The National Institutes of Health (NIH), specifically through the National Institute of Mental Health (NIMH), has reissued a Funding Opportunity Announcement (FOA) for Collaborative Clinical Studies of Mental Illness under the R01 Research Project Grant mechanism. This opportunity focuses on supporting multi-site clinical studies, particularly those that explore mental health genetics, biomarkers, and various forms of mental illness. A key aspect of this FOA is the collaboration across multiple research sites, enhancing the ability to collect large sample sizes, improve recruitment, and increase diversity in participant demographics, including underrepresented populations.

The primary purpose of this FOA is to fund large-scale collaborative studies that may not be feasible at a single site, allowing for more extensive and integrated research efforts across multiple locations. It aims to support research that could accelerate understanding of psychopathology and the biological mechanisms underlying mental illness. For instance, the studies might focus on genetic/genomic research, sex differences in mental illness risk, or the identification of biological markers for early detection and treatment response. Each site within the collaborative research must follow the same protocol and work together for effective data management, quality control, and statistical analysis.

The funding provided under this FOA is flexible and supports both new and ongoing research, with no specified budget cap. However, the proposed budget must match the actual needs of the project, with a maximum project period of up to five years. In cases where collaborative studies require a high level of NIH involvement, some projects may be converted to a cooperative agreement (U01) with mutual consent between the recipients and NIMH.

Eligibility for this funding is broad and includes higher education institutions (both public and private), nonprofit organizations, government agencies, and foreign institutions. Applications from minority-serving institutions, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, and Tribal Colleges, are strongly encouraged. The FOA allows the inclusion of NIH-defined clinical trials and biomarker research as long as the research falls within the scope of mental health. Applicants are also encouraged to include diverse populations and NIH-defined health disparity groups in their studies.

Applicants must submit their proposals through Grants.gov or the NIH ASSIST system, and it is critical to follow the NIH's standard application forms (FORMS-H) and guidelines. The proposal must include detailed collaborative plans, a clear strategy for data management, and mechanisms for ensuring the consistency and integration of research procedures across sites. Each site should have its own principal investigator, and the project must justify the need for collaboration.

Key submission deadlines are staggered throughout the year, with the earliest application date beginning on February 5, 2023, and additional cycles continuing until October 2024. A letter of intent is recommended 30 days before the application due date. Early submissions are encouraged to ensure that any technical issues can be resolved before the deadline. The final expiration date for this FOA is January 8, 2025.

For applications involving human subjects or clinical trials, NIH policies on data sharing, human research protections, and biomarker validation apply. Applicants proposing clinical trials must also ensure compliance with NIH's definitions and guidance on such trials. Additionally, NIH has established a robust data-sharing requirement, with investigators expected to contribute their research data to the NIMH Data Archive (NDA) for broad use in the scientific community.

In terms of evaluation, the applications will be reviewed based on significance, investigator qualifications, innovation, and the scientific approach, among other criteria. Each project will be assessed for its ability to meet the objectives of the collaborative research model and its alignment with NIMH’s strategic priorities. Interested applicants are encouraged to contact NIMH program staff to ensure alignment with current research priorities before submission.