Clinical Trial Readiness to Understand and Develop Solutions to Social, Ethical, Behavioral Implications and Barriers to Health Equity in ADRD (R01 - Clinical Trial Not Allowed) | RFA NS 25 013

Opportunity Information: Apply for RFA NS 25 013

This NIH funding opportunity (RFA-NS-25-013) supports R01 research projects focused on building "clinical trial readiness" for community-driven interventions that aim to reduce inequities in Alzheimer disease and related dementias (ADRD). The central idea is to do the foundational work needed before a future intervention can be tested in a full clinical trial, especially when the intervention is designed with and for communities that have been underserved, marginalized, or otherwise experience NIH-defined health disparities. While the long-term goal is to enable more effective and equitable ADRD interventions, the projects supported under this announcement cannot include an actual clinical trial as part of the application.

The scientific emphasis is on understanding and developing solutions to social, ethical, and behavioral implications (often abbreviated as SEBI) that shape how ADRD risk is assessed, how people are identified or diagnosed, and how treatments or care approaches are offered and taken up in real-world settings. In practical terms, applicants are expected to examine how issues like mistrust, stigma, discrimination, structural racism, language barriers, low access to specialty care, caregiver burden, cultural beliefs about aging and memory loss, and unequal exposure to social and environmental risks can affect participation, acceptability, feasibility, and eventual effectiveness of interventions. The NOFO is also explicitly concerned with how these SEBI factors become barriers to achieving health equity in ADRD outcomes and how addressing them early can improve the design and impact of later-stage clinical studies.

A key feature is the requirement for a community-driven orientation. Proposed work should be grounded in genuine partnership with the populations of interest, with the intention of shaping interventions and study approaches that fit the lived realities of those communities. "Clinical trial readiness" in this context generally means generating the evidence and infrastructure needed so that a future trial is doable and ethical: clarifying community priorities, refining intervention components with community input, establishing recruitment and retention strategies that work, validating culturally and linguistically appropriate measures, improving consent and communication processes, building trust and governance structures, and identifying implementation barriers that could derail a later trial. The work can also include developing or adapting tools and protocols that reduce bias in screening, diagnosis, referral, and care pathways, as long as the project remains preparatory rather than a trial that tests efficacy.

The eligible applicant pool is broad and includes many types of U.S.-based organizations: state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other organizations. The announcement also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), regional organizations, U.S. territories or possessions, and eligible federal agencies. Foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant can include certain foreign activities if they meet NIH policy definitions and are appropriately justified.

Administratively, this is a discretionary NIH grant opportunity under the health funding activity category, using the R01 mechanism. The CFDA numbers listed are 93.853 and 93.866. The opportunity was created on 2024-06-10, with an original closing date of 2024-10-04. The award ceiling and expected number of awards are not specified in the provided listing, which usually means applicants should rely on the full NOFO details and NIH standard R01 budgeting expectations when planning scope and costs.

Overall, the program is aimed at moving the field closer to equitable ADRD research and care by funding the careful, community-engaged preparatory work that makes later clinical trials more feasible, more ethical, more inclusive, and more likely to produce benefits that actually reach populations experiencing disparities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trial Readiness to Understand and Develop Solutions to Social, Ethical, Behavioral Implications and Barriers to Health Equity in ADRD (R01 - Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
• This funding opportunity was created on 2024-06-10.
• Applicants must submit their applications by 2024-10-04. (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.

Apply for RFA NS 25 013

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