Standardizing Data and Metadata from Wearable Devices (R01 Clinical Trial Not Allowed)

The National Institute of Mental Health (NIMH) has issued a Notice of Funding Opportunity (NOFO), PAR-24-250, titled "Standardizing Data and Metadata from Wearable Devices (R01 Clinical Trial Not Allowed)." This initiative seeks to address challenges in aggregating data from wearable devices—such as activity trackers, jewelry, watches, and glasses—as well as cell phones by establishing unified data and metadata standards. These standards will facilitate secondary analysis and integration, supporting efforts to develop biomarkers and diagnostic tools for mental health research. The NOFO encourages applicants to create standards akin to the Digital Imaging and Communications in Medicine (DICOM) standards used in medical imaging, which have become essential for data interoperability and analysis. Eligible applications may focus on standards for raw or derived data, addressing issues such as device-specific metadata, time synchronization, and cultural considerations in interpreting derived data related to sleep, stress, or emotional states. Awardees will need to coordinate with device manufacturers and researchers to ensure the standards are feasible, widely usable, and compatible across devices. Device manufacturers are particularly encouraged to participate in developing the standards to promote eventual adoption. Applicants must assemble multidisciplinary teams that include experts familiar with data from wearable devices, device manufacturers, and representatives from the research and end-user communities. The proposed approach should involve prototype development, testing with real data from multiple devices, and soliciting community feedback. A structured plan for maintaining and updating the standard over time is also necessary, as technology in wearable devices evolves rapidly. Standards developed under this NOFO must be freely available to the research community, and training activities should be proposed to help researchers integrate these standards into their workflows. The funding period is capped at four years, and there is no budget limitation, though proposed budgets should reflect the actual project needs. Eligible applicants include U.S. and non-U.S. institutions, higher education institutions, nonprofits, for-profit organizations, and government entities. Registration with SAM, NCAGE (for foreign entities), eRA Commons, and Grants.gov is required prior to submission, as is adherence to NIH data management and sharing policies. Letters of intent are encouraged but not required and are due 30 days before the application due date. Applications will be evaluated on their significance, innovation, rigor, feasibility, and impact. Reviewers will assess the standard's scope, its compatibility across various devices, the proposed methods for ensuring widespread adoption, and how effectively the application addresses data and metadata requirements. Plans for dissemination, training, and ongoing community engagement will also be critically reviewed. Applications requesting $500,000 or more in direct costs in any year must consult with NIMH Scientific/Research contacts at least six weeks prior to submission. All applications are due by June 10, 2025, or June 10, 2026, with respective earliest project start dates in April of the following year. Upon award, recipients must follow NIH reporting requirements, including the annual Research Performance Progress Report (RPPR) and any additional requirements stipulated in the Notice of Award (NoA). For inquiries, applicants are advised to contact NIMH Scientific/Research contacts Christina Liu, Ph.D., or Adam Haim, Ph.D., for scientific questions, and Christine Clarkson for financial or grants management inquiries.