The purpose of this study is to discover the relationship between the specifications of medical institutes, FERCAP (Forum for Ethical Review Committees in Asia and the Western Pacific), TJCHA IRB Accreditation (Taiwan Joint Commission on Hospital Accreditation, TJCHA) and the practice of IRBs. By using questionnaires, and comparing the differences between all these medical institutes, we would have the information Research Ethics and the differentials in all the medical institutes. In this study, 268 completed questionnaires to the most southern region (64.7%), Medical Center (66.4%), physicians (36.9%), research assistants (21.3%), nurses (14.6%) and so on. About 60¢H can answer correctly of the knowledge of Human Research Ethics. We found that different medical institutions (Medical Centers and non-medical centers) and distinction (north, south and other regions) score differences in terms of cognition, in "human trials testing program information must be saved after three years", "IRB memberlist should be submitted to DOH", "study of individual or group characteristics or behavior (such as feeling, cognition, motivation, identity, language, communication, cultural beliefs or habits and social behavior, etc.) is expetided review " and "IRB membership and minutes should be open" have significantly difference (p <0.05). Also, we need to pay attention that only 30¢H of IRB members and staff have correct answer of "IRB memberlist should be submitted to DOH". Medical Centers and non-medical centers score differences in terms of attitude, in ¡uunit IRB that the information provided sufficient for you to understand the operation of the IRB¡v,¡uIRB promote education in human trials of great help to the project execution¡v,¡uIRB review process can focus on the implementation of the risk-benefit plans to provide specific advice¡v and ¡uyou are familiar with the regulations of the Department of Health ¡isuch as GCP, Medical Law and Research collected by the human body provides¡j¡vhave significantly difference (p <0.05). And expect the future to have further information for health policy evaluation and questionnaire data will be cross-comparison analysis of human trials to confirm the operation of the Board to provide further quality assurance and the IRB timely help.

La qualité méthodologique en recherche clinique est une exigence garantissant la fiabilité des expérimentations médicales, au bénéfice des praticiens comme à celui des patients. Cette thèse a pour objectif de mesurer la qualité des essais thérapeutiques présentés au Comité d’Ethique de la Région Sud-Est II et son évolution sur des périodes pluriannuelles. Deux études transversales exhaustives ont été réalisées. La première a pour objet de mesurer l’impact du Règlement Pédiatrique Européen de 2007 sur l’évolution qualitative et quantitative de essais pédiatriques, compte tenu du faible nombre de recherches dans cette population. La deuxième analyse le niveau de qualité des essais contrôlés randomisés en utilisant le score de Jadad et identifie les éléments qui l’influencent. L'outil de travail est constitué des protocoles détenus par le Comité d’Ethique, et non de publications de la littérature. Le concept de qualité et ses deux composantes, éthique et fiabilité scientifique, a été étudié. Les différents outils proposés par les experts pour mesurer la qualité ont été expertisés, ce qui a permis la sélection de l’échelle méthodologiquement la plus adaptée. Le niveau de qualité observé pour les essais pédiatriques est élevé, mais n’a pas été influencé par le Règlement Européen, qui a pu, cependant, entraîner une progression forte du nombre des essais pédiatriques, pouvant être l’indice d’un développement de la recherche en pédiatrie. Concernant les essais contrôlés randomisés, deux marqueurs sont associés à un haut score qualité des protocoles, identifiés après une analyse multivariée : le caractère multicentrique de la recherche et les essais portant sur les médicaments. / Methodological quality in clinical research is mandatory to ensure the reliability of medical experiments, with benefits for both practitioners and patients. This PhD thesis aims at measuring the quality of therapeutic trials submitted to the Ethics Committee of the South-East Region II, and its evolution over several years. Two comprehensive cross-sectional studies were conducted. The first explore the field of pediatric research, and aims at measuring the impact of the introduction of European Pediatric Regulation in 2007, on the evolution of the quantity and quality of trials in this field, given the low number of research in this population. The second analyzes the quality of randomized controlled trials using the JADAD score and seeks to identify the elements that influence it. These studies were conducted using the protocols submitted to the Ethics Committee, and not from a literature analysis. The concept of quality was first studied based on their ethical and scientific reliability. The various assessing tools proposed by the experts to measure the quality were appraised, which allowed the selection of the most methodologically scale adapted to this study. Conclusion: we show that the level of quality observed for pediatric trials is high, but was not influenced by the introduction of the European Regulation, which could, on the other hand, have led to an important increase in the number of pediatric trials. Regarding randomized controlled trials, a multivariate analysis allowed the identification of two statistically significant markers associated with high quality score of the protocol: the multicentric character of the research, and the drugs trials.

OBJETIVO: Analisar a frequência da submissão do protocolo de pesquisa aos Comitês de Ética em Pesquisa e da aplicação do Termo de Consentimento Livre e Esclarecido do projeto intitulado “Protocolo Brasileiro para o Tratamento de Pacientes com Tumores da Família de Sarcoma de Ewing”. MÉTODOS: Trata-se de estudo transversal retrospectivo. Através das fichas clínicas dos pacientes foi realizada uma análise do trâmite regulatório, bem como, do processo de obtenção do Termo de Consentimento Livre e Esclarecido de 180 pacientes de 16 instituições. RESULTADOS: Dez dos dezesseis centros submeteram o Protocolo ao Comitê de Ética em Pesquisa local. Em relação ao Termo de Consentimento Livre e Esclarecido, 161 dos 180 pacientes e/ou seus representantes legais consentiram e assinaram o Termo aplicado pelo pesquisador. Destes, 123 assinaram o Termo de Consentimento específico do protocolo e 38 assinaram o Termo de Consentimento institucional. Em relação à data da assinatura do consentimento, 141 dos 161 pacientes assinaram o Termo de Consentimento após receberem as informações referentes ao estudo clínico e antes de iniciar o tratamento. CONCLUSÃO: A maioria das instituições participantes apresenta uma estrutura adaptada ao assistencialismo e não estavam familiarizadas com aspectos éticos, legais e regulatórios que envolvem um projeto desta natureza. / OBJECTIVE: To analyze the frequency of submission of the research protocol to the Institutional Research Board and application of Informed Consent Form related to a clinical trial entitled “Treatment of Patients with Ewing Sarcoma Family of Tumors: A study of the Brazilian Cooperative Group”. METHODS: Retrospective cross-sectional study. Through patient records were performed an analysis of the regulatory proceeding and the signing of the Informed Consent Form by 180 patients from 16 institutions. RESULTS: Ten of the sixteen centers submitted the Protocol to the local Institutional Review Board. Regarding the Informed Consent Form, 161 of 180 patients and/or their legal representatives consented and signed the Form applied by the researcher. Of these, 123 signed the consent form specific to the protocol and 38 signed an institutional form. Regarding the date the consent form was signed, 141 of 161 patients signed it after receiving information about the trial and before starting treatment. CONCLUSION: Most of the participating institutions had a structure adapted to welfare and were not familiar with the ethical, legal and regulatory systems involved in a project like this.

OBJETIVO: Analisar a frequência da submissão do protocolo de pesquisa aos Comitês de Ética em Pesquisa e da aplicação do Termo de Consentimento Livre e Esclarecido do projeto intitulado “Protocolo Brasileiro para o Tratamento de Pacientes com Tumores da Família de Sarcoma de Ewing”. MÉTODOS: Trata-se de estudo transversal retrospectivo. Através das fichas clínicas dos pacientes foi realizada uma análise do trâmite regulatório, bem como, do processo de obtenção do Termo de Consentimento Livre e Esclarecido de 180 pacientes de 16 instituições. RESULTADOS: Dez dos dezesseis centros submeteram o Protocolo ao Comitê de Ética em Pesquisa local. Em relação ao Termo de Consentimento Livre e Esclarecido, 161 dos 180 pacientes e/ou seus representantes legais consentiram e assinaram o Termo aplicado pelo pesquisador. Destes, 123 assinaram o Termo de Consentimento específico do protocolo e 38 assinaram o Termo de Consentimento institucional. Em relação à data da assinatura do consentimento, 141 dos 161 pacientes assinaram o Termo de Consentimento após receberem as informações referentes ao estudo clínico e antes de iniciar o tratamento. CONCLUSÃO: A maioria das instituições participantes apresenta uma estrutura adaptada ao assistencialismo e não estavam familiarizadas com aspectos éticos, legais e regulatórios que envolvem um projeto desta natureza. / OBJECTIVE: To analyze the frequency of submission of the research protocol to the Institutional Research Board and application of Informed Consent Form related to a clinical trial entitled “Treatment of Patients with Ewing Sarcoma Family of Tumors: A study of the Brazilian Cooperative Group”. METHODS: Retrospective cross-sectional study. Through patient records were performed an analysis of the regulatory proceeding and the signing of the Informed Consent Form by 180 patients from 16 institutions. RESULTS: Ten of the sixteen centers submitted the Protocol to the local Institutional Review Board. Regarding the Informed Consent Form, 161 of 180 patients and/or their legal representatives consented and signed the Form applied by the researcher. Of these, 123 signed the consent form specific to the protocol and 38 signed an institutional form. Regarding the date the consent form was signed, 141 of 161 patients signed it after receiving information about the trial and before starting treatment. CONCLUSION: Most of the participating institutions had a structure adapted to welfare and were not familiar with the ethical, legal and regulatory systems involved in a project like this.

OBJETIVO: Analisar a frequência da submissão do protocolo de pesquisa aos Comitês de Ética em Pesquisa e da aplicação do Termo de Consentimento Livre e Esclarecido do projeto intitulado “Protocolo Brasileiro para o Tratamento de Pacientes com Tumores da Família de Sarcoma de Ewing”. MÉTODOS: Trata-se de estudo transversal retrospectivo. Através das fichas clínicas dos pacientes foi realizada uma análise do trâmite regulatório, bem como, do processo de obtenção do Termo de Consentimento Livre e Esclarecido de 180 pacientes de 16 instituições. RESULTADOS: Dez dos dezesseis centros submeteram o Protocolo ao Comitê de Ética em Pesquisa local. Em relação ao Termo de Consentimento Livre e Esclarecido, 161 dos 180 pacientes e/ou seus representantes legais consentiram e assinaram o Termo aplicado pelo pesquisador. Destes, 123 assinaram o Termo de Consentimento específico do protocolo e 38 assinaram o Termo de Consentimento institucional. Em relação à data da assinatura do consentimento, 141 dos 161 pacientes assinaram o Termo de Consentimento após receberem as informações referentes ao estudo clínico e antes de iniciar o tratamento. CONCLUSÃO: A maioria das instituições participantes apresenta uma estrutura adaptada ao assistencialismo e não estavam familiarizadas com aspectos éticos, legais e regulatórios que envolvem um projeto desta natureza. / OBJECTIVE: To analyze the frequency of submission of the research protocol to the Institutional Research Board and application of Informed Consent Form related to a clinical trial entitled “Treatment of Patients with Ewing Sarcoma Family of Tumors: A study of the Brazilian Cooperative Group”. METHODS: Retrospective cross-sectional study. Through patient records were performed an analysis of the regulatory proceeding and the signing of the Informed Consent Form by 180 patients from 16 institutions. RESULTS: Ten of the sixteen centers submitted the Protocol to the local Institutional Review Board. Regarding the Informed Consent Form, 161 of 180 patients and/or their legal representatives consented and signed the Form applied by the researcher. Of these, 123 signed the consent form specific to the protocol and 38 signed an institutional form. Regarding the date the consent form was signed, 141 of 161 patients signed it after receiving information about the trial and before starting treatment. CONCLUSION: Most of the participating institutions had a structure adapted to welfare and were not familiar with the ethical, legal and regulatory systems involved in a project like this.

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