利用人体生物标本进行研究的伦理思考——美国受试者保护“通用法则”的修改建议及启示

Ethical Consideration on the Researches Using Human Biological Specimen-Revision Suggestion and Enlightenment of "Common Rule" for Subject Protection in the United States

人体生物标本的利用对推动生物医学的进展有重大意义,与此同时,强大的电子数据库信息处理能力给个人信息的保密带来了挑战。对于利用人体生物标本的研究,如何在确保遵循伦理原则的基础上促进研究的顺利开展,是美国卫生与人类服务部在修改美国联邦法规——人体研究受试者保护"通用法则"过程中的重要考虑因素之一。其公布的"建议规则制定通知"提出:通过泛知情同意,强化对受试者自主权的尊重,几乎不再有免除知情同意的情况;对于研究风险仅仅涉及隐私保护,将在明确保证执行隐私法等保护措施的前提下,简化审查程序。围绕NPRM中提出的有关利用人体生物标本的研究的修改情况进行介绍,对NPRM中关于知情同意、豁免审查和排除审查的相关条款进行整理分析,在此基础上探讨对我国伦理审查工作的启发和借鉴。

The use of human biological specimen has great significance to the development of biomedicine. Meanwhile, the powerful electronic data set with sophisticated analytic techniques creates challenge to the protec-tion of private information. As for the research with human biological specimen, how to facilitate the research con-duct on the basis of ethical principles is one of the key considerations when the US Department of Health and Hu-man Service initiated the revision of Code of Federal Regulations （ CFR） -the＂Common Rule＂ for subject protec-tion. The Notice of Proposed Rulemaking （ NPRM） proposed：Respect for autonomy will be enforced by broad con-sent to enforce and waiver of consent intend to be rare;If the research risks only involve privacy protection, review process will be simplified under the premise of ensuring the implementation of privacy laws and other protective measures. The paper introduced the revisions related to the researches using human biological specimen in NPRM, analyzed the terms of broad consent, exemption and exclusion, and explored the elicitation to ethical review prac-tice in China.