Revision Applications for Validation of Mobile/Wireless Health Tools for Measurement and Intervention (R01) Clinical Trial Optional | PA 18 339

Opportunity Information: Apply for PA 18 339

Revision Applications for Validation of Mobile/Wireless Health Tools for Measurement and Intervention (R01) Clinical Trial Optional (PA 18-339) is an NIH grant opportunity designed for research teams that already hold an active NIH-supported research project award and want to expand that funded project through a formal revision (often called a supplement or competing revision, depending on NIH mechanisms). The central aim is to let investigators broaden the approved scope of their existing R01-level work to take advantage of newer mobile and wireless health technologies, specifically by adding activities that validate these tools for two major purposes: (1) measurement, meaning the accurate and reliable capture of health- and behavior-related data in real-world settings, and (2) intervention delivery, meaning the use of mobile or wireless platforms to deliver or support health interventions. The FOA is explicitly focused on validation, so proposals are expected to go beyond simply using an app or wearable and instead generate evidence that the tool produces trustworthy data or can deliver an intervention as intended, under the conditions and populations relevant to the parent project.

A key feature of the announcement is that it is restricted to revision applications tied to an existing, active NIH award. In practical terms, applicants are not starting an entirely new standalone project; they are proposing a justified expansion of an already peer-reviewed and funded research plan. NIH is signaling that it wants researchers to incorporate recent advances in mobile/wireless health tools into ongoing science rather than forcing a full restart via a new application. Importantly, the FOA welcomes revisions even when the parent study does not currently use mobile or wireless tools, as long as the revised application includes a team with the scientific and technical expertise needed to implement and validate those technologies appropriately. That means an eligible revision could involve adding smartphone-based assessments, passive sensing, connected devices, or other wireless platforms to a traditional clinical or behavioral protocol, so long as the new work is well-integrated and supports the original project goals while extending them in a defensible way.

The “Clinical Trial Optional” label indicates that the proposed revision may include a clinical trial but does not have to. This is helpful for teams whose validation work might involve testing a mobile delivery method for an intervention, optimizing engagement strategies, or evaluating clinical or behavioral outcomes, which could rise to the level of a clinical trial depending on NIH definitions. At the same time, purely methodological validation work, such as studies of measurement accuracy, reliability, sensitivity to change, feasibility, usability, or equivalence to gold-standard instruments, may be proposed without necessarily constituting a clinical trial. The point is flexibility: applicants can propose the design that best fits the validation question and the parent award’s aims, while still meeting NIH’s human subjects and clinical trial policies when applicable.

NIH cast a wide eligibility net for institutions, reflecting the broad interest in digital health research across sectors. In addition to typical applicants such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, the FOA lists many governmental units as eligible, including state, county, city/township, special district governments, independent school districts, public housing authorities/Indian housing authorities, and eligible federal agencies. It also explicitly includes a range of mission-serving and community-rooted institutions and organizations, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based or community-based organizations. Eligibility further extends to Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), as well as Indian/Native American tribal governments that are not federally recognized. The FOA also allows non-domestic (non-U.S.) entities (foreign organizations), regional organizations, and U.S. territories or possessions, which is notable for collaborative technology validation work that may involve international field settings or global health contexts.

From an administrative standpoint, the opportunity is categorized as a discretionary grant program under NIH, using the grant funding instrument. The funding activity area is listed under Education and Health, and it is associated with multiple CFDA program numbers (93.173, 93.233, 93.242, 93.286, 93.399, 93.837, 93.838, 93.839, 93.840), reflecting NIH’s multi-institute structure and the cross-cutting nature of mobile/wireless health research across disease areas and populations. The opportunity was created on 2017-11-02, and the original closing date shown is 2019-01-07. While the listing does not specify an award ceiling or expected number of awards, the framing as a revision mechanism typically means funding levels and counts depend heavily on the size and scope of the proposed expansion, the remaining project period, and the priorities and budgets of the relevant NIH Institutes and Centers supporting the parent award.

Overall, this FOA is best understood as a pathway for existing NIH-funded investigators to modernize and extend their ongoing research by adding rigorous validation of mobile and wireless tools that can capture health data or deliver interventions outside traditional clinic settings. The emphasis on validation and on leveraging “recent advances” suggests NIH is looking for proposals that directly address real-world performance, data quality, and intervention fidelity, and that can demonstrate that these technologies are fit for purpose in the study’s target population and context, rather than simply adding technology for convenience or novelty.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Revision Applications for Validation of Mobile/Wireless Health Tools for Measurement and Intervention (R01) Clinical Trial Optional" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.233, 93.242, 93.286, 93.399, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2017-11-02.
• Applicants must submit their applications by 2019-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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