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[康复研究中的数据保护]

[Data protection in rehabilitation research].

作者信息

Exner A K, Gerold H, Breckenkamp J, Bahmer J, Klemke R, Berg-Beckhoff G, Horschke A, Razum O

机构信息

Fakultät für Gesundheitswissenschaften, AG3 - Epidemiologie & International Public Health, Universität Bielefeld.

Deutsche Rentenversicherung Bund, Referat für Datenschutz, Berlin.

出版信息

Rehabilitation (Stuttg). 2014 Aug;53(4):258-67. doi: 10.1055/s-0033-1357115. Epub 2013 Dec 20.

Abstract

Data protection is regulated by legislation and has to be adhered to by scientists, too. This overview shows where aspects of data protection have to be considered in rehabilitation research. Important legal sources are the code of social law X, the German Federal Data Protection Act and the data protection acts of the German states. Specific recommendations about patient information sheet and written informed consent are given for research based on interviews with study participants. Furthermore, operations such as collecting, processing, using, storing, publishing and archiving of personal data are explained, taking into account the requirements of data protection. A practical example (URL: www.thieme-connect.de/ejournals/toc/rehabilitation) shows how to separate personal data and research data using the services of an external data custodian.

摘要

数据保护受法律监管,科学家也必须遵守。本概述展示了在康复研究中必须考虑数据保护的哪些方面。重要的法律依据包括《社会法典》第十卷、德国联邦数据保护法以及德国各州的数据保护法。基于对研究参与者的访谈,针对患者信息表和书面知情同意书给出了具体建议。此外,还考虑到数据保护的要求,对个人数据的收集、处理、使用、存储、发布和存档等操作进行了解释。一个实际例子(网址:www.thieme-connect.de/ejournals/toc/rehabilitation)展示了如何利用外部数据保管机构的服务来分离个人数据和研究数据。

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