Single-Site Investigator-Initiated Clinical Trials (R61/R33) | PAR 16 405

Opportunity Information: Apply for PAR 16 405

The Single-Site Investigator-Initiated Clinical Trials (R61/R33) opportunity (Funding Opportunity Number PAR 16-405) is a National Institutes of Health (NIH) grant program designed to help researchers launch and carry out phase II and later-stage clinical trials at a single study site. The focus is on investigator-initiated trials, meaning the study is conceived and led by the applicant investigator rather than being a multi-site network trial coordinated by NIH. To be responsive, the proposed work must align with the mission and research priorities of the National Heart, Lung, and Blood Institute (NHLBI), and it must meet the NIH definition of a clinical trial as described in NIH guidance (referenced in the announcement as NOT-OD-15-015). In practical terms, this FOA targets clinical research that tests interventions in people within NHLBI-relevant areas such as heart and vascular disease, lung diseases, blood disorders, and sleep-related conditions, as well as cross-cutting topics that NHLBI prioritizes.

A key feature of this FOA is its two-phase, milestone-driven award structure using the R61/R33 mechanism. The first phase (R61) supports early, time-limited activities needed to finalize and prepare the trial for full execution, while the second phase (R33) supports the implementation and conduct of the clinical trial itself. Progression from the R61 phase to the R33 phase is not automatic; it depends on meeting pre-specified performance and readiness milestones. This structure is meant to reduce risk and ensure that trials move forward only when the protocol, operations, and recruitment approach are realistically positioned to succeed. Applicants are therefore expected to define clear milestones and measurable deliverables, and to show how they will track progress and make decisions if targets are missed.

Applications are expected to include both a strong scientific rationale and a detailed operational plan. On the scientific side, the proposal should make a compelling case for why the intervention should work, why the target population is appropriate, and why the trial is needed now (for example, addressing gaps left by prior studies or translating promising earlier-phase results). On the operational side, the FOA anticipates a comprehensive plan for how the single-site trial will actually be run, including trial governance, project management, staffing, data management, safety oversight, and day-to-day coordination. Particular attention is expected for subject recruitment and retention, since enrolling and keeping participants engaged is often the main determinant of whether a clinical trial succeeds on schedule. The application should spell out recruitment sources, enrollment projections, retention strategies, barriers and contingencies, and how performance will be monitored against stated milestones.

The FOA also emphasizes rigorous trial conduct and dissemination of results. That includes planning for high-quality implementation consistent with regulatory and ethical standards, maintaining data integrity, ensuring participant safety, and using appropriate monitoring and oversight. Just as importantly, applicants are expected to describe how findings will be communicated, which typically involves plans for publishing results, sharing conclusions with scientific and patient communities, and supporting transparency around outcomes. The intent is not only to run the trial, but to ensure that the results are credible, accessible, and useful for the field.

Eligibility for this program is broad. In addition to typical academic and research institutions, eligible applicants include a wide range of domestic entities such as state, county, and local governments; special district governments; independent school districts; public housing authorities; federally recognized Native American tribal governments; and other Native American tribal organizations. Nonprofit organizations (both with and without 501(c)(3) status), private institutions of higher education, for-profit organizations (other than small businesses), and small businesses are also eligible. The FOA explicitly highlights additional eligible applicant types including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, U.S. territories or possessions, and even non-U.S. (foreign) organizations. This wide eligibility is intended to encourage participation from diverse institutions and communities, including those that may be well positioned to recruit specific patient populations or address health disparities.

Administratively, the opportunity is categorized as a discretionary grant in the health area and is associated with CFDA program numbers 93.233, 93.837, 93.838, 93.839, and 93.840. The agency is NIH, with the programmatic focus tied to NHLBI priorities. The source listing indicates an original closing date of October 25, 2017, reflecting the historical posting details for this particular announcement. Overall, the opportunity is best understood as support for well-justified, later-stage, single-site clinical trials that are ready to move forward with disciplined planning, clear milestones, realistic recruitment and retention strategies, and a commitment to producing and sharing actionable clinical evidence within NHLBI mission areas.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Single-Site Investigator-Initiated Clinical Trials (R61/R33)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2016-08-15.
• Applicants must submit their applications by 2017-10-25. (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 16 405

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