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.

Thesis (Ph. D.)--Public Policy, Georgia Institute of Technology, 2005. / Richard P. Barke, Committee Chair ; Roberta Berry, Committee Member ; Ann Bostrom, Committee Member ; Barry Bozeman, Committee Member ; Mary Frank Fox, Committee Member. Vita. Includes bibliographical references.

Submitted by Ana Elisa Thomazella Gazzola (ana.thomazella@gmail.com) on 2017-07-27T18:03:20Z No. of bitstreams: 1 dissertação_Gazzola.pdf: 835321 bytes, checksum: aab4acdec05701b00d65df29acb4a242 (MD5) / Approved for entry into archive by LUIZA DE MENEZES ROMANETTO (luizamenezes@reitoria.unesp.br) on 2017-07-31T19:07:49Z (GMT) No. of bitstreams: 1 gazzola_aet_me_mar.pdf: 835321 bytes, checksum: aab4acdec05701b00d65df29acb4a242 (MD5) / Made available in DSpace on 2017-07-31T19:07:49Z (GMT). No. of bitstreams: 1 gazzola_aet_me_mar.pdf: 835321 bytes, checksum: aab4acdec05701b00d65df29acb4a242 (MD5) Previous issue date: 2017-06-30 / Outra / O objetivo desta pesquisa é comparar dois momentos do desenvolvimento institucional do Mercosul, tendo como eixo estruturante a revisão institucional de 2004. Para a realização deste objetivo, se faz necessário avaliar a evolução do bloco em dois períodos: de sua configuração institucional em 1994 até os antecedentes da revisão em 2004; e, a partir de 2004, com os debates acerca da criação de novas instituições e o surgimento de novos temas na agenda da integração até 2014. Para isto, se fez necessário entender os antecedentes da formação do bloco, ou seja, o fortalecimento das relações bilaterais entre Brasil e Argentina e o período de transição do bloco (1991-1994). Durante a primeira fase da integração, foram apresentadas as variáveis acompanhadas durante a pesquisa, principalmente a perpetuação das assimetrias sociais e de poder entre os membros do bloco, com foco nas crises enfrentadas especialmente no final da década de 1990. A segunda fase foi tratada a partir da revisão institucional de 2004, explorando o contexto das mudanças de forças políticas na região e a revisão histórica do regionalismo sul-americano. Por fim, a análise da institucionalidade do Mercosul foi realizada por meio da comparação desses dois dos momentos. / This master dissertation aims to compare two different moments of Mercosur's institutional development, having as its structural axis the institutional revision of 2004. In order to achieve this objective, it is necessary to evaluate the evolution of the bloc in two periods: from its institutional configuration in 1994 to the institutional review in 2004; as well as from 2004 the debates about the creation of new institutions and the emergence of new themes in the integration agenda until 2014. For this, it was necessary to understand the antecedents of the formation of the bloc, that is, the strengthening of relations between Brazil and Argentina and the transition period of the bloc (1991-1994). During the first phase of regional integration, the variables followed during the research were presented, mainly the perpetuation of social and power asymmetries among the members of the bloc, focusing on crises especially faced in the late 1990s. From the institutional review of 2004, exploring the context of changes in political forces in the region and the historical review of South American regionalism. Finally, the Mercosur institutional analysis was carried out by comparing these two moments.

Thesis (M.A.)--Old Dominion University, 2001. / Includes bibliographical references.

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.

Thesis (DPhil)--University of Stellenbosch, 2004. / ENGLISH ABSTRACT: Human participant research raises a conflict between medical progress as a societal good and the protection of participants as an individual good. Prior to 1960 the discretionary authority for the protection of participants resided in the hands of individual investigators. However, a wave of research atrocities from Tuskegee in 1932 to the Beecher expose in 1966 stimulated a change to a principle based system of regulation. Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) were henceforth charged with the responsibility of human participant protection. Since 1966, this system of research review was established internationally and at one institution in South Africa. In 1997, placebo-controlled HIV vertical transmission trials in a number of developing countries including South Africa raised unprecedented controversy in research ethics internationally and nationally. In 2000, the fraudulent breast cancer trials conducted by Dr Bezwoda at Baragwanath Hospital drew international attention to research ethics in South Africa. However, the events that called into question the efficiency of the system of ethical review most poignantly were the recent deaths of volunteers in research at centres of excellence in the United States. It was charged that if there were deficiencies in the research ethics review system in developed countries, these were more likely to be present in developing countries. Around the same time the Interim National Health Research Ethics Committee (INHREC) was established in South Africa to explore and regulate the ethical review system in South Africa. Cognisant of these issues, the current study was undertaken to establish the various structural, procedural and substantive ethical challenges facing justifiable and ethical review of research in South Africa. A combination of conceptualphilosophical reflection and empirical research was employed in this dissertation. The empirical work employed both quantitative and qualitative research methodology. The quantitative survey explored the composition of RECs reviewing clinical trials research in South Africa with an emphasis on committee composition and structure as well as the review process. The qualitative research was conducted using semi-structured interviews of ten REC Chairpersons in South Africa to explore complex substantive issues like informed consent, standards of care and participant remuneration, inter alia. While the review system in South Africa is functioning at a reasonable level, there is wide variation from one REC to the next. RECs are geographically distant and function in isolation without opportunity to communicate and share ideas. Amongst institutional RECs, there is a stark contrast between historically disadvantaged institutions and historically advantaged institutions. REC membership, ten years into democracy remains white male dominated. Community representation is inadequate. Most RECs are dominated by scientists and clinicians. The review process is widely variable with delays in review ranging from ten days to ten weeks. Procedural and bureaucratic demands impact on the ability of REC members to engage in debate on important substantive ethics issues like standards of care, informed consent and participant remuneration. Research ethics training and educational needs vary widely across the country. Serious attention must be paid to the way in which RECs are constituted in South Africa. Restructuring of RECs with a view to improving representation in terms of race, gender and religion must be prioritized. There is a need for community representation and non-scientific membership to be explored. RECs in South Africa need to revisit the question of whether they should be conducting both scientific and ethics review or ethics review alone. The review process requires a paradigm shift in emphasis from adverse event reporting to monitoring, from informed consent forms to a culturally relevant informed consent process. Aparadigm shift is indicated to shift the focus from informed consent to a more comprehensive review framework. Policies regarding standards of care and participant remuneration must be clarified and articulated. Although the role of RECs in human participant protection has been questioned, it is clear that in the vast majority of cases, they are fulfilling an important role. Their function could certainly be enhanced. This is being facilitated by training programs and an electronic newsletter. However, responsibility for human participant protection does not reside in the domain of the REC alone. A collective responsibility shared by researchers, institutions, research ethics committees, sponsors and participants is integral to human participant protection and the generation of new, valid and relevant scientific knowledge. / AFRIKAANSE OPSOMMING: Navorsing op menslike subjekte gee aanleiding tot ‘n konflik tussen mediese vooruitgang as ‘n voordeel vir die samelewing en die beskerming van deelnemers as iets waarby die individu direkte belang het. Voor 1960 het die diskresionêre gesag vir die beskerming van deelnemers by die individuele navorsers berus. ‘n Golf van navorsingsvergrype, van Tuskegee in 1932 tot die Beecher onthulling in 1966, het egter veranderinge in die rigting van ‘n stelsel van beginsel-gebaseerde regulasie gestimuleer. Navorsingsetiekkomitees (NEKs) en Institusionele Beoordelings- en toesigrade (IBRs) is gevolglik belas met die verantwoordelikheid om toe te sien dat mense wat deelneem, sover moontlik beskerm word. Sedert 1966 is hierdie stelsel van navorsingshersiening en -toesig internasionaal tot stand gebring – ook, aanvanklik, by een instansie in Suid-Afrika. In 1997 het plasebo-beheerde HIV-vertikale oordrag-proewe in ‘n aantal ontwikkelende lande, insluitend Suid-Afrika, tot ongekende kontroversie op die terrein van navorsingsetiek aanleiding gee, internasionaal en nasionaal. In 2000 het die bedrog met borskankerproewe, uitgevoer deur dr Bezwoda by Baragwanath Hospitaal, internasionale aandag op navorsing in Suid-Afrika gevestig. Hierdie gebeure het egter die effektiwiteit van die stelsel van etiese toesig in Suid-Afrika en elders in die wêreld bevraagteken. Die mees kommerwekkende onlangse insident was die dood van navorsingsvrywilligers by sentra van uitmuntendheid in die Verenigde State. Daar is beweer dat as daar tekortkominge in die navorsingsetiektoesigsisteem in ontwikkelende lande is, daar ‘n groter moontlikheid bestaan dat dit ook (en moontlik meer) in ontwikkelende lande voorkom. Ongeveer dieselfde tyd is die Interim Nasionale Gesondheidsnavorsings-etiekkomitee (INGNEK) [Interim National HealthResearch Ethics Committee (INHREC)] in Suid-Afrika gestig om die etiekoorsigstelsel in Suid-Afrika te ondersoek en te reguleer. Met dit in gedagte is die huidige studie onderneem om die verskillende strukturele-, prosedurele- en substantiewe etiese uitdagings wat regverdigbare en etiese oorsig van en toesig oor navorsing in Suid-Afrika in die gesig staar, vas te stel. Daar is van ‘n kombinasie van konseptuele, filosofiese refleksie en empiriese navorsing in hierdie proefskrif gebruik gemaak. Die empiriese werk maak gebruik van sowel kwantitatiewe as kwalitatiewe navorsingsmetodes. Die kwantitatiewe opname bestudeer die samestelling van NEKs wat toesig hou oor kliniese proewe in Suid-Afrika, met die klem op komiteesamestelling, -struktuur en die toesigproses. Die kwalitatiewe navorsing is gedoen met behulp van van semi-gestruktureerde onderhoude van tien NEK-voorsitters in Suid-Afrika om die komplekse substantiewe aspekte, soos onder andere ingeligte toestemming, standaard van versorging en deelnemervergoeding, te ondersoek. Terwyl die etiek-toesigstelsel in Suid-Afriks op ‘n redelike vlak funksioneer, is daar ‘n groot verskil tussen verskillende NEKs. NEKs is geografies verspreid en funksioneer dikwels in isolasie sonder ‘n geleentheid om te kommunikeer en idees te deel. Ten opsigte van die institusionele NEKs bestaan daar ‘n duidelike kontras tussen histories benadeelde instansies en histories bevoordeelde instansies. NEK-lidmaatskap word, tien jaar na demokrasie, steeds gedomineer deur blanke mans. Gemeenskapsverteenwoordiging is onvoldoende. Die meerderheid NEKs word gedomineer deur wetenskaplikes en klinici. Die toesig- en hersieningsprosesse in die verskillende komitees verskil grootliks, met vertragings wat wissel van 10 dae to 10 weke. Prosedurele- en burokratiese vereistes het ‘n impak op die vermoëns van NEK-lede om by debatte oor belangrike substantiewe etiese aangeleenthede betrokke te raak, soos byvoorbeeld die standaard van versorging, ingeligte toestemming en deelnemervergoeding. Opleiding en opvoedkundige behoeftes verskil wyd oor die land.Ernstige aandag moet geskenk word aan die wyse waarop NEKs in Suid-Afrika saamgestel is. Herstrukturering van NEKs met ‘n visie op verbeterde verteenwoordiging in terme van ras, geslag en geloof is ‘n prioriteitsvereiste. Gemeenskapsverteenwoordiging en lidmaatskap van nie-wetenskaplikes moet verder ondersoek word. NEKs in Suid-Afrika moet die vraag of hulle sowel wetenskaplike- as etiektoesig moet uitvoer, of sl slégs etiektoesig, opnuut ondersoek. Die nasiensproses vereis ‘n paradigmaskuif, vanaf ‘n klem op rapportering van gebeurtenisse, na monitering van ingeligte toestemmingsvorms sowel as na ‘n kultureel toepaslike ingeligte toestemmingsproses. ’n Paradigmaskuif is noodsaaklik ten einde die fokus te verskuif vanaf ingeligte toestemming na ‘n meer omvattende toesig- en nasiensraamwerk. Beleid rakende standaard van versorging en deelnemervergoeding moet verduidelik en geartikuleer word. Alhoewel die rol van NEKs in die beskerming van menslike deelnemers aan navorsing bevraagteken word, is dit duidelik dat NEKs in die meerderheid van gevalle wel ‘n belangrike rol vervul. Hul funksie kan natuurlik uitgebrei word. Dit sal gefasiliteer word deur opleidingsprogramme en ‘n elektroniese nuusbrief. Verantwoordelikheid vir die beskerming van mense wat deelneem aan navorsing berus egter nie uitsluitlik by NEKs nie. ‘n Kollektiewe verantwoordelikheid, gedeel deur navorsers, instellings, navorsingsetiekkomitees, borge en deelnemers is ‘n integrale vereiste vir hierdie beskerming sowel as vir die verwerwing van nuwe, geldige en relevante wetenskaplike kennis.

No description available.