M.Ed. / The birth of a democratic South Africa demanded that all people of this country be integrated into one society (Hariparsad, 2005:1). This implies that people from various cultural backgrounds brought with them their individual, cultural and normative values into the integrative process. For example, there were more than one education system in this country and all were integrated into one system (Bray, 2000:31). According to Bennet (1997:71), the term 'work ethic' describes the preposition that work is a moral obligation and that work occupies a central position in a person's life. Van der Westhuizen (2003:71) argues that a school reflects traits of both societal relationships and organizations. The school is a formal organization consisting of structure and activity that has to be managed to fulfill the intended function. A fundamental management function is leadership (Smith & Cronje, 2001:278), which Gunter (2001:19) defines as the process of directing the behaviour of others towards the accomplishment of objectives and goals of the organization. In a school environment, the task of leadership is accorded to the principal, who needs to be responsible in his/her job for maintaining an effective school environment. Organizations do not achieve their objectives on their own. Someone has to deploy the basic resources that the organization has at its disposal to help it achieve its goals. This important element is management. Managers must activate and guide the organization (Hariparsad, 2005:4), and the responsibility for professional management of a public school is also vested in the principal (South African Schools Act, 1996:16[3]). The researcher believes that the work ethic of the educators will dictate the manner in which the school functions. Hariparsad (2005:5) states that if the work ethic of the educators is based on sound principles of efficient and effective work practices, emerging from a sound value system and a strong individual moral fibre, it can be expected that the school will function as a meaningful organization in society. It seems, however, that some schools face management problems which emanate from the work ethic of the educators. In addition, the management practices and procedures selected by the principal impact on the ethos of the school which in all likelihood will affect the work ethic of the educators (Hariparsad 2005: 6). Educators in South Africa have recently been accused by the public of going on strike far too easily; and hence have been labeled as having a poor work ethic (Makgoba, 2007:7). The work ethic among South African educators has, however, not been determined in any empirical way and this research will attempt to obtain a benchmark for educators in the Limpopo Province of South

Orientadores: Ellen Hardy, Maria José Martins Duarte Osis / Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciências Médicas / Made available in DSpace on 2018-11-27T12:15:17Z (GMT). No. of bitstreams: 1 Bento_SilvanaAparecidaFerreira_D.pdf: 1598414 bytes, checksum: 918d6e9b8147a560227b95c0e45413c5 (MD5) Previous issue date: 2010 / Resumo: Introdução: Em 1996, foi aprovada a Resolução 196/96 sobre Pesquisa envolvendo Seres Humanos, do Conselho Nacional de Saúde (CNS)/ Ministério da Saúde. Essa Resolução estabelece que todas as pesquisas devem ser avaliadas por um Comitê de Ética em Pesquisa (CEP), registrado na Comissão Nacional de Ética em Pesquisa (CONEP), que é responsável por coordená-los. A Resolução também define a composição, organização, atuação e atribuições dos CEP. Sujeitos e métodos: Realizou-se estudo descritivo com abordagens quantitativa e qualitativa. Na etapa quantitativa participaram 502 Coordenadores de CEP, dentre os 508 registrados na CONEP em 2006. Eles responderam um questionário estruturado, via telefone. Para análise dos dados, selecionaram-se 15 itens da Resolução 196 que todos os CEP deveriam cumprir. A variável dependente foi o número de itens cumpridos, analisada de duas formas: 1) dicotomizada em menos de 12 itens e 12 ou mais itens; 2) pelo escore médio dos itens cumpridos. Os CEP que cumpriam 12 ou mais itens foram considerados "adequados" e os que cumpriam menos de 12 "não adequados". Testou-se a associação entre o número de itens cumpridos e algumas características dos CEP, incluindo análise múltipla. Na etapa qualitativa, foram selecionados propositalmente 20 CEP localizados nas cinco regiões geográficas do país. Realizaram-se 80 entrevistas semiestruturadas com coordenadores, membros e pessoal administrativo. Procedeu-se à análise temática do conteúdo das entrevistas. Resultados: Apenas 3,2% dos CEP cumpriam todos os 15 itens selecionados e dois terços (66,3%) cumpriam 80% ou mais deles. Os itens menos cumpridos foram: elaboração de algum texto sobre ética e/ou bioética em 2006 (26,1%); membros eleitos pelos pares (43,4%); acompanhamento dos protocolos avaliados através de relatórios (54,6%). A porcentagem de CEP considerados adequados foi maior entre aqueles em que o Coordenador era do sexo feminino (71,3% - p<0,05), que avaliaram 60 ou mais protocolos em 2006 (73,1% - p<0,005), que tinham regimento interno próprio (69% - p<0,001). O escore médio de itens cumpridos foi significativamente maior quando o CEP respondia administrativamente a uma universidade/faculdade (p<0,05), o número de protocolos avaliados era de 60 ou mais (p<0,005); e quando os CEP tinham regimento interno próprio (p<0,001). Essa variável também foi a única associada ao maior número de itens cumpridos, na análise múltipla. Na etapa qualitativa, verificou-se que, de modo geral, os CEP possuíam funcionamento semelhante, a infraestrutura física foi considerada adequada, porém com ressalvas. Em geral, os CEP não faziam o acompanhamento das pesquisas aprovadas. A dificuldade mais enfatizada foi o excesso de trabalho e a falta de tempo dos coordenadores e membros para se dedicarem às atividades dos CEP, que se acumulavam com as demais atividades nas respectivas instituições que abrigavam os comitês. Referiu-se que os pesquisadores tendiam a ser resistentes quanto a enviar seus projetos para serem avaliados e aos pareceres emitidos. Conclusão: Apesar do grande avanço indicado pelo expressivo número de CEP, cuja maioria parece adequada à Resolução 196/96 e se esforça por desempenhar o seu papel, há várias dificuldades envolvidas nesse processo e existe necessidade de aprimoramento em vários aspectos da organização e funcionamento dos CEP. / Abstract: Introduction: In 1996, the National Health Council of the Brazilian Ministry of Health approved Resolution 196/96 concerning research involving human beings. This resolution establishes that all studies involving human beings must be evaluated by an institutional review board (IRB) registered with the National Commission for Ethics in Research (CONEP), the entity responsible for coordinating all IRBs in the country. The Resolution also established IRB composition, organization, role and attributions. Methods: A descriptive study was conducted with quantitative and qualitative approaches. In the quantitative approach, 502 IRB Coordinators answered a structured questionnaire by telephone. For data analysis, 15 of the most relevant items of Resolution 196/96, which all IRBs should follow, were evaluated. The dependent variable was the number of items complied with, analyzed in two ways: 1) dichotomized into less than 12 and12 items or more; 2) the average score of the items completed. The IRBs that completed 12 or more items were considered "adequate"; and those which complete less than 12 were considered "not adequate". The association between the number of items complied with and some characteristics of the IRBs was also tested, including multiple analyses. In the qualitative approach, twenty IRBs located in the five geographical regions of the country were purposely selected. Eighty semi-structured interviews were conducted with coordinators, members, user representatives, ad hoc consultants and administrative workers. A thematic analysis of the content of interviews was performed. Results: Only 3.2% of the IRBs complied with all the items selected and two thirds (66.3%) completed 80% or more of them. The items that were less followed by IRBs were: preparation of a text on ethics and/or bioethics (26.1%); members elected by peers (43.4%), and monitoring protocols through evaluation reports (54.6%). The percentage of IRBs considered adequate was higher among those in which the Coordinator was female (71.3% - p <0.05), those that evaluated 60 or more research protocols in 2006 (73.1% - p<0.005) and those having their own internal rules (69% - p<0.001). The average score of items completed was significantly higher among IRBs administratively dependent on a university/college (p <0.05), those that had assessed 60 protocols or more in 2006 (p<0.005) and when the IRB had its own internal rules (p<0.001). This last variable was also the only one associated with the greater number of items completed, in multivariate analysis. In the qualitative approach, it was generally found that the IRBs operated in a similar manner and their physical infrastructure was considered adequate, although with some restrictions. In general, the IRBs did not follow-up the studies that they approved. The most emphasized difficulty was overwork and lack of time for IRB coordinators and members to dedicate more fully to IRB activities as a consequence of their other duties in the institution where the IRB is located. It was mentioned that investigators tended to be unwilling to send their projects for evaluation and to challenge the reports issued. Conclusion: In spite of the great progress indicated by the significant number of IRBs, the majority of which seem to be adequate to the Resolution 196/96 and to be making an effort to carry out their roles appropriately, there are many difficulties involved in several organizational and functionality aspects which should be overcome. / Doutorado / Saúde Materna e Perinatal / Doutor em Ciências da Saúde

M.A. / This study was set on making a survey of the current status of business ethics as academic field in Africa, as no comprehensive survey has yet been made. It is this need that prompted the main research problem namely: What is the current status of business ethics as an academic field in Africa? Which I translated into two sub-questions of which the first was a descriptive question: How has business ethics been institutionalised? And the other reflective in nature, What are the strengths and weaknesses of business ethics as an Academic field in Africa? In setting up the research aims, I wanted to determine: what African business ethics researchers, lecturers and facilitators of professional associations think business ethics is the extent and content of business courses in Africa, where they were taught, whether they were taught as sub-sections of other courses or as independent subjects, how many were taught on undergraduate level and how many on post-graduate level and whether students were getting academic credit for those courses. Looking at research I wanted to determine the amount and content of articles, books and unpublished dissertations on business ethics in Africa. I also wanted to determine the extent of the institutionalisation of business ethics, whether there were African journals dealing mainly with business ethics, how many centres, institutes and networks were dealing with what aspects business ethics in Africa and finally how many conference and seminars were addressing what issues of business ethics in Africa. After having established this, I finally wanted to determine whether business ethics was an academic field or discipline in Africa The results yielded the following information: A lot of misunderstanding still exists on the nature of business ethics: most of the researchers, lecturers and facilitators of professional business ethics associations focus mainly if not exclusively on the normative level of inquiry. This trend was reflected in their definitions, courses, research and central focus of the professional associations. There are 67 business ethics courses (55 undergraduate, 12 post-graduate) being taught at 30 departments in 4 African countries, namely Egypt, Kenya, Uganda and South Africa. Most courses focus on descriptive and normative ethics. I was able to locate and analyse 136 of the 167 articles, books and unpublished dissertations on business ethics in Africa. The content of the articles focus heavily on descriptive and normativeethical issues. The survey revealed 7 centres dealing with business ethics in Africa. They are located in Kenya, Nigeria, South Africa and Uganda. Their main focus leans heavily towards normativeethical solutions. I found 4 institutes dealing with business ethics in one way or another. Not one of the institutes focus exclusively on business ethics. They are located in Egypt, South Africa and Uganda. As with the centres, the focus is heavily on normative-ethical solutions. Apart from the recently established Business Ethics Network of Africa (BEN-Africa) there are no other networks dealing with business ethics in Africa. Six recorded conferences / seminars were held in Kenya, South Africa and Uganda. The main focus seems to be on normative ethical issues. Business ethics is still an academic field in Africa but it has the potential for developing into an academic discipline with the associated independent courses, research, journals and professional associations.

The thesis is focused on innovations and marketing of funeral services in the Czech republic. The first part is devoted to theoretical background, including marketing theory, marketing mix, theory of services and theory of marketing research. The practical part describes the funeral business in the Czech republic, including legislative restrictions and marketing regulations. It also lists typical products and services that are offered on the funeral market. The aim of this thesis is to research the marketing of funeral services and to find out, whether Czech funeral services are following the trends in innovations. The thesis is also focused on ethics in funeral business.

Previous research has noted that members of research ethics committees are unclear about the extent of their roles. In this study, research amongst members of independent ethics committees (IECs) about how the ‘expert’ and ‘lay’ roles are understood and operationalized offers an explanation for this lack of clarity. IECs were selected for study because they have only addressed one type of research (Phase 1 ‘healthy volunteer’ studies) and this limited remit suggested that it would be in such committees that the member roles would have become most pronounced. Drawing on findings from the sociology of professions and employing a phenomenological approach to understanding, 20 semi-structured interviews with both expert and lay members of these committees revealed that a number of members were not only unclear about the roles, but unclear too whether they, or certain of their colleagues, were in which membership category. Notwithstanding this fact, and paradoxically, the ‘expert’ designation was seen as granting its members a privileged position on the committees. The expert member was seen to be either a medically qualified member or one tightly associated with the medical model. Such a repository of expertise being with the medical model privileges this model in ethics review such that other matters formally to be scrutinized by ethics committees become marginalised. Participant safety was the prime concern of the ethics review for IEC members. This relegated other matters including the adequacy of the insurance arrangements, the readability of the consent forms, the fairness of the inclusion criteria, and so forth, into areas of lesser concern. That this occurs though when the science, the safety and the methodology of the trials are already – separately - subject to an independent analysis by a body of experts, whose statutory role is to concern itself with these issues such that no trial may occur without their sanction, is of significance. IEC members were cognizant of this duplication of role but unable to resolve it. The situation could be accounted for as due to capture by the medical model and a cognitive dissonant process. Members’ training and education were found to have been neglected because under the medical professions’ gaze no other type of knowledge was considered necessary in ethics review. The study revealed that the medical profession’s dominance of such committees accounts for the members’ role uncertainty and as such allies itself to Freidson’s theory of professional dominance. If such a concept has been thought to be an obsolete one, this study suggests such a notion of the status of the theory is premature. The medical model’s status is implicitly accepted such that nothing else need be considered. The research calls for further studies to corroborate such findings in other research ethics settings and for a debate about what society wants its ethics committees to focus upon in their review.

Os objetivos deste estudo são: descrever o nível de alfabetismo funcional dos usuários do ambulatório do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; comparar o nível de alfabetismo funcional dos usuários ambulatoriais do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) com os do Hospital de Clínicas de Porto Alegre (HCPA); identificar recomendações para adequar a redação do Termo de Consentimento Livre e Esclarecido utilizado nas pesquisas do HCFMUSP ao nível de alfabetismo de seus usuários. Trata-se de um estudo transversal quantitativo com 399 sujeitos, a amostra foi intencional, selecionada entre usuários dos ambulatórios do HCFMUSP. A coleta de dados utilizou um instrumento que continha um texto em prosa compatível para a avaliação das habilidades de leitura necessárias para a compreensão de um TCLE. Os dados apontam que mais de 46,6% dos entrevistados foram classificados como analfabetos funcionais, desses, 12,7% sequer foram capazes de entender a tarefa proposta no texto lido. Apesar disto, quase 50% dos entrevistados declararam ter ao menos iniciado o ensino médio. Os resultados e as orientações para a redação de texto centrada no leitor permitiu que elaborássemos recomendações para tornar os termos de consentimento mais fáceis de ler. Recomendamos que o pesquisador elabore o TCLE como um texto em estrutura narrativa, dirigido ao leitor, usando palavras e termos familiares aos sujeitos, ou seja, termos comuns à linguagem dos sujeitos e à linguagem médica. Além de contribuir para melhorar a relação entre o sujeito e o pesquisador, acredita-se que estas recomendações possam contribuir para a diminuição do tempo de tramitação de projetos de pesquisa, já que os problemas na redação do TCLE motivam boa parte das pendências que retardam este andamento / This study aimed to describe the literacy of the patients at the Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo; compare literacy between the patients at the Faculty of Medicine, University of Sao Paulo (HCFMUSP) and those at the Hospital de Clínicas de Porto Alegre (HCPA); and recommend how to suit the Consent Form in research protocols to HCFMUSP patients literacy .This is a quantitative cross-sectional study with 399 subjects. Sample was intentionally selected among users of ambulatory HCFMUSP. Data collection used a narrative text compatible for assessing the reading skills needed for understanding consent forms. Results point out that 46.6% of the respondents were funcionally illiterate, and 12.7% of them were not even able to understand the task presented in the questions. Despite this, almost 50% of the respondents declared that they had, at least, started the high school. Based on the results and guidelines for writing texts centered on subjects literacy we recommend how to make consent forms easier for reading. We recommend that researchers write consent forms as a narrative texts addressed to the research subject reader; use words and expressions suitable to subjects culture and literacy. In other words, researchers should use words common to both languages: the popular language spoken by the patients and the medical language. We believe that these recommendations might improve the relationship between researchers and subjects and, as well, reduce the time taken to obtain the ethical approval of research projects

Os objetivos deste estudo são: descrever o nível de alfabetismo funcional dos usuários do ambulatório do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; comparar o nível de alfabetismo funcional dos usuários ambulatoriais do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) com os do Hospital de Clínicas de Porto Alegre (HCPA); identificar recomendações para adequar a redação do Termo de Consentimento Livre e Esclarecido utilizado nas pesquisas do HCFMUSP ao nível de alfabetismo de seus usuários. Trata-se de um estudo transversal quantitativo com 399 sujeitos, a amostra foi intencional, selecionada entre usuários dos ambulatórios do HCFMUSP. A coleta de dados utilizou um instrumento que continha um texto em prosa compatível para a avaliação das habilidades de leitura necessárias para a compreensão de um TCLE. Os dados apontam que mais de 46,6% dos entrevistados foram classificados como analfabetos funcionais, desses, 12,7% sequer foram capazes de entender a tarefa proposta no texto lido. Apesar disto, quase 50% dos entrevistados declararam ter ao menos iniciado o ensino médio. Os resultados e as orientações para a redação de texto centrada no leitor permitiu que elaborássemos recomendações para tornar os termos de consentimento mais fáceis de ler. Recomendamos que o pesquisador elabore o TCLE como um texto em estrutura narrativa, dirigido ao leitor, usando palavras e termos familiares aos sujeitos, ou seja, termos comuns à linguagem dos sujeitos e à linguagem médica. Além de contribuir para melhorar a relação entre o sujeito e o pesquisador, acredita-se que estas recomendações possam contribuir para a diminuição do tempo de tramitação de projetos de pesquisa, já que os problemas na redação do TCLE motivam boa parte das pendências que retardam este andamento / This study aimed to describe the literacy of the patients at the Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo; compare literacy between the patients at the Faculty of Medicine, University of Sao Paulo (HCFMUSP) and those at the Hospital de Clínicas de Porto Alegre (HCPA); and recommend how to suit the Consent Form in research protocols to HCFMUSP patients literacy .This is a quantitative cross-sectional study with 399 subjects. Sample was intentionally selected among users of ambulatory HCFMUSP. Data collection used a narrative text compatible for assessing the reading skills needed for understanding consent forms. Results point out that 46.6% of the respondents were funcionally illiterate, and 12.7% of them were not even able to understand the task presented in the questions. Despite this, almost 50% of the respondents declared that they had, at least, started the high school. Based on the results and guidelines for writing texts centered on subjects literacy we recommend how to make consent forms easier for reading. We recommend that researchers write consent forms as a narrative texts addressed to the research subject reader; use words and expressions suitable to subjects culture and literacy. In other words, researchers should use words common to both languages: the popular language spoken by the patients and the medical language. We believe that these recommendations might improve the relationship between researchers and subjects and, as well, reduce the time taken to obtain the ethical approval of research projects

No description available.

O consentimento informado consiste em um processo capaz de informar o participante de pesquisa sobre as intervenções médicas previstas a serem aplicadas no decorrer do estudo e faz com que este participe ativamente no processo de tomada de decisão. O Termo de Consentimento Livre e Esclarecido (TCLE) caracteriza-se por ser um documento explicativo, de forma escrita, no qual são abordadas informações referentes ao projeto de pesquisa, com o objetivo de garantir a voluntariedade do indivíduo. A qualidade do TCLE em pesquisa clínica é determinada pelo grau de compreensão que os participantes desenvolvem durante o processo de consentimento informado. O objetivo deste estudo consiste em avaliar o processo de consentimento dos participantes de pesquisa clínica. Trata-se de um estudo híbrido, com coleta prospectiva. Para o seu desenvolvimento dividiu-se nas seguintes fases: Elaboração e validação do formulário, Treinamento da Equipe de Entrevistadores, Estudo Piloto, Coleta de Dados e Avaliação da Legibilidade dos TCLEs. Foi realizada análise descritiva dos dados e comparação entre as variáveis por meio de análises univariadas. Dos 70 participantes que compuseram a amostra, 83% eram mulheres, a média de idade foi de 46,7 anos (S ±13.99 anos), 55,7% eram brancos, 45,75% casados, 52,9% analfabetos ou com ensino fundamental, 49,3% economicamente ativos e renda média de 1496,2 reais. Dos participantes, 35,7% desconheciam o tipo de estudo que participavam 38,6% não sabiam contar sobre a pesquisa que participavam, 64,7% não receberam informações referentes a outros tipos de tratamento, 62,7% não tinham informações sobre indenização, 66,2% não leram todo o TCLE antes de assinar, 86,8% relataram que o documento foi fácil de ser lido, 62,2% acharam o documento longo. Após o cálculo do ILFK dos 12 TCLEs analisados, 100% apresentaram valor de 0 a 30, considerado como leitura muito difícil. É de suma importância incentivar o desenvolvimento de estudos nacionais que avaliem a percepção dos participantes de pesquisa quanto aos seus direitos e a criação de instrumentos que possibilitem essa verificação na população brasileira / Informed consent consists a process that is able to inform, the research participant, of the planned medical interventions to be apply during the course of the study, and actively participate in the decision-making process. The Informed Consent Form (ICF) characterized by being an explanatory document, in written form, in which information about the research project is addressed, with the purpose of guaranteeing the individual\'s willingness. The quality of ICF in clinical research determined by the degree of understanding that participants develop during the informed consent process. The objective of this study is to evaluate the consent process of clinical research participants. It is a hybrid study, with prospective collection. For its development, it divided into the following phases: Elaboration and validation of the form, Training of the Team of Interviewers, Pilot Study, Data Collection and Evaluation of the Readability of ICF. A descriptive analysis of the data and a comparison between the variables performed using univariate analyses. Of the 70 participants, 83% were women, mean age was 46,7 years (S ± 13.99 years), 55,7% were white, 45,75% married, 52,9% illiterate or basic education, 49,3% economically active and average income of 1496,2 Reais. Of the participants, 35,7% didn\'t know the type of study they participated in, 38,6% didn\'t know about the research they participated, 64,7% didn\'t receive information regarding other types of treatment, 62,7% didn\'t have information about compensation, 66,2% didn\'t read the entire ICF before signing, 86,8% reported that the document was easy to read, 62,2% found the document long. After the ILFK calculation of the 12 ICF analysed, 100% presented values from 0 to 30, considered as very difficult reading. It is extremely important to encourage the development of national studies that evaluate the perception of research participants regarding their rights and the creation of instruments that enable such verification in the Brazilian population

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.