El Biobanco Institucional como pilar de las ciencias médicas / Institutional Biobank as a pillar of medical science

Resumen: Los biobancos constituyen puentes efectivos entre grupos de investigación básicos y clínicos para generar conocimientos y aplicaciones que eleven su competitividad internacional. Se revisaron las tareas realizadas y los logros alcanzados durante la implementación del Biobanco Institucional de la Universidad Autónoma de Nuevo León (UANL). Se abordó el equipamiento, entrenamiento del personal, aspectos bioéticos y regulatorios, y procesos de laboratorio y de gestión de calidad, entre otros. A partir del apoyo a más de una docena de proyectos de investigación, la inscripción de más de 3 000 individuos y la colecta, procesamiento y almacenamiento de casi 6 000 bioespecímenes, el Biobanco Institucional contribuye de manera importante a la integración de las actividades de asistencia, docencia e investigación básica y clínica del Hospital Universitario y de la Facultad de Medicina de la UANL. Se iniciaron planes para transitar del Biobanco Institucional hacia el Laboratorio Nacional.

Abstract: A biobank facility is one of the most valuable means that academic medical organizations have to offer researchers for improving the competitiveness of their medical research. We describe the implementation of our institutional biobank. Our efforts focused on the design and equipment of work areas, staff training, quality control, bioethical and regulatory issues, generating research collaborations and developing funding strategies. We implemented an institutional biobank at the School of Medicine of the Autonomous University of Nuevo León, Mexico. The biobank has supported more than a dozen research protocols with over 3 000 individuals enrolled and almost 6 000 sampled biospecimens stored. The institutional biobank has become an essential bridge and effective catalyst for research synergies between basic and clinical sciences and it is on its way to becoming a National Laboratory.

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. .

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.

Diretrizes nacionais para biorrepositório e biobanco de material biológico humano / Brazilian guidelines for biorepositories and biobanks of human biological material

OBJETIVO: Caracterizar a construção participativa e democrática das Diretrizes Nacionais para Biorrepositório e Biobanco de Material Biológico Humano com Finalidade de Pesquisa, baseada nos princípios éticos da dignidade humana, da autonomia, da beneficência, da justiça e da precaução. MÉTODOS: Para a elaboração do documento formou-se um grupo de trabalho interdisciplinar Bioética considerando os seguintes critérios: experiência na operacionalização de biobancos, Biobancos representatividade regional, tipo de material biológico acondicionado e especialistas em Biorrepositório bioética. Participaram, também, membros da Agência Nacional de Vigilância Sanitária Diretrizes - Anvisa, pela competência regulatória e da Comissão Nacional de Ética em Pesquisa - Conep, enquanto controle social. RESULTADOS: O documento, baseado nos preceitos éticos, legais e técnicos, apresenta os conceitos, as atividades, finalidades e diferenças entre biorrepositórios e biobancos, as formas de consentimento do sujeito, além de outros aspectos permeados pela preocupação do uso adequado da informação. As Diretrizes Nacionais para Biorrepositório e Biobanco de Material Biológico Humano com Finalidade de Pesquisa contém 39 artigos, dispostos em cinco capítulos. CONCLUSÃO: A importância de uma regulamentação surge da reflexão ética, considerando a moral, e tendo como norteador os aspectos legais, os quais se traduzem em um documento que não se esgota em si mesmo. A dinamicidade da ciência sempre nos remete à mudança de paradigmas, que podem ir além das legislações existentes.

OBJECTIVE: To characterize the participatory and democratic creation of the Brazilian guidelines for biorepositories and biobanks of human biological material with the purpose of research based on the ethical principles of human dignity, autonomy, beneficence, justice, and precaution. METHODS: An interdisciplinary work group was constituted to prepare the document, considering the following criteria: experience in biobank operation, regional representation, type of stored biological material, and bioethics specialists. Members of the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA), also participated due to their regulatory competence. Members from the National Commission on Ethics in Research (Comissão Nacional de Ética em Pesquisa - Conep) participated as the social control organization. RESULTS: The document, based on ethical, legal, and technical guidelines, presents the concepts, activities, purposes, and differences between biorepositories and biobanks; forms of consent on the part of the subject; in addition to other aspects permeated by concerns regarding the appropriate use of information. The Brazilian guidelines for biorepository and biobank of human biological material with the purpose of research contains 39 articles, which are distributed in five chapters. CONCLUSION: The importance of legislation arises from the ethical concern, considering morals and taking into account the legal aspects, which translate into a document that does not end in itself. The dynamics of science always leads to changes in paradigms, which can go beyond the existing laws.

Biobanking for health research in Brazil: present challenges and future directions / Bancos de materiales biológicos para la investigación en salud en el Brasil: retos actuales y perspectivas futuras

This article outlines and discusses Brazil's new regulations on the use of human biological materials for research, specifically, Resolution CNS 441/11, enacted by the National Health Council of Brazil in May 2011, and the National Guidelines for Biorepositories and Biobanks (Ordinance No. 2201) published by the Ministry of Health in September 2011. The authors examine the differences between sample collections for single studies and large-scale collections for multiple studies (e.g., the National Tumor Bank at the Brazilian National Cancer Institute and the A. C. Camargo Hospital Biobank). Also discussed are the ethical and operational implications, i.e.,informed consent process, strategies for sample collection, custodianship, access to samples, and rules for disposal. Insights gained may be useful for developing national biobanking regulations in other countries in Latin America.

En este artículo se describen y se analizan los nuevos reglamentos del Brasil -para el uso de materiales biológicos humanos para la investigación; específicamente, la Resolución CNS 441/11, sancionada por el Consejo Nacional de Salud del Brasil en mayo del 2011, y las Directrices Nacionales para Repositorios Biológicos y Bancos de Materiales Biológicos (Ordenanza Nº. 2201), publicadas por el Ministerio de Salud en septiembre del 2011. Los autores examinan las diferencias entre la recolección de muestras para un estudio único y la recolección en gran escala para múltiples estudios (por ejemplo, el Banco Nacional de Tumores del Instituto Nacional del Cáncer del Brasil y el Banco de Materiales Biológicos del Hospital A. C. Camargo). También se analizan las implicaciones éticas y operativas, como el proceso de consentimiento informado, las estrategias de obtención de las muestras, su custodia, el acceso a las muestras y las reglas para desecharlas. Estos conocimientos pueden ser útiles para establecer reglamentos nacionales para los bancos de materiales biológicos en otros países de América Latina.

Consideraciones éticas y legales de los biobancos para investigación: [revisión] / Research biobanks: ethical and legal considerations: [review]

Un biobanco es una colección de muestras biológicas y datos asociados con fines diagnósticos, terapéuticos o de investigación. Las actividades llevadas a cabo por los bancos de muestras biológicas conllevan muchos dilemas éticos y legales, por lo que en el ámbito internacional existen diversas normas y recomendaciones establecidas para salvaguardar los derechos de los donantes. En Colombia, el Instituto Nacional de Cancerología considera prioritario la creación de un biobanco con fines de investigación. El propósito de este artículo es realizar una revisión de la literatura, internacional como nacional, sobre los aspectos éticos y legales relacionados con los biobancos para investigación científica. La adaptación de los requerimientos internacionales sería el primer paso para la implementación de los estándares éticos y legales de los biobancos en Colombia. Se hace necesario el establecimiento de regulaciones nacionales que controlen las actividades de dichos biobancos y de esta manera se contribuya a la participación activa de la sociedad colombiana.

Biobanco do Hospital de Clínicas de Porto Alegre: aspectos técnicos, éticos, jurídicos e sociais / Hospital de Clínicas de Porto Alegre biobank: technical, ethical, legal and social issues

As atividades de pesquisa em saúde cada vez mais necessitam do armazenamento de materiais biológicos em biorepositórios e em biobancos. O estabelecimento de políticas institucionais para lidar com aspectos técnicos, éticos, legais e sociais é imprescindível para garantir a sua adequação. O Hospital de Clínicas de Porto Alegre está com um projeto de desenvolvimento em execução para propiciar que estas atividades sejam harmônicas e integradas.

Health research increasingly requires the storage of biological samples in biorepositories and in biobanks. The establishment of institutional policies to deal with technical, ethical, legal and social issues is essential to ensure the adequacy of these activities. Hospital Clínicas de Porto Alegre has a development project to bring harmony and integration to these activities.

Embryonic stem cell bank.

Embryonic stem cell bank is a cornerstone for stem cell research. It is providing essential resources to support advances in research in this challenging field that promises broad-ranging cell and tissue therapy. It is important to make good quality and well characterized embryonic cell lines that will be available for both research and clinical purposes. This article provides a concise summary on embryonic stem cell banking processes from cell line characterization, storage, quality assurance, safety testing, distribution, and post-distribution monitoring. It also states the importance of an international network and collaboration for technology and knowledge transfer Moreover, the Bank should play a substantial role as a national reference and a training center for stem cell research.

Estruturação do banco de dentes humanos decíduos da Universidade Federal de Santa Maria/RS/Brasil / Structuralization of the human primary teeth bank of the Universidade Federal de Santa Maria

A criação de bancos de dentes nas instituições brasileira de ensino odontológico é o melhor meio para eliminar o comércio ilegal de dentes, diminuir o risco de infecções cruzadas, em razão do manuseio indiscriminado de dentes extraídos, e conscientizar os indivíduos sobre a importância dos dentes como órgãos (FERREIRA et al., 2003); IMAPARATO, 2003). O Banco de Dentes Humanos Decíduos da Universidade Federal de Santa Maria (BDH-D/UFSM) é uma instituição sem fins lucrativos, cujo propósito é organizar e facilitar a doação de dentes decíduos, formalizando suas origens e destinos, criando condições ideais para a utilização desses órgãos de acordo com a Lei de Tranplante Brasileira (lei n.9.434 de 4/2/1997) e com o Conselho Nacional de Saúde (resolução n.196 de 10/10/1996) (BRASIL, 1996; BRASIL, 1997). Assim, este artigo tem como objetivo abordar a estruturação do BDH-D/UFSM, esclarecendo as normas e os protocolos para o seu funcionamento, explicitando aspectos importantes, como arrecadação de dentes, a separação, a limpeza, o armazenamento e a cessão ou o empréstimo de orgãos dentais

Desarrollo de bancos de muestras para investigación en epidemiología molecular / Development of sample banks for research in molecular epidemiology

En los últimos años se ha implementado la metodología para el desarrollo de bancos de material genético, mediante el establecimiento de líneas celulares transformadas, la extracción directa del DNA, el almacenamiento de sangre u otros tejidos criopreservados y el estudio de muestras conservadas en bloques de parafina. Los propósitos principales para la creación de estos bancos pueden ser académicos y de investigación, principalmente relacionados con el mapeo génico o contemplar aspectos de servicio, tales como estudios familiares de ligamiento por riesgo genético, identificación en casos de medicina forense y tipificación para trasplantes. Estos desarrollos tienen muy importantes implicaciones éticas y legales y crean derechos y obligaciones por parte de los donadores y por quienes manejan los bancos de material biológico