Sharing Restricted Data for Secondary Research: Evolving Tools and Protocols

说明(申请人提供)：在二次研究中成功使用数据的关键问题之一是数据的可用性和存储库，如国家老龄问题计算机化数据档案馆(NACDA)，以建立数据质量标准和可靠地获取所支持的研究。近年来，对数据保密性的日益关注已成为直接影响二次分析研究数据获取和有效性的核心问题。虽然长期以来一直存在明确和系统的指导方针，以帮助研究人员识别和消除直接识别符带来的风险，但针对通常所称的“演绎披露”的新进展越来越影响我们对分享什么是安全，什么不安全的思考。这项申请并没有具体讨论这场争论，因为从建立合理的数据共享政策的角度来看，NACDA只是接受了这样一个事实，即演绎披露模式正在改变主要数据收集者对其研究的安全共享的看法，以进行二次分析。NACDA认为它的作用是与研究人员合作创建数据共享协议，以促进机密研究数据的共享，同时最大限度地保护研究的披露。目前，对于处理包含有问题的变量组合的数据的研究人员，没有明确的指导方针。认识到根据某种形式的限制使用协议，将必须共享越来越多的二次分析研究，该应用程序寻求研究支持，以制定和实施一致的协议，以共享限制使用数据收集。为了实现这些目标，这项建议将解决三个具体目标：1)共享受限访问数据的创新战略：NACDA将与NIA老龄中心和其他主要研究实体合作，制定“安全港”协议，允许一组明确的、已建立合规的“客户组织”简化对受限数据资源的访问；2)为HIPAA数据建立标准化的分发协议：根据1996年“健康保险可携带性和责任法”(HIPAA)的规定，数据的增长增加了人们对如何以及何时可以共享这些数据的困惑。通过将NACDA作为“非覆盖实体”的角色正规化，我们可以创建数据共享协议，在尊重HIPAA要求的同时简化此类数据的共享。3)开发标准化工具和文件，以满足IRB对二次分析的要求：随着机构审查委员会继续在使用数据进行二次分析方面发挥更积极的作用，二级研究人员必须越来越多地将他们的项目提交给当地IRB审查，NACDA才能发布数据。我们将为研究人员提供一个工具包，使他们能够有效地记录 以符合联邦人类受试者研究标准的方式使用NACDA的受限数据收集。总体而言，这些目标将极大地加强和促进将受限数据用于二次分析，从而对联邦资助的具有特定披露风险问题的研究的潜力产生广泛和持久的影响。

DESCRIPTION (provided by applicant): One of the key issues associated with the successful use of data in secondary research is its availability and repositories such as the National Archive of Computerized Data on Aging (NACDA) in establishing standards for data quality and reliable access to supported studies. In recent years growing concern over data confidentiality has emerged as a core directly impacting access to and the availably of research data for secondary analysis. While clear and systematic guidelines have long existed to help researchers identify and eliminate risks presented by direct identifiers, new developments addressing what is commonly called "deductive disclosure" increasingly impact our thinking in what is and is not safe to share. This application does not specifically address this debate because, from the perspective of establishing rational data sharing policies, NACDA simply accepts the fact that deductive disclosure models are changing the way primary data collectors view the safe sharing of their studies for secondary analysis. NACDA views its role as one where we work with researchers to create data sharing protocols that facilitate the sharing of confidential research data while maximizing disclosure protections for the study. At present, no clear guidelines exist for a researcher dealing with data that contains problematic variable combinations. Recognizing that a growing number of secondary analysis studies will have to be shared under some form of restricted use agreement, this application seeks research support to develop and implement consistent protocols for sharing of restricted use data collections. To accomplish these goals this proposal will address three specific goals: 1) Innovative Strategies for the Sharing of Restricted Access Data: NACDA will work with NIA Aging Centers and other major research entities to develop "safe harbor" agreements which allows a defined set of known "client organizations" with established compliance to have streamlined access to restricted data resources; 2) Establish Standardized Distribution Protocols for HIPAA Data: The growth of data falling under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) has increased confusion over how and when these data can be shared. By formalizing NACDA's role as a "non-covered entity" we can create data sharing protocols that simplify the sharing of such data while respecting HIPAA requirements. 3) Developing Standardized Tools and Documents to Address IRB Requirements for Secondary Analysis: As Institutional Review Boards continue to play a more active role in the use of data for secondary analysis, secondary researchers must increasingly submit their projects for local IRB review before the NACDA can release the data. We will offer researchers a tool kit that allows them to effectively document the use of NACDA's restricted data collections in a manner that is compliment with federal standards for human subjects research. Collectively, these goals will greatly enhance and facilitate the use of restricted data for secondary analysis providing a broad and lasting impact on the research potential of federally funded studies with specific disclosure risk issues.