Collaborative R01s for Clinical Studies of Mental Illness Not Involving Clinical Trials (Collaborative R01) | PAR 17 256

Opportunity Information: Apply for PAR 17 256

The NIH funding opportunity PAR-17-256, titled "Collaborative R01s for Clinical Studies of Mental Illness Not Involving Clinical Trials (Collaborative R01)," is designed to support multi-site, collaborative clinical research on mental illness that is not a clinical trial. In practical terms, it funds human-subjects clinical studies that aim to understand mental health conditions rather than test treatments. This means the FOA is not meant for treatment development projects, nor for efficacy or effectiveness trials that evaluate whether an intervention works. Instead, it focuses on building knowledge about mental disorders through coordinated clinical research efforts that require participation from two or more study sites.

The main scientific priorities highlighted in the announcement include mental health genetics, biomarker research, and broader clinical studies of mental illness such as investigations of psychopathology and neurodevelopmental trajectories that contribute to psychopathology over time. The scope also explicitly includes studies of mental illnesses in the context of HIV/AIDS, reflecting an interest in the ways HIV-related factors and mental health interact, overlap, or influence outcomes. Overall, the emphasis is on rigorous, protocol-driven clinical research that can clarify mechanisms, identify measurable biological or behavioral signals, and deepen understanding of how mental illnesses emerge, progress, and vary across individuals and populations.

A defining feature of this opportunity is that it is intended for situations where a single site cannot feasibly accomplish the research aims on its own. Applicants are expected to use this FOA when multiple sites are needed to achieve adequate sample size, speed up recruitment, or increase diversity and representation in the participant population. The collaborating sites are expected to use a shared, specific protocol across locations, so that data collected at each site can be combined and compared in a consistent way. The multi-site structure is therefore not incidental; it is central to the design, because the scientific value comes from coordinated implementation and the ability to draw stronger conclusions from larger and more representative datasets.

For projects involving a large number of sites, the FOA anticipates a more formal organizing structure in which one application is submitted as a coordinating R01. That coordinating site typically takes responsibility for centralized functions such as data management, overall administration, and other cross-site operations that keep the project aligned. At the same time, the program is structured as a linked set of collaborative R01 applications, with each participating site submitting its own R01 application and naming its own Program Director/Principal Investigator. This arrangement allows each site to be accountable for its own work while still operating under a unified protocol and a shared scientific plan.

The collaborative R01 mechanism described in the FOA is meant to make multi-site studies run like a single coherent enterprise rather than a loose network of related projects. It explicitly supports cross-R01 coordination, quality control procedures, database management, statistical analysis, and reporting across the participating sites. In effect, it recognizes that multi-site clinical science requires robust infrastructure for harmonizing procedures, maintaining data quality, ensuring consistency in recruitment and assessments, and managing analysis plans that reflect pooled data from multiple locations.

From an administrative standpoint, this is a discretionary grant opportunity offered by the National Institutes of Health under the health funding activity category, with CFDA number 93.242. The original posting date is April 14, 2017, and the original closing date listed in the source information is June 10, 2019. The source data does not specify an award ceiling or the expected number of awards, which usually means applicants need to rely on standard NIH budgeting practices for R01s and consult any related NIH institute guidance to understand likely funding ranges and portfolio priorities at the time of submission.

Eligibility for this FOA is broad and includes many common applicant types for NIH research grants, spanning public and private institutions of higher education, nonprofits (including both 501(c)(3) and non-501(c)(3) organizations), for-profit organizations (other than small businesses), small businesses, and multiple levels of government such as state, county, city or township, special district governments, and independent school districts. It also includes Native American tribal governments (federally recognized), tribal organizations (other than federally recognized tribal governments), and public housing authorities/Indian housing authorities. Beyond these standard categories, the FOA explicitly calls out additional eligible applicants such as Historically Black Colleges and Universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations). Taken together, the eligibility language signals an intent to encourage broad participation and to support research networks that can recruit and study diverse populations across a wide range of settings.

In summary, this opportunity supports coordinated, multi-site clinical studies that advance understanding of mental illness through genetics, biomarkers, and related clinical and developmental research, including when mental health is intertwined with HIV/AIDS. The key fit is a study that needs multiple sites to succeed, uses a shared protocol, and benefits from formal coordination and centralized data and quality infrastructure, all while staying clearly outside the boundaries of treatment testing and other clinical trial activities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Collaborative R01s for Clinical Studies of Mental Illness Not Involving Clinical Trials (Collaborative R01)" 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 2017-04-14.
• Applicants must submit their applications by 2019-06-10. (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 17 256

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