Opportunity Information: Apply for PA 09 196
Apply for PA 09 196
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Ancillary Studies of Acute Kidney Injury, Chronic Kidney Disease, and End Stage Renal Disease Accessing Information from Clinical Trials, Epidemiological Studies, and Databases (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837 Cardiovascular Diseases Research 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on May 28, 2009 and posted on May 28, 2009.
- Applicants must submit their applications by Sep 7, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Public housing authorities/Indian housing authorities Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Special district governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County governments City or township governments.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
This NIH grant opportunity (PA-09-196) is an R01 funding announcement from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI) focused on ancillary studies that leverage information already being collected in clinical trials, epidemiologic cohorts, and large administrative or clinical databases. The main idea is to support investigator-initiated projects that do not necessarily start a brand-new standalone study from scratch, but instead build on the infrastructure and data resources of ongoing or completed investigations. Applicants can propose fresh analyses of existing datasets from finished studies, or they can add new data elements, outcomes, or biospecimen collection onto studies that are still underway, as long as the work is clearly tied to understanding kidney disease.
Scientifically, the announcement targets research that can deepen knowledge about acute kidney injury (AKI), chronic kidney disease (CKD), and end-stage renal disease (ESRD), especially around why these conditions develop, how they progress, and what they mean for patients in daily life. A major emphasis is identifying risk factors for developing kidney disease and for experiencing faster-than-expected loss of kidney function among people who already have CKD. The opportunity explicitly encourages work that connects kidney disease with important related conditions and complications, including cardiovascular disease and malnutrition, recognizing that kidney problems often coexist with broader systemic illness and that these comorbidities can shape outcomes. Beyond clinical endpoints, the announcement also calls for studies that evaluate the impact of kidney disease on quality of life and on mental and physical functioning, which opens the door to patient-centered outcomes, functional status measures, and longer-term follow-up questions that may not have been primary aims in the parent studies.
AKI research is specifically welcomed, including investigations that incorporate biomarkers. In practice, this could include using stored samples from a trial to test emerging biomarkers, adding specimen collection to an ongoing cohort, or reanalyzing existing lab data to refine AKI definitions and prediction models. More broadly, the FOA is designed to encourage efficient, high-value science by extracting additional knowledge from investments already made in trials, cohorts, and databases, including studies that were originally designed for other diseases or populations but are still well-suited to answering kidney-related questions.
From a data-source standpoint, the opportunity is intentionally broad. It supports ancillary projects tied to both government-funded and non-government-funded trials and epidemiologic studies, and it also encourages analysis of large public-access datasets and other databases. That means proposals could be built around established clinical trial datasets, longitudinal population studies, electronic health record-derived registries, claims data, or other large-scale administrative sources, as long as the project’s kidney-focused questions are strong and the dataset can credibly address them.
Administratively, this is a discretionary grant mechanism using the NIH R01 research project grant. It does not require cost sharing or matching. Eligible applicants span a wide range of organizations, including public and private institutions of higher education, nonprofits (including and beyond 501(c)(3) organizations), small businesses, for-profit organizations (other than small businesses), state and local governments, tribal governments and tribal organizations, U.S. territories or possessions, and various mission-focused institutions such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities. The announcement also indicates eligibility for non-U.S. (foreign) entities and regional organizations, reflecting an intent to cast a wide net for high-quality ancillary kidney research.
Key identifying details included in the posting are the funding opportunity number PA-09-196, the posting date of May 28, 2009, and an original and final closing date listed as September 7, 2012 (with an archive date of October 8, 2012). The sponsoring agency is the National Institutes of Health, with program leadership from NIDDK and NHLBI, and the full announcement was made available through the NIH grants guide at the provided link.
FAQs: NIH Grant PA-09-196 (R01) Ancillary Studies in Kidney Disease
What is this funding opportunity?
This is an NIH funding opportunity announcement (FOA) number PA-09-196 that uses the R01 research project grant mechanism to support ancillary studies related to kidney disease.
Which NIH Institutes are leading this FOA?
Program leadership is from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI), under the National Institutes of Health (NIH).
What is the main purpose of the grant?
The main goal is to fund investigator-initiated ancillary studies that leverage information already being collected in clinical trials, epidemiologic cohorts, and large administrative or clinical databases, rather than requiring a completely new standalone study to be launched from scratch.
What does "ancillary study" mean in this FOA?
In this context, an ancillary study is a project that builds on existing studies or datasets. It might involve new analyses of existing data from completed studies, or adding new data elements, outcomes, or biospecimen collection onto studies that are still underway, as long as the work is clearly tied to understanding kidney disease.
Does the FOA support projects using completed studies?
Yes. Applicants may propose fresh analyses of existing datasets from finished studies.
Does the FOA support projects that add new data collection to ongoing studies?
Yes. Applicants may propose adding new data elements, outcomes, or biospecimen collection to ongoing clinical trials or cohorts, provided the ancillary work is clearly tied to kidney disease questions.
What kidney conditions are a focus of this announcement?
The FOA targets research that improves understanding of acute kidney injury (AKI), chronic kidney disease (CKD), and end-stage renal disease (ESRD), including why these conditions develop, how they progress, and what they mean for patients in daily life.
What kinds of CKD research questions are encouraged?
A major emphasis is identifying risk factors for developing kidney disease and for faster-than-expected loss of kidney function among people who already have CKD.
Are studies connecting kidney disease with other health problems encouraged?
Yes. The announcement explicitly encourages research that links kidney disease with related conditions and complications such as cardiovascular disease and malnutrition, recognizing that comorbidities can shape outcomes.
Does this FOA support patient-centered or quality-of-life outcomes?
Yes. The FOA calls for studies that evaluate how kidney disease affects quality of life and mental and physical functioning, which can include functional status measures and longer-term follow-up questions that may not have been the primary aims of the parent studies.
Is acute kidney injury (AKI) research specifically welcomed?
Yes. AKI research is specifically welcomed, including investigations that incorporate biomarkers.
Can biomarker work be part of an ancillary study under this FOA?
Yes. Examples described include testing emerging biomarkers using stored samples from a trial, adding specimen collection to an ongoing cohort, or reanalyzing existing laboratory data to refine AKI definitions and prediction models.
Does the FOA require that the parent study originally be about kidney disease?
No. The FOA notes that ancillary projects may build on studies that were originally designed for other diseases or populations, as long as the dataset or infrastructure is well-suited to answering strong kidney-related questions.
What types of data sources can be used?
The FOA is intentionally broad and supports ancillary projects leveraging clinical trials, epidemiologic cohorts, and large administrative or clinical databases. It also encourages analysis of large public-access datasets and other databases.
Are government-funded studies required as the parent resource?
No. The FOA supports ancillary projects tied to both government-funded and non-government-funded trials and epidemiologic studies.
Can projects use electronic health records or claims data?
Yes. The FOA indicates that proposals can be built around electronic health record-derived registries, claims data, and other large-scale administrative sources, as long as the kidney-focused questions are strong and the dataset can credibly address them.
What grant mechanism is used?
This opportunity uses the NIH R01 research project grant mechanism.
Is cost sharing or matching required?
No. The FOA states that it does not require cost sharing or matching.
What types of organizations are eligible to apply?
Eligible applicants include a wide range of organizations such as public and private institutions of higher education; nonprofits (including and beyond 501(c)(3) organizations); small businesses; for-profit organizations (other than small businesses); state and local governments; tribal governments and tribal organizations; U.S. territories or possessions; and mission-focused institutions including HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities.
Are non-U.S. (foreign) entities eligible?
Yes. The announcement indicates eligibility for non-U.S. (foreign) entities and regional organizations.
What is the funding opportunity number?
The funding opportunity number is PA-09-196.
When was this FOA posted?
The posting date listed is May 28, 2009.
What are the closing dates shown in the posting?
The original and final closing date listed is September 7, 2012.
Is this opportunity archived?
Yes. An archive date of October 8, 2012 is listed.
Where was the full announcement made available?
The full announcement was made available through the NIH grants guide via the provided link referenced in the posting.
What is the overall scientific theme of the FOA?
The theme is efficient, high-value kidney research that extracts additional knowledge from prior investments in trials, cohorts, and databases by using existing infrastructure and data resources to answer kidney-focused questions.
What is a key requirement for ancillary work under this FOA?
The ancillary project must be clearly tied to understanding kidney disease, and the chosen data source must credibly address the proposed kidney-related questions.
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