Leadership Group for a Clinical Research Network on HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations (UM1) | Apply Online

What is RFA-AI-12-001?

RFA-AI-12-001 is a National Institutes of Health (NIH) funding opportunity announcement that solicits a cooperative agreement (UM1) to support the Leadership Group for a Clinical Research Network focused on HIV/AIDS and HIV-associated infections in pediatric and maternal populations.

What is the main purpose of this funding opportunity?

The central purpose is to fund the leadership structure that will steer an entire multi-site clinical research network. This includes coordinating network operations and shaping, launching, and continually refining the network's scientific agenda so it remains aligned with National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS research priorities referenced in the announcement.

What populations and health topics does the network focus on?

The mission emphasis is clinical research in HIV/AIDS and HIV-associated infections as they affect maternal and pediatric populations. This includes infants, children, adolescents, pregnant people, and mothers, as well as infectious complications and comorbidities that disproportionately affect these groups.

What kind of award mechanism is used (and why does it matter)?

This opportunity uses a cooperative agreement mechanism (UM1). A cooperative agreement indicates NIH expects to be actively involved in the program's conduct and oversight, rather than serving only as a passive funder. Under a UM1 structure, the funded group typically works closely with NIH program staff on governance, prioritization of studies, operational decisions, and performance expectations.

What does NIH mean by a "Leadership Group" in this context?

Here, the Leadership Group is the core leadership team and infrastructure that runs a large clinical research network. It is responsible for building and maintaining the network's operational capacity and for guiding the network's scientific direction, including planning and implementing clinical studies and adapting priorities over time as science and public health needs evolve.

What are the required components of the Leadership Group application?

NIH requires the Leadership Group to be submitted as three separate but linked UM1 applications:

• Leadership and Operations Center (LOC)
• Laboratory Center (LC)
• Statistical and Data Management Center (SDMC)

Why does NIH require three separate but linked UM1 applications instead of one application?

NIH explicitly requires this three-part structure because operating a complex HIV clinical research network depends on strong centralized coordination, consistent laboratory methods and quality assurance, and rigorous statistical and data management leadership. NIH wants applicants to demonstrate strength in each area rather than combining everything into a single, undifferentiated application.

What does the Leadership and Operations Center (LOC) do?

The LOC serves as the administrative and operational hub for the network. It is responsible for overall coordination and the day-to-day operational functions needed to run an efficient multi-site research enterprise, including harmonized processes, coordinated communications, and responsive problem-solving when studies or sites face barriers.

What does the Laboratory Center (LC) do?

The LC provides laboratory expertise and capacity to support network studies. This includes standardized testing and quality assurance across sites to ensure laboratory methods are consistent and reliable throughout the network.

What does the Statistical and Data Management Center (SDMC) do?

The SDMC is responsible for data systems and data quality, provides study monitoring support as applicable, and leads statistical design and analysis for the network's clinical research studies.

What kinds of activities is the Leadership Group expected to carry out?

The Leadership Group is expected to develop the network's research agenda, implement that agenda through well-run clinical studies, and adapt scientific priorities over time. Operationally, this includes creating the conditions for efficient multi-site research, such as shared standards, harmonized protocols, coordinated communications, and addressing operational barriers as they arise.

How does NIAID involvement show up during the award?

Because this is a cooperative agreement, NIH program staff are expected to be actively involved in governance, study prioritization, operational decisions, and performance expectations, working closely with the awardees rather than operating at a distance.

What federal activity area is this opportunity associated with?

The opportunity is categorized under the broad federal activity area of Health, Income Security and Social Services.

Are specific CFDA areas associated with this opportunity?

Yes. The opportunity is associated with multiple CFDA numbers reflecting cross-cutting science areas, including allergy and infectious diseases, microbiology and infectious diseases, child health and human development research, and related areas.

Who is eligible to apply?

Eligibility is broad for domestic U.S. organizations and governmental entities. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) types, with stated limitations), for-profit organizations (including small businesses and other for-profits), and multiple levels of government (state, county, city/township, special district governments, and certain housing authorities).

Are community-serving and minority-serving institutions included in eligibility?

Yes. The announcement explicitly includes several institution types and community-serving categories, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, and others referenced in the eligibility language.

Can a foreign (non-U.S.) institution apply as the prime applicant?

No. Foreign institutions (non-U.S. entities) are not eligible to apply as prime applicants under this opportunity.

Can foreign components participate in any way?

Yes. Non-domestic components of U.S. organizations can participate, and foreign components are allowed consistent with NIH policy. This can be important for global HIV research collaborations where some clinical or laboratory activities may occur outside the U.S. under a U.S.-led award.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement. Applicants are not required to commit non-federal funds as a condition of the award.

When was the opportunity posted, and what were the application deadlines?

The opportunity was posted on January 27, 2012. The original and final closing date was September 28, 2012.

Is this funding opportunity still open?

No. It was archived on October 29, 2012, and archived opportunities are no longer accepting applications.

Where can applicants find the full official requirements and instructions?

The full announcement (including official requirements, attachments, and detailed instructions) was made available through the NIH grants guide at the link provided in the announcement.

Who should be contacted for technical issues accessing the announcement?

The notice includes NIH Office of Extramural Research (OER) webmaster contacts for technical access issues, which is consistent with standard NIH practice for helping users retrieve and navigate the full funding announcement online.