Opportunity Information: Apply for RFA NS 16 016
Apply for RFA NS 16 016
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network Clinical Center (Hub) (U24)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837, 93.838, 93.839, 93.853.
- This funding opportunity was created on Mar 09, 2016 and posted on Mar 09, 2016.
- Applicants must submit their applications by Jun 01, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
This grant opportunity (RFA-NS-16-016) is a National Institutes of Health cooperative agreement (U24) designed to build out the clinical center portion of a national emergency care clinical trials network called SIREN, short for Strategies to Innovate EmeRgENcy Care Clinical Trials Network. The central idea is to create a ready-to-activate infrastructure that can run large, practical, multi-site clinical trials in the emergency department and in pre-hospital settings, where time is critical and traditional research approaches are often too slow or too complicated. By funding Network Clinical Centers called "Hubs," NIH aims to speed up high-quality research that can directly improve outcomes for patients experiencing acute, high-stakes emergencies.
SIREN is structured as a coordinated network rather than a collection of stand-alone projects. It will include one Clinical Coordinating Center (CCC) and one Data Coordinating Center (DCC), plus up to 10 funded clinical centers (the Hubs). Each Hub is expected to function as a major enrollment engine for the network, typically based at an academic medical center or tertiary referral center with the clinical volume, expertise, and operational capacity to support rigorous trials. A key expectation is that each Hub will actively enroll patients into every SIREN trial, regardless of the specific disease area, meaning participation is network-wide rather than selective. This all-in model is meant to ensure rapid enrollment and consistent performance across trials, which is especially important for emergency conditions where eligible cases may be sporadic at any single site.
In addition to enrolling patients at the main Hub site, the Hub is responsible for building and leading a group of affiliated satellite sites referred to as "Spokes." The Hub provides scientific leadership and administrative oversight to these Spokes, essentially acting as the organizing center that expands the network's reach into different hospitals, EMS systems, and communities. The combined Hub-and-Spoke setup is intended to provide access to a large and diverse patient population, improving generalizability of results and enabling faster recruitment into large studies.
The clinical focus areas for SIREN reflect the major categories of life-threatening emergencies where rapid intervention can change outcomes: neurologic, cardiac, respiratory, hematologic, and trauma-related events. Rather than funding a single trial, this FOA supports the infrastructure and readiness needed to run multiple trials over time. The network is expected to carry out at least four large, simple, pragmatic clinical trials, each targeting around 1,000 patients. "Simple" and "pragmatic" signals an emphasis on trials that fit into real-world emergency workflows, minimize unnecessary complexity, and produce results that can be implemented broadly in frontline care.
Importantly, the trials themselves are not awarded under this Hub FOA. The studies will be peer-reviewed, meritorious projects funded through separate funding announcements, and then executed through the SIREN network once selected. In practice, that means awardees under this opportunity are being funded to serve as standing, high-functioning clinical trial sites and regional leaders that can rapidly implement whichever trials the network approves, using common procedures, shared coordination, and centralized data support through the CCC and DCC.
Eligibility is broad and includes many types of organizations, such as state and local governments, public and private institutions of higher education, tribal governments and tribal organizations, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, among others as specified in the FOA. The sponsoring agency is HHS/NIH (listed as HHS-NIH11), and the opportunity falls under the health research activity category with CFDA numbers 93.837, 93.838, 93.839, and 93.853. Up to 10 awards were anticipated. The original and current closing date listed is June 1, 2016, and the posting/creation date is March 9, 2016.
Overall, this opportunity is about creating a durable, high-performance national platform for emergency care research. By funding Hub sites that can both enroll patients consistently and manage a network of Spokes, NIH is aiming to overcome long-standing barriers to running large, rigorous trials in emergency and pre-hospital environments, ultimately producing evidence that can improve survival and recovery across multiple categories of acute, time-sensitive illness and injury.
Frequently Asked Questions (FAQs)
What is the RFA-NS-16-016 grant opportunity?
RFA-NS-16-016 is a National Institutes of Health (NIH) cooperative agreement (U24) intended to build the clinical center portion of a national emergency care clinical trials network called SIREN (Strategies to Innovate EmeRgENcy Care Clinical Trials Network).
What is the main goal of this funding opportunity?
The goal is to create a ready-to-activate infrastructure that can run large, practical, multi-site clinical trials in emergency departments and pre-hospital settings, where time is critical and conventional research approaches can be too slow or operationally complex.
What does SIREN stand for?
SIREN stands for Strategies to Innovate EmeRgENcy Care Clinical Trials Network.
What type of award mechanism is used?
This opportunity uses a cooperative agreement mechanism (U24), which is designed to support coordinated, network-based activities rather than isolated stand-alone projects.
What parts make up the SIREN network?
SIREN is described as a coordinated network consisting of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC), and up to 10 funded clinical centers referred to as Network Clinical Centers or "Hubs."
What is a SIREN Hub (Network Clinical Center)?
A Hub is a funded clinical center expected to serve as a major enrollment engine for SIREN trials. Hubs are typically based at an academic medical center or tertiary referral center with sufficient clinical volume, expertise, and operational capacity to support rigorous emergency care trials.
How are "Spokes" related to a Hub?
Each Hub is responsible for building and leading a group of affiliated satellite sites called "Spokes." The Hub provides scientific leadership and administrative oversight to its Spokes to expand the network's reach across hospitals, EMS systems, and communities.
Are Hubs allowed to participate only in trials that match their specialty?
No. A key expectation described is that each Hub will actively enroll patients into every SIREN trial, regardless of the specific disease area. Participation is network-wide rather than selective.
Why does the network require Hubs to enroll in every SIREN trial?
The all-in model is meant to support rapid enrollment and consistent performance across trials. This is particularly important in emergency conditions where eligible cases may be sporadic at a single site.
What clinical areas does SIREN focus on?
The network focus areas include major categories of life-threatening emergencies where rapid intervention can change outcomes: neurologic, cardiac, respiratory, hematologic, and trauma-related events.
Is this funding opportunity intended to fund a single clinical trial?
No. This opportunity supports infrastructure and readiness to run multiple trials over time, rather than funding one specific trial.
How many trials is the network expected to conduct?
The network is expected to carry out at least four large, simple, pragmatic clinical trials.
What does "simple" and "pragmatic" mean in the context of these trials?
In this context, "simple" and "pragmatic" indicates an emphasis on trials that fit real-world emergency workflows, minimize unnecessary complexity, and generate results that can be broadly implemented in frontline care.
How large are the expected SIREN trials?
Each trial is described as targeting around 1,000 patients.
Are the actual clinical trials funded under this Hub FOA?
No. The trials themselves are not awarded under this Hub funding opportunity. The studies will be peer-reviewed and funded through separate funding announcements, then executed through the SIREN network once selected.
What is the role of the CCC and DCC?
SIREN includes a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC), which provide centralized coordination and data support for trials executed across the network.
What is the practical outcome NIH is aiming for by funding Hubs?
NIH is aiming to establish standing, high-functioning clinical trial sites and regional leaders that can rapidly implement whichever trials the network approves using common procedures and shared coordination.
Who is eligible to apply?
Eligibility is described as broad and includes (among others): state and local governments; public and private institutions of higher education; tribal governments and tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses, as specified in the FOA.
What agency is sponsoring this opportunity?
The sponsoring agency is HHS/NIH (listed as HHS-NIH11).
What is the activity category for this opportunity?
The opportunity is listed under the health research activity category.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.837, 93.838, 93.839, and 93.853.
How many awards were anticipated?
Up to 10 awards were anticipated for the Hub portion of the network.
What are the key dates for this opportunity?
The posting/creation date is March 9, 2016. The original and current closing date listed is June 1, 2016.
Where are trials expected to take place?
Trials are intended to be conducted in emergency departments and in pre-hospital settings.
Why build a Hub-and-Spoke structure?
The Hub-and-Spoke structure is intended to expand access to a large and diverse patient population, improve the generalizability of findings, and enable faster recruitment into large studies.
What problem in emergency research is this network designed to address?
The described purpose is to overcome long-standing barriers to running large, rigorous trials in emergency and pre-hospital environments, where time pressure and operational constraints can make traditional research methods difficult to execute.
What does "ready-to-activate infrastructure" mean here?
It refers to maintaining the people, processes, and coordinated network structure needed so that large multi-site emergency care trials can be launched and implemented quickly once specific studies are selected for the network.
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