Clinical Studies of Mental Illness (Collaborative R01 Clinical Trial Optional) | PAR 19 297

Opportunity Information: Apply for PAR 19 297

Clinical Studies of Mental Illness (Collaborative R01 Clinical Trial Optional), Funding Opportunity Number PAR 19-297, is a National Institutes of Health (NIH) discretionary grant opportunity designed to support collaborative, multi-site clinical studies focused on understanding mental illnesses rather than testing new treatments. The central idea is to fund research that can answer important clinical and mechanistic questions about mental health by bringing together two or more research sites under a shared, single protocol. This multi-site structure is meant to make studies stronger and more generalizable by increasing total sample size, speeding up recruitment, and improving participant diversity and representation across different communities and settings.

The scientific scope emphasizes clinical studies in areas such as mental health genetics, biomarker discovery or validation, and deeper characterization of mental illnesses. Examples include research on psychopathology and the ways symptoms present and change across individuals, as well as studies of neurodevelopmental trajectories that track how risk, symptoms, and related biological or behavioral measures evolve over time. The announcement also highlights that studies may address mental illnesses in the context of HIV/AIDS, recognizing that mental health conditions can intersect with HIV-related factors and outcomes in clinically meaningful ways. While the FOA allows clinical trials to be optional, it is explicit that the purpose is not treatment development and not efficacy or effectiveness testing; in other words, this is not the right mechanism for projects whose primary goal is to determine whether an intervention works.

A defining feature of this opportunity is the expectation of true collaboration across sites. Applicants are expected to use a common protocol and aligned methods across participating locations so that data can be pooled and compared cleanly. When a project involves many sites, NIH expects that one application will function as a coordinating R01, responsible for centralized duties such as data management and other administrative coordination needed to keep the overall study consistent and on track. This coordinating structure is intended to reduce fragmentation, maintain data quality, and ensure that all sites adhere to the same study procedures, measures, and governance.

Eligibility is broad and includes many types of organizations that can carry out clinical research. In addition to standard applicants such as public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses) and small businesses, and multiple levels of government (state, county, city/township, special district, and independent school districts), the FOA explicitly includes tribal entities and housing authorities as eligible applicants. It also calls out a wide range of additional eligible applicants and partner-ready institutions, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Notably, non-domestic (non-U.S.) entities (foreign organizations) are also listed among eligible applicants, which can support international collaboration when scientifically justified.

From an administrative standpoint, the award mechanism is the NIH R01 research project grant, categorized under Health, with CFDA number 93.242. The FOA was created on 2019-06-10, and the original closing date listed in the source information is 2022-09-07. The source data does not specify an award ceiling or the expected number of awards, so applicants typically would look to NIH institute guidance, budget justification norms for R01s, and the specific scientific and operational needs of a multi-site study when planning project scope and budget.

Overall, this opportunity is aimed at teams that need a coordinated, multi-site approach to answer clinically relevant questions about mental illness using shared protocols, with particular encouragement for work in genetics, biomarkers, and developmental or phenomenological studies of psychopathology, including when mental health conditions intersect with HIV/AIDS. The best fit projects are those where collaboration is essential to achieve adequate sample size, recruitment speed, or representation, and where the primary goal is to generate robust clinical and biological knowledge rather than to test whether a treatment works.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Studies of Mental Illness (Collaborative 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): 93.242.
• This funding opportunity was created on 2019-06-10.
• Applicants must submit their applications by 2022-09-07. (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.

Apply for PAR 19 297

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