss of efficiency occurred among wrestlers under simulated competitive conditions.

Caffeine is the most widely consumed socially acceptable drug in the world and is commonly used for its ergogenic properties with demonstrated performance enhancing effects in endurance, power and strength based activities. Despite a wealth of evidence concluding a caffeine induced performance benefit, the direct effects of the drug on peripheral physiological processes have not been fully examined. Early works showed high dose caffeine has direct force potentiating effect on skeletal muscle, a notion that has only recently been confirmed by James et al. (2005) to also occur at a maximal human physiological concentration (70µM). The present research, using mouse muscle as a model for mammalian muscle in general, provides an in-depth assessment of the direct effect of physiological concentrations of caffeine on isolated skeletal muscle performance. This research uniquely: quantifies the dose response relationship; assesses the effects of caffeine on maximal and sub maximal muscle power output and fatigue; looks at the relationship between muscles with different fiber type compositions. As high concentrations of caffeine and taurine are a constituent of many energy drinks, the suggested interaction of these ingredients to further potentiate muscle mechanical performance was also assessed. The study further examines how mammalian muscle mechanical properties change over an age range of development to aged, and how this differs between muscles with predominantly different anatomical locations and functions. In light of this the age related direct effect of physiological concentrations of caffeine was assessed in order to examine whether the ergogenic benefit changed with age. The present results demonstrate a direct muscle performance enhancing effect of physiological concentrations of caffeine that is likely to promote greater benefit on long duration endurance based activities. Furthermore, the present study demonstrates that there is no direct effect of physiological concentrations of taurine and no further performance enhancing benefit when combined with caffeine. Finally this research uniquely highlights the muscle specific age related changes in mechanical performance and further indicates that the direct effect of caffeine changes with age.

Weight loss maintenance and emotional and physical problems were investigated in subjects on a protein-sparing modified fast. Four months following a weight reduction program using the protein-sparing modified fast, twenty of the forty-two subjects were contacted. Each was asked to complete a questionnaire related to emotional and physical effects of the diet and a diet history checksheet. Each subject was weighed to determine if weight loss had been maintained. Results of the questionnaire, diet history, and blood chemistry analysis indicate that for these subjects, the modified fast may be safe and effective in reducing and maintaining weight loss over a short time period under close supervision by a physician.

INTRODUÇÃO: O transplante de pulmão é parte fundamental no tratamento das doenças terminais do pulmão, constituindo uma modalidade terapêutica eficaz para pacientes com doença pulmonar incapacitante, progressiva e em estágio final. No entanto, as drogas imunossupressoras usadas para evitar a rejeição do enxerto podem causar efeitos colaterais em diversos tecidos. O sistema mucociliar, presente nas vias aéreas, é um dos principais mecanismos de defesa do trato respiratório e pode ser alterado por ação das drogas imunossupressoras. Desta forma, o objetivo deste estudo foi avaliar o sistema mucociliar traqueobrônquico de ratos submetidos a dois esquemas de terapia tríplice imunossupressora. MÉTODOS: Foram utilizados 90 ratos machos Wistar distribuídos em 3 grupos conforme o tratamento: controle (C) = solução salina; terapia 1 (TI) = tacrolimus + micofenolato de mofetil + prednisona; terapia 2 (TII) = ciclosporina + azatioprina + prednisona. Após o período de tratamento (7, 15 ou 30 dias), os animais foram sacrificados e realizadas as seguintes medidas: transportabilidade do muco (TM), frequência de batimento ciliar (FBC), quantificação de muco neutro e ácido, velocidade de transporte mucociliar (VTMC), e contagem total e diferencial de células no lavado broncoalveolar (LBA). RESULTADOS: A TM não foi afetada pelas terapias em nenhum dos tempos estudados. Ambas as terapias causaram significativa redução da FBC dos animais tratados por 7 e 15 dias. A produção de muco neutro foi menor nos animais tratados com a TI por 7, 15 e 30 dias. Porém, com a TII, essa redução ocorreu apenas aos 7 dias. Por outro lado, a quantidade de muco ácido foi significativamente maior em todos os animais tratados com as duas terapias. Todos os animais tratados com as terapias imunossupressoras apresentaram redução da VTMC nos três tempos. Houve aumento do número total de células e de macrófagos e neutrófilos no grupo TI em 7 dias. CONCLUSÕES: Ambas as terapias imunossupressoras foram prejudiciais ao transporte mucociliar das vias aéreas de ratos, tanto pela redução da FBC e da VTMC, quanto pela maior produção de muco ácido e menor produção de muco neutro. A TI foi mais prejudicial ao sistema mucociliar em comparação à TII / INTRODUCTION: Lung transplantation is an essential part in the treatment of terminal lung diseases, providing an effective therapeutic modality for patients with disabling, progressive and final stage lung disease. However, the immunosuppressant drugs used to prevent graft rejection may cause side effects in several tissues. The mucociliary system, present in the airways, is a major defense mechanism of the respiratory tract and can be changed by action of immunosuppressive drugs. Thus, the aim of this study was to evaluate the tracheobronchial mucociliary system of rats submitted to two triple immunosuppressive therapy regimens. METHODS: We used 90 male Wistar rats divided into 3 groups according to treatment: control (C) = saline solution; therapy 1 (TI) = tacrolimus + mycophenolate mofetil + prednisone therapy; therapy 2 (TII) = cyclosporine + azathioprine + prednisone. After the period of treatment (7, 15, or 30 days), the animals were sacrificed and the following measures taken: mucus transportability (MT), ciliary beating frequency (CBF), quantification of neutral and acid mucus, mucociliary transport velocity (MCTV), and total and differential counting of cells in bronchoalveolar lavage (BAL). RESULTS: MT was not affected by treatments in any of the periods studied. Both therapies have caused significant reduction of CBF of animals treated for 7 and 15 days. The neutral mucus production was lower in animals treated with TI for 7, 15 and 30 days. But with TII, this reduction occurred only at 7 days. Moreover, the amount of acid mucus was significantly higher in all animals treated with both therapies. All animals treated with immunosuppressive therapies had reduced MCTV at the three times. There was an increase of total cells and macrophages and neutrophils in the TI group in 7 days. CONCLUSIONS: Both immunosuppressive therapies were harmful to the mucociliary clearance of the airways of rats, either by reducing the CBF and MCTV, as by the increased production of acid mucus and decreased production of neutral mucus. TI was more harmful to the mucociliary system in comparison to TII

A avaliação do risco é um processo sistemático pelo qual a possibilidade de dano, a exposição e o próprio risco são identificados e quantificados. A consideração, de que a participação em um estudo é de risco, fundamenta-se no princípio da precaução, que é a garantia da existência de medidas de proteção contra riscos potenciais. De acordo com a gravidade dos eventos adversos, e de sua probabilidade de ocorrência, determina-se se o risco previsto é negligenciável, tolerável ou intolerável. Portanto, a caracterização do risco representa um importante elo entre os dados científicos obtidos nos diferentes estudos e as tomadas de decisões, ao monitoramento e à comunicação do risco. O objetivo deste estudo é avaliar os riscos previstos de eventos adversos gastrintestinais em projetos de pesquisa em seres humanos na área farmacológica, realizados no Hospital de Clínicas de Porto Alegre (HCPA), através da análise do Termo de Consentimento Livre e Esclarecido (TCLE), do manual do pesquisador e do projeto. Realizou-se um estudo transversal, com unidade de observação nos eventos adversos (EAs) gastrintestinais, através do levantamento de risco de projetos de pesquisa farmacológica, com patrocínio privado, submetidos e aprovados pelo Comitê de Ética em Pesquisa (CEP) do HCPA, no ano de 2004. De 58 projetos analisados, identificou-se 9734 referências de riscos de EAs gerais, sendo que 1463 (15,0%) eram gastrintestinais. Destas, 181 (12,4%) aparecem somente no TCLE, desprovida de embasamento teórico; já 1047 (71,6%) estão descritas nos documentos não disponibilizados ao participante, informação não compartilhada, tendo embasamento teórico; e apenas 235 referências de riscos, que representam 16,0% dos riscos gastrintestinais totais, como informação compartilhada e documentada, para o participante e pesquisador, com embasamento teórico. Essas 1463 referências de riscos de EAs gastrintestinais foram padronizadas, fazendo-se uso do Código Internacional de Doenças, décima revisão (CID 10), obtendo-se 170 tipos diferentes de riscos. Os riscos com maior repetição de referência nos projetos foram: náusea e vômitos 14,1%; alteração do hábito intestinal 6,5%; aumento dos níveis de transaminases e da desidrogenase lática 5,7%; outras dores abdominais e as não especificadas 4,9%. Quanto à gravidade, dos 170 tipos de riscos, obteve-se 65 (38,2%) graves, 52 (30,6%) moderados, 30 (17,6%) leves e 23 (13,5%) múltipla classificação. Todos os documentos relativos ao projeto de pesquisa deveriam conter a descrição e quantificação dos riscos importantes, seja pela alta gravidade ou freqüência associada. No TCLE, parte dos riscos estavam descritos, porém desprovidos de uma quantificação e caracterização adequadas. O manual apresentava as informações sobre os riscos, mas de forma dispersa ao longo do documento, levando a uma dificuldade de utilização desses dados nas intervenções propostas. Nos projetos analisados, observa-se a falta de homogeneidade e padronização para se expressar adequadamente os riscos já ocorridos em estudos prévios. Isso demonstra a importância da leitura atenta de toda documentação encaminhada para avaliação pelo CEP, visando a proteção ativa dos sujeitos da pesquisa. / Risk evaluation is a systematic process whereby damage possibility, exposure and the risk itself are identified and quantified. The consideration that the participation in a study is risky is founded on the precaution principle, i.e., the warranty of existing protection measures against potential risks. According to the severity of the adverse events and of its occurrence probability, one determines if the foreseen risk is negligible, tolerable or intolerable. Therefore, risk characterization represents an important link between the scientific data obtained from the different studies and the decision-makings, to monitoring and to risk communication. The objective of this study is evaluating the foreseen risks of gastrointestinal adverse events (AEs) in research projects with human beings in the pharmacological field carried out at Hospital de Clínicas de Porto Alegre – HCPA by means of the Informed Consent Form – ICF, of the researcher brochure and of the Research Protocol. A transversal study was carried out with an observation unit in the gastrointestinal AEs, through the survey of risk of projects of clinical trial with private sponsorship submitted to and approved by the Research Ethics Committee – REC of the HCPA in 2004. Out of 58 analyzed protocols were identified 9734 risk references of general AEs, being 1463 (15.0%) gastrointestinal. Out of these, 181 (12.4%) appear on the ICF only, deprived of theoretical basis; while 1047 (71.6%) are described in documents non available for the participant, non-shared information, with theoretical basis; only 235 risk references that represent 16.0% of the total gastrointestinal risk, as shared and documented information for the participant and the researcher, having theoretical basis. These 1463 risk references of gastrointestinal AEs were standardized by making use of the International Code of Diseases – 10th Revision –, and 170 different risk types were obtained. The risks with more reference repetition in the protocols were: nausea and vomit 14.1%; alteration of intestinal habit 6.5%; increase of the levels of transaminases and of lactic dehydrogenase 5.7%; abdominal pain 4.9%. As to the severity, out of the 170 risk types, 65 (38.2%) are severe, 52 (30.6%) moderate, 30 (17.6%) soft and 23 (13.5%) of multiple classification. All of the documents regarding the research protocol should contain the description and quantification of the important risks either due to high severity or to frequency. In the ICF, some of the risks were described however deprived of an adequate quantification and characterization. The brochure presented the information about the risks, however in a disperse way over the document leading to a difficult utilization of these data in the proposed interventions. In the analyzed protocols was observed lack of homogeneity and standardization to adequately express the risks that had already occured in previous studies. This observation demonstrates the importance of careful reading of all of the documentation addressed for evaluation by the REC aiming at the active protection of the research subjects.

The South African fresh fruit industry is a significant exporter, accounting for approximately 45% of the country’s agricultural exports. Of the total exported fruit in the 2005/06 season, 60% was subtropical fruit. However, certain physiological rind disorders such as mango lenticel damage and citrus rind pitting are frequently observed, reducing the commercial value of the fruit. This thesis deals with the epidemiology of these rind physiological disorders, in an attempt to obtain basic information that could serve as a guideline to predict and manage the fruit susceptibility to these disorders. The study further investigated the relative effects that certain pre-harvest factors have on the postharvest development of these disorders. Factors of particular interest were harvest maturity, climate and the mineral content of the fruit. Rind pitting is a physiological disorder of citrus that develops during storage. A study was conducted to investigate the relative effects that certain pre-harvest factors have on the post-harvest development of superficial rind pitting in ‘Benny Valencia’ oranges. Factors of particular interest were harvest maturity, climate and the mineral content of the fruit. In addition, trees were treated with two different formulations of nitrogen viz. limestone ammonium nitrate (LAN) and a slow release nitrogen fertilizer (Horticote®), during March 2006. The fruit were then sampled on a two-weekly basis over a period of three months. On each sampling date a set of quality related readings, such as juice sugar and titratable acid concentration were taken, after which the mineral concentration of the exocarp and mesocarp was measured. Fruit were also stored under export simulation conditions. The results indicate that fruit from trees that received additional N were more susceptible to rind pitting than those from control trees. Of the two N applications, fruit from trees that received slow release N were more susceptible to rind pitting than fruit from trees that received the LAN treatment. Another important observation made was that the nitrogen concentration of oranges from trees that received extra nitrogen fertilizer was lower than that from the controls. In addition, experimental fruit were smaller than control fruit. Fruit from trees that received the slow release nitrogen treatment were smallest. A sink/source hypothesis aimed at explaining this phenomenon has been formulated and is currently being investigated. A number of control mechanisms are also being explored. Mango lenticel damage is a serious defect that occurs on the rind of the fruit. This condition causes fruit to attain a speckled appearance and become unattractive to the buyer. Each season, the disorder reduces the packout of fresh fruit by about 16%. Several preharvest factors play a critical role in the postharvest development of lenticel damage. Preliminary studies have shown that the incidence of lenticel damage has some relationship to fruit moisture and fruit nutrient concentration, depending on which of these factors first achieve a critical threshold. A study was conducted to develop appropriate skin moisture content parameters to predict lenticel damage potential before harvest. The study further aimed to provide certain biological markers regarding appropriate nitrogen fertilization practices to reduce lenticel damage. To do this, two trials were conducted approximately a month before harvest. Firstly, a plastic ground cover to restrict water supply was laid under ‘Tommy Atkins’ trees at Numbi Estates in the Hazyview area of the Mpumalanga province, South Africa. Secondly, additional nitrogen was applied as three different formulations, viz. limestone ammonium nitrate (LAN), potassium nitrate (KNO3), and a slow release nitrogen fertilizer under trade name Horticote®, to two ‘Tommy Atkins’ and two ‘Keitt’ orchards at Bavaria Estates in the Hoedspruit area of the Limpopo province, South Africa. Fruit samples were harvested, packed and stored at different intervals after rain during January 2006. With regard to lenticel damage on ’Tommy Atkins’ fruit from Numbi, there was no significant difference between the control and plastic cover treatments. However, when compared to fruit from other localities, the Numbi fruit had the highest incidence of lenticel damage, followed by the conventional orchard at Bavaria. The Numbi fruit, which had the highest incidence of lenticel damage, also had the highest pulp and skin nitrogen concentration. Of the four treatments at Bavaria, the LAN treatment had the highest incidence of lenticel damage, but the pulp and skin nitrogen concentrations of this treatment were comparable with the other treatments. The organic fruit had significantly lower lenticel damage incidence and also had the lowest pulp and rind nitrogen concentrations. Similarly, ‘Keitt’ results showed that the intensity of lenticel damage was significantly higher in the orchard that received additional nitrogen in the form of LAN. From the results it was, however, not possible to formulate nitrogen-lenticel damage correlations. The study failed to prove the case for a direct relationship between the disorder and with nitrogen, as there were no significant or consistent correlations with nitrogen content. An interesting relationship was nevertheless observed between lenticel damage and the time of harvest before and after rainfall. The results indicated that both ‘Tommy Atkins’ and ‘Keitt’ fruit become more susceptible to lenticel damage when harvested a day after rainfall and this gradually reduces afterwards. The effect of rainfall in this regard and a sink-source hypothesis arising from these observations are also discussed. / Thesis (M.Sc.)-University of KwaZulu-Natal, Pietermaritzburg, 2008.

Orientador: João Domingos Rodrigues / Banca: Elizabeth Orika Ono / Banca Rumy Goto / Banca: Juliano Tadeu Vilela de Resende / Banca: Rerison Catarino da Hora / Resumo: A Lippia alba (Mill.) N.E.Br. ex Britt & Wilson é uma importante espécie medicinal de uso popular conhecida como erva cidreira brasileira. Trata-se de um arbusto, cujas folhas frescas ou secas e inflorescências são utilizadas na forma de chás, macerados, compressas, pomadas, banhos e extratos alcoólicos. Suas folhas apresentam ação antiespasmódica, moluscicida, fungicida, calmante e digestiva. Considerando, a) a inexistência de estudos sobre a L. alba em hidroponia b) a utilização de solução nutritiva para atender as necessidades da espécie, fornecendo nutrientes de maneira balanceada e possibilitando a produção de plantas com adequada qualidade e em menor espaço de tempo, c) a necessidade de produção de matéria prima para uso medicinal popular e farmacêutico, o presente estudo objetivou avaliar o desenvolvimento e as trocas gasosas de L. alba submetida à variação das concentrações dos nutrientes a partir da diluição da solução nutritiva de Hoagland e Arnon (1950). Assim, as plantas foram cultivadas em quatro tratamentos, constituídos pela variação de nutrientes na solução nutritiva n°2 de Hoagland e Arnon (1950), ou seja, em solução completa (100%) e diluída à 80%, 60% e 40% em relação à completa. As variáveis avaliadas foram área foliar, massas secas dos diferentes órgãos, razão de área foliar (RAF), área foliar específica (AFE), razão de massa foliar (RMF), taxa de crescimento absoluto (TCA), taxa assimilatória líquida (TAL), taxa de crescimento relativo (TCR), taxa de assimilação de CO2 (A, mmolCO2 m-2 s-1), condutância estomática (gs, mol m-2s-1), transpiração (E, mmol H2O m-2 s-1), concentração intercelular de CO2 na folha (Ci, mmolCO2 mol-1ar) e eficiência de uso da água (EUA). Os resultados obtidos permitem concluir que: 1. As concentrações dos nutrientes na solução nutritiva, de maneira geral, foram excessivas ... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: The present study aimed to evaluate physiological effects of the boscalida-based fungicide on phytotechnical, physiological and biochemical aspects of grafted and ungrafted Japanese cucumber plants. The experiment was carried out under protected cultivation at São Manuel Experimental Farm, Faculty of Agronomical Sciences (FCA), São Paulo State University (UNESP), Botucatu Campus, São Paulo State, Brazil. Both the cucumber hybrid 'Tsuyataro' grafted onto the pumpkin 'Excite Ikky' and ungrafted plants were subjected to different levels (0, 25, 50, 75 and 100 g a.i. ha-1) of the boscalida fungicide through leaf application at weekly intervals. Experimental design was in randomized blocks, in a 5x2 factorial arrangement, with four replicates and six plants per plot, so that the four central plants were considered in the evaluation. Higher CO2 assimilation and water use efficiency and lower internal CO2 concentration were observed in grafted plants at 39 DAT. The levels 75 and 100 g a.i. ha-1 favored CO2 assimilation in grafted plants and led to lower internal CO2 concentration in the substomatal chamber. Grafted plants had higher total soluble protein concentration and a linear response to boscalida levels at 81 D.A.T. SOD and CAT activities were higher in ungrafted plants, whereas the highest boscalida levels, especially 100 g a.i. ha-1, led to a decrease in the activity of both enzymes. POD activity was higher in grafted plants and decreased as the fungicide levels increased. Higher activity of nitrate reductase was ... (Complete abstract click electronic access below) / Doutor

A avaliação do risco é um processo sistemático pelo qual a possibilidade de dano, a exposição e o próprio risco são identificados e quantificados. A consideração, de que a participação em um estudo é de risco, fundamenta-se no princípio da precaução, que é a garantia da existência de medidas de proteção contra riscos potenciais. De acordo com a gravidade dos eventos adversos, e de sua probabilidade de ocorrência, determina-se se o risco previsto é negligenciável, tolerável ou intolerável. Portanto, a caracterização do risco representa um importante elo entre os dados científicos obtidos nos diferentes estudos e as tomadas de decisões, ao monitoramento e à comunicação do risco. O objetivo deste estudo é avaliar os riscos previstos de eventos adversos gastrintestinais em projetos de pesquisa em seres humanos na área farmacológica, realizados no Hospital de Clínicas de Porto Alegre (HCPA), através da análise do Termo de Consentimento Livre e Esclarecido (TCLE), do manual do pesquisador e do projeto. Realizou-se um estudo transversal, com unidade de observação nos eventos adversos (EAs) gastrintestinais, através do levantamento de risco de projetos de pesquisa farmacológica, com patrocínio privado, submetidos e aprovados pelo Comitê de Ética em Pesquisa (CEP) do HCPA, no ano de 2004. De 58 projetos analisados, identificou-se 9734 referências de riscos de EAs gerais, sendo que 1463 (15,0%) eram gastrintestinais. Destas, 181 (12,4%) aparecem somente no TCLE, desprovida de embasamento teórico; já 1047 (71,6%) estão descritas nos documentos não disponibilizados ao participante, informação não compartilhada, tendo embasamento teórico; e apenas 235 referências de riscos, que representam 16,0% dos riscos gastrintestinais totais, como informação compartilhada e documentada, para o participante e pesquisador, com embasamento teórico. Essas 1463 referências de riscos de EAs gastrintestinais foram padronizadas, fazendo-se uso do Código Internacional de Doenças, décima revisão (CID 10), obtendo-se 170 tipos diferentes de riscos. Os riscos com maior repetição de referência nos projetos foram: náusea e vômitos 14,1%; alteração do hábito intestinal 6,5%; aumento dos níveis de transaminases e da desidrogenase lática 5,7%; outras dores abdominais e as não especificadas 4,9%. Quanto à gravidade, dos 170 tipos de riscos, obteve-se 65 (38,2%) graves, 52 (30,6%) moderados, 30 (17,6%) leves e 23 (13,5%) múltipla classificação. Todos os documentos relativos ao projeto de pesquisa deveriam conter a descrição e quantificação dos riscos importantes, seja pela alta gravidade ou freqüência associada. No TCLE, parte dos riscos estavam descritos, porém desprovidos de uma quantificação e caracterização adequadas. O manual apresentava as informações sobre os riscos, mas de forma dispersa ao longo do documento, levando a uma dificuldade de utilização desses dados nas intervenções propostas. Nos projetos analisados, observa-se a falta de homogeneidade e padronização para se expressar adequadamente os riscos já ocorridos em estudos prévios. Isso demonstra a importância da leitura atenta de toda documentação encaminhada para avaliação pelo CEP, visando a proteção ativa dos sujeitos da pesquisa. / Risk evaluation is a systematic process whereby damage possibility, exposure and the risk itself are identified and quantified. The consideration that the participation in a study is risky is founded on the precaution principle, i.e., the warranty of existing protection measures against potential risks. According to the severity of the adverse events and of its occurrence probability, one determines if the foreseen risk is negligible, tolerable or intolerable. Therefore, risk characterization represents an important link between the scientific data obtained from the different studies and the decision-makings, to monitoring and to risk communication. The objective of this study is evaluating the foreseen risks of gastrointestinal adverse events (AEs) in research projects with human beings in the pharmacological field carried out at Hospital de Clínicas de Porto Alegre – HCPA by means of the Informed Consent Form – ICF, of the researcher brochure and of the Research Protocol. A transversal study was carried out with an observation unit in the gastrointestinal AEs, through the survey of risk of projects of clinical trial with private sponsorship submitted to and approved by the Research Ethics Committee – REC of the HCPA in 2004. Out of 58 analyzed protocols were identified 9734 risk references of general AEs, being 1463 (15.0%) gastrointestinal. Out of these, 181 (12.4%) appear on the ICF only, deprived of theoretical basis; while 1047 (71.6%) are described in documents non available for the participant, non-shared information, with theoretical basis; only 235 risk references that represent 16.0% of the total gastrointestinal risk, as shared and documented information for the participant and the researcher, having theoretical basis. These 1463 risk references of gastrointestinal AEs were standardized by making use of the International Code of Diseases – 10th Revision –, and 170 different risk types were obtained. The risks with more reference repetition in the protocols were: nausea and vomit 14.1%; alteration of intestinal habit 6.5%; increase of the levels of transaminases and of lactic dehydrogenase 5.7%; abdominal pain 4.9%. As to the severity, out of the 170 risk types, 65 (38.2%) are severe, 52 (30.6%) moderate, 30 (17.6%) soft and 23 (13.5%) of multiple classification. All of the documents regarding the research protocol should contain the description and quantification of the important risks either due to high severity or to frequency. In the ICF, some of the risks were described however deprived of an adequate quantification and characterization. The brochure presented the information about the risks, however in a disperse way over the document leading to a difficult utilization of these data in the proposed interventions. In the analyzed protocols was observed lack of homogeneity and standardization to adequately express the risks that had already occured in previous studies. This observation demonstrates the importance of careful reading of all of the documentation addressed for evaluation by the REC aiming at the active protection of the research subjects.