Komotar Ricardo J, Zacharia Brad E, Mocco J, Ransom Evan R, Davis Jeffrey P, Gasparis George, Bruce Jeffrey N, Anderson Richard C E
Department of Neurological Surgery, Columbia University, New York, New York, USA.
Neurosurgery. 2006 May;58(5):985-9; discussion 985-9. doi: 10.1227/01.NEU.0000210228.08117.17.
THE PRIVACY RULE, as part of the Health Insurance Portability and Accountability Act, was implemented in 2003 as a response to public concern over potential abuses of private health information. Although the Privacy Rule was not intended to place limits on clinical research, its complexity has caused much confusion throughout the academic medicine and research communities. Many clinical and translational researchers have created clinical databases or human tissue banks to facilitate future research. Maintenance of such databases is considered a research activity under the Privacy Rule, and researchers are, therefore, subject to its regulations. We present a novel Internet-based method to generate and maintain a neurooncology patient registry and human tissue bank. Through our web site, we secure both Health Insurance Portability and Accountability Act research authorization and informed consent, enabling us to contact the treating physician for clinical data and pathological specimens. Considering the importance of continued use of clinical databases and tissue banks in the genetic era of medicine, our method offers one way for researchers to adapt to the changing world of clinical research.
《隐私规则》作为《健康保险流通与责任法案》的一部分，于2003年实施，以回应公众对私人健康信息可能被滥用的担忧。尽管《隐私规则》并非旨在限制临床研究，但其复杂性在整个学术医学和研究界引发了诸多困惑。许多临床和转化研究人员创建了临床数据库或人体组织库，以促进未来的研究。根据《隐私规则》，维护此类数据库被视为一项研究活动，因此研究人员须遵守其规定。我们提出了一种基于互联网的新颖方法，用于生成和维护神经肿瘤患者登记册及人体组织库。通过我们的网站，我们获得了《健康保险流通与责任法案》研究授权及知情同意，从而能够联系主治医生获取临床数据和病理标本。鉴于在医学的基因时代持续使用临床数据库和组织库的重要性，我们的方法为研究人员适应不断变化的临床研究世界提供了一种途径。
