Division of Cancer Biology, National Cancer Institute, 6130 Executive Boulevard, Suite 5000, Bethesda, MD 20892, USA.
Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1012-5. doi: 10.1158/1055-9965.EPI-10-0029. Epub 2010 Mar 23.
Human biological specimens (biospecimens) are increasingly important for research that aims to advance human health. Yet, despite significant proliferation in specimen-based research and discoveries during the past decade, research remains challenged by the inequitable access to high-quality biospecimens that are collected under rigorous ethical standards. This is primarily caused by the complex level of control and ownership exerted by the myriad of stakeholders involved in the biospecimen research process. This article discusses the ethical model of custodianship as a framework for biospecimen-based research to promote fair research access and resolve issues of control and potential conflicts between biobanks, investigators, human research participants (human subjects), and sponsors. Custodianship is the caretaking obligation for biospecimens from initial collection to final dissemination of research findings. It endorses key practices and operating principles for responsible oversight of biospecimens collected for research. Embracing the custodial model would ensure transparency in research, fairness to human research participants, and shared accountability among all stakeholders involved in biospecimen-based research.
人类生物标本（生物样本）对于旨在促进人类健康的研究越来越重要。然而，尽管在过去十年中基于标本的研究和发现显著增加，但研究仍然受到严格伦理标准下收集的高质量生物样本获取不平等的挑战。这主要是由于参与生物样本研究过程的众多利益相关者施加的复杂控制和所有权水平造成的。本文讨论了保管伦理模型作为促进公平研究准入和解决生物库、研究人员、人类研究参与者（人类受试者）和赞助商之间的控制和潜在冲突问题的生物样本研究框架。保管是指从生物样本的最初收集到最终研究结果发布期间对其进行保管的责任。它认可了负责任地监督为研究收集的生物样本的关键实践和操作原则。采用保管模式将确保研究的透明度、对人类研究参与者的公平性以及参与生物样本研究的所有利益相关者的共同问责制。
