Opportunity Information: Apply for RFA AR 19 013
Research Innovations for Scientific Knowledge (RISK) for Musculoskeletal Diseases (R61/R33 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) designed to back bold, unconventional musculoskeletal research that does not fit comfortably into more traditional NIH grant programs. The central goal is to push the field forward by supporting projects that start from unusual observations, challenge prevailing assumptions, or propose imaginative hypotheses and new conceptual models. In practice, this means NIAMS is explicitly inviting applications that reviewers might otherwise label as too risky, too early-stage, too controversial, or too far outside mainstream thinking, as long as the idea is scientifically grounded and relevant to NIAMS priorities.
The science scope is disease-focused and translational, centered on musculoskeletal diseases and conditions within the NIAMS mission. Supported studies can include work aimed at understanding disease mechanisms (for example, uncovering biological pathways driving tissue degeneration, inflammation, pain, impaired healing, or structural failure in musculoskeletal tissues) and work aimed at developing or testing diagnostics, therapeutic candidates, or preventive interventions. However, the program draws a firm line at human testing: it will support development and preclinical evaluation up to, but not including, first-in-human studies. This is reinforced by the label "Clinical Trial Not Allowed," meaning the FOA is not intended to fund clinical trials, and applicants should avoid proposing trial-like human studies under this mechanism.
The funding mechanism uses the NIH R61/R33 phased innovation structure. The R61 phase is generally intended as an early, milestone-driven stage that allows investigators to establish feasibility, generate critical proof-of-concept data, or de-risk a high-uncertainty idea. If the R61 milestones are met, the project can transition to the R33 phase, which is typically used to expand, validate, and further develop the concept in a more substantial way. This structure is meant to make it easier to support high-risk, high-reward translational projects by tying progression to clear, objective benchmarks rather than requiring a fully mature dataset at the start.
Eligibility is broad across U.S.-based organizations and includes many types of applicants commonly allowed in NIH programs: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also highlights additional eligible applicant categories such as 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, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it is restrictive regarding foreign involvement: non-U.S. entities (foreign organizations or foreign institutions) are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
Administratively, this is a discretionary grant opportunity in the health category (CFDA 93.846). The funding opportunity number is RFA-AR-19-013, and the opportunity was created on 2018-07-20 with an original closing date of 2020-01-09. The posted information does not specify an award ceiling or the expected number of awards in the provided excerpt, so applicants would typically need to consult the full FOA or NIH Grants.gov posting for budget limits, project period details, and any institute-specific expectations about milestones, allowable costs, or review considerations.
Overall, the program is best suited for teams pursuing musculoskeletal translational ideas that could meaningfully change thinking or practice but currently lack the conventional level of preliminary evidence required for more standard mechanisms. Competitive applications would generally be expected to articulate why the concept is transformative, why it is genuinely high-risk yet testable, how the work fits NIAMS mission areas, and what concrete milestones will demonstrate success in the R61 phase and justify transition to the R33 phase, all while staying clearly on the preclinical or non-trial side of human research.Apply for RFA AR 19 013
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Research Innovations for Scientific Knowledge (RISK) for Musculoskeletal Diseases (R61/R33 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
- This funding opportunity was created on 2018-07-20.
- Applicants must submit their applications by 2020-01-09. (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.
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Frequently Asked Questions (FAQs): Research Innovations for Scientific Knowledge (RISK) for Musculoskeletal Diseases (R61/R33 Clinical Trial Not Allowed)
What is this funding opportunity?
This opportunity is the NIH funding announcement titled "Research Innovations for Scientific Knowledge (RISK) for Musculoskeletal Diseases (R61/R33 Clinical Trial Not Allowed)." It is run by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and is intended to support bold, unconventional research in musculoskeletal diseases and conditions within the NIAMS mission.
Which NIH Institute is sponsoring this program?
The sponsoring NIH Institute is NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases).
What is the main goal of the RISK program?
The central goal is to push musculoskeletal research forward by supporting projects that may be considered too risky, too early-stage, too controversial, or too far outside mainstream thinking for traditional NIH grant programs, as long as the ideas are scientifically grounded and relevant to NIAMS priorities.
What kinds of projects are a good fit for this FOA?
This FOA is designed for high-risk, high-reward translational ideas in musculoskeletal diseases that may start from unusual observations, challenge prevailing assumptions, or propose imaginative hypotheses and new conceptual models. It is particularly suited to projects that do not fit comfortably into more traditional NIH mechanisms due to uncertainty or limited preliminary data.
What scientific areas are within scope?
The scope is disease-focused and translational, centered on musculoskeletal diseases and conditions within the NIAMS mission. The supported science can include studies to understand disease mechanisms (for example, pathways driving tissue degeneration, inflammation, pain, impaired healing, or structural failure in musculoskeletal tissues) and projects aimed at developing or testing diagnostics, therapeutic candidates, or preventive interventions up to the preclinical stage.
Does this program support translational research?
Yes. The program is explicitly translational and disease-focused. It can support development and preclinical evaluation of diagnostics, therapeutics, or preventive strategies, but it stops short of human testing.
Are clinical trials allowed under this funding opportunity?
No. This FOA is labeled "Clinical Trial Not Allowed," meaning it is not intended to fund clinical trials. Applicants should avoid proposing trial-like human studies under this mechanism.
Can the project include first-in-human studies?
No. The program supports development and preclinical evaluation up to, but not including, first-in-human studies.
Can human research be included at all?
The provided description draws a firm line at human testing and advises applicants to avoid trial-like human studies. The safest interpretation from the provided information is to keep proposed work clearly on the preclinical side and outside anything that resembles a clinical trial.
What does the R61/R33 mechanism mean?
This FOA uses the NIH phased innovation structure. The project begins in the R61 phase, which is an early, milestone-driven stage used to establish feasibility, generate critical proof-of-concept data, or reduce key uncertainties. If the R61 milestones are achieved, the project can transition to the R33 phase to expand, validate, and further develop the concept in a more substantial way.
How does a project transition from R61 to R33?
Transition is tied to meeting clear, objective milestones set for the R61 phase. The intent is to support high-uncertainty ideas by requiring measurable benchmarks rather than a fully mature dataset at the time of application.
What should milestones look like for the R61 phase?
Based on the program description, R61 milestones should be concrete and objective, focused on feasibility, proof-of-concept, and de-risking critical uncertainties. They should clearly indicate what success looks like and why achieving them justifies moving into the R33 phase.
What makes an application competitive for this program?
Competitive applications are generally expected to explain: (1) why the concept could be transformative for musculoskeletal diseases, (2) why it is genuinely high-risk but still testable and scientifically grounded, (3) how it fits NIAMS mission areas and priorities, and (4) what specific R61 milestones will demonstrate success and support transition to the R33 phase, while remaining clearly outside clinical trials and first-in-human studies.
Is this opportunity intended for projects with limited preliminary data?
Yes. The program is meant to make it easier to support high-risk, high-reward translational projects that may lack the conventional level of preliminary evidence typically expected in more standard mechanisms, provided the idea is scientifically grounded and testable.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities.
Are certain institution types specifically highlighted as eligible?
Yes. The FOA highlights additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Can foreign organizations apply?
No. Non-U.S. entities (foreign organizations or foreign institutions) are not eligible to apply under this FOA.
Can a U.S. organization include a non-U.S. component?
No. Non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA-AR-19-013.
What is the CFDA number and category?
The CFDA number is 93.846, and the opportunity is in the health category.
What type of grant is this?
It is a discretionary grant opportunity.
When was this opportunity created and when did it close?
The opportunity was created on 2018-07-20. The original closing date listed is 2020-01-09.
Is the award ceiling or number of awards provided in the excerpt?
No. The posted information excerpt does not specify an award ceiling or the expected number of awards. Applicants would typically need to consult the full FOA or the NIH/Grants.gov posting for budget limits, project period details, and other administrative specifics.
Where should applicants look for budget limits and project period details?
The excerpt indicates these details are not included, so applicants would generally need to review the full FOA text or the corresponding NIH Grants.gov posting for budget limits, the project period, institute-specific expectations, allowable costs, milestone guidance, and review considerations.
What is the key "do not do" for applicants?
Do not propose clinical trials, trial-like human studies, or first-in-human research under this FOA. The program is explicitly preclinical and "Clinical Trial Not Allowed."
What is the overall best use case for this program?
This program is best suited for teams with musculoskeletal translational ideas that could meaningfully change thinking or practice but are not yet mature enough for standard mechanisms, especially when the project hinges on testing an unconventional hypothesis, exploring an unusual observation, or building a new conceptual model with clear milestone-driven feasibility steps.
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