AIDS has had a negative impact on developing countries. Because most developing countries cannot afford the new antiretroviral drug therapies, it has been suggested that preventive vaccines might reduce the spread of the HIV/AIDS epidemic (Bloom, 1998). The clinical trials of AIDS vaccines do, however, present with complex ethical issues such as informed consent. Informed consent is primarily grounded on the Western principle of respect for individuals as autonomous agents. This may be at variance, however, with African societies' emphasis on the social embeddedness of the individual. The current study forms part of the HIVNET vaccine trials to be conducted in Hlabisa, in Northern Zululand, under the auspices of the South African Medical Research Council. The main aim of the study was to explore key informants' cultural conceptions of research and informed consent in order to facilitate community consultation and cultural sensitivity. Maximum variation sampling was used to select twenty-three key informants, who are in leadership positions within Hlabisa. An interview guide was used to facilitate narrative disclosure of cultural conceptions of research and informed consent. Perceptions of research, conceptions of the informed consent process, and projected motivations for why individuals agree to participate in studies were explored during interviews. Results suggest that members of the Hlabisa community have a limited understanding of the Western research process. Community education about research is therefore warranted. Informants indicated that community members would value the establishment of a relationship characterised by mutual respect for cultural differences between researchers and participants. This was perceived as likely to facilitate shared decision-making, and the reduction of the power differentials that exist between researchers and participants. While the involvement of key community leaders and family members was recommended by most informants, a few informants felt that participants could also make individual decisions about participation. The theoretical implications of the study are considered last. / Thesis (M.A.)-University of Natal, Pietermaritzburg, 1999.

La recherche biomédicale réalisée en situation d'urgence traduit la confrontation entre différents principes conducteurs éthiques. Le respect de l'autonomie de la personne, illustré à travers l'obtention du consentement libre et éclairé du sujet pressenti, peut sembler un concept vide de sens dans le cas des malades présentant une condition médicale critique. Pour ces patients en proie à une crise médicale, et donc vulnérables, une protection individuelle accrue s'impose. Une surprotection irait, toutefois, à la fois à l'encontre du principe de justice distributive et du principe de bienfaisance, impliquant de ne pas exclure totalement un groupe de sujets des expectatives élevées de bénéfices d'une recherche correctement balisée. Ce texte a pour objectif de cerner quel est le fondement - éthique - des textes législatifs, réglementaires et normatifs qui permettent l'enrôlement de ces malades atteints de pathologies foudroyantes dans des protocoles de recherche, alors même qu'aucun consentement, qu'il soit autonome ou substitué, n'a été donné. Inspirée du modèle de réflexion éthique pluraliste, l'auteur pose comme hypothèse que c'est le principe de justice distributive qui sous-tend la politique éthique de tels textes, puisque contribuant au développement des avancées thérapeutiques en urgence et à la nécessité d'augmenter l'efficacité des traitements disponibles. Ce texte cherche finalement à définir une démarche d'approbation des protocoles de recherche qui seront réalisés en situation d'urgence. / Biomedical research performed under emergency conditions highlights the conflict between competing ethical principles. The respect for the autonomy of the person, illustrated by the need to obtain a subject's informed consent, can seem an empty concept in the case of a patient presenting severe medical conditions. For those patients in a midst of a medical crisis, and therefore vulnerable, particular protection is necessary. An overprotection would, however, contravene both the principles of distributive justice and of beneficence, principles that hold that an entire group of subjects ought not to be excluded from the expectations of the benefits of properly controlled research. The object of this text is to discem the ethical foundation of the legislative, regulatory and normative texts that permit those stricken with devasting diseases to participate in research projects without consent having been granted. Based on the pluralist ethical model, the author asserts as a hypothesis that it is the principle of distributive justice which supports the ethical policies underlying such texts, since contributing to the development of therapeutic advances in emergencies and to the necessity of increasing the effectiveness of available treatments. This text attempts ultimately to establish procedures to be followed in obtaining approval in research projects in the case of an emergency. / "Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de maîtrise en droit option Droit et Biotechnologies". Ce mémoire a été accepté à l'unanimité et classé parmi les 15% des mémoires de la discipline.

This paper analyses mental patient’s rights. Mental patient has all political, economic, social and cultural rights. Mental patient with a mental illness has a right to appropriate, accessible and suitable medical aid provided free of charge at state health-care institutions. The paper further discusses such patients’ rights as the right to confidentiality with regard to information concerning their health. Involuntary hospitalization is studied in consideration of the constitutional right to liberty of an individual. Paper analyses criteria for involuntary hospitalization. The institute of guardianship is also discussed.

Over the last few years, policies have been introduced in the UK which aim to improve organ transplantation rates by changing the way that potential organ donors are treated before death. Patients incapacitated due to catastrophic brain injury may now undergo ante-mortem donor optimisation procedures to facilitate deceased organ donation. As I identify in this thesis, the most significant ethical and legal problem with these policies is that they are not based on what the patient would have chosen for themselves in the specific circumstances. The policies identify and treat patients meeting certain clinical criteria as a group rather than the individuals, with their own viewpoints, that the law on best interests requires. They equate registration on the Organ Donation Register with ante-mortem donor optimisation procedures being in their best interests, despite registrants having neither been informed about nor given consent to ante-mortem interventions. The overarching claim I make in this thesis is that a system of specific advance consent is needed to provide a clear and unequivocal legal justification for ante-mortem donor optimisation procedures. The ethical foundation for this claim is autonomy, and this is the central theme running through all six chapters. I argue that autonomy should be incorporated into donor optimisation policy to promote the dignity and integrity of potential organ donors and to safeguard trust in the organ donation programme. I argue that a system of specific advance consent is needed as part of the duty of care owed to registrants on the Organ Donor Register and to facilitate the determination of the best interests of the potential organ donor. I argue that the state has not established the necessity of the current policy of non-consensual donor optimisation procedures and that they are under an ethical and legal obligation to introduce an autonomy-based framework for ante-mortem interventions to facilitate organ donation.

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.

Pour la bioéthique, le consentement éclairé est un processus dialogique qui, au travers d’un échange d’informations, garantit le respect du droit du patient à l’autodétermination. Or, il est souvent confondu avec le formulaire de consentement éclairé, document signé par le patient ou son responsable légal, à la demande du médecin ou de l’établissement hospitalier, reconnaissant que toutes les informations sur le traitement et ses risques lui ont été fournies. Cette thèse se propose de vérifier dans quelle mesure, pour ce qui est des soins médicaux, l’usage du « formulaire de consentement éclairé » sans ce processus communicatif dialogique dit de « consentement éclairé » suffit, en soi, à déclarer irrecevables les actions en responsabilité civile pour non respect ou manquement au respect du devoir d’expliquer les risques inhérents aux procédures diagnostiques et thérapeutiques. Notre méthode d’investigation s’appuie sur une révision bibliographique et une recherche documentaire des arrêts contenant l’expression « consentement éclairé » (ou un de ses équivalents). Elle examine 60 arrêts de cours de justice d’états brésiliens pour déterminer le profil des actions et vérifier leur résultat. Le test exact de Fisher a également été utilisé pour déterminer l’association entre les variables « utilisation ou non du formulaire » et « recevabilité ou non des demandes ». Il en ressort que, bien qu’aucune norme brésilienne ne réglemente les formes d’expression du consentement éclairé, un fondement juridique a surgi de l’association systématique de l’intitulé de l’Art. 5 de la Constitution fédérale, du Code civil, en particulier de ses Arts.11 à 21 qui protègent les droits de la personnalité, de l’Art. 6-III du code de la consommation, qui dispose des devoirs d’information et de transparence, et du code de déontologie médicale qui exige l’éclaircissement et le consentement préalables du patient ou de son responsable légal (Art. 22) et interdit toute limitation du droit du patient à disposer de lui-même et de son bien-être (Arts. 24 et 31). Les devoirs d’information des médecins intègrent donc le processus de consentement éclairé, dont la violation peut entraîner la responsabilité civile de ce professionnel, à condition qu’existent les présomptions de dommage au patient, de culpabilité du médecin et de rapport causal entre cette culpabilité et le dommage découlant de la violation du devoir d’information sans que rien ne justifie le manquement au devoir du docteur. / O consentimento informado é entendido, pela Bioética, como um processo dialógico que, por meio da troca de informações, garante o respeito à autodeterminação do paciente, sendo, porém, freqüentemente confundido com o Termo de Consentimento Informado, documento assinado pelo paciente ou seus familiares, a pedido do médico ou da instituição hospitalar, dando ciência de ter recebido informação pertinente ao tratamento e aos seus riscos. Esta tese tem como objetivo verificar em que medida o uso do “termo de consentimento informado”, na assistência médica, de forma desacompanhada do processo comunicativo dialógico chamado “consentimento informado” é de per si suficiente para afastar a procedência de demandas judiciais de responsabilidade civil por ausência ou deficiência do dever de informar riscos inerentes aos procedimentos diagnósticos e terapêuticos. Utilizou-se como método de pesquisa a revisão bibliográfica e a pesquisa documental em acórdãos que contém a expressão “consentimento informado”(ou equivalentes). A análise foi realizada sobre uma base de 60 acórdãos de Tribunais de Justiça estaduais para verificar o perfil e resultado das demandas. Também aplicou-se o Teste Exato de Fisher, para medir a associação entre variáveis “uso ou não do termo de consentimento” e “procedência ou improcedência das demandas”. Verificou-se que, embora não haja norma nacional que o regulamente as formas de expressão do consentimento informado, há fundamentação jurídica, decorrente da coligação sistemática entre o Art. 5º, caput, da Constituição Federal; o Código Civil, especialmente nos direitos de personalidade, entre os Arts.11 a 21 do Código Civil, que resguardam os Direitos de Personalidade; o Art. 6, III do Código de Defesa do Consumidor, relativo aos deveres de informação e transparência; e o Código de Ética Médica, que exige o esclarecimento e o consentimento prévios do paciente ou de seu responsável legal (Art. 22) e veda qualquer limitação ao exercício do direito do paciente de decidir livremente sobre sua pessoa ou seu bem-estar (Arts. 24 e 31). Os deveres informativos dos médicos integram o processo de consentimento informado e sua violação pode ter como conseqüência a responsabilidade civil do profissional, desde que verificados os pressupostos do dano ao paciente, da culpa do médico e do nexo causal entre a culpa e o dano decorrente da violação de dever informativo e não haja excludente ao dever. / According to Bioethics, informed consent is a dialogic process that, by means of information sharing, accords respect to patients’ self-determination. However, this is often confused with the Informed Consent Form, which is a document signed by patients and family members at the doctor’s or hospital administrator’s request, confirming that they have received information about the treatment and its risks. This thesis is aimed at checking to what extent the use of the “informed consent form” in medical assistance, unaccompanied by the dialogic communicative process called “informed consent”, is per se sufficient to prevent civil liability claims for absence of or deficiency in the duty to inform people about the risks inherent in diagnostic and therapeutic procedures. The adopted research method was bibliographical review and documental investigation into appellate decisions containing the expression “informed consent” (or equivalents). The analysis was conducted based on 60 appellate decisions reached by state Appellate Courts in order to examine the profile and result of claims Fisher's Exact Test was also administered to measure the association between the variables “use or non-use of the “consent form” and the “validity or invalidity of claims”. It was found that, although there are no national rules governing the forms of expression about informed consent, there are legal foundations arising from the systematic link among the head provision of Art. 5 of the Federal Constitution; the Civil Code, especially in reference to personality rights, Articles 11-21 of the Civil Code, which protect the Personality Rights; Art. 6, III of the Consumer Protection Code concerning information and transparence duties; and the Code of Medical Ethics, which requires the clarification and prior consent of the patient or his/her legal guardian (Art. 22) and forbids any limitation to the patient’s right to freely decide on his/her person or well-being (Articles 24 and 31). Doctors’ informative duties are an integral part of the informed consent process and violation thereof might result in the professional’s civil liability if harm to the patient, the doctor’s fault, and the causal relation between the fault and the harm resulting from violation of the informative duty are confirmed and if no duty exclusion mechanism exists.

Pour la bioéthique, le consentement éclairé est un processus dialogique qui, au travers d’un échange d’informations, garantit le respect du droit du patient à l’autodétermination. Or, il est souvent confondu avec le formulaire de consentement éclairé, document signé par le patient ou son responsable légal, à la demande du médecin ou de l’établissement hospitalier, reconnaissant que toutes les informations sur le traitement et ses risques lui ont été fournies. Cette thèse se propose de vérifier dans quelle mesure, pour ce qui est des soins médicaux, l’usage du « formulaire de consentement éclairé » sans ce processus communicatif dialogique dit de « consentement éclairé » suffit, en soi, à déclarer irrecevables les actions en responsabilité civile pour non respect ou manquement au respect du devoir d’expliquer les risques inhérents aux procédures diagnostiques et thérapeutiques. Notre méthode d’investigation s’appuie sur une révision bibliographique et une recherche documentaire des arrêts contenant l’expression « consentement éclairé » (ou un de ses équivalents). Elle examine 60 arrêts de cours de justice d’états brésiliens pour déterminer le profil des actions et vérifier leur résultat. Le test exact de Fisher a également été utilisé pour déterminer l’association entre les variables « utilisation ou non du formulaire » et « recevabilité ou non des demandes ». Il en ressort que, bien qu’aucune norme brésilienne ne réglemente les formes d’expression du consentement éclairé, un fondement juridique a surgi de l’association systématique de l’intitulé de l’Art. 5 de la Constitution fédérale, du Code civil, en particulier de ses Arts.11 à 21 qui protègent les droits de la personnalité, de l’Art. 6-III du code de la consommation, qui dispose des devoirs d’information et de transparence, et du code de déontologie médicale qui exige l’éclaircissement et le consentement préalables du patient ou de son responsable légal (Art. 22) et interdit toute limitation du droit du patient à disposer de lui-même et de son bien-être (Arts. 24 et 31). Les devoirs d’information des médecins intègrent donc le processus de consentement éclairé, dont la violation peut entraîner la responsabilité civile de ce professionnel, à condition qu’existent les présomptions de dommage au patient, de culpabilité du médecin et de rapport causal entre cette culpabilité et le dommage découlant de la violation du devoir d’information sans que rien ne justifie le manquement au devoir du docteur. / O consentimento informado é entendido, pela Bioética, como um processo dialógico que, por meio da troca de informações, garante o respeito à autodeterminação do paciente, sendo, porém, freqüentemente confundido com o Termo de Consentimento Informado, documento assinado pelo paciente ou seus familiares, a pedido do médico ou da instituição hospitalar, dando ciência de ter recebido informação pertinente ao tratamento e aos seus riscos. Esta tese tem como objetivo verificar em que medida o uso do “termo de consentimento informado”, na assistência médica, de forma desacompanhada do processo comunicativo dialógico chamado “consentimento informado” é de per si suficiente para afastar a procedência de demandas judiciais de responsabilidade civil por ausência ou deficiência do dever de informar riscos inerentes aos procedimentos diagnósticos e terapêuticos. Utilizou-se como método de pesquisa a revisão bibliográfica e a pesquisa documental em acórdãos que contém a expressão “consentimento informado”(ou equivalentes). A análise foi realizada sobre uma base de 60 acórdãos de Tribunais de Justiça estaduais para verificar o perfil e resultado das demandas. Também aplicou-se o Teste Exato de Fisher, para medir a associação entre variáveis “uso ou não do termo de consentimento” e “procedência ou improcedência das demandas”. Verificou-se que, embora não haja norma nacional que o regulamente as formas de expressão do consentimento informado, há fundamentação jurídica, decorrente da coligação sistemática entre o Art. 5º, caput, da Constituição Federal; o Código Civil, especialmente nos direitos de personalidade, entre os Arts.11 a 21 do Código Civil, que resguardam os Direitos de Personalidade; o Art. 6, III do Código de Defesa do Consumidor, relativo aos deveres de informação e transparência; e o Código de Ética Médica, que exige o esclarecimento e o consentimento prévios do paciente ou de seu responsável legal (Art. 22) e veda qualquer limitação ao exercício do direito do paciente de decidir livremente sobre sua pessoa ou seu bem-estar (Arts. 24 e 31). Os deveres informativos dos médicos integram o processo de consentimento informado e sua violação pode ter como conseqüência a responsabilidade civil do profissional, desde que verificados os pressupostos do dano ao paciente, da culpa do médico e do nexo causal entre a culpa e o dano decorrente da violação de dever informativo e não haja excludente ao dever. / According to Bioethics, informed consent is a dialogic process that, by means of information sharing, accords respect to patients’ self-determination. However, this is often confused with the Informed Consent Form, which is a document signed by patients and family members at the doctor’s or hospital administrator’s request, confirming that they have received information about the treatment and its risks. This thesis is aimed at checking to what extent the use of the “informed consent form” in medical assistance, unaccompanied by the dialogic communicative process called “informed consent”, is per se sufficient to prevent civil liability claims for absence of or deficiency in the duty to inform people about the risks inherent in diagnostic and therapeutic procedures. The adopted research method was bibliographical review and documental investigation into appellate decisions containing the expression “informed consent” (or equivalents). The analysis was conducted based on 60 appellate decisions reached by state Appellate Courts in order to examine the profile and result of claims Fisher's Exact Test was also administered to measure the association between the variables “use or non-use of the “consent form” and the “validity or invalidity of claims”. It was found that, although there are no national rules governing the forms of expression about informed consent, there are legal foundations arising from the systematic link among the head provision of Art. 5 of the Federal Constitution; the Civil Code, especially in reference to personality rights, Articles 11-21 of the Civil Code, which protect the Personality Rights; Art. 6, III of the Consumer Protection Code concerning information and transparence duties; and the Code of Medical Ethics, which requires the clarification and prior consent of the patient or his/her legal guardian (Art. 22) and forbids any limitation to the patient’s right to freely decide on his/her person or well-being (Articles 24 and 31). Doctors’ informative duties are an integral part of the informed consent process and violation thereof might result in the professional’s civil liability if harm to the patient, the doctor’s fault, and the causal relation between the fault and the harm resulting from violation of the informative duty are confirmed and if no duty exclusion mechanism exists.

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.

This article samples possible uses of psychoanalysis in law from the academic work of Joseph Goldstein and Jay Katz. Both start to recognize the importance of psychoanalysis to provide a serious and courageous attention to the non-rational dimensions of the human being, we should be aware in the world of law. Starting from this premise, the author explores two possible uses of psychoanalysis in law: one represented by Goldstein, focuses on using «psychoanalytic premises to resolve legal disputes», for example by providing psychoanalytic information to determine the best interests of the child in cases of custody, while the other, represented by Katz, who seeks to «create an awareness of conflict where all of the actors had previously been locked in a mutually reinforcing fantasy that no conflict existed», as it occurs in doctor-patient relationship, in order to rethink standards that had been set by law under an illusion of objectivity and rationality. The article explores these two approaches through examples, linking two perspectives adopted by Freud throughout his academic work and taking a preferred position by the position of Katz. / El presente artículo muestras los posibles usos del psicoanálisis en el derecho a partir del trabajo académico de Joseph Goldstein y Jay Katz. Ambos parten de reconocer la importancia del psicoanálisis para prestar una atención seria y valiente a las dimensiones no racionales del ser humano, de las que debemos ser conscientes en el mundo del derecho. Partiendo de dicha premisa, el autor explora dos posibles usos del psicoanálisis en el derecho. Uno, representado por Goldstein, se centra en utilizar «premisas psicoanalíticas para resolver conflictos jurídicos», como, por ejemplo, al aportar información psicoanalítica para determinar el interés superior del niño en casos de tenencia. Mientras tanto, el otro, representado por Katz, busca «concientizar acerca de un conflicto en casos donde los todos actores se habían dedicado a reforzar mutuamente su fantasía de que no existía conflicto alguno» entre sujetos de una relación, como ocurría en la relación médico-paciente, con la finalidad de repensar estándares que habían sido fijados por el derecho bajo una ilusión de objetividad y racionalidad. El artículo explora estas dos aproximaciones a través de ejemplos, vinculándolas a dos perspectivas adoptadas por Freud a lo largo de su trabajo académico y tomando una postura preferente por la mirada de Katz.

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.