Opportunity Information: Apply for RFA AI 12 012
Apply for RFA AI 12 012
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Leadership Group for a Clinical Research Network on Vaccines to Prevent HIV infection (UM1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jan 27, 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: Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities County governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts 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) 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-12-012) is a National Institutes of Health (NIH) cooperative agreement solicitation for a Leadership Group that will run a clinical research network focused on vaccines to prevent HIV infection. The core aim is to put in place a central leadership structure that can design the network's clinical research agenda, carry it out efficiently, and adjust priorities over time in response to scientific findings and NIAID's HIV/AIDS research priorities. In practical terms, the award is meant to support the high-level coordination and day-to-day operational backbone required to plan vaccine-related clinical studies, standardize approaches across the network, and ensure that trials and supporting activities stay aligned with the institute's evolving scientific direction.
A defining feature of this opportunity is that applicants cannot submit a single, standalone application. Instead, the Leadership Group must be proposed as three separate but linked UM1 cooperative agreement applications that function together as one integrated leadership platform. Those three required components are: a Leadership and Operations Center (LOC), a Laboratory Center (LC), and a Statistical and Data Management Center (SDMC). The LOC is expected to provide overall administrative leadership and operational management for the network, including coordinating trial development and implementation, managing communications and collaborations, and handling the kinds of governance and logistics that allow multiple clinical sites and partners to function as one coherent network. The LC is expected to provide the laboratory infrastructure and expertise needed to support HIV vaccine clinical research, which commonly includes standardized laboratory methods, quality systems, assay performance and validation activities, specimen handling strategies, and consistent lab support that allows results to be comparable across studies and sites. The SDMC is expected to serve as the network's hub for statistics, trial design support, data collection and quality oversight, analysis, reporting, and broader data management functions, ensuring that studies are planned with appropriate rigor and that resulting data are reliable, auditable, and usable for decision-making.
The mechanism is a cooperative agreement (UM1), which typically indicates that NIH, and here specifically NIAID, anticipates substantial involvement in the program beyond what is seen in a standard research project grant. While the awardees would be responsible for running the network leadership functions, the cooperative structure generally means there will be ongoing collaboration with NIH program staff on matters like scientific direction, coordination across network activities, performance expectations, and adaptations to the research agenda as priorities change. The opportunity also explicitly states that the Leadership Group will have responsibility for developing, implementing, and adapting the network's clinical research agenda to address NIAID HIV/AIDS scientific priorities referenced in the full announcement.
From an eligibility standpoint, the announcement is broadly open to many types of U.S.-based organizations, including public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and a wide range of governmental entities (state, county, city/township, special district, and others). It also notes eligibility or inclusion considerations for organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribally controlled and certain tribal organizations, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions. Non-U.S. (foreign) institutions are not eligible to apply as the applicant organization, but non-U.S. components of U.S. organizations may participate, and foreign components as defined under NIH policy are allowed, which leaves room for certain international collaborations under a U.S. applicant's leadership.
Administrative details included in the source information indicate this is a discretionary funding opportunity and was posted on January 27, 2012, with an original and current closing date of September 28, 2012, and an archive date of October 29, 2012. The CFDA numbers listed include 93.242, 93.855, and 93.856, reflecting alignment with NIH program areas spanning mental health research grants and allergy, infectious diseases, and microbiology/infectious diseases research. The opportunity states there is no cost sharing or matching requirement. The sponsoring agency is NIH, and the full announcement is hosted on the NIH grants site at the link provided in the notice, with NIH Office of Extramural Research (OER) webmaster contact information supplied for technical issues accessing or linking to the announcement.
Frequently Asked Questions (FAQs)
What is the funding opportunity number and what does it support?
This opportunity is RFA-AI-12-012. It supports an NIH cooperative agreement (UM1) for a Leadership Group that will run a clinical research network focused on vaccines to prevent HIV infection.
What is the main purpose of the award?
The purpose is to establish a central leadership structure that can design the network's clinical research agenda, carry it out efficiently, and adjust priorities over time in response to scientific findings and NIAID's HIV/AIDS research priorities. In practice, it funds the coordination and day-to-day operational backbone needed to plan vaccine-related clinical studies, standardize approaches across the network, and keep trials and supporting activities aligned with evolving scientific direction.
Which NIH institute is associated with this opportunity?
The opportunity is issued by NIH, with the program context and substantial involvement described specifically in relation to NIAID (National Institute of Allergy and Infectious Diseases) and its HIV/AIDS research priorities.
What type of award mechanism is being used?
The mechanism is a cooperative agreement (UM1).
What does it mean that this is a cooperative agreement (UM1)?
A cooperative agreement typically means NIH (here, NIAID) expects substantial involvement beyond what is typical for a standard research project grant. Based on the information provided, this includes ongoing collaboration with NIH program staff on scientific direction, coordination across network activities, performance expectations, and adapting the research agenda as priorities change.
Can an applicant submit a single application for the Leadership Group?
No. Applicants cannot submit a single, standalone application. The Leadership Group must be proposed as three separate but linked UM1 cooperative agreement applications that function together as one integrated leadership platform.
What are the three required, linked applications that make up the Leadership Group?
The three required components are: (1) a Leadership and Operations Center (LOC), (2) a Laboratory Center (LC), and (3) a Statistical and Data Management Center (SDMC).
What is the role of the Leadership and Operations Center (LOC)?
The LOC is expected to provide overall administrative leadership and operational management for the network. This includes coordinating trial development and implementation, managing communications and collaborations, and handling governance and logistics that enable multiple clinical sites and partners to operate as one coherent network.
What is the role of the Laboratory Center (LC)?
The LC is expected to provide laboratory infrastructure and expertise needed to support HIV vaccine clinical research. As described, this commonly includes standardized laboratory methods, quality systems, assay performance and validation activities, specimen handling strategies, and consistent lab support so results are comparable across studies and sites.
What is the role of the Statistical and Data Management Center (SDMC)?
The SDMC is expected to serve as the network hub for statistics, trial design support, data collection and quality oversight, analysis, reporting, and broader data management functions. It helps ensure studies are planned with appropriate rigor and that resulting data are reliable, auditable, and usable for decision-making.
Who is responsible for developing and adapting the clinical research agenda?
The opportunity states the Leadership Group has responsibility for developing, implementing, and adapting the network's clinical research agenda to address NIAID HIV/AIDS scientific priorities referenced in the full announcement.
What scientific area does the network focus on?
The network is focused on clinical research related to vaccines to prevent HIV infection.
What kinds of organizations are eligible to apply?
Eligibility is broadly open to many U.S.-based organizations, including public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and many governmental entities (state, county, city/township, special district, and others).
Are any institution types specifically noted as eligible or encouraged/included?
The information notes eligibility or inclusion considerations for HBCUs, Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribally controlled and certain tribal organizations, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions.
Are non-U.S. (foreign) institutions eligible to apply as the applicant organization?
No. Non-U.S. (foreign) institutions are not eligible to apply as the applicant organization.
Can international components participate in the work?
Yes, within the constraints described. Non-U.S. components of U.S. organizations may participate, and foreign components as defined under NIH policy are allowed, which supports certain international collaborations under a U.S. applicant's leadership.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Is this a discretionary funding opportunity?
Yes. The source information indicates it is a discretionary funding opportunity.
When was this opportunity posted, and what were the key dates?
It was posted on January 27, 2012. The original and current closing date is listed as September 28, 2012. The archive date is October 29, 2012.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.242, 93.855, and 93.856.
Where can applicants find the full announcement?
The full announcement is hosted on the NIH grants site at the link provided in the notice for this opportunity.
Who is listed as a contact for technical issues accessing or linking to the announcement?
The NIH Office of Extramural Research (OER) webmaster contact information is supplied for technical issues accessing or linking to the announcement.
What is being funded in practical, operational terms?
In practical terms, the award supports high-level coordination and the day-to-day operational backbone required to plan vaccine-related clinical studies, standardize approaches across the network, and ensure trials and supporting activities stay aligned with NIAID's evolving scientific direction.
Why are three linked applications required instead of one?
Based on the description provided, the Leadership Group is intended to function as an integrated leadership platform with three distinct, required cores: network leadership/operations (LOC), laboratory infrastructure (LC), and statistical/data management leadership (SDMC). The opportunity explicitly requires these as three separate but linked UM1 applications rather than a single standalone application.
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