Opportunity Information: Apply for RFA AR 15 014
Apply for RFA AR 15 014
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Validation of Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium (U19)" 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 Mar 19, 2015 and posted on Mar 6, 2015.
- Applicants must submit their applications by Jun 2, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $12,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Private institutions of higher education State governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments For profit organizations other than small businesses County governments Independent school districts.
- 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) 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 Validation of Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium (U19) funding opportunity (RFA-AR-15-014) is a National Institutes of Health initiative led by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to strengthen how pediatric clinical research and care capture the real-world experiences of children living with chronic disease. The central goal is to validate and expand the use of modern patient-reported outcome (PRO) measurement in pediatrics by combining PROMIS-based assessments with rich, standardized clinical characterization and, where appropriate, biospecimen collection in well-described human cohorts. In plain terms, NIH is funding a small network of coordinated projects to prove, in a rigorous and disease-relevant way, that PROMIS tools can reliably measure how children feel and function across a range of long-term conditions, and that these measures can be meaningfully tied to clinical features and biology.
A key scientific focus of the opportunity is leveraging the Patient Reported Outcomes Measurement Information System (PROMIS), which is a set of highly reliable and precise measures designed to capture physical, mental, and social well-being from the patient perspective. PROMIS tools work through structured questions that assess what patients can do (function) and how they feel (symptoms, emotional state, social health). NIH highlights that PROMIS measures are intended to be suitable for use as primary or secondary endpoints in clinical studies, including trials that evaluate how well treatments work. For pediatrics, this is especially important because children’s symptom burden, day-to-day functioning, and quality of life can be difficult to quantify consistently across conditions, ages, and developmental stages; validated PROs help close that gap.
The consortium’s scope is intentionally broad across pediatric chronic diseases and conditions. Examples listed include asthma, juvenile arthritis, cystic fibrosis, diabetes, obesity and overweight, chronic kidney disease, inflammatory bowel disease, sickle cell disease, malnutrition, developmental disabilities (including attention deficit/hyperactivity disorder and autism spectrum disorder), cerebral palsy, and mental illnesses. This breadth signals an emphasis on cross-cutting measurement science: building confidence that PROMIS-based outcomes can be interpreted within specific diseases while also enabling comparisons across different pediatric populations. The expectation is that funded projects will work in well-characterized cohorts and will pair PRO collection with detailed phenotyping, and/or biospecimen collection, so that patient-reported experiences can be linked to clinical status, disease activity, severity, treatment exposure, and potentially underlying biological markers.
Mechanistically, this is a cooperative agreement (U19), which typically means NIH expects substantial involvement in coordinating, steering, and harmonizing the work across awardees. Rather than isolated single-site studies, the design implies a collaborative consortium model where multiple funded teams align methods, share data standards, and collectively address common validation questions (for example, reliability, responsiveness to change, interpretability, and feasibility of PROMIS use in different pediatric settings). The opportunity sits in the “Health” activity category and is listed under CFDA 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research), reflecting NIAMS leadership even though the targeted conditions extend well beyond traditional NIAMS diseases.
From a funding standpoint, NIH anticipated making about four awards with an estimated total funding level of $12,000,000. There is no cost sharing or matching requirement. The opportunity was posted in March 2015, with an original closing date of June 1, 2015 (and a current closing date of June 2, 2015 in the listing), and it was later archived in July 2015. These dates indicate this particular announcement cycle has closed, but the summary remains useful for understanding the program’s intent and the kind of consortium-based pediatric PRO validation work NIH has sought to advance.
Eligibility is broad and includes many types of U.S.-based organizations: public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), small businesses and other for-profit organizations (other than small businesses), and multiple levels of government (state, county, city/township, special district), along with independent school districts and public/Indian housing authorities. Tribal governments and tribal organizations are eligible, as are a range of mission-focused institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions, among others. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components are allowed as defined by NIH policy, which generally means discrete collaborations or elements performed abroad can be included under certain rules even though the applicant organization must be domestic.
Overall, the PEPR Consortium FOA is aimed at making pediatric patient-reported outcomes more scientifically solid and more usable in real clinical research by testing PROMIS tools in carefully characterized pediatric cohorts, harmonizing approaches across multiple sites and diseases, and producing validated measures that can serve as credible endpoints in observational studies and clinical trials. The long-term payoff NIH is pushing toward is clearer, more consistent measurement of children’s lived experiences of chronic illness, enabling better evaluation of treatments and more patient-centered care.
Frequently Asked Questions (FAQs)
What is the PEPR Consortium (U19) funding opportunity?
The Validation of Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium (U19) opportunity (RFA-AR-15-014) is a National Institutes of Health (NIH) initiative led by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It was designed to strengthen how pediatric clinical research and care capture the real-world experiences of children living with chronic diseases by validating modern patient-reported outcome (PRO) measures in pediatrics.
What is the main goal of this initiative?
The central goal is to validate and expand the use of modern PRO measurement in children by combining PROMIS-based assessments with standardized clinical characterization and, where appropriate, biospecimen collection in well-described human cohorts. In practical terms, the program aims to show that PROMIS tools can reliably measure how children feel and function across chronic conditions, and that these patient-reported measures can be meaningfully connected to clinical features and potentially biological markers.
Which NIH institute leads this opportunity?
NIAMS leads the initiative. Even though NIAMS is the lead institute, the scope of diseases and conditions highlighted extends beyond traditional NIAMS areas, reflecting an intentionally broad pediatric chronic disease focus.
What does PROMIS mean in this funding opportunity?
PROMIS stands for the Patient Reported Outcomes Measurement Information System. It is a set of highly reliable and precise measures intended to capture physical, mental, and social well-being from the patient perspective using structured questions about function (what patients can do) and feelings/symptoms (including emotional and social health).
Why is PROMIS emphasized for pediatric research?
NIH emphasizes PROMIS because pediatric symptom burden, daily functioning, and quality of life can be difficult to quantify consistently across conditions, ages, and developmental stages. Validated PRO measures help fill that gap by providing standardized tools that can be used across pediatric populations and interpreted in disease-relevant ways.
How are PROMIS measures expected to be used in studies?
The opportunity highlights that PROMIS measures are intended to be suitable as primary or secondary endpoints in clinical studies, including clinical trials that evaluate treatment effectiveness. A major aim is to support rigorous validation so these measures can serve as credible outcomes in pediatric research.
What kinds of pediatric conditions are within scope?
The scope is broad across pediatric chronic diseases and conditions. Examples listed include asthma, juvenile arthritis, cystic fibrosis, diabetes, obesity and overweight, chronic kidney disease, inflammatory bowel disease, sickle cell disease, malnutrition, developmental disabilities (including attention deficit/hyperactivity disorder and autism spectrum disorder), cerebral palsy, and mental illnesses.
Is the focus limited to a single disease area?
No. The breadth of conditions signals an emphasis on cross-cutting measurement science: supporting confidence that PROMIS-based outcomes can be interpreted within specific diseases while also enabling comparisons across different pediatric populations.
What is meant by validating pediatric patient-reported outcomes?
Based on the description, validation involves proving in a rigorous and disease-relevant way that PROMIS tools can reliably measure pediatric experiences (how children feel and function) and that the resulting scores can be interpreted alongside clinical characterization and, when appropriate, biospecimen-related biological information.
What types of cohorts are expected for projects under this initiative?
The initiative expects work in well-described, well-characterized human cohorts. Projects are expected to pair PRO collection with rich, standardized clinical phenotyping and, where appropriate, biospecimen collection so that PROs can be linked to clinical status, disease activity, severity, treatment exposure, and potentially biological markers.
Are biospecimens required?
The description indicates biospecimen collection is included "where appropriate." That implies biospecimens may be used when they make scientific sense for linking patient-reported experiences to biology, but the opportunity is framed to allow flexibility depending on the disease context and study design.
What does "U19 cooperative agreement" mean for applicants?
This opportunity uses a U19 cooperative agreement mechanism, which typically means NIH expects substantial involvement in coordinating, steering, and harmonizing work across awardees. The design implies a collaborative consortium where multiple funded teams align methods and data standards rather than operating as isolated single-site efforts.
Is this intended to be a consortium rather than standalone projects?
Yes. The opportunity describes a coordinated network of projects. It emphasizes harmonization across awardees, shared standards, and collective progress on common validation questions.
What kinds of validation questions are expected to be addressed across the consortium?
The description provides examples of consortium-wide validation topics such as reliability, responsiveness to change, interpretability, and feasibility of PROMIS use across different pediatric settings and diseases.
What is the activity category and CFDA listing for this opportunity?
The opportunity is listed in the "Health" activity category and under CFDA 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research), reflecting NIAMS leadership.
How much funding was anticipated, and how many awards?
NIH anticipated making about four awards with an estimated total funding level of $12,000,000.
Is there a cost sharing or matching requirement?
No. The opportunity states there is no cost sharing or matching requirement.
When was this funding opportunity posted and when did it close?
The opportunity was posted in March 2015. The original closing date was June 1, 2015, and the listing shows a current closing date of June 2, 2015. It was archived in July 2015.
Is this specific announcement still open for applications?
No. The dates indicate this particular announcement cycle has closed and the opportunity was archived in July 2015.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based organizations: public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), small businesses, other for-profit organizations (other than small businesses), and multiple levels of government (state, county, city/township, special district). Independent school districts and public/Indian housing authorities are also eligible. Tribal governments and tribal organizations are eligible, and the opportunity includes a range of mission-focused institutions such as HBCUs, Hispanic-serving institutions, TCCUs, and Alaska Native and Native Hawaiian Serving Institutions, among others.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible.
Can the project include any international collaboration?
Yes, foreign components are allowed as defined by NIH policy. This generally means discrete collaborations or elements performed abroad may be included under certain rules, even though the applicant organization must be domestic.
What is the long-term outcome NIH is aiming for with this consortium?
The long-term payoff described is clearer, more consistent measurement of children’s lived experiences of chronic illness, enabling better evaluation of treatments in observational studies and clinical trials and supporting more patient-centered clinical care.
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