Opportunity Information: Apply for RFA AI 12 004
Apply for RFA AI 12 004
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV associated Infections in Adults (UM1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research 93.242 Mental Health Research Grants 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research 93.396 Cancer Biology Research 93.399 Cancer Control 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Mar 12, 2012 and posted on Jan 27, 2012.
- Applicants must submit their applications by Sep 28, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: For profit organizations other than small businesses County governments 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) City or township governments Native American tribal governments (Federally recognized) State governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses Special district governments 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.
- 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 eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
This funding opportunity (RFA-AI-12-004) is an NIH National Institute of Allergy and Infectious Diseases (NIAID) call for applications to run the Leadership Group for a clinical research network focused on therapeutics for HIV/AIDS and HIV-associated infections in adults. The central idea is that NIAID is supporting a coordinated, network-based clinical research program, and it wants a dedicated leadership structure with the authority and capacity to set the network research agenda, launch and manage studies, and continuously adapt priorities as the science and public health landscape changes. Because this is a cooperative agreement (UM1), awardees should expect substantial scientific and operational involvement from NIH staff, with shared responsibilities typical of cooperative agreements rather than the more hands-off approach used for standard grants.
The Leadership Group is expected to carry overall responsibility for developing, implementing, and adjusting the network’s clinical research agenda in line with NIAID’s HIV/AIDS scientific priorities referenced in the full announcement. In practical terms, that means the funded team is not only coordinating projects administratively, but also driving the scientific strategy: identifying the most pressing therapeutic questions for adult HIV disease and related infections, translating them into feasible clinical protocols, and ensuring the network can execute trials and other clinical studies efficiently and to high quality standards. The emphasis on “therapeutics†signals work centered on treatment and clinical management (for HIV itself and for infections that occur alongside HIV), rather than basic science alone, and the adult focus distinguishes it from pediatric or perinatal programs.
A key structural requirement is that an application for the Leadership Group must be submitted as three separate but linked UM1 applications, each covering a distinct center that together form the Leadership Group. These components are a Leadership and Operations Center (LOC), a Laboratory Center (LC), and a Statistical and Data Management Center (SDMC). The LOC functions as the program’s operational hub, typically handling network governance support, protocol development logistics, study activation and coordination, regulatory and compliance workflows, communications, meetings, and overall project management. The LC component is meant to provide the laboratory backbone needed for a therapeutics-focused clinical network, such as standardized assays, specimen handling and testing strategies, quality systems, and laboratory support that allows multiple clinical sites to generate comparable, reliable laboratory endpoints. The SDMC provides the data and analytics infrastructure: study database development and maintenance, data capture and cleaning, statistical design and analysis plans, interim monitoring support, and the overall data management processes required for multi-site clinical research. The “linked†nature of the three submissions is important because NIH is effectively funding a single integrated leadership entity made up of these complementary centers, and the expectation is that these units will work as a coordinated system rather than as independent projects.
The opportunity falls under the broad NIH health-related funding activity category (Health, Income Security and Social Services) and is associated with multiple CFDA listings, including but not limited to Allergy and Infectious Diseases Research (93.855) and Microbiology and Infectious Diseases Research (93.856), reflecting the cross-cutting nature of HIV therapeutics research and its connections to comorbidities and related fields. There is no cost sharing or matching requirement, so applicants are not required to contribute non-federal matching funds as a condition of the award. The funding instrument is discretionary, and the administrative mechanism is a cooperative agreement, which generally means applicants should be prepared for collaborative planning, reporting, and decision-making structures that include NIH program leadership.
Eligibility is broad across U.S.-based organizations and governments, including for-profit organizations (other than small businesses are explicitly listed, and small businesses are also listed), nonprofit organizations with and without 501(c)(3) status, private and public institutions of higher education, and a range of governmental entities (state, county, city/township, special district, independent school districts, and certain housing authorities). The eligibility section also highlights inclusion of specific institution types and communities such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribal colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, among others. Foreign institutions (non-U.S. entities) are not eligible to apply as the applicant organization, but non-U.S. components of U.S. organizations may participate, and foreign components are allowed as defined by NIH policy, which typically means international collaboration can be part of the project when well-justified, even though the prime applicant must be a U.S.-eligible entity.
In terms of timing and status, the FOA was posted January 27, 2012, with an original and final closing date of September 28, 2012, and it was archived October 29, 2012. That means it is no longer open for applications, but it remains a useful reference for understanding how NIAID structures large HIV clinical research networks and what it expects from leadership, laboratory, and data/statistics cores in an integrated network model. The sponsor agency is the National Institutes of Health, and the full announcement was hosted through the NIH grants site, with contact routes provided via the NIH Office of Extramural Research web support for access or technical linking issues.
Frequently Asked Questions (FAQ) - RFA-AI-12-004 (NIAID/NIH)
What is this funding opportunity?
RFA-AI-12-004 is an NIH National Institute of Allergy and Infectious Diseases (NIAID) call for applications to support a Leadership Group for a clinical research network focused on therapeutics for HIV/AIDS and HIV-associated infections in adults.
What is the overall purpose of the Leadership Group?
The Leadership Group is expected to provide the scientific and operational leadership for a coordinated, network-based clinical research program. This includes setting and adjusting the network research agenda, launching and managing studies, and adapting priorities as scientific and public health needs change.
What does "therapeutics" mean in this opportunity?
"Therapeutics" indicates an emphasis on treatment and clinical management research for adult HIV disease and HIV-associated infections. The focus is on clinical studies that inform or evaluate treatment approaches rather than basic science alone.
Is this opportunity focused on adults or children?
This opportunity is specifically focused on adults. The description distinguishes it from pediatric or perinatal HIV research programs.
What funding mechanism is used (and why does it matter)?
The mechanism is a cooperative agreement (UM1). This matters because UM1 cooperative agreements typically involve substantial scientific and operational involvement from NIH staff, with shared responsibilities and collaborative decision-making rather than a fully hands-off approach.
What is the expected role of NIH staff in a UM1 cooperative agreement?
Applicants should expect substantial NIH involvement in scientific and operational aspects of the program, consistent with cooperative agreements. Responsibilities are described as shared, with collaborative planning, reporting, and decision-making structures that include NIH program leadership.
What are the required components of the Leadership Group application?
An application for the Leadership Group must be submitted as three separate but linked UM1 applications. The three required components are:
- Leadership and Operations Center (LOC)
- Laboratory Center (LC)
- Statistical and Data Management Center (SDMC)
What does it mean that the three UM1 applications must be "linked"?
"Linked" means NIH is effectively funding a single integrated leadership entity made up of the three complementary centers. The expectation is that the LOC, LC, and SDMC operate as a coordinated system rather than as independent projects.
What does the Leadership and Operations Center (LOC) do?
The LOC functions as the program's operational hub. Responsibilities typically include network governance support, protocol development logistics, study activation and coordination, regulatory and compliance workflows, communications, meetings, and overall project management.
What does the Laboratory Center (LC) do?
The LC provides the laboratory backbone for a therapeutics-focused clinical network. This can include standardized assays, specimen handling and testing strategies, quality systems, and lab support so that multiple clinical sites can generate comparable and reliable laboratory endpoints.
What does the Statistical and Data Management Center (SDMC) do?
The SDMC provides the data and analytics infrastructure for network studies. Responsibilities can include study database development and maintenance, data capture and cleaning, statistical design and analysis plans, interim monitoring support, and overall data management processes needed for multi-site clinical research.
Is this opportunity about coordinating projects only, or also about scientific leadership?
It includes both, with a strong emphasis on scientific leadership. The Leadership Group is expected to drive scientific strategy by identifying urgent therapeutic questions, translating them into feasible clinical protocols, and ensuring the network can execute studies efficiently and with high quality.
What kinds of research topics are in scope?
The scope centers on therapeutics for adult HIV/AIDS and HIV-associated infections, aligned with NIAID HIV/AIDS scientific priorities referenced in the full announcement. The opportunity is framed around clinical research and network-run studies, including trials and other clinical studies.
What are the CFDA program areas associated with this opportunity?
The opportunity is associated with multiple CFDA listings, including (but not limited to) Allergy and Infectious Diseases Research (93.855) and Microbiology and Infectious Diseases Research (93.856), reflecting the cross-cutting nature of HIV therapeutics and related comorbidities.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement, so applicants are not required to contribute non-federal matching funds as a condition of award.
What types of organizations are eligible to apply?
Eligibility is broad across U.S.-based organizations and governments. Eligible applicants include for-profit organizations (including small businesses), nonprofit organizations with and without 501(c)(3) status, private and public institutions of higher education, and many governmental entities (such as state, county, city/township, special district, independent school districts, and certain housing authorities).
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The eligibility description highlights inclusion of organization types and communities such as Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, among others.
Can a foreign (non-U.S.) institution apply as the main applicant?
No. Foreign institutions are not eligible to apply as the applicant organization (prime). However, non-U.S. components of U.S. organizations may participate, and foreign components are allowed as defined by NIH policy.
Are international collaborators allowed at all?
Yes, international participation can be included as part of the project when justified, because foreign components are allowed under NIH policy even though the prime applicant must be a U.S.-eligible entity.
When was this FOA posted and when did it close?
The FOA was posted January 27, 2012. It had an original and final closing date of September 28, 2012.
Is this funding opportunity still open?
No. It was archived on October 29, 2012, which indicates it is no longer open for applications.
Why might someone still read an archived FOA like this?
Even though it is closed, it can still be a useful reference for understanding how NIAID structures large HIV clinical research networks, including expectations for leadership, laboratory support, and data/statistics cores within an integrated network model.
Who is the sponsor agency?
The sponsor agency is the National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID).
Where was the full announcement hosted and where were support contacts provided?
The full announcement was hosted through the NIH grants site, and contact routes were provided via the NIH Office of Extramural Research web support for access or technical linking issues.
How is the Leadership Group expected to handle changing scientific and public health priorities?
The Leadership Group is expected to continuously adapt and adjust the network's clinical research agenda over time, maintaining the authority and capacity to shift priorities as the science and public health landscape changes.
Is the Leadership Group expected to run clinical trials?
Yes. The description emphasizes launching and managing studies and ensuring the network can execute trials and other clinical studies efficiently and to high quality standards.
Does the FOA indicate a specific NIH activity category?
Yes. It is described under the broad NIH health-related funding activity category of Health, Income Security and Social Services.
Browse more opportunities from the same agency: National Institutes of Health
Browse more opportunities from the same category: Health Income Security and Social Services
Next opportunity: Leadership Group for a Clinical Research Network on Microbicides to Prevent HIV Infection (UM1)
Previous opportunity: Leadership Group for a Clinical Research Network on HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations (UM1)
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Applicants who have applied for this opportunity (RFA AI 12 004) also looked into and applied for these:
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| Development of Mathematical Cognition and Reasoning and the Prevention of Math Learning Disabilities (R03) Apply for PA 12 247 Funding Number: PA 12 247 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Development of Mathematical Cognition and Reasoning and the Prevention of Math Learning Disabilities (R01) Apply for PA 12 248 Funding Number: PA 12 248 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers (U54) Apply for RFA AR 13 012 Funding Number: RFA AR 13 012 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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