Creación del primer biorrepositorio nacional de bacterias multirresistentes disponible para el estudio de la resistencia bacteriana en Chile / Creation of the first national biorepository of multi-resistant bacteria available for the study of bacterial resistance in Chile

La disponibilidad de cepas bacteriana para el estudio de la resistencia bacteriana es clave para los avances en la investigación básica y clínica respecto del tema. Existen pocos biorrepositorios o bancos de bacterias con mecanismos de resistencia conocidos, aisladas de infecciones clínicamente significativas. Una revisión de la literatura revela que sólo en los Estados Unidos de América existe un biobanco de aislados resistentes disponibles para estudios. En esta publicación se cuenta cómo se creó el primer biorrepositorio de bacterias resistentes en Chile asociados a la Red de Laboratorios MICROB-R, con la participación de 11 centros distribuidos a lo largo del país, que a la fecha cuenta con más de 3.500 aislados bacterianos estudiados fenotípica y genotípicamente, disponibles para la comunidad científica chilena.

The availability of bacterial strains for the study of bacterial resistance is key to advances in basic and clinical research. There are few biobanks of bacteria with known resistance mechanisms, isolated from clinically significant infections. A review of the literature reveals that only in the United States of America is there a biobank of resistant isolates. This publication shows the creation of the first biorepository of resistant bacteria Chile associated with the MICROB-R Laboratory Network, with the participation of 11 centers distributed throughout the country, which to date has more than 3,500 bacterial isolates studied phenotypically and genotypically, available to the Chilean scientific community.

Biobancos y COVID-19: implicaciones éticas / Biobanks and COVID-19: Ethical implications / Biobanks e COVID-19: Implicações éticas

Propósito/Contexto: De acuerdo con los antecedentes de epidemias anteriores, y en el contexto de la emergencia actual por COVID19, se ha reconocido como prioritario el desarrollo de investigaciones y la creación de biobancos o biorepositorios, que permitan el acceso a muestras e información para comprender la enfermedad, formular intervenciones, evaluar la seguridad y eficacia de exámenes, pruebas de diagnóstico, tratamientos, vacunas y estrategias de manejo. Aunque la investigación durante eventos de importancia en salud pública es fundamental, los estudios con seres humanos durante las emergencias deben contar con mayores garantías éticas que en las situaciones ordinarias. Metodología/Enfoque: para esta revisión se realizó la búsqueda de literatura relacionada con normatividad y legislación, biobancos, colecciones de muestras, y su relevancia en el contexto de la pandemia. Discusión/Conclusiones/Contribuciones: En esta revisión incluimos algunas reflexiones sobre el establecimiento y uso de los biobancos en el contexto de la pandemia que aqueja al mundo actualmente.

Purpose/Context. According to the history of previous epidemics, and in the context of the current emergency caused by COVID-19, it is a priority to carry out research and create biobanks or biorepositories. These allow accessing samples and information to understand the disease, formulate interventions, and evaluate the safety and efficacy of examinations, diagnostic tests, treatments, vaccines, and management strategies. Although research during significant public health emergencies is essential, studies on human beings in these cases must have higher ethical guarantees than ordinary situations. Method/Approach. This review includes literature related to regulations and legislation, biobanks, sample collections, and their relevance to the context of the pandemic. Results/Findings. Accelerated sample collection and the establishment of biobanks have been typical during this pandemic, which induces the adoption of sample management guidelines with major ethical, legal, and social differences among countries. Discussion/Conclusions/Contributions. This review comprises reflections on the establishment and use of biobanks during the pandemic that is currently afflicting the world.

Objetivo/Contexto. De acordo com os antecedentes de epidemias anteriores e no contexto da atual emergência causada pelo COVID-19, tem-se reconhecido como prioritário o desenvolvimento de pesquisas e a criação de biobancos ou bio-repositórios, que permitam o acesso a amostras e informações para entender a doença, formular intervenções, avaliar a segurança e eficácia dos exames, dos testes de diagnóstico, dos tratamentos, as vacinas e as estratégias de manejo. Embora a pesquisa durante eventos importantes em saúde pública seja essencial, os estudos com seres humanos em situações de emergência devem ter maiores garantias éticas do que em situações comuns. Metodologia/Abordagem. Para esta revisão, se efetuo a busca de literatura relacionada com o regulamento e legislação, biobancos, coletas de amostras e sua relevância no contexto da pandemia. Resultados/Descobertas. Achamos que, no contexto da pandemia, é comum a coleta acelerada de amostras e o estabelecimento de biobancos, o que induz à adoção de diretrizes para o tratamento dessas amostras, com diferenças importantes em aspectos éticos, legais e sociais entre os diferentes países. Discussão/Conclusões/Contribuições. Nesta revisão, incluímos algumas reflexões sobre o estabelecimento e o uso de biobancos no contexto da pandemia que atualmente afeta o mundo.

Cross-sectional survey of cognitive status and attitude of different population about biobanking donation / 中华医院管理杂志

Objective To understand the cognition and attitude of patients, medical staff and medical examination people on biobanks and their willingness to donation. Methods A cross-sectional study was conducted among 452 individuals, including patients, medical staff and people receiving health checkup at a hospital in Beijing from July to September, 2017. The questionnaire assessed the respondents′demographic data, general knowledge about biobanking and the factors influencing their willingness to donate specimens to biobanks. Pearson′s Chi-square test, student t test or ANOVA were used for univariate analysis. Additionally, the linear regression analysis and logistic regression analysis were used for multivariate analyses. Results A total of 452 questionnaires were delivered, and the effective questionnaires amounted to 440, including 196 medical staff, 123 patients and 121 health checkup individuals. The awareness score of biobanks was significantly different among the medical staff, patients and health checkup individuals ( P < 0. 05 ) . After adjustment for potential risk factors, we found that the population characteristics and the experience of participation in a medical research were the independent beneficial factors of the awareness score. The percentage of the willingness of donation in medical staff, health checkup individuals and patients were 83. 7％, 76. 9％ and 70. 7％, respectively. The results of univariate analyses suggested that the population characteristics, education level, health conditions, the history of blood donation, and the experience of participation in a medical research were significantly associated with the willingness to donate ( all P <0. 05 ) . Population characteristics and health conditions were independently relevant to the willingness of donation, after multivariate analyses of logistic regression. Conclusions Despite the strong willingness to donate biospecimens, patients and health checkup individuals lack knowledge of biobanking. It is apparent that we need to strengthen promotions and to encourage the ethics and humanities to improve the knowledge of biosample donation, for healthy development of hospital-based biobanks.

Omics techniques and biobanks to find new biomarkers for the early detection of acute lymphoblastic leukemia in middle-income countries: a perspective from Mexico / Técnicas ómicas y biobancos para el hallazgo de nuevos biomarcadores para la detección temprana de leucemia linfoblástica aguda en países de ingresos medios: una perspectiva mexicana

Abstract: Acute lymphoblastic leukemia (ALL) affects the quality of life of many children in the world and particularly in Mexico, where a high incidence has been reported. With a proper financial investment and with well-organized institutions caring for those patients, together with solid platforms to perform high-throughput analyses, we propose the creation of a Mexican repository system of serum and cells from bone marrow and blood samples derived from tissues of pediatric patients with ALL diagnosis. This resource, in combination with omics technologies, particularly proteomics and metabolomics, would allow longitudinal studies, offering an opportunity to design and apply personalized ALL treatments. Importantly, it would accelerate the development of translational science and will lead us to further discoveries, including the identification of new biomarkers for the early detection of leukemia.

Resumen: La leucemia linfoblástica aguda (LLA) afecta la calidad de vida de una gran cantidad de individuos en edad pediátrica en todo el mundo; particularmente en México, donde se ha reportado una alta incidencia. Con un apropiado fondo de inversión financiera, así como instituciones adecuadamente organizadas al cuidado de los pacientes con LLA, en conjunto con plataformas sólidas para llevar a cabo análisis globales y de alto rendimiento, se propone la creación de un repositorio para la conservación de suero y células provenientes de médula ósea y sangre derivadas de pacientes pediátricos con LLA al diagnóstico. Estos recursos, en combinación con las tecnologías ómicas, en particular la proteómica y la metabolómica, podrían permitir el establecimiento de estudios longitudinales y ofrecer una oportunidad para el diseño y aplicación de tratamientos personalizados para la LLA. Esta estrategia permitiría acelerar el desarrollo de la ciencia traslacional, favoreciendo el hallazgo de importantes descubrimientos, incluyendo la identificación de nuevos biomarcadores para la detección temprana de la leucemia.

Biobanking: A Challenge Facing Pathologists in Egypt.

Background: Biobanking today plays a key tool in biomedical research. Establishment and proper running of biobanks in developing countries is confronted with a number of challenges of legal, ethical, and financial nature. Considering that there are no guidelines or regulations to control biobanking in Egypt; major ethical issues arise and are often managed by research ethics committees (RECs). Pathologists are the custodians of tissue samples in different universities and hospitals; they have an important role in advancement of scientific research. So, they have to equip themselves adequately to manage the evolution of pathology work towards integration of biomarker analysis in clinical research and to deal with the ethical and legal issues of biobanks in Egypt. Objective/Aim: The purpose of this review is to highlight the current situation of human tissue research and biobanking in Egypt with Comparative policy of other countries. We will address the role of pathologists and the difficulties and challenges facing the process of initiating biobanks and give some recommendations that might help different stakeholders for biobanking in Egypt. Conclusion: Egypt is one of the developing countries which are in need to implement biobanks to improve the quality of research. The review highlights the different challenges facing biobanks in Egypt, mainly: lack of legislations, consent form, public trust, tissue transfer and commercialization. It also discuss the role of pathologists and research ethics committees in establishing and maintaining the work in these biobanks; and to make every effort for the interests of the participants, community and scientific progress, hopefully for good future biomedical research in Egypt.

Ethical Issues of Privacy Protection Caused by Biobanks Research in Data Context / 世界科学技术-中医药现代化

In traditional biomedical research, a series of mechanism and measures had been taken for identity protection of data subjects, such as data disclosure in aggregated methods, information restricted in public only after identified variables removal and etc. The purpose of such process was aimed to properly keep confidentiality of health information for the target subjects in research. As the protection of subject privacy was viewed as one of the most essential principle of medical ethics in human research, the effects to fulfill and accomplish such process can help to maintain the trust and support among participants and social public. Currently, such traditional modes of privacy safeguard are widely-applied in genetics and genomics study. However, the universal applicability also causes a number of controversies, and the effectiveness remains to be proven. Nowadays, the risk assessments of data subjects’ privacy call for taking the whole“data context” into consideration, not just self-restricted in isolation and confined to quality control of data disclosure. With the soaring increasing of data resources in research involved human subjects, the issues of releasing genetic data have caused more and more public attention, especially for the sensitive domains of privacy protection. Based on the core problem and principles, this article attempted to discuss the controversial bioethical issues such as data context, data-intruder concept, privacy of data subject, identity control of releasing data, potential risk of individual identification, privacy protection of data subject, and etc. We hope these considerations can provide references to the bioethical understanding of biobanks research and decision-making of ethic review.

La medicina personalizada, la revolución genómica y el Sistema Nacional de Salud / Customized medicine, genomic revolution and the national health care system

La profundización del conocimiento de los mecanismos moleculares del proceso salud-enfermedad ha hecho que avances científicos hayan encontrado lugar en la práctica clínica, como ha ocurrido en Cuba con las células madre. Los resultados derivados de la secuenciación del genoma humano y de otras especies mejora diagnósticos y tratamientos, sin embargo, dentro del sistema sanitario cubano no abundan las aplicaciones de las tecnologías genómicas. Esta nueva medicina necesita acumular todavía evidencia acerca de su seguridad y eficacia, se requiere una estrategia propia del Ministerio de Salud Pública en relación con la evaluación de sus usos, presentes y potenciales, en beneficio de la salud de la población. Se propone, entre otras acciones, constituir un grupo de trabajo multiinstitucional e intersectorial para estudiar las dimensiones clínicas, tecnológicas, reguladoras y bioéticas de la medicina genómica. Resulta imprescindible la preparación inmediata del personal que estudia en el pregrado o ya ejerce en las ciencias médicas, pues corresponderá a ellos la introducción y la extensión de estas tecnologías en el ejercicio de su práctica profesional. De manera inmediata es posible conformar cohortes que sean representativas de la población cubana, estudiarlas y conservar sus muestras en biobancos establecidos para tales fines. La progresiva introducción de las aplicaciones en la práctica clínica de la genómica y las tecnologías relacionadas, reclama del Sistema Nacional de Salud una atención que conduzca al estudio, la evaluación y propuesta de las acciones que permitan su implementación, según las evidencias y las condiciones y necesidades del modelo cubano de atención sanitaria(AU)

Deepening into the knowledge of the molecular mechanisms of the health/disease process has made many scientific advances to find a place into the clinical practice, as is the case of stem cells therapy in Cuba. The results derived from the sequencing of the human genome, as well of other species, have had an impact in the improvement of diagnoses and therapies; however, within the Cuban national health system the applications of genomic technologies are not widespread. Despite the fact that this new medicine still needs to accumulate much more evidence supporting its safety and efficacy, it is urgent to design a customized strategy by the Cuban Ministry of Public Health towards the assessment of current and potential uses of genomic medicine for the benefit of the population's health. Among other actions, this paper submitted the proposal of the creation of a multi-institutional and intersectoral taskforce to study the clinical, technological, regulatory and bioethical dimensions of genomic medicine. It is mandatory to train both undergraduate students and staff since they will be responsible to introduce and extend such technologies in their professional practice. It is already possible to make up cohorts resembling as much as possible the Cuban population, to study them and to collect and preserve their samples in biobanks established for such purposes(AU)

Changes in Contexts, Issues and Ethical Approaches:Encyclopedia of Applied Ethics--From First Edition to Second Edition / 中国医学伦理学

Since the publication of the first edition of the Encyclopedia of Applied Ethics in 1998 , the world has changed .The post-millennium and post 9/11 context brought with it a shift of emphasis concerning the re-sponse to terrorism , for example , including growing interest in measures such as biometric identification technolo-gies.But it is not only in the socio -political context that we see a change .In science the sequencing of the human genome , the promise of stem cell science and the rise of synthetic biology have all led to considerable debate .Ethi-cal issues also increasingly have a global dimension .The second edition of the Encyclopedia of Applied Ethics in-volved some issues that not or little mentioned in the 1998 version.Neverthless, it still reserved those classicpa-pers and updated when necessary , to reflect the progress of applied ethical approaches .Here, I tried to draw the outline of the main trends and ways of debates during this time .I think these ways can be divided into three catego-ries, due to the changes in contexts , issues and ethical approaches .

Genomic sovereignty or the enemy within / Soberanía genómica o el enemigo interior / Soberania genômica ou o inimigo interior

Genomic sovereignty is a concept that has become very popular among developing countries such as India, China, South Africa and Mexico. This concept is a response to developed countries that have taken advantage of those countries and researchers who don't have the means for protecting their own biogenetic resources. In this article we argue that genomic sovereignty is not about the “others” extracting and exploiting local “human genetic resources”, but developing and implementing the ethical, legal and administrative tools, based on transparency, openness and equal access to biological material, in order to build up a robust research networks. Being biological samples a scarce and valuable good, we conclude that controlling the access to this resource by means of the law, without a well implemented biobanking system and a clear scientific policy may lead to a situation where asymmetric relations are generated among research groups of the very same developing country. We would advice to those countries pretending to protect their biological samples and data from the outside, before developing laws against possible “intrusions”, they need to design strategies to promote equal and fair access to both resources paramount to biomedical research.

“Soberanía genómica” es un concepto que se ha hecho muy popular entre los países en desarrollo, como India, China, Sudáfrica y México. Este concepto es una respuesta a los países desarrollados que han tomado ventaja, aprovechándose de aquellos países y de los investigadores que no tienen los medios para proteger sus propios recursos biogenéticos. En este artículo argumentamos que la soberanía genética no se trata de impedir que “otros” extraigan y exploten “los recursos genéticos humanos” locales, sino del desarrollo y de la aplicación de las herramientas éticas, jurídicas y administrativas basadas en la transparencia, la apertura e igualdad en el acceso al material biológico, con el fin de construir redes de investigación sólidas. Al ser las muestras biológicas un bien escaso y valioso, concluimos que el control del acceso a este recurso, por medio de la ley, sin un sistema de biobancos bien implementado y sin una política científica clara, puede llevar a una relación asimétrica entre los grupos de investigación del mismo país en desarrollo. Nos gustaría advertir a los países que pretenden proteger sus muestras biológicas y datos asociados que, antes que elaborar leyes contra posibles intrusiones, es necesario diseñar estrategias para promover el acceso justo y equitativo a los recursos primordiales para la investigación biomédica.

“Soberania genômica” é um conceito que se fez muito popular entre os países em desenvolvimento, como Índia, China, África do Sul e México. Este conceito é uma resposta aos países desenvolvidos que obtiveram vantagem, aproveitando-se daqueles países e dos investigadores que não têm meios para proteger os seus próprios recursos biogenéticos. Neste artigo argumentamos que a soberania genética não trata de impedir que “outros” extraiam e explorem “os recursos genéticos humanos” locais, senão do desenvolvimento e da aplicação das ferramentas éticas, jurídicas e administrativas baseadas na transparência, abertura e igualdade no acesso ao material biológico, com a finalidade de construir redes de investigação sólidas. Por serem as amostras biológicas um bem escasso e valioso, concluimos que o controle do acesso a este recurso, por meio da lei, sem um sistema de biobancos bem implementado e sem uma política científica clara, pode levar a uma relação assimétrica entre os grupos de investigação de um mesmo país em desenvolvimento. Gostaríamos advertir aos países que pretendem proteger suas amostras biológicas e dados associados que, antes de elaborar leis contra possíveis intromissões, é necessário projetar estratégias para promover o acesso justo e equitativo aos recursos primordiais para a investigação biomédica.

Administración biopolítica de la intimidad en los biobancos / Administração biopolítica da intimidade nos biobancos / Biopolitical administration within biobanks

Desde los experimentos originales de Mendel sobre las características hereditarias de las plantas de arvejas, las ciencias biológicas han desplegado una trayectoria que pareciera no tener límites y que ha cristalizado en nuestros días en la generación de sistemas de información acerca de la genética humana, cuya expresión más consumada representan, indudablemente, los Biobancos. El empleo de este material de tejido humano, capaz de revelar la historia de las enfermedades y los estilos de vida de los individuos por parte de la investigación biomédica, ha suscitado un alto interés de científicos, filósofos, juristas y otros estudiosos, que han querido reflexionar acerca de los desafíos teóricos y prácticos de esta nueva apertura del conocimiento. En este trabajo se examinan las dificultades éticas que se podrían derivar de la administración de la información almacenada en los Biobancos, en la medida en que se entienda que su concepción, implementación y desarrollo implican riesgos asociados a la expresión y expansión de una “biopolítica” contemporánea, tal como el término en cuestión ha sido caracterizado e interpretado por el filósofo francés Michel Foucault.

Since Mendel´s original experiments on genetic characteristics of greenpeas, the biological sciences have evolved in an apparently unlimited fashion and created information systems on human genetics, whose most complete expression are undoubtedly the Biobanks. Use of human tissue able to revel disease history and individual lifestyle has generated interest in scientists, philosophers, lawyers and other scholars who reflect on the practical and theoretical challenges of this new knowledge. This paper explores ethical difficulties derived from administration of biobanks insofar as their implementation and development imply risks associated to the expression and expansion of contemporary “biopolitics”, as conceived by Michel Foucault.

partir dos experimentos originais de Mendel sobre as características hereditárias das plantas de ervilhas, as ciências biológicas descolaram uma trajetória que parecia não ter limites e que cristalizou-se em nossos dias numa geração de sistemas de informação sobre a genética humana, cuja expressão mais consumada representam, indubitavelmente, os Biobancos. O emprego deste material de tecido humano, capaz de revelar a história das enfermidades e os estilos de vida dos indivíduos por parte da investigação biomédica, têm suscitado um alto interesse de cientistas, filósofos, juristas e outros estudiosos, que têm querido refletir acerca dos desafios teóricos e práticos desta nova abertura do conhecimento. Neste trabalho tenta-se perscrutar as dificuldades éticas que poderiam derivar da administração da informação armazenada nos Biobancos, na medida em que se entenda que sua concepção, implementação e desenvolvimento implicam riscos associados à expressão e expansão de uma “biopolítica” contemporânea, tal como o termo em questão foi caracterizado e interpretado pelo filósofo francês Michel Foucault.

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.

Biobancos, dados genéticos e proteção jurídico-penal da intimidade / Biobanks, genetic data and legal and criminal protection of privacy

O artigo trata da questão dos biobancos para pesquisa e dos aspectos jurídicos relacionados à proteção de dados genéticos dos sujeitos de pesquisa. Mais especificamente, além da definição de biobancos e dados genéticos, analisa-se os dados genéticos e testes genéticos e a relação médico-sujeito de pesquisa, bem como a proteção criminal da intimidade genética, sugerindo-se a criação de uma lei que regulamente a coleta, o acesso, a utilização e o armazenamento dos dados genéticos a fim de prevenir testes genéticos para fins médicos arbitrários (AU)

The article deals with the issue of biobanks for research and legal aspects related to the protection of genetic data of study subjects. More specifically, besides the definition of biobanks and genetic data, we analyze genetic data and genetic testing and the physician-subject relationship in research, as well as criminal protection of genetic privacy, suggesting the creation of a law that regulates the collection, access, use and storage of genetic data to prevent genetic testing for arbitrary medical purposes (AU)

Bioética de los Bancos de muestras en la Pesquisa Neonatal / Bioetics of the bio-banks in the neonatal screening / Bioética dos biobancos na pesquisa neonatal

La creación y empleo de bancos de muestras o biobancos ha demostrado tener una gran importancia dentro del desarrollo e Implementación de programas de pesquisa neonatal. Estos nos permite no sólo diagnosticar enfermedades que no pueden ser detectadas clínicamente y que con un tratamiento temprano pueden ser evitadas secuelas como el retraso mental y la muerte sino que nos permite realizar estudios poblacionales para evaluar la influencia de diferentes parámetros como la edad gestacional, el sexo, el peso al nacer, la edad de toma de muestra, así como otros factores que pueden afectar los resultados de los ensayos clínicos. El uso de biobancos supone tener en cuenta aspectos bioéticos, debido a que una muestra biológica se considera como parte del organismo inclusive cuando está separada de él, por lo que debe ser respetada y cuidada su integridad, aún cuando ya ha sido extraída y almacenada. La pesquisa neonatal y el empleo de biobancos son regulados en todos los países donde se encuentran implementados con el fin de garantizar que se cumplan estos aspectos éticos.

The creation and use of sample databases or biobanks has proven to be extremely important in the development and implementation of neonatal screening programs. This allows us to not only diagnose diseases that can not be detected clinically and that early treatment can prevent sequelae such as mental retardation and death, but allows us to conduct population studies to assess the influence of different parameters such as gestational age, sex, birth weight, age of sampling and other factors that may affect the results of these trials. The use of biobanks involves consideration of bioethical issues, because a biological sample is considered part of the body even when separated from this so it must be respected and cared for his integrity, even when it has been extracted and stored. The neonatal screening and use of bio-banks are regulated in all countries where they are implemented in order to ensure compliance with these ethical.

A criação e a utilização de bancos de amostras ou biobancos são importantes no desenvolvimento e a posta em prática de programas de pesquisa neonatal. Esse permite não apenas diagnosticar doenças que não pode ser detectada clinicamente -das que o tratamento precoce pode evitar seqüelas, como retardo mental e morte-, mas também a realização de estudos populacionais para avaliar a influência de diferentes parâmetros, por exemplo, idade gestacional, sexo, peso ao nascer, idade da amostragem e outros fatores que podem afetar os resultados destes ensaios clínicos. O uso de biobancos envolve a consideração de questões de bioética, pois uma amostra biológica é considerada parte do corpo -mesmo que esté separada deste-; portanto, sua integridade deve ser respeitada e cuidada, mesmo se esta já foi extraída e armazenada. Para assegurar o cumprimento desses aspetos éticos, a pesquisa neonatal e a utilização de biobancos são regulamentadas em todos os países onde se levam a cabo.