Gabriela Marodin , Jennifer Braathen Salgueiro , Márcia da Luz Motta , Leonor Maria Pacheco Santos
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Members from the National Commission on Ethics in Research (Comissão Nacional de Ética em Pesquisa – Conep) participated as the social control organization.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":101100,"journal":{"name":"Revista da Associa??o Médica Brasileira (English Edition)","volume":"59 1","pages":"Pages 72-77"},"PeriodicalIF":0.0000,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2255-4823(13)70432-6","citationCount":"7","resultStr":"{\"title\":\"Brazilian guidelines for biorepositories and biobanks of human biological material\",\"authors\":\"Gabriela Marodin , Jennifer Braathen Salgueiro , Márcia da Luz Motta , Leonor Maria Pacheco Santos\",\"doi\":\"10.1016/S2255-4823(13)70432-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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. 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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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>\",\"PeriodicalId\":101100,\"journal\":{\"name\":\"Revista da Associa??o Médica Brasileira (English Edition)\",\"volume\":\"59 1\",\"pages\":\"Pages 72-77\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2013-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/S2255-4823(13)70432-6\",\"citationCount\":\"7\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Revista da Associa??o Médica Brasileira (English Edition)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2255482313704326\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Revista da Associa??o Médica Brasileira (English Edition)","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2255482313704326","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 7
摘要
目的:描述巴西人类生物材料生物储存库和生物库指导方针的参与性和民主性制定，目的是基于人类尊严、自主、仁慈、正义和预防等伦理原则进行研究。方法根据生物库运营经验、区域代表性、储存生物材料类型、生物伦理学专家等标准，组成跨学科工作组编写文件。国家卫生监督局(Agência National de vigilatalncia Sanitária - Anvisa)的成员由于其监管能力也参加了会议。国家研究伦理委员会(comisso Nacional de Ética em Pesquisa - Conep)的成员作为社会控制组织参加了会议。结果该文件以伦理、法律和技术指南为基础，介绍了生物库和生物库的概念、活动、目的和差异;当事人同意的形式;除了关于适当使用信息的关切所渗透的其他方面之外。巴西以研究为目的的人类生物材料生物库和生物库指南包含39篇文章，分五章分发。立法的重要性源于伦理问题，考虑道德和考虑法律方面，这转化为一份文件，而不是以自身为目的。科学的动态总是导致范式的变化，这种变化可以超越现有的规律。
Brazilian guidelines for biorepositories and biobanks of human biological material
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.
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