BACKGROUND
Background: The rapid growth in human research data, storage, and analysis tools, and skilled researchers combined with the declining costs and new federal policies are creating an immense drive for research data sharing. At the same, triangulating various types of human research data proportionately increase the risks of re-identification when used for secondary research purposes. Various institutional gatekeepers are involved in the governance of human data for research. Of those with data governance responsibilities, signing officials (SOs) most often serve as signatories on research data submission and access request agreements between institutions. Although SOs play important leadership roles in research data compliance, we know surprisingly little about the ways in which new data management and sharing (DMS) requirements for researchers adopted at the National Institutes of Health (NIH) affects SO’s data governance responsibilities.
OBJECTIVE
The purpose of this study was to understand the potential impacts of new DMS policies on secondary data governance of genomic and related health data among SOs in the United States
METHODS
We administered online surveys to 56 institutional SOs working at biomedical research institutions across the United States. We investigated their understanding about where research data supported with extramural funding are deposited, how researchers outside the institution access these data, and what happens to the data after grant funding ends.
RESULTS
We found SOs frequently approve duplicate data deposits and impose stricter access controls when data use limitations are unclear or unspecified. In addition, only 23.08% of SOs reported that their institutions track where data from federally funded projects are deposited after funding for the project sunsets. Consequently, investigators often deposit their scientific data into “an NIH-funded repository” to meet the DMS requirements, but also within the “institution’s own repository” or “a third-party repository.
CONCLUSIONS
Our findings inform five policy recommendations and best practices for researchers, institutional authorities, and institutional review boards to improve coordination and develop comprehensive and consistent data governance policies that balance the need for scientific progress with effective human data protections.
CLINICALTRIAL
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