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

• 批准号: 8738579
• 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
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8738579
• 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

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的关键问题之一是其可用性和存储库，如国家老龄化计算机化数据档案馆（NACDA），以建立数据质量标准和可靠访问支持的研究。近年来，对数据保密性的日益关注已成为直接影响获得和提供用于二次分析的研究数据的核心问题。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，但针对通常所谓的“演绎披露”的新发展日益影响我们对什么是安全的和不安全的共享的思考。本申请没有具体解决这一争论，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，即演绎披露模型正在改变主要数据收集者看待安全共享其研究以进行二次分析的方式。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，这些协议有助于共享机密研究数据，同时最大限度地保护研究的披露。目前，没有明确的指导方针存在的研究人员处理数据，包含有问题的变量组合。认识到越来越多的二次分析研究将不得不根据某种形式的限制使用协议进行共享，本申请寻求研究支持，以制定和实施用于共享限制使用数据收集的一致协议。为了实现这些目标，本提案将涉及三个具体目标：1）共享受限访问数据的创新策略：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，允许一组已建立合规性的已知“客户组织”简化对受限数据资源的访问; 2）建立标准化的数据分发协议：1996年健康保险便携性和责任法案（HIPAA）下的数据增长增加了关于如何以及何时共享这些数据的混乱。通过将NACDA的角色正式定义为“非覆盖实体”，我们可以创建数据共享协议，简化此类数据的共享，同时遵守HIPAA要求。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，二次研究人员必须越来越多地将其项目提交当地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 以符合人类受试者研究联邦标准的方式使用NACDA的受限数据收集。总的来说，这些目标将大大提高和促进使用有限的数据进行二次分析，提供了一个广泛和持久的影响，联邦资助的研究与具体的披露风险问题的研究潜力。