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瑞典的《医疗生物银行法》在实施过程中出现适用范围有限、伦理原则缺失、有关职责界定不清等问题,科学界和医疗界提议出台新的生物银行法以替代旧法,促进医疗领域健康发展。瑞典新的生物银行法报告在尊重个体完整和隐私的前提下,将监管所有人类组织样本的收集、存储和使用,并将完善样本捐献者的知情同意,强化样本捐献者的自决权,增加可追溯性规定和样本库个人资料处理原则,申明生物样本跨界合作的安全问题,对正在修订《涉及人的生物医学研究伦理审查办法》的我国具有借鉴意义。
In the course of the implementation of the “Medical Biological Banking Law” in Sweden, there are problems such as limited applicability, lack of ethical principles and unclear responsibilities. The scientific community and the medical community have proposed a new bio-banking law to replace the old law and promote the healthy development of the medical field . The new Swedish Biological Bank Act regulates the collection, storage and use of samples of all human tissues with respect to individual integrity and privacy and will improve the informed consent of sample donors and enhance the self-determination of sample donors, Retrospective provisions and the principle of personal data processing of sample banks, affirming the safety of cross-border cooperation in biological samples is of great significance to our country that is revising the “Measures for Ethical Review of Biomedical Research Involving Human Beings.”