Opportunity Information: Apply for RFA DK 10 015
Apply for RFA DK 10 015
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Lifestyle Interventions in Overweight and Obese Pregnant Women Consortium Research Coordinating Unit (RCU) (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Jan 4, 2011 and posted on Jan 4, 2011.
- Applicants must submit their applications by Mar 24, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $500,000.00 to eligible and selected applicants.
- Eligible applicants include: Private institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments Native American tribal governments (Federally recognized) Small businesses For profit organizations other than small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public housing authorities/Indian housing authorities Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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.
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Opportunity Summary:
The funding opportunity RFA-DK-10-015 is a National Institutes of Health (NIH) cooperative agreement (U01) issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to support a single organization that will serve as the Research Coordinating Unit (RCU) for the Lifestyle Interventions in Pregnancy Clinical Trials Consortium. Rather than funding a stand-alone research project, this award is designed to fund the central coordinating hub that helps multiple clinical trial sites work as one integrated program. The RCU is meant to strengthen collaboration, ensure consistent operations across studies, and make it easier for investigators and NIDDK to share information, harmonize procedures, and move the consortium’s research forward efficiently.
This FOA is paired with a separate, parallel announcement (RFA-DK-10-014) that funds the actual clinical trial centers conducting behavioral and lifestyle intervention studies in overweight and obese pregnant women. The consortium’s broader scientific aim is to test whether structured lifestyle and behavioral interventions during pregnancy can improve maternal weight-related and metabolic outcomes and also benefit the offspring. In that context, the RCU’s role is to support the collective success of the clinical trials by coordinating the behind-the-scenes work that allows multi-site studies to run smoothly and produce comparable, high-quality data.
Key responsibilities for the RCU include facilitating communication and coordination among participating clinical centers and between the centers and NIDDK, promoting data sharing, and supporting the development of collaborative publications and manuscripts that reflect consortium-wide results. The RCU is also expected to organize and support the consortium’s governance and oversight structure by planning, arranging, and supporting meetings and conference calls for the Steering Committee and its subcommittees, as well as for the Data and Safety Monitoring Board (DSMB). Because this is a cooperative agreement, the work is carried out in close collaboration with NIDDK, with substantial federal scientific and programmatic involvement typical of NIH U01 mechanisms, especially for complex, multi-site clinical research programs.
From an administrative standpoint, the opportunity is categorized as discretionary funding and uses the cooperative agreement instrument. The activity category is listed under food and nutrition/health, and the CFDA number is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). The estimated total funding amount is $500,000, with no cost-sharing or matching requirement. The announcement was posted on January 4, 2011, with an original and current closing date of March 24, 2011, and an archive date of April 24, 2011.
Eligibility is broad and includes many types of domestic entities that can administer NIH awards. Eligible applicants include public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, state and local governments (including county, city/township, special districts, and independent school districts), tribal governments and tribal organizations (including federally recognized tribes and other tribal entities), U.S. territories or possessions, public housing/Indian housing authorities, regional organizations, small businesses, and for-profit organizations (including those other than small businesses). The eligibility language also explicitly includes various mission-serving institutions and community-based categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, as well as eligible agencies of the federal government.
In practical terms, an applicant organization for the RCU would be expected to demonstrate strong capabilities in multi-center clinical trial coordination, cross-site communications, meeting and committee support, data coordination and sharing practices, and the logistical and administrative infrastructure needed to keep a consortium aligned. The core value of the award is enabling the clinical trial sites funded under the companion FOA to operate with shared standards, efficient governance, and timely dissemination of findings, all aimed at improving pregnancy-related health outcomes in overweight and obese women and their children.
Frequently Asked Questions (FAQs)
What is the funding opportunity RFA-DK-10-015?
RFA-DK-10-015 is a National Institutes of Health (NIH) funding opportunity issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It uses a cooperative agreement mechanism (U01) to support one organization to serve as the Research Coordinating Unit (RCU) for the Lifestyle Interventions in Pregnancy Clinical Trials Consortium.
What is the main purpose of this award?
The award is designed to fund a central coordinating hub rather than a stand-alone research project. The RCU supports and aligns multiple clinical trial sites so they can operate as one integrated consortium with consistent operations, harmonized procedures, and high-quality, comparable data.
Is this funding meant to support a clinical trial center that enrolls participants?
No. This opportunity supports the consortium's Research Coordinating Unit (RCU), which coordinates behind-the-scenes operations across clinical trial sites. The clinical trial centers conducting the behavioral and lifestyle intervention studies are funded under a separate, parallel announcement (RFA-DK-10-014).
What is the companion funding announcement for the clinical trial centers?
The companion, parallel announcement that funds the clinical trial centers is RFA-DK-10-014.
What consortium does this RCU support?
The RCU supports the Lifestyle Interventions in Pregnancy Clinical Trials Consortium, a multi-site program focused on lifestyle and behavioral intervention studies in overweight and obese pregnant women.
What is the broader scientific aim of the consortium?
The consortium aims to test whether structured lifestyle and behavioral interventions during pregnancy can improve maternal weight-related and metabolic outcomes and also benefit the offspring.
What does the RCU do for the consortium?
The RCU functions as the central coordinating unit that strengthens collaboration, ensures consistent operations across studies, facilitates cross-site coordination, and helps investigators and NIDDK share information and harmonize procedures to move the consortium's work forward efficiently.
What are the key responsibilities of the RCU?
Key responsibilities include facilitating communication and coordination among participating clinical centers and between the centers and NIDDK, promoting data sharing, supporting development of collaborative publications and manuscripts reflecting consortium-wide results, and organizing the governance and oversight infrastructure through meetings and calls.
What kinds of meetings and groups must the RCU support?
The RCU is expected to plan, arrange, and support meetings and conference calls for the Steering Committee and its subcommittees, as well as for the Data and Safety Monitoring Board (DSMB).
How does the cooperative agreement (U01) mechanism affect how the work is done?
Because this is a cooperative agreement, the work is carried out in close collaboration with NIDDK, with substantial federal scientific and programmatic involvement typical of NIH U01 mechanisms, particularly for complex multi-site clinical research programs.
How many awards will be made under this opportunity?
This opportunity is intended to support a single organization to serve as the Research Coordinating Unit (RCU).
What is the estimated total funding amount?
The estimated total funding amount is $500,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
What type of funding is this categorized as?
It is categorized as discretionary funding and uses the cooperative agreement instrument.
What is the activity category for this opportunity?
The activity category is listed under food and nutrition/health.
What is the CFDA number associated with this opportunity?
The CFDA number is 93.847, titled "Diabetes, Digestive, and Kidney Diseases Extramural Research."
When was the announcement posted?
The announcement was posted on January 4, 2011.
What was the closing date for applications?
The original and current closing date listed for the announcement is March 24, 2011.
When was the archive date?
The archive date is April 24, 2011.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic entities that can administer NIH awards. Examples include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), state and local governments, tribal governments and tribal organizations, U.S. territories or possessions, public housing/Indian housing authorities, regional organizations, small businesses, and for-profit organizations (including those other than small businesses). The eligibility language also includes eligible federal government agencies.
Are mission-serving institutions and community-based organizations explicitly included in eligibility?
Yes. The eligibility language explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, as well as faith-based or community-based organizations.
Does the RCU need experience with multi-center clinical trial coordination?
Yes. In practical terms, an applicant organization would be expected to demonstrate strong capabilities in multi-center clinical trial coordination, cross-site communications, meeting and committee support, and data coordination and sharing practices.
What infrastructure is expected of an applicant organization?
The applicant organization is expected to have the logistical and administrative infrastructure needed to keep a consortium aligned, including organizing governance and oversight activities and supporting consistent operations across multiple sites.
What role does the RCU play in publications?
The RCU is expected to support the development of collaborative publications and manuscripts that reflect consortium-wide results.
How does the RCU contribute to data quality and comparability?
By promoting data sharing, harmonizing procedures, and ensuring consistent operations across studies, the RCU helps the clinical trial sites produce comparable, high-quality data across the consortium.
What is the intended value of the RCU to the consortium?
The core value is enabling the clinical trial sites funded under the companion FOA to operate with shared standards, efficient governance, and timely dissemination of findings, all aimed at improving pregnancy-related health outcomes in overweight and obese women and their children.
Which NIH institute is sponsoring this opportunity?
The opportunity is issued by NIDDK, which is part of NIH.
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