Sharing Restricted Data for Secondary Research: Evolving Tools and Protocols

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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.