Sharing Restricted Data for Secondary Research: Evolving Tools and Protocols

共享二次研究的受限数据：不断发展的工具和协议

基本信息

批准号：
8619699
负责人：
JAMES W MCNALLY
金额：
$ 15.55万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-30 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8619699
关键词：
Access to Information Address Aging Agreement Archives Characteristics Client Communities Complex Confidentiality Confusion Data Data Collection Data Quality Development Disclosure Economics Ensure Environment Funding Future Goals Growth Guidelines Health Health Insurance Portability and Accountability Act Human Subject Research Individual Institutional Review Boards Internet Life Cycle Stages Modeling Monitor Names Outcome Play Policies Procedures Process Protocols documentation Public Domains Quality of life Research Research Personnel Research Project Grants Research Support Resources Respondent Risk Role Scientist Social Security Number Thinking United States National Center for Health Statistics Update Work base computerized data sharing falls innovation repository research and development research study response social tool trend

项目摘要

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.

描述（由申请人提供）：在二级研究中成功使用数据相关的关键问题之一是其可用性和存储库，例如国家对老化计算机数据（NACDA）的档案馆（NACDA），以建立数据质量和可靠的支持研究标准。近年来，人们对数据机密性的关注已成为直接影响访问的核心以及用于次级分析的研究数据。尽管长期存在清晰而系统的准则，以帮助研究人员识别和消除直接标识符提出的风险，但针对通常称为“演绎披露”的新发展越来越多地影响了我们对分享和不安全的思想。该应用程序并未明确解决这一辩论，因为从建立合理数据共享政策的角度来看，NACDA只是接受了以下事实：演绎披露模型正在改变主要数据收集者对其研究的安全共享的方式进行二级分析。 NACDA将其角色视为我们与研究人员合作创建数据共享协议的角色，以促进共享机密研究数据，同时最大程度地提高研究披露保护。目前，对于处理包含有问题的变量组合的数据的研究人员，尚无明确的指南。认识到，越来越多的二级分析研究将必须在某种形式的限制使用协议下共享，因此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，该提案将解决三个特定目标：1）共享限制访问数据的创新策略：NACDA将与NIA老化中心和其他主要研究实体合作，以制定“安全港”协议，以允许一组已知的“客户组织”与既定的“客户组织”相关，以使既定的合规性简化有限的访问权限来简化受限数据资源； 2）建立HIPAA数据的标准分配协议：根据《健康保险可移植性和问责制法》（HIPAA）落入数据的数据的增长增加了对如何以及何时共享这些数据的困惑。通过将NACDA作为“未覆盖实体”的角色形式化，我们可以创建数据共享协议，以简化此类数据的共享，同时尊重HIPAA要求。 3）开发标准化工具和文档以满足IRB的次要分析要求：随着机构审查委员会继续在使用数据进行次级分析中发挥更为积极的作用，二级研究人员必须越来越多地提交其本地IRB审查项目，然后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使用NACDA的限制数据收集方式，以符合联邦对人类受试者研究的标准。总的来说，这些目标将极大地增强和促进限制性数据进行二级分析，从而对具有特定披露风险问题的联邦资助研究的研究潜力产生广泛而持久的影响。