The National Institutes of Health (NIH) recently announced a new data sharing policy that went into effect on January 25, 2023. This new policy is in line with the NIH’s mission to promote the advancement of biomedical research and improve public health. By making data more discoverable and accessible, other researchers will be able to build on the work of previous studies and accelerate the pace of discovery.
Under the new policy, all investigators who receive NIH funding must submit a data management and sharing plan as part of their grant application. This plan must include details on how data will be shared, preserved, and accessed by other researchers. In the case of human subject research, NIH recognizes in supplemental guidance that research data “can allow inferences to be made about a participant’s identity, even if the information is de-identified according to HIPAA or the Common Rule”. Thus, sharing detailed data might only be appropriate in the context of a controlled-access repository or under the terms of a data sharing contract.
iTHRIV has a curated set tools and guides to assist researchers in complying with the policy while protecting privacy of research subjects. Resources include, but are not limited to: webinars, templates, and sample language. To learn more about and access the complete list please visit: https://portal.ithriv.org/#/resource/1689. iTHRIV also worked with the UVA Patient Privacy Office to establish guidance around aggregation of patient data prior to publicly sharing in order to protect from re-identification through inference. This guidance is linked on the resource page.
Also provided is a sample UVA data sharing and management plan leveraging the iTHRIV Research Data Commons. The iTHRIV Commons supports a range of data management and sharing options, ranging from private secure data files accessible only to researchers on an active IRB protocol, to pointers to data stored elsewhere (such as an NIH controlled-access repository), to fully public files consisting of data aggregates. Data descriptions and metadata can be exposed to be discoverable by the public with data file access is separately managed by the data administrators. The iTHRIV Commons interface allows study teams to track data and manage access at every stage, while also helping them provide a robust data management plan to the NIH or other funding source.
The new NIH data sharing policy is a significant step forward in promoting transparency, accessibility, and collaboration in biomedical research. All investigators are encouraged to familiarize themselves with the new policy and take advantage of the resources provided. Please, do not hesitate to reach out to iTHRIV regarding access to the iTHRIV Commons or with any other questions you might have: ITHRIVADMIN@uvahealth.org
iTHRIV is a cross-state translational research institute which combines the expertise of clinical translational biomedical researchers and data scientists to create infrastructure and investigator resources for using data to improve health across the Commonwealth of Virginia. Partner sites include University of Virginia, Virginia Tech, Carilion Clinic and Inova Health System. iTHRIV is funded by the National Center for Advancing Translational Sciences, part of the National Institutes of Health, through award number UL1TR003015.