Regulatory and ethical considerations for linking clinical and administrative databases
Regulatory and ethical considerations for linking clinical and administrative databases
复制标题
DOI：
10.1016/j.ahj.2009.03.023
复制
发表时间：
2009-06-01
影响因子：
4.8
通讯作者：
Peterson, Eric D.
中科院分区：
文献类型：
--
作者：
Dokholyan, Rachel S.;Muhlbaier, Lawrence H.;Peterson, Eric D.
临床数据登记是支持证据开发、性能评估、比较有效性研究以及在常规临床实践中采用新治疗的宝贵工具。虽然这些登记没有关于长期治疗或临床事件的重要信息，但管理索赔数据库提供了潜在的有价值的补充。本文重点介绍了使用注册数据进行研究所产生的监管和伦理问题，包括临床和管理数据集的联系。(1)这些活动是否主要用于质量评估和改进、研究或两者兼而有之，因为这决定了适当的道德和监管标准？(2)向中心登记中心提交数据（随后可能链接到其他数据源）是否需要每个参与组织的机构审查委员会（IRB）进行审查？(3)IRB的哪些监督级别和机制适用于链接的中央数据存储库的存在以及随后可能使用它开发的特定研究？(4)在什么情况下需要放弃知情同意和健康保险携带和责任法案授权？(5)对于一个有限的数据集有什么要求，可以使一项研究活动不涉及人类受试者，因此不需要进一步的IRB审查？本文中概述的方法代表了在几个临床数据注册项目的背景下对法规的本地解释，并侧重于胸外科医师协会国家数据库的特定案例研究。(Am Heart J 2009;157：971-82.）
Clinical data registries are valuable tools that support evidence development, performance assessment, comparative effectiveness studies, and the adoption of new treatments into routine clinical practice. Although these registries do not have important information on long-term therapies or clinical events, administrative claims databases offer a potentially valuable complement. This article focuses on the regulatory and ethical considerations that arise from the use of registry data for research, including linkage of clinical and administrative data sets. (1) Are such activities primarily designed for quality assessment and improvement, research, or both, as this determines the appropriate ethical and regulatory standards? (2) Does the submission of data to a central registry, which may subsequently be linked to other data sources, require review by the institutional review board (IRB) of each participating organization? (3) What levels and mechanisms of IRB oversight are appropriate for the existence of a linked central data repository and the specific studies that may subsequently be developed using it? (4) Under what circumstances are waivers of informed consent and Health Insurance Portability and Accountability Act authorization required? (5) What are the requirements for a limited data set that would qualify a research activity as not involving human subjects and thus not subject to further IRB review? The approaches outlined in this article represent a local interpretation of the regulations in the context of several clinical data registry projects and focuses on a specific case study of the Society of Thoracic Surgeons National Database. (Am Heart J 2009;157:971-82.)