Langanke Martin, Brothers Kyle B, Erdmann Pia, Weinert Jakob, Krafczyk-Korth Janina, Dörr Marcus, Hoffmann Wolfgang, Kroemer Heyo K, Assel Heinrich
Faculty of Theology, University of Greifswald, Greifswald, Germany.
Per Med. 2011 Jul;8(4):437-444. doi: 10.2217/pme.11.34.
In this article, two different scientific approaches to personalized medicine are compared. Biorepository at Vanderbilt University (BioVU) is a genomic biorepository at Vanderbilt University Medical Center in Nashville, TN, USA. Genetic biosamples are collected from leftover clinical blood samples; medical information is derived from an electronic medical records. Greifswald Approach to Individualized Medicine is a research resource at the University of Greifswald, Germany, comprised of clinical records combined with biosamples collected for research. We demonstrate that although both approaches are based on the collection of clinical data and biosamples, different legal milieus present in the USA and Germany as well as slight differences in scientific goals have led to different 'ethical designs'. While BioVU can successfully operate with an 'opt-out' mechanism, an informed consent-based 'opt-in' model is indispensable to allow GANI_MED to reach its scientific goals.
在本文中，对个性化医疗的两种不同科学方法进行了比较。范德堡大学生物样本库（BioVU）是美国田纳西州纳什维尔范德堡大学医学中心的一个基因组生物样本库。基因生物样本取自剩余的临床血液样本；医学信息则来自电子病历。格赖夫斯瓦尔德个性化医疗方法是德国格赖夫斯瓦尔德大学的一项研究资源，由临床记录与为研究收集的生物样本组成。我们证明，尽管这两种方法都基于临床数据和生物样本的收集，但美国和德国不同的法律环境以及科学目标上的细微差异导致了不同的“伦理设计”。虽然BioVU可以通过“退出”机制成功运作，但基于知情同意的“加入”模式对于让格赖夫斯瓦尔德大学个性化医疗项目（GANI_MED）实现其科学目标来说是必不可少的。
