Marco ético y jurídico en la investigación científica en chile: acreditación de comités ético científicos / Ethical and legal framework in scientific research from Chile: functioning of accredited scientific ethics committees

RESUMEN: La investigación científica en seres humanos es fundamental para el desarrollo y avance en la ciencia de la salud y para el bienestar de la sociedad. La necesidad de contar con principios éticos explícitos y un marco regulatorio, permitió en el año 2001 la aprobación de la Norma sobre Regulación de Ensayos Clínicos en Seres Humanos. La ley 20.120 (2006), norma la investigación científica en el ser humano, describe aspectos centrales para el desarrollo de la investigación, dando sustento legal a la creación de los Comités Éticos Científicos (CEC), entidades colegiadas que tienen por objeto velar por la protección de la vulneración de derechos y libertades de los participantes, pudiendo aprobar o rechazar los protocolos de los proyectos. En Chile al año 2021 se registran 62 CEC acreditados. La región Metropolitana concentra el 58,2 %, la zona Norte un 11,2 % y en el sur del país un 30,6 %, de ellos solo el 12,9 % están acreditados para evaluar ensayos clínicos aleatorizados (ECA). Los criterios éticos internacionales más utilizados son la Declaración de Helsinki, pautas éticas sobre la salud, bienestar y los derechos de los pacientes; El Consejo Internacional de Ciencias Médicas (CIOMS) que protege en entornos vulnerables de escasos recursos; y el Informe Belmont en la protección de los sujetos de investigación. Se concluye que las guías éticas nacionales e internacionales son pautas que guardan relación con la adecuada protección jurídica de los participantes, velando por el respeto a la autonomía, la justicia y la selección justa de los participantes, a través del consentimiento informado voluntario. El desarrollo de una cultura de conducta ética en la investigación se debe basar en tres dimensiones generales; el ambiente humano, ambiente político y mecanismos de la sociedad civil.

SUMMARY: Scientific research in human beings is essential for the development and advancement of health science and for the well-being of society. The need to have explicit ethical principles and a regulatory framework allowed in 2001 the approval of the Standard on the Regulation of Clinical Trials in Human Beings. Law 20,120 (2006), regulates scientific research in human beings and describes central aspects for the development of research, giving legal support to the creation of Scientific Ethics Committees (SEC), collegiate entities whose purpose is to ensure the protection of the vulnerability of rights and freedoms of the participants, being able to approve or reject the protocols of the projects. In Chile by 2021, 62 accredited CECs are registered. The Metropolitan region concentrates 58.2 %, the North zone 11.2 % and in the south of the country 30.6 %, of which only 12.9 % are accredited to evaluate randomized clinical trials (RCTs). The most widely used international ethical criteria are the Helsinki Declaration, ethical guidelines on health, well-being and the rights of patients; The International Council of Medical Sciences (CIOMS) that protects in vulnerability low-resource settings; and the Belmont Report on the protection of research subjects. It is concluded that the national and international ethical guidelines are appropriate legal ethical guidelines and risk-benefit ratio that protect the participants, ensuring respect for the autonomy, justice and fair selection of the participants, through voluntary informed consent. The development of a culture of ethical conduct in research must be based on three general dimensions; the human environment, political environment and mechanisms of civil society.

Ética y jurisprudencia administrativa de los derechos de los sujetos de investigación en pandemia (COVID-19): función de los comités éticos científicos: Chile / Ethics and administrative jurisprudence of the rights of subjects of research in pandemic (COVID-19): role of the scientific ethics committees: Chile

RESUMEN: Todo gobierno debe reaccionar rápida y efectivamente ante cualquier pandemia, Chile no es la excepción y apoyado en el estado de Excepción Constitucional, ha tenido que implementar medidas que podrían involucrar poca información sobre las percepciones de las personas y las reacciones durante la implementación de las restricciones. Las instituciones internacionales de salud han determinado que es un deber moral realizar investigaciones que generen evidencia que promuevan y mejoren la atención de la salud y la mitigación de la pandemia, instando a reducir los "obstáculos" prácticos de la revisión ética. Los objetivos de este trabajo fueron analizar desde las perspectivas de las consideraciones éticas y jurídicas, el rol que cumplen los Comités Éticos Científicos en el manejo y la protección de las personas durante la pandemia de la COVID-19. La metodología de trabajo se basó en la recolección de la información de Instituciones nacionales e internacionales de Salud y luego analizarla según la jurisprudencia administrativa del gobierno de Chile. Se concluye que los cambios de criterios que deben observar los CECs en el proceso de revisión de los protocolos de los proyectos de investigación científica, deben velar por proteger los derechos de los pacientes y sujetos de investigación en cuanto puede involucrar información sensible, más aún, si se consideran las graves consecuencias de su transgresión, dar un sentido distinto al que corresponda a las normas sobre derechos de pacientes, puede resultar en "falta de servicio" y eventual vulneración en los derechos del sujeto de investigación. La labor de los CEC, debe realizarse siempre desde una interpretación restrictiva, reconociendo la función pública que cumplen como parte integrante de la labor ética encomendada por el legislador al efecto.

SUMMARY: Every government must react quickly and effectively to any pandemic, Chile is no exception and supported by the state of Constitutional Exception, it has had to implement measures that could involve little information about people's perceptions and reactions during the implementation of the restrictions. International health institutions have determined that it is a moral duty to carry out research that generates evidence that promotes and improves health care and the mitigation of the pandemic, urging to reduce the practical "obstacles" to ethical review. The objective of this study was to analyze from the perspectives of ethical and legal considerations, the role that Scientific Ethics Committees play in the management and protection of people during the COVID-19 pandemic. The methodology used was based on collecting information from national and international Health Institutions and then analyzing it according to the administrative jurisprudence of the Chilean government. It is concluded that the changes in criteria that the CECs must observe in the process of reviewing the protocols of scientific research projects, must ensure the protection of the rights of patients and research subjects insofar as it may involve sensitive information, even more if the serious consequences of its transgression are considered. Giving a different meaning to the one that corresponds may result in "lack of service" and eventual violation of the rights of the research subject. The task of the CEC, must always be carried out from a restrictive interpretation, recognizing the public function that they fulfill as an integral part of the ethical work entrusted by the legislators to that effect.

Las investigaciones biomédicas y los reportes de caso realizados en la Caja Costarricense de Seguro Social requieren autorización para su publicación científica / Biomedical investigations and case reports carried out at the Caja Costarricense de Seguro Social require authorization for scientific publication

Resumen Objetivo: La mayoría de colaboraciones recibidas para su publicación en Acta Médica Costarricense surgen de las investigaciones realizadas en la Caja Costarricense de Seguro Social, estas cumplen con las disposiciones que establece la ley sobre investigación biomédica y su reglamento, así como con la diversa normativa que tiene esta institución sanitaria. En el contexto de la revisión constante y actualización periódica de normas para la publicación en esta revista, el objetivo de este trabajo fue analizar los requerimientos vigentes en la Caja Costarricense de Seguro Social para la publicación de las investigaciones biomédicas realizadas en sus servicios. Métodos: Se realizó una investigación documental con una búsqueda dirigida sobre tales disposiciones en la página oficial del Centro de Desarrollo Estratégico e Información en Salud y Seguridad Social; el análisis se amplió con los elementos regulatorios del consentimiento informado. Resultados: Se encontró que los investigadores deben solicitar una autorización al área de Bioética del Centro de Desarrollo Estratégico e Información en Salud y Seguridad Social para publicar, o comunicar en actividades científicas las investigaciones biomédicas que han sido realizadas en la institución; así mismo se estipula la gestión para dar a conocer los reportes de casos y la solicitud se tramita con el cumplimiento de una serie de requisitos. Conclusión: Las investigaciones biomédicas realizadas en la Caja Costarricense de Seguro Social requieren la solicitud de una autorización y el cumplimiento de una serie de requisitos para la publicación en la bibliografía científica o su exposición en una actividad científica, al igual que los reportes de caso. Es por tanto, necesario que el/los investigador/es gestionen oportunamente la autorización institucional.

Abstract Aim: Most of the contributions received for publication in this journal arise from the investigations carried out by the Caja Costarricense de Seguro Social, these comply with the provisions established by the law on biomedical research and its regulations, as well as with the various regulations that it has this health institution. In the context of the constant review and periodic updating of standards for publication in this journal, the objective of this work was to analyze the current requirements in the Caja Costarricense de Seguro Social for the publication of biomedical research carried out in its services. Methods: A documentary investigation was conducted with a directed search about regulations was made on the official website of the Centro de Desarrollo Estratégico e Información en Salud y Seguridad Social; information was compiled and analyzed, then prepared for orderly display; the analysis was extended with the regulatory elements of informed consent. Results: It was found that researchers must request an authorization from the Bioethics area to publish, or communicate in scientific activities, the biomedical research that has been carried out in the institution. Likewise, the management to publicize the case reports is stipulated and the request is processed with the fulfillment of a series of requirements. Conclusion: The authorization request and the requirements apply to biomedical research and case reports, whether a publication is sought in the scientific literature or its exposure in a scientific activity; therefore, it is the responsibility of the researcher to manage the institutional authorization in a timely manner.

Especialismo, especificidade e identidade - as controvérsias em torno do autismo no SUS / Specialism, specificity and identity - the controversiessurrounding autism in the Brazilian Unified Health System (SUS)

Resumo A aprovação da Lei no 12.764/2012 representou uma vitória do ativismo político de familiares de autistas no Brasil, mas também deu visibilidade a um enorme antagonismo entre uma parcela significativa de pais de autistas e a rede de saúde mental. Este artigo analisa o posicionamento dos diferentes atores envolvidos na controvérsia que se sucedeu à aprovação e regulamentação da lei, e procura demonstrar as razões pelas quais essa polêmica antecede à lei e não se resolve com ela. Argumenta-se que a conturbada relação entre o movimento político de pais de autistas e a rede de saúde mental pode ser mais bem entendida se tomarmos a construção e a legitimação de uma rede de "expertise" a respeito dos transtornos do espectro autista como indissociável da construção de uma identidade social e política para os autistas no Brasil. O artigo utiliza como referência teórica os Estudos sobre Expertise e Experiência, que têm como principal pano de fundo uma discussão acerca do novo regime de relações entre a pesquisa científica e a sociedade civil. Entretanto, demonstramos também que a consolidação dessa rede de expertise vem ocorrendo apesar da ausência de uma ampla rede de tratamentos especializados e de uma reconfiguração profunda no regime de pesquisa e de produção de conhecimento sobre autismo no Brasil.

Abstract The passing of federal law 12,764/2012 marked a victory for the political activism of parents of autistic individuals in Brazil, but it also drew attention to the serious antagonism between parents of autistic individuals and the mental health network. This article examines the perspectives of social actors involved in the controversy that took place after the enactment of this law and seeks to show why this controversy precedes the passing of the law and is not resolved by it. The argument is that the troubled relationship between the political movement of parents of autistic individuals and the mental health network can be better understood when the construction and consolidation of a network of expertise around autism spectrum disorders as being inseparable from the construction of a social and political identity for autistic people in Brazil is taken into consideration. The article draws inspiration from the Studies of Expertise and Experience, which discuss the new regime of relations between scientific research and civil society. Nevertheless, it is also seen that the consolidation of this expertise network has arisen despite the absence of a broad specialized treatment network and of a profound reconfiguration in the regime of scientific research and production of knowledge about autism in Brazil.

Tensiones en torno a la inclusión de personas con el diagnóstico de demencia en investigación científica / Tensions around including persons with diagnosis of dementia in scientific research / Tensões sobre a inclusão de pessoas com diagnóstico de demência na investigação científica

Resumen: La demencia -Trastorno Neurocognitivo Mayor- se caracteriza por deterioro cognitivo adquirido y otros síntomas psicológicos y conductuales que impactan en la capacidad de la persona para responder efectivamente a las demandas del ambiente. El número de personas con demencia aumenta de forma consistente en el mundo, volviéndose una prioridad para la salud pública y elevando la urgencia de contar con estrategias para enfrentar su impacto. La investigación científica biomédica, clínica y psicosocial es fundamental en toda estrategia de abordaje de la demencia. Este artículo sintetiza elementos relacionados con la inclusión de personas con demencia en investigación científica desde diferentes perspectivas, incluyendo el impacto del déficit cognitivo y la jurisprudencia local. Entre los dilemas bioéticos vinculados a investigación en demencia se encuentra la evaluación de capacidad de consentimiento. Las leyes 20.120 y 20.584 levantan controversias en el caso de la discapacidad, atingentes a la participación de personas con demencia en investigación científica. El presente manuscrito busca aportar una síntesis de elementos clave para el análisis de la participación de personas con demencia en investigación científica.

Abstract: Dementia -Major Neurocognitive Disorder- features cognitive impairment and other behavioral and psychological symptoms that impact the person's capacity to respond effectively to the environmental demands. The number of persons with dementia is consistently increasing in the world and therefore has become a public health priority that urges the development of strategies to address its impact. Biomedical, clinical and psychosocial scientific research in dementia must be part of any dementia strategy. Dementia research raises bioethical issues and people with dementia are often excluded from research. This article seeks to synthesize relevant elements related to the inclusion of persons with dementia in research from different perspectives, including the impact of cognitive impairment and local jurisprudence. Bioethical dilemmas in dementia research involve, among others, the determination of capacity to consent. Chilean laws 20.120 and 20.084 rise controversies in the case of disability that relate directly to participation of persons with dementia in researching. This manuscript seeks to contribute with a synthesis of key elements for the analysis of the participation of persons with dementia in scientific research.

Resumo: A demência - Transtorno Neurocognitivo Maior - caracteriza-se pela deterioração cognitiva adquirida e outros sintomas psicológicos e comportamentais que impactam sobre a capacidade da pessoa para responder eficazmente às demandas do ambiente. O número de pessoas com demência aumenta consistentemente no mundo, tornando-se uma prioridade para a saúde pública e elevando a urgência de formulação de estratégias para lidar com o seu impacto. A investigação científica biomédica, clínica e psicossocial, é fundamental em toda estratégia de abordagem da demência. Este artigo sintetiza elementos relacionados com a inclusão de pessoas com demência na investigação científica a partir de diferentes perspectivas, incluindo o impacto dos déficits cognitivos e a jurisprudência local. Dentre os dilemas éticos vinculados à investigação em demência se incluem a avaliação da capacidade de consentimento. As leis 20.120 e 20.584 suscitam controvérsias no caso da deficiência, com relação à participação de pessoas com demência em pesquisa científica. O presente artigo visa contribuir com uma síntese de elementos-chave para a análise da participação das pessoas com demência na investigação científica.

Declaración de la Academia Chilena de Medicina sobre el Título V de la Ley 20. 850 (Ley Ricarte Soto) y su proyecto de reglamento "De los ensayos clínicos de productos farmacéuticos y elementos de uso médico" / Declaration of the Chilean Academy of Medicine of Law 20. 850 "On clinical trials of pharmaceutical products and medical devices" and of the bylaw that will regulate its application

In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1) The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2) The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3) Individuals submitted to the trials are entitled to free post trial access to the treatment received during the study, financed by the trial supporting entities and as long as the drug or devise is considered to be useful. While agreeing with the need to have a National Registry of Clinical Trials, we predict that the mentioned critical issues in the bylaw will lead to difficulties and unnecessary judicial processes, thus limiting clinicians’ interest in performing research. We propose to modify the bylaw, excluding responsibilities on events associated with the natural evolution of the medical condition, with patients’ ageing or with comorbidities and clinical events considered unpredictable when the protocol was accepted. We recommend that the free post trial access should be a joint decision involving the patient and the attending physician, taking in consideration that the volunteer has been exposed to risks and burdens, or when discontinuation of treatment entails a vital risk until the treatment under study has been approved and becomes available in the national market.

En Chile los tratamientos de alto costo requeridos por seleccionadas condiciones médicas son financiados por el Estado, de acuerdo a la Ley 20.85, que se hizo efectiva en noviembre de 2015. Un reglamento de esta ley -actualmente en discusión por el Senado- incluye la regulación de los ensayos clínicos y plantea importantes aspectos que van a poner en riesgo la realización de investigaciones clínicas avanzadas: 1) El control exclusivo y mandatorio otorgado al Instituto de Salud Pública durante todas las etapas de los ensayos y la vigilancia de las instituciones que los realizan, que sobrepasa las atribuciones de los Comités de Ética Científica Institucionales; 2) El período de hasta 10 años después de la aparición de cualquier efecto adverso, durante el cual se asume causado por el medicamento o dispositivo evaluado en el ensayo, mientras no se demuestre lo contrario en un proceso judicial; 3) Los participantes de los estudios tienen derecho a continuar con el tratamiento recibido durante el estudio una vez terminado este, financiado por las entidades que patrocinan los estudios y mientras el fármaco o dispositivo se consideren útil. Estamos de acuerdo con la necesidad de contar con un Registro Nacional de Ensayos Clínicos. Sin embargo, predecimos que los aspectos críticos del reglamento causarán dificultades y procesos judiciales innecesarios, lo que limitará el interés de los clínicos en realizar investigación. Proponemos que el reglamento debe modificarse a fin de excluir responsabilidades sobre eventos asociados con la evolución natural de la condición clínica, el envejecimiento del paciente, comorbilidades y eventos clínicos no predecibles cuando se aceptó el estudio. Recomendamos que el acceso gratuito posterior al estudio debe constituir una decisión conjunta del paciente y su médico tratante, considerando los riesgos y la carga a que se expuso el paciente, o al riesgo vital secundario a la suspensión del tratamiento del estudio mientras no esté disponible en el mercado nacional.

Impact of regulatory assessment on clinical studies in Brazil / Impacto da avaliação regulatória em estudos clínicos no Brasil

SUMMARY Introduction: Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. Objective: This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process. Method: The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process. Results: 46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses. Conclusion: Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country’s scientific development.

RESUMO Introdução: apesar da recente expansão de estudos clínicos alocados para o Brasil, a demora dos prazos regulatórios locais impacta diretamente em sua realização. Objetivo: este artigo analisa o processo de alocação de estudos clínicos para o Brasil em comparação a outros países, bem como o impacto financeiro dos estudos não realizados em decorrência da interrupção pela demora no processo regulatório. Método: foram comparados os processos de alocação de estudos em nove países com estágios semelhantes de desenvolvimento econômico e países da América Latina através dos siteshttp://data.worldbank.org/data-catalog/GDP-ranking-table, http://worldpopulationreview.com e clinicaltrials.gov, que engloba 185 países. Os 46 estudos patrocinados pela indústria farmacêutica tiveram o processo de avaliação regulatória analisado. Resultados: foram analisados 46 estudos patrocinados pela indústria submetidos no país entre junho de 2007 e junho de 2013; 18 (39%) foram descontinuados pelo atraso na obtenção das aprovações necessárias. Para os estudos aprovados, o recrutamento de pacientes começou, em média, aos 11 meses após os demais países. Estima-se que 530 pacientes brasileiros não tiveram a oportunidade de participar desses estudos. As perdas financeiras foram da ordem de 14,6 milhões de dólares para o país, incluindo custos com paciente, medicação, suprimentos e despesas administrativas. Conclusão: o Brasil tem um enorme potencial para a realização de estudos clínicos. Investigadores, associações de deficientes e pacientes portadores de doenças crônicas, patrocinadores e autoridades devem trabalhar juntos para desenvolver um processo de aprovação eficiente, previsível e antes de tudo transparente. O atual ambiente regulatório deve e pode ser melhorado e aperfeiçoado, caso contrário não resultará em benefícios tangíveis para o paciente, para a sociedade e a evolução médico-científica do país.

Intrarenal Surgery vs Percutaneous Nephrolithotomy in the Management of Lower Pole Stones Greater than 2 cm

Purpose To compare the efficacy of RIRS and PNL in lower pole stones ≥2 cm. Materials and and Methods: A total of 109 patients who underwent PNL or RIRS for solitary lower pole stone between April 2009 and December 2012, were retrospectively analyzed. Lower pole stone was diagnosed with CT scan. Stone size was assessed as the longest axis of the stone. All patients were informed about the advantages, disadvantages and probable complications of both PNL and RIRS before the selection of the procedure. Patients decided the surgery type by themselves without being under any influences and written informed consent was obtained from all patients prior to the surgery. Patients were divided into two groups according to the patients’ preference of surgery type. Group 1 consisted of 77 patients who underwent PNL and Group 2 consisted of 32 patients treated with RIRS. Stone free statuses, postoperative complications, operative time and hospitalization time were compared in both groups. Results There was no statistical significance between the two groups in mean age, stone size, stone laterality, mean follow-up periods and mean operative times. In PNL group, stone-free rate was 96.1% at first session and 100% after the additional procedure. In Group 2, stone-free rate was 90.6% at the first procedure and 100% after the additional procedure. The final stone-free rates and operative times were similar in both groups. Conclusions RIRS should be an effective treatment alternative to PNL in lower pole stones larger than 2 cm, especially in selected patients. .

A snapshot of cancer in Chile: analytical frameworks for developing a cancer policy

INTRODUCTION: The South American country Chile now boasts a life expectancy of over 80 years. As a consequence, Chile now faces the increasing social and economic burden of cancer and must implement political policy to deliver equitable cancer care. Hindering the development of a national cancer policy is the lack of comprehensive analysis of cancer infrastructure and economic impact. OBJECTIVES: Evaluate existing cancer policy, the extent of national investigation and the socio-economic impact of cancer to deliver guidelines for the framing of an equitable national cancer policy. METHODS: Burden, research and care-policy systems were assessed by triangulating objective system metrics -epidemiological, economic, etc. - with political and policy analysis. Analysis of the literature and governmental databases was performed. The oncology community was interviewed and surveyed. RESULTS: Chile utilizes 1% of its gross domestic product on cancer care and treatment. We estimate that the economic impact as measured in Disability Adjusted Life Years to be US$ 3.5 billion. Persistent inequalities still occur in cancer distribution and treatment. A high quality cancer research community is expanding, however, insufficient funding is directed towards disproportionally prevalent stomach, lung and gallbladder cancers. CONCLUSIONS: Chile has a rapidly ageing population wherein 40% smoke, 67% are overweight and 18% abuse alcohol, and thus the corresponding burden of cancer will have a negative impact on an affordable health care system. We conclude that the Chilean government must develop a national cancer strategy, which the authors outline herein and believe is essential to permit equitable cancer care for the country.

Scientific sanctions: a catastrophe for the civilised world.

Nowadays, Iranians are being subjected to the strictest sanctions ever imposed against a country. The political deadlock between six international powers and Iranian officials has resulted in a proliferation of sanctions touching all aspects of Iranian activities. Economic sanctions have caused intolerable suffering to the people and now, another type of sanctions has been foisted on us - scientific sanctions.

Ethical challenges in biobanking: moving the agenda forward in India.

There is no agreement on the typology and definition of biobanks. The present regulations across countries, including India, focus on genomic and genetic databases and DNA and cell line biobanking. It is unclear how the range of the holdings of biological samples in diagnostic and research laboratories fall under these regulatory frameworks. Biobank-related research has become very attractive because of advances in sample storage and data processing, a better understanding of the human genome, and high throughput laboratory assays.

Analysis of Human Tissue Management Models for Medical Research: Preparation for Implementation of the 2012 Revision of the Bioethics and Safety Act of Korea

Efficient management of human tissue samples is a critical issue; the supply of samples is unable to satisfy the current demands for research. Lack of informed consent is also an ethical problem. One of the goals of the 2012 revision of Korea's Bioethics and Safety Act was to implement regulations that govern the management of human tissue samples. To remain competitive, medical institutions must prepare for these future changes. In this report, we review two tissue management models that are currently in use; model 1 is the most common system utilized by hospitals in Korea and model 2 is implemented by some of the larger institutions. We also propose three alternative models that offer advantages over the systems currently in use. Model 3 is a multi-bank model that protects the independence of physicians and pathologists. Model 4 utilizes a comprehensive single bioresource bank; although in this case, the pathologists gain control of the samples, which may make it difficult to implement. Model 5, which employs a bioresource utilization steering committee (BUSC), is viable to implement and still maintains the advantages of Model 4. To comply with the upcoming law, we suggest that physicians and pathologists in an institution should collaborate to choose one of the improved models of tissue management system that best fits for their situation.

Desenvolvimento de um sistema para gerenciar os processos regulatórios do Laboratório de Pesquisa Clínica em DST e Aids do Instituto de Pesquisa Clínica Evandro Chagas da Fundação Oswaldo Cruz / Development of a system to manage the Regulatory Process the Laboratório de Pesquisa Clínica in DST e Aids at Instituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz

A atividade regulatória em pesquisa clínica visa o cumprimento de todas as etapas frente às autoridades regulatórias para a condução da pesquisa em conformidade com as Boas Práticas Clínicas. Segundo a International Conference on Harmonization (ICH – Conferência Internacional de Harmonização), as autoridades regulatórias são instâncias dotadas de poder de regulamentação que, conforme as normas de Boas Práticas Clínicas, incluem as autoridades que revisam os dados clínicos e as autoridades que realizam a inspeção. Devido à complexidade do processo regulatório no Brasil é necessário estar atento às modificações na legislação e normas para submissão dos projetos de pesquisa às autoridades reguladoras em um curto prazo de tempo, para cumprir o planejamento dos períodos de duração dos estudos clínicos. O presente trabalho tem o objetivo de desenvolver e disponibilizar um sistema para gerenciar os processos regulatórios do Laboratório de Pesquisa Clínica em DST e Aids do Instituto de Pesquisa Clinica Evandro Chagas, da Fundação Oswaldo Cruz, atendendo à regulamentação nacional e internacional. Uma vez que processo é um conjunto de ações ordenadas e integradas para um fim produtivo específico, ao final do qual serão gerados produtos e/ou serviços e/ou informações, foi realizado o mapeamento das atividades desenvolvidas no dia a dia do setor de assuntos regulatórios do centro para obtenção das aprovações regulatórias das pesquisas em DST e Aids, bem como do processo administrativo para ingresso da equipe de trabalho nos protocolos. Para a representação gráfica dos processos foi usada a notação de modelagem de processos de negócios, Business Process Model Notation (BPMN), que é um padrão definido pelo Governo Federal e já utilizada pela Fundação Oswaldo Cruz. O software BizAgi® foi usado para modelagem dos processos regulatórios...

Regulatory activity in Clinical Research aims at the compliance of all the steps required bythe Regulatory Authorities for the conduction of research in accordance with Good ClinicalPractices. According to the International Conference on Harmonization (ICH), RegulatoryAuthorities are instances endowed with regulatory power that, according to the standards ofGood Clinical Practices, include the authorities who review the clinical data, and theauthorities conducting the inspection. Due to the complexity of the regulatory process inBrazil is crucial to be aware of changes in legislation and regulations for the submission ofresearch projects to regulatory authorities in a short period of time, to comply with the clinicalstudies scheduled time periods. This study aims to develop and make available a database tomanage the regulatory processes of Laboratório de Pesquisa Clínica em DST/Aids at Institutode Pesquisa Evandro Chagas (IPEC), Fundação Oswaldo Cruz (Fiocruz), according tonational and international regulations. As process is a set of coordinated and integratedactions to a specific productive result, which will eventually yieldproducts/services/information, a mapping of the daily activities of the Laboratory RegulatoryAffairs to obtain regulatory approvals for research on STD and Aids, as well as theadministrative procedures for including the study team in the protocols. For the process’graphical representation modeling business processes’ notation was used, the BusinessProcess Model Notation (BPMN), which is a standard defined by the Federal Government,and already used by the Oswaldo Cruz Foundation. The BizAgi ® software was used formodeling of the regulatory processes...