PDF(Pubmed)
Abstract：
Incidental research findings pose a considerable challenge to hospital-based research biobanks since they are acting as intermediaries between healthcare and research. In a joint action the centralized biobank ibdw (Interdisciplinary Bank of Biomaterials and Data Wuerzburg) together with local authorities drafted a coherent concept to manage incidental research findings in full compliance with relevant ethical and data privacy regulations. The concept was developed and elaborated in close collaboration with the German Biobank Alliance (GBA). Comprehensive documentation of all steps guarantees the traceability of the process. By a mandatory assessment of the findings prior to re-identification of the individual concerned, unnecessary measures can be avoided. The individual\'s \"right not to know\" is respected according to the stipulations of the informed consent. As a general principle any communication with the individual occurs exclusively through the hospital and by competent physicians with appropriate knowledge and communication skills. We propose this scheme as a blueprint for reporting workflows for incidental research findings at hospital-based biobanks.
摘要：
偶然的研究发现对基于医院的研究生物库构成了相当大的挑战，因为它们是医疗保健和研究之间的中介。在一项联合行动中，中央生物银行ibdw（生物材料和数据的跨学科银行）与地方当局一起起草了一个连贯的概念，以完全符合相关的道德和数据隐私法规来管理偶然的研究结果。该概念是与德国生物库联盟（GBA）密切合作制定和阐述的。所有步骤的全面文档保证了过程的可追溯性。通过在重新识别有关个人之前对调查结果进行强制性评估，可以避免不必要的措施。根据知情同意书的规定，尊重个人的“不知情权”。作为一般原则，与个人的任何沟通都仅通过医院和具有适当知识和沟通技巧的合格医生进行。我们建议将此方案作为报告基于医院的生物库附带研究结果的工作流程的蓝图。
