Opportunity Information: Apply for PAR 27 011
Apply for PAR 27 011
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)" 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 2026-03-18.
- Applicants must submit their applications by 2028-11-02.
- 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.
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Opportunity Summary:
The Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) funding opportunity (PAR-27-011) from the National Institutes of Health, aligned with the National Heart, Lung, and Blood Institute (NHLBI) mission, is designed to support investigators who want to launch and run a single-site clinical trial. The NOFO is intentionally broad about the kinds of trials it will consider, as long as they fit NHLBI priorities and meet the NIH definition of a clinical trial (as referenced in NOT-OD-15-015). In practical terms, this means applicants can propose studies focused on heart, lung, blood, and sleep-related conditions and outcomes, and they can do so using a range of trial intents and real-world orientations, including traditional efficacy trials, comparative effectiveness trials, pragmatic trials, and dissemination and implementation (D and I) science trials. The program also explicitly welcomes prevention strategies and behavioral or therapeutic interventions, which signals that proposals do not need to be limited to drugs or devices; they can include behavioral programs, care delivery approaches, and implementation strategies that are tested in a clinical trial framework.
A major emphasis of the NOFO is encouraging modern, efficient trial methodologies. Applicants are invited to use innovative designs such as platform trials (where multiple interventions can be evaluated under a shared infrastructure), adaptive designs (where features of the trial can be modified based on accumulating data while maintaining scientific rigor), and Bayesian approaches (which can incorporate prior information and update evidence as data accrue). The intent here is to promote better learning per participant enrolled, faster decision-making, and designs that more closely match real clinical and community settings when appropriate, especially for pragmatic and implementation-focused studies.
The award uses a bi-phasic, milestone-driven mechanism (R61/R33). This structure typically supports an initial phase focused on planning, feasibility, and preparation activities (R61), followed by a second phase focused on executing the full trial (R33), with clear go/no-go milestones determining whether the project transitions from the first phase to the second. The application is therefore expected to do more than present an interesting hypothesis. It must provide a strong scientific rationale for the trial and a detailed operational blueprint showing that the team can actually deliver the study. Reviewers will be looking for credible, well-specified plans for project management, recruitment and retention, data and trial operations, quality control, adherence to the protocol, and meeting pre-defined performance benchmarks. The NOFO also expects applicants to think through how results will be disseminated, meaning how findings will be shared with scientific audiences and, where relevant, with practitioners, health systems, and communities that could adopt the intervention.
Team structure is another key feature. While not mandatory, the NOFO strongly encourages a multiple PD/PI approach, reflecting the reality that successful clinical trials usually require complementary leadership across clinical content, operations, and quantitative methods. Even if an application uses a single PD/PI, the NOFO encourages including leadership-level expertise in biostatistics, clinical trial design, and trial coordination. In effect, applicants should be prepared to show they have the right expertise at the decision-making table, not merely as ad hoc support, and that roles and responsibilities are clearly defined.
The NOFO also places meaningful weight on health equity, community partnership, and real-world sustainability. Applicants are expected to describe how they will increase community engagement from the earliest stages, including conceptual design of the intervention, through implementation, and into sustainability planning. This goes beyond general statements about outreach; it implies proactive involvement of participants and communities in shaping the intervention, recruitment approaches that are culturally and contextually appropriate, and trial procedures that reduce barriers to participation. Relatedly, applicants should articulate how the proposed work will help close gaps in health outcomes across the US population and contribute to improving health for all, which aligns with NIH-wide expectations around reducing disparities and ensuring research benefits are broadly accessible.
Eligibility is expansive and includes many common applicant types, such as state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses, among others. This wide eligibility reflects the fact that single-site trials can be run by academic medical centers, community-based organizations with clinical infrastructure, health systems, and other entities capable of conducting regulated human subjects research and trial operations.
International participation is allowed in specific ways, but with an important restriction that affects budget and partnering structures. Non-US entities (foreign organizations) may apply, and foreign components of US organizations are allowed under NIH policy definitions. However, NIH policy effective May 1, 2025 creates a hard limitation: NIH will not issue awards that involve foreign subawards or subcontracts unless the application is submitted under a NOFO explicitly designated for funded international collaborations. For this NOFO, applications that include foreign subawards/subcontracts are considered noncompliant and will not be reviewed for funding. This restriction does not eliminate all international involvement. It still allows unfunded international collaborations, foreign components (as permitted), payment to foreign consultants, and purchasing unique equipment or supplies from foreign vendors, but it blocks the common approach of sending grant funds to a foreign institution via a subaward/subcontract under this particular announcement.
From an administrative standpoint, the opportunity is categorized as a discretionary grant in the health area and is listed under multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840). The original closing date provided is November 2, 2028, and the posting indicates a creation date of March 18, 2026. The NOFO does not specify an award ceiling or expected number of awards in the provided text, which usually means applicants should consult the full announcement and NHLBI guidance for budget expectations, allowable costs, and any institute-specific limits or considerations.
Overall, this NOFO is best understood as support for investigators with a well-justified, NHLBI-relevant single-site clinical trial idea who can present a credible end-to-end plan to execute it, including rigorous design (with encouragement for innovative methods), strong operational readiness (with milestones and management infrastructure), a capable multidisciplinary leadership team, and a clear strategy for community engagement, equity impact, and dissemination so that results can influence practice and health outcomes beyond the study site.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is the NIH Single-Site Investigator-Initiated Clinical Trials funding opportunity using the R61/R33 mechanism (Clinical Trial Required), identified as PAR-27-011. It is aligned with the mission and priorities of the National Heart, Lung, and Blood Institute (NHLBI).
What type of study does the program support?
It supports investigator-initiated, single-site clinical trials that meet the NIH definition of a clinical trial (as referenced in NOT-OD-15-015) and fit within NHLBI priorities.
Does the trial have to be single-site?
Yes. The opportunity is specifically designed to support a single-site clinical trial, meaning the planning and execution are centered at one site.
What disease or health areas are appropriate for this NOFO?
Applications can focus on heart, lung, blood, and sleep-related conditions and outcomes, as long as the proposed trial aligns with NHLBI priorities.
What kinds of clinical trials are encouraged?
The NOFO is intentionally broad. It indicates that traditional efficacy trials, comparative effectiveness trials, pragmatic trials, and dissemination and implementation (D and I) science trials can be appropriate if they match NHLBI priorities and meet the NIH clinical trial definition.
Are prevention studies allowed?
Yes. The program explicitly welcomes prevention strategies.
Do interventions have to be drugs or devices?
No. The opportunity explicitly welcomes behavioral or therapeutic interventions and signals that studies do not need to be limited to drugs or devices. Examples of eligible approaches may include behavioral programs, care delivery approaches, and implementation strategies tested within a clinical trial framework.
What does "Clinical Trial Required" mean in this context?
It means the proposed project must meet the NIH definition of a clinical trial (as referenced in NOT-OD-15-015) and is expected to be conducted as a clinical trial under this funding mechanism.
What is the R61/R33 mechanism and how does it work?
The award uses a bi-phasic, milestone-driven structure. The first phase (R61) typically supports planning, feasibility, and preparation activities. The second phase (R33) supports execution of the full clinical trial. Transition from R61 to R33 is based on achieving pre-specified go/no-go milestones.
What are "go/no-go milestones" and why do they matter?
Go/no-go milestones are clearly defined performance benchmarks that determine whether the project can transition from the planning/feasibility phase (R61) into the full trial phase (R33). Reviewers will look for credible, well-specified milestones tied to operational readiness and trial performance.
What will reviewers expect beyond the scientific hypothesis?
The application is expected to include both a strong scientific rationale and a detailed operational blueprint demonstrating the team can deliver the study. The NOFO emphasizes credible plans for project management, recruitment and retention, data and trial operations, quality control, protocol adherence, and meeting pre-defined benchmarks.
What trial methods and designs does the NOFO encourage?
The NOFO encourages modern, efficient methodologies and invites innovative designs such as platform trials, adaptive designs, and Bayesian approaches, when scientifically appropriate. The intent is to support efficient learning, faster decision-making, and designs that can better reflect real clinical and community settings, particularly for pragmatic and implementation-focused work.
What is a platform trial in the context of this NOFO?
A platform trial is described as an approach where multiple interventions can be evaluated under a shared infrastructure, improving efficiency by leveraging common trial operations.
What is an adaptive design as described here?
An adaptive design is described as a design where features of the trial can be modified based on accumulating data while maintaining scientific rigor.
Are Bayesian approaches allowed?
Yes. The NOFO explicitly invites Bayesian approaches, described as methods that can incorporate prior information and update evidence as data accrue.
Is a multiple PD/PI team required?
It is not mandatory, but it is strongly encouraged. The NOFO reflects that successful clinical trials often require complementary leadership across clinical content, operations, and quantitative methods.
If we apply with a single PD/PI, what expertise is expected on the team?
Even with a single PD/PI, the NOFO encourages leadership-level expertise in biostatistics, clinical trial design, and trial coordination. The emphasis is on having the right expertise involved in decision-making and clearly defined roles and responsibilities.
How important are recruitment, retention, and trial operations in the application?
They are central. The NOFO signals that reviewers will be looking for credible, well-specified plans for recruitment and retention, data and trial operations, quality control, adherence to the protocol, and the ability to meet pre-defined performance benchmarks.
Does the NOFO address dissemination of results?
Yes. Applicants are expected to think through dissemination, including how findings will be shared with scientific audiences and, where relevant, with practitioners, health systems, and communities that could adopt the intervention.
What expectations are included around health equity?
The NOFO places meaningful weight on health equity and expects applicants to articulate how the proposed work will help close gaps in health outcomes across the US population and contribute to improving health for all.
What does the NOFO mean by community engagement and partnership?
It indicates that applicants should increase community engagement from the earliest stages through implementation and sustainability planning. This goes beyond general outreach and implies proactive involvement of participants and communities in shaping the intervention, culturally and contextually appropriate recruitment, and trial procedures that reduce barriers to participation.
Does the NOFO expect sustainability planning?
Yes. Community engagement is framed as extending into sustainability planning, with an emphasis on real-world sustainability where relevant.
Who is eligible to apply?
Eligibility is broad and includes (among others) state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations (other than small businesses) and also separately includes small businesses.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations are included in the eligibility description.
Can non-US (foreign) organizations apply?
Yes. Non-US entities (foreign organizations) may apply, and foreign components of US organizations are allowed under NIH policy definitions, as described in the provided information.
Are foreign subawards or foreign subcontracts allowed under this opportunity?
No. NIH policy effective May 1, 2025 limits awards involving foreign subawards/subcontracts unless the application is submitted under a NOFO explicitly designated for funded international collaborations. For this NOFO, applications that include foreign subawards/subcontracts are considered noncompliant and will not be reviewed for funding.
Is any international involvement still possible if foreign subawards are not allowed?
Yes. The information provided indicates that unfunded international collaborations, foreign components (as permitted), payment to foreign consultants, and purchasing unique equipment or supplies from foreign vendors may still be allowed. The key restriction described is sending grant funds to a foreign institution via a subaward/subcontract under this announcement.
What category of grant is this listed as?
It is categorized as a discretionary grant in the health area.
What CFDA numbers are associated with this opportunity?
The listing includes CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840.
What is the closing date and when was the opportunity created?
The original closing date provided is November 2, 2028, and the creation date listed is March 18, 2026.
Is there an award ceiling or an expected number of awards stated in the provided information?
No. The provided text does not specify an award ceiling or expected number of awards, and it suggests applicants consult the full announcement and NHLBI guidance for budget expectations, allowable costs, and any institute-specific limits or considerations.
What is the overall profile of a strong application based on this description?
Based on the provided information, strong applications combine NHLBI-relevant clinical trial questions with rigorous (and potentially innovative) trial design, clear milestone-driven planning for the R61/R33 phases, credible operational readiness (management, recruitment/retention, trial operations, quality, adherence), a capable multidisciplinary leadership team, and a clear plan for equity-focused community engagement, dissemination, and real-world sustainability.
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