Martín Arribas María Concepción, Arias Díaz Javier
Comité de Ética de Investigación y Bienestar Animal. Instituto de Salud Carlos III (ISCIII), Madrid, España.
Cir Esp. 2011 Apr;89(4):207-12. doi: 10.1016/j.ciresp.2010.07.014. Epub 2011 Jan 21.
In recent years, there has been a growing interest in the development of biological samples and biobanks that make it easier for investigators to have access to quality samples and their associated clinical and epidemiological data. Thus, biobanks have become indispensible technological platforms for the development of both basic and clinical research. The properties of the biological sample as a support medium of personal and family information require that they are treated in accordance with new ethical standards. For this reason, the Law on Biomedical Research, provides a new regulatory framework in the process of obtaining samples and their storage for research purposes, where the consent of the source subject, data protection, the favourable opinion of a Research Ethics Committee, the prior taking out of an insurance policy against possible adverse effects, and the quality and safety requirements in the handling and management of these materials are key elements.
近年来，人们对生物样本和生物样本库的开发越来越感兴趣，这使得研究人员更容易获得高质量的样本及其相关的临床和流行病学数据。因此，生物样本库已成为基础研究和临床研究发展不可或缺的技术平台。生物样本作为个人和家庭信息的载体，其特性要求按照新的伦理标准进行处理。因此，《生物医学研究法》在获取样本及其用于研究目的的储存过程中提供了一个新的监管框架，其中源主体的同意、数据保护、研究伦理委员会的赞成意见、事先购买针对可能的不利影响的保险政策，以及这些材料处理和管理中的质量和安全要求是关键要素。
