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巴西关于人体部分用于研究的捐赠及专利的法律和生物伦理方法。

Brazilian legal and bioethical approach about donation for research and patents of human body parts.

作者信息

Fernandes Márcia Santana, Silla Lúcia, Goldim José Roberto, Martins-Costa Judith

机构信息

Social and Legal Institute - Instituto de Estudos Culturalistas (IEC), Canela, Brazil.

Hospital de Clinicas de Porto Alegre (HCPA), Porto Alegre, Brazil.

出版信息

J Community Genet. 2017 Jul;8(3):199-208. doi: 10.1007/s12687-017-0303-y. Epub 2017 May 29.

Abstract

The aim of this paper is to explain why the Brazilian legal system does not accept commercialization or commodification of human body parts, including genes or cells. As a consequence, in Brazil, the donation of human body parts for research-including basic or translational-must be made altruistically. For the same reason, the Brazilian patent system cannot be applied to human parts, cells or genes. Here, we present a qualitative analysis of juridical, bioethical, and social reasoning related to the legal status of human body parts especially in biobanks, as well as a description of the Brazilian legal system for clarification. Our aim is to discuss the responsibility of researchers for making available the scientific information resulting from scientific research and biobank storage of human body parts and to ensure the free utilization of knowledge in human health research.

摘要

本文旨在解释为何巴西法律体系不接受人体部分(包括基因或细胞)的商业化或商品化。因此,在巴西,用于研究(包括基础研究或转化研究)的人体部分捐赠必须是利他性的。出于同样的原因,巴西专利制度不适用于人体部分、细胞或基因。在此,我们对与人体部分法律地位相关的法律、生物伦理和社会推理进行定性分析,特别是在生物样本库方面,并描述巴西法律体系以作澄清。我们的目的是讨论研究人员在提供人体部分科研及生物样本库储存所产生的科学信息方面的责任,并确保人类健康研究中知识的自由利用。

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