Marodin Gabriela, Salgueiro Jennifer Braathen, Motta Márcia da Luz, Santos Leonor Maria Pacheco
National Commission on Research Ethics (CONEP), National Health Council, Department of Science and Technology (DECIT), Secretariat of Science, Technology and Strategic Inputs (SCTIE), Ministry of Health, Brasília, DF, Brazil.
Rev Assoc Med Bras (1992). 2013 Jan-Feb;59(1):72-7.
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.
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.
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.
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.
基于人类尊严、自主性、 beneficence（此处疑有误，可能是“仁爱”或“善行”等相近意思）、正义和预防等伦理原则，描述巴西人类生物材料生物样本库和生物银行指南的参与式和民主创建过程，用于研究目的。
组建了一个跨学科工作小组来编写该文件，考虑了以下标准：生物样本库运营经验、区域代表性、储存生物材料的类型以及生物伦理专家。国家卫生监督局（Agência Nacional de Vigilância Sanitária - ANVISA）的成员也因其监管能力而参与其中。国家研究伦理委员会（Comissão Nacional de Ética em Pesquisa - Conep）的成员作为社会控制组织参与其中。
该文件基于伦理、法律和技术指南，阐述了生物样本库和生物银行之间的概念、活动、目的和差异；受试者的同意形式；此外还涉及到关于信息恰当使用的其他方面。巴西人类生物材料用于研究的生物样本库和生物银行指南包含39条条款，分为五章。
考虑到道德并兼顾法律层面，立法的重要性源于伦理关切，这转化为一份并非自足的文件。科学的动态发展总是导致范式的变化，这可能超越现有法律。
