Opportunity Information: Apply for PAR 15 115
Apply for PAR 15 115
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846 Arthritis, Musculoskeletal and Skin Diseases Research.
- This funding opportunity was created on Feb 6, 2015 and posted on Feb 6, 2015.
- Applicants must submit their applications by Nov 1, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses State governments Native American tribal governments (Federally recognized) Independent school districts Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities City or township governments County governments Small businesses Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity PAR 15-115, titled "Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01)," supports R01 research project grant applications that carry out clinical observational studies specifically aimed at generating the real-world data needed to design stronger, more informative clinical trials in musculoskeletal, rheumatic, and skin diseases or related conditions. The core idea is that well-planned observational cohort research can answer practical trial-design questions before a trial begins, reducing uncertainty about who to enroll, when to intervene, what outcomes to measure, and how quickly meaningful changes can be detected.
This FOA emphasizes observational cohort studies as a way to map disease symptoms and trajectories over time, clarify stages of disease and the timing of progression, and identify common comorbidities that may affect outcomes or eligibility. It also highlights the importance of learning what outcomes matter most to patients and what outcomes are realistically measurable in clinical settings. Another major purpose is to help investigators develop, refine, and/or validate tools that trials depend on, including objective biomarkers (for example, lab-based or imaging-based measures) and subjective or patient-reported outcome measures that can serve as endpoints in later interventional studies.
Applications are expected to tackle clear obstacles or uncertainties that commonly interfere with rigorous trial design. Examples given in the announcement include determining appropriate primary and secondary outcome measures, and identifying the disease stage or patient subgroup most likely to respond to an eventual intervention. In other words, the observational work funded here should not be purely descriptive for its own sake; it should be directly connected to improving the feasibility, efficiency, and interpretability of future clinical trials in these disease areas.
A key restriction is that only observational studies are supported under this FOA. That means the proposed work should not test an intervention or otherwise function as a clinical trial. The intended deliverable is evidence and infrastructure that inform a future trial or trials, such as estimates of progression rates, baseline variability, recruitment pools, endpoint performance, or biomarker validity.
The opportunity is offered by the National Institutes of Health under the health research activity area (CFDA 93.846: Arthritis, Musculoskeletal and Skin Diseases Research). The funding instrument is a grant, using the R01 mechanism. The posted and creation date for the opportunity was February 6, 2015. The original and current closing date listed is November 1, 2017, with an archive date of December 2, 2017. The listed award ceiling is $225,000, and there is no cost sharing or matching requirement.
Eligibility is broad and includes many types of U.S.-based organizations and governmental units, such as public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, state and local governments (including city/township, county, special district), public housing authorities/Indian housing authorities, and tribal governments and tribal organizations (including federally recognized and other-than-federally recognized categories). The FOA also notes additional eligible applicant types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, as well as faith-based or community-based organizations and eligible federal agencies.
The announcement also clarifies limits related to foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply directly, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined by the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may include certain foreign elements when permitted under NIH policy.
For more details, the FOA points to the NIH Grants Guide page at http://grants.nih.gov/grants/guide/pa-files/PAR-15-115.html and provides NIH Office of Extramural Research (OER) webmaster contacts for technical issues accessing or linking to the announcement.
FAQs: NIH PAR-15-115 - Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01)
What is the funding opportunity PAR-15-115?
PAR-15-115 is a National Institutes of Health (NIH) funding opportunity titled "Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01)." It supports R01 research project grant applications proposing clinical observational cohort studies designed to generate real-world data that will strengthen the design of future clinical trials in musculoskeletal, rheumatic, and skin diseases (or related conditions).
What is the main goal of this FOA?
The main goal is to fund well-planned observational cohort research that answers practical clinical trial design questions before a trial begins. The intent is to reduce uncertainty about who to enroll, when to intervene, which outcomes to measure, and how quickly meaningful changes can be detected.
What type of research does this FOA support?
This FOA supports clinical observational studies, particularly observational cohort studies, focused on producing information that improves the feasibility, efficiency, and interpretability of later interventional clinical trials.
Are clinical trials or intervention studies allowed under this opportunity?
No. A key restriction is that only observational studies are supported. The proposed work should not test an intervention or otherwise function as a clinical trial.
What makes an observational study responsive to this FOA?
To be responsive, the observational work should directly address obstacles or uncertainties that commonly interfere with rigorous trial design. The FOA emphasizes that studies should not be purely descriptive for their own sake; they should be explicitly connected to improving future clinical trials.
What kinds of trial-design questions is the NIH looking to answer through these studies?
Examples described in the announcement include determining appropriate primary and secondary outcome measures and identifying the disease stage or patient subgroup most likely to respond to a future intervention. More broadly, studies may reduce uncertainty around enrollment criteria, timing of intervention, endpoint selection, and expected rates/timing of detectable change.
What disease areas are targeted by PAR-15-115?
The targeted areas are musculoskeletal, rheumatic, and skin diseases, as well as related conditions.
How do observational cohort studies help future clinical trials, according to this FOA?
The FOA describes observational cohort studies as a way to map symptoms and disease trajectories over time, clarify disease stages and timing of progression, identify common comorbidities that may affect outcomes or eligibility, and learn which outcomes matter most to patients and are realistically measurable in clinical settings.
Does the FOA emphasize patient-centered outcomes?
Yes. It highlights the importance of learning what outcomes matter most to patients and what outcomes can realistically be measured in clinical settings.
Does this opportunity support biomarker or endpoint development?
Yes. A major purpose is to help investigators develop, refine, and/or validate tools that trials depend on, including objective biomarkers (such as lab-based or imaging-based measures) and subjective or patient-reported outcome measures that can serve as endpoints in later interventional studies.
What are examples of deliverables expected from funded projects?
The intended deliverable is evidence and infrastructure that informs future trials. Examples mentioned include estimates of progression rates, baseline variability, recruitment pools, endpoint performance, and biomarker validity.
What is the funding mechanism for this opportunity?
The funding mechanism is the NIH R01 research project grant.
Which agency is offering this opportunity?
This opportunity is offered by the National Institutes of Health (NIH).
What is the CFDA number and program area listed for this FOA?
The opportunity is listed under CFDA 93.846: Arthritis, Musculoskeletal and Skin Diseases Research.
What is the award ceiling listed for PAR-15-115?
The listed award ceiling is $225,000.
Is cost sharing or matching required?
No. The announcement states there is no cost sharing or matching requirement.
When was the opportunity posted?
The posted and creation date listed is February 6, 2015.
What are the closing and archive dates shown for this FOA?
The original and current closing date listed is November 1, 2017, and the archive date is December 2, 2017.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and governmental units. Examples listed include public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities); for-profit organizations (other than small businesses); small businesses; state and local governments (including city/township, county, and special district governments); public housing authorities/Indian housing authorities; and tribal governments and tribal organizations (including federally recognized and other-than-federally recognized categories).
Are specific institution types called out as eligible?
Yes. The FOA notes additional eligible applicant types including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions. It also references faith-based or community-based organizations and eligible federal agencies as eligible applicant types.
Can foreign organizations apply directly as the applicant?
No. The announcement clarifies that non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply directly.
Can a U.S. organization apply if part of the project is outside the United States?
The FOA states that non-domestic components of U.S. organizations are not eligible to apply. However, it also notes that foreign components (as defined by the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain foreign elements when permitted under NIH policy.
Where can applicants find the official FOA page?
The FOA directs readers to the NIH Grants Guide page at: http://grants.nih.gov/grants/guide/pa-files/PAR-15-115.html
Who is listed for technical help accessing or linking to the announcement?
The FOA provides NIH Office of Extramural Research (OER) webmaster contacts for technical issues accessing or linking to the announcement.
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