Opportunity Information: Apply for RFA AR 12 007
Apply for RFA AR 12 007
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Ancillary Domain Validation Patient Reported Outcomes Measurement Information System (PROMIS) Studies (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research 93.399 Cancer Control 93.846 Arthritis, Musculoskeletal and Skin Diseases Research.
- This funding opportunity was created on Feb 8, 2012 and posted on Feb 6, 2012.
- Applicants must submit their applications by Apr 10, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: Public and State controlled institutions of higher education Independent school districts Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Special district governments City or township governments For profit organizations other than small businesses Private institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) State governments Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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:
This NIH grant opportunity (RFA-AR-12-007) is an R01 research grant designed to support ancillary studies that add Patient Reported Outcomes Measurement Information System (PROMIS) domains onto clinical studies that are already underway. The basic idea is that many clinical trials, observational cohorts, and patient care populations already have a well-characterized group of participants and an established infrastructure for recruitment, follow-up, and data management. NIH is asking investigators to leverage those existing platforms to collect PROMIS patient-reported outcome data, so PROMIS measures can be more broadly validated and more confidently used across the wide range of diseases represented in the NIH portfolio.
The scientific focus is on outcomes research that tests, validates, and evaluates existing PROMIS item banks in real-world patient populations. Applications are expected to treat PROMIS domains as the central added value of the proposed ancillary work, using the parent study as the vehicle for efficient data collection and analysis. NIH is particularly interested in studies that help determine how well PROMIS measures perform in specific disease contexts, including whether the PROMIS domains capture meaningful symptoms and functioning, whether they are sensitive to clinical change, and whether they behave consistently across different subgroups of patients. A key expectation is that these ancillary projects will contribute evidence that helps establish PROMIS domains as reliable, comparable, and interpretable endpoints that can be incorporated into future clinical research and potentially clinical care.
Collaboration and data sharing are emphasized. NIH encourages applicants to work with the PROMIS Network and to share data in ways that strengthen the collective evidence base around PROMIS measurement. In practical terms, this means proposals that coordinate methods, align PROMIS domain selection with broader network priorities, and plan for dissemination of findings and datasets are consistent with the intent of the announcement. The goal is not simply to collect additional questionnaires, but to generate results that advance measurement science and improve confidence in PROMIS tools across multiple disease areas.
From an administrative standpoint, this is a discretionary NIH grant using the R01 mechanism, with no cost sharing or matching requirement. The FOA listed an estimated total funding level of about $1,000,000, and an award ceiling of $250,000. The opportunity was posted in early February 2012, with an application due date of April 10, 2012, and it was later archived in May 2012, meaning it was tied to that specific solicitation window rather than being an ongoing open call.
Eligibility is broad across the kinds of U.S.-based organizations that typically compete for NIH research funding. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) entities), small businesses and other for-profit organizations (other than small businesses are also listed as eligible), and multiple levels of government entities (state, county, city/township, special districts), as well as school districts and public housing authorities. The FOA also explicitly includes a range of mission-focused institutions and community-based organizations, such as HBCUs, Hispanic-serving institutions, tribal colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations. Foreign institutions themselves were not eligible to apply, and non-U.S. components of U.S. organizations were not eligible, but foreign components as defined under NIH policy were allowed, which typically means a primarily U.S.-led project can include certain justified international elements under NIH rules.
Overall, this opportunity was aimed at accelerating the integration of standardized patient-reported outcomes into ongoing clinical research by funding add-on studies that use existing cohorts and infrastructure. NIH’s intent was to build stronger, disease-relevant validation evidence for PROMIS item banks, encourage consistent use of PROMIS domains in outcomes research, and promote collaboration and data sharing so that results from many different clinical areas can collectively improve PROMIS measurement and interpretation.
Frequently Asked Questions (FAQs)
What is NIH RFA-AR-12-007?
RFA-AR-12-007 is a National Institutes of Health (NIH) funding opportunity announcement for an R01 research grant focused on ancillary studies that add Patient Reported Outcomes Measurement Information System (PROMIS) domains to clinical studies that are already underway.
What type of grant mechanism is used for this opportunity?
This opportunity uses the NIH R01 research project grant mechanism and is described as a discretionary NIH grant.
What is the main purpose of this grant?
The main purpose is to leverage existing clinical research platforms (such as clinical trials, observational cohorts, or patient care populations) to collect PROMIS patient-reported outcome data. The intent is to broaden validation and confidence in PROMIS measures across many diseases represented in the NIH portfolio.
What kinds of projects are being funded?
The grant is intended to fund ancillary (add-on) studies. These projects add PROMIS domains onto a parent clinical study that is already in progress and has an established infrastructure for recruitment, follow-up, and data management.
Does the parent study need to already be underway?
Yes. The opportunity is specifically designed for ancillary studies that add PROMIS domains to clinical studies that are already underway and have a well-characterized participant group and established research infrastructure.
What are PROMIS domains in the context of this opportunity?
Within this opportunity, PROMIS domains refer to standardized patient-reported outcome areas measured using existing PROMIS item banks. The goal is to test, validate, and evaluate these item banks in real-world patient populations.
Is the focus on developing new PROMIS measures or evaluating existing ones?
The scientific focus is on testing, validating, and evaluating existing PROMIS item banks in real-world patient populations, rather than creating entirely new measures.
How central do PROMIS measures need to be in the application?
Applications are expected to treat PROMIS domains as the central added value of the proposed ancillary work. The parent study serves as the vehicle for efficient data collection and analysis.
What scientific questions is NIH especially interested in for these ancillary studies?
NIH is particularly interested in evidence showing how PROMIS measures perform in specific disease contexts, including whether PROMIS domains capture meaningful symptoms and functioning, whether they are sensitive to clinical change, and whether they behave consistently across different patient subgroups.
What is meant by "real-world patient populations" in this announcement?
Based on the announcement, "real-world patient populations" refers to participants already enrolled in ongoing clinical trials, observational cohorts, or patient care populations that are well-characterized and supported by an established research infrastructure.
What is the expected contribution of funded projects to PROMIS?
A key expectation is that funded ancillary projects will generate evidence supporting PROMIS domains as reliable, comparable, and interpretable endpoints that can be incorporated into future clinical research and potentially clinical care.
Is NIH looking for projects that simply add more questionnaires to an existing study?
No. The intent is not simply to collect additional questionnaires. NIH is looking for results that advance measurement science and improve confidence in PROMIS tools across multiple disease areas.
Is collaboration encouraged?
Yes. Collaboration is emphasized, and NIH encourages applicants to work with the PROMIS Network.
Are data sharing and dissemination expected?
Yes. Data sharing and dissemination are emphasized. Proposals that plan for sharing data and disseminating findings in ways that strengthen the collective evidence base around PROMIS measurement align with the intent of the announcement.
What does it mean to "align PROMIS domain selection with broader network priorities"?
The opportunity notes that proposals coordinating methods and aligning PROMIS domain selection with broader PROMIS Network priorities are consistent with the intent of the announcement, meaning domain choices and approaches should fit into a larger, collaborative measurement effort.
Is there a cost sharing or matching requirement?
No. The announcement states there is no cost sharing or matching requirement.
How much funding was available under this solicitation?
The FOA listed an estimated total funding level of about $1,000,000.
What was the award ceiling for individual grants?
The award ceiling was $250,000.
When was the opportunity posted and when were applications due?
The opportunity was posted in early February 2012, and the application due date was April 10, 2012.
Is this funding opportunity still open?
No. The opportunity was later archived in May 2012, indicating it was tied to that specific solicitation window and not an ongoing open call.
What types of organizations were eligible to apply?
Eligibility was broad across U.S.-based organizations typically eligible for NIH research funding, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, other for-profit organizations, and a range of government entities (state, county, city/township, and special districts), as well as school districts and public housing authorities.
Were mission-focused and community-based institutions included in eligibility?
Yes. The FOA explicitly included HBCUs, Hispanic-serving institutions, tribal colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations.
Could foreign institutions apply as the primary applicant?
No. Foreign institutions themselves were not eligible to apply.
Could a U.S. organization include non-U.S. components?
No. Non-U.S. components of U.S. organizations were not eligible.
Are any international elements allowed under this opportunity?
Yes. The FOA states that foreign components (as defined under NIH policy) were allowed, generally meaning a primarily U.S.-led project could include justified international elements consistent with NIH rules.
What kinds of parent studies does NIH expect applicants to leverage?
The opportunity highlights leveraging studies with an established infrastructure for recruitment, follow-up, and data management, including clinical trials, observational cohorts, and patient care populations.
What is the overall goal of this grant opportunity?
The overall goal is to accelerate integration of standardized patient-reported outcomes into ongoing clinical research by funding add-on studies that use existing cohorts and infrastructure, build disease-relevant validation evidence for PROMIS item banks, and promote collaboration and data sharing to improve PROMIS measurement and interpretation across clinical areas.
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