Sharing Restricted Data for Secondary Research: Evolving Tools and Protocols

描述（由申请人提供）：在二级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，如国家老龄化计算机数据档案馆（NACDA）建立数据质量标准和可靠访问支持研究。近年来，对数据保密性的日益关注已经成为直接影响二次分析研究数据获取和可用性的核心问题。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标识符带来的风险，但解决通常被称为“演绎披露”的新发展日益影响我们对分享安全与否的思考。本申请并没有特别针对这一争论，因为从建立理性数据共享政策的角度来看，NACDA只是接受这样一个事实，即演绎披露模型正在改变原始数据收集者对其研究的安全共享进行二次分析的方式。NACDA认为，它的作用是与研究人员合作，制定数据共享协议，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，对于研究人员处理包含有问题的变量组合的数据，没有明确的指导方针。认识到越来越多的二次分析研究将不得不在某种形式的限制使用协议下共享，本申请寻求研究支持，以开发和实施一致的协议，共享限制使用的数据收集。为了实现这些目标，本提案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老龄化中心和其他主要研究实体合作，制定“安全港”协议，允许一组明确的已知“客户组织”按照既定的合规性简化访问受限数据资源；2)建立HIPAA数据的标准化分发协议：1996年《健康保险流通与责任法案》（HIPAA）下的数据增长增加了如何以及何时共享这些数据的混乱。通过将NACDA的角色形式化为“非覆盖实体”，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)开发标准化的工具和文件以满足IRB对二次分析的要求：随着机构审查委员会在使用数据进行二次分析方面继续发挥更积极的作用，在NACDA发布数据之前，二级研究人员必须越来越多地将他们的项目提交给当地的IRB审查。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

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.