Opportunity Information: Apply for RFA NS 22 015
This funding opportunity, titled "Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network Clinical Center (Hub) (U24 Clinical Trial Not Allowed)," is a National Institutes of Health (NIH) cooperative agreement (U24) that supports the infrastructure and operational capacity for clinical trial enrollment sites within the SIREN Network. It is a reissue of an earlier announcement (RFA-NS-16-016) and invites applications from both new and currently participating institutions to serve as SIREN Clinical Centers, also referred to as "Hubs." The focus is not on proposing a new clinical trial under this award. Instead, the award is meant to maintain and strengthen a network site that can reliably carry out multiple trials that are competed and funded separately under other announcements.
SIREN is designed to run multi-center, Phase III clinical trials that target urgent, high-impact conditions commonly encountered in emergency care, including neurologic, cardiac, respiratory, hematologic, and traumatic emergencies. A key emphasis is on practical, streamlined, and pragmatic clinical trials that can be implemented in real-world environments like emergency departments and pre-hospital settings (for example, EMS). Because these settings are fast-paced and time-sensitive, the network model is intended to solve common barriers to emergency research such as rapid identification of eligible patients, consistent enrollment workflows, standardized data capture across sites, and coordination across many hospitals and EMS systems.
Structurally, SIREN consists of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and 11 clinical centers (Hubs). The Hub model is central to how SIREN reaches enough patients, quickly enough, to answer important clinical questions. A Hub is typically an academic medical center or tertiary referral center that is expected to actively enroll patients into all SIREN trials. Each Hub also leads and oversees multiple affiliated satellite enrollment sites known as "Spokes." Together, the Hub-and-Spoke configuration expands geographic reach and patient diversity, making it easier to recruit large and varied patient populations and improving the generalizability of trial results. In addition to enrolling participants, the Hub is expected to provide scientific leadership at the local level and to handle administrative oversight for its Spokes, helping ensure that the entire local network is trial-ready and compliant with study requirements.
Because this is a cooperative agreement, awardees should expect substantial NIH involvement in governance and network operations compared with a standard research grant. The award supports participation in the network and execution of peer-reviewed trials that have been selected and funded separately, rather than supporting an applicant-initiated clinical trial under this particular FOA. The "Clinical Trial Not Allowed" designation reflects that the Hub award is for network capacity and implementation roles, not for running a clinical trial that is proposed as part of the application itself.
Eligibility is broad and includes many types of U.S.-based organizations and governments, such as state, county, and city governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities. The announcement also explicitly highlights eligibility for institutions and organizations such as Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning certain types of international collaboration may be permissible under NIH rules even though the applicant organization must be U.S.-based.
Administratively, the opportunity is listed as RFA-NS-22-015 under the NIH, categorized as discretionary funding and a health-related activity. The original closing date was January 18, 2022, and the listed award ceiling is $250,000. Multiple CFDA numbers are associated with the announcement (93.233, 93.837, 93.838, 93.839, 93.840, 93.853), reflecting NIH program and institute linkages relevant to the emergency care and neurologic/related research areas that SIREN trials may span. Overall, the main purpose of the award is to ensure the SIREN Network maintains a strong, trial-ready set of enrolling centers that can efficiently implement time-critical, real-world emergency care trials across a coordinated national infrastructure.Apply for RFA NS 22 015
- The National Institutes of Health 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 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840, 93.853.
- This funding opportunity was created on 2021-11-19.
- Applicants must submit their applications by 2022-01-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- 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.
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network Clinical Center (Hub) (U24 Clinical Trial Not Allowed)."
Which agency is offering this award?
This is a National Institutes of Health (NIH) funding opportunity.
What is the FOA number for this opportunity?
The opportunity is listed as RFA-NS-22-015.
What type of NIH award is this?
This is a cooperative agreement under the U24 mechanism. Cooperative agreements typically involve substantial NIH participation in governance and network operations compared with a standard research grant.
What does "Clinical Trial Not Allowed" mean for this FOA?
It means the application should not propose a new clinical trial to be conducted under this award. Instead, the award supports network capacity and implementation responsibilities for clinical trials that are competed, selected, peer-reviewed, and funded separately under other announcements.
What is SIREN?
SIREN is the Strategies to Innovate EmeRgENcy Care Clinical Trials Network, a multi-center clinical trials network designed to support Phase III clinical trials in emergency care settings.
What is the main purpose of the SIREN Network Clinical Center (Hub) award?
The purpose is to support the infrastructure and operational capacity of a SIREN clinical trial enrollment site so it can reliably enroll participants and execute multiple network trials over time. The award is intended to maintain and strengthen a trial-ready network site rather than fund a single applicant-initiated study.
Is this opportunity a reissue of an earlier announcement?
Yes. It is described as a reissue of an earlier announcement (RFA-NS-16-016).
Who can apply to serve as a SIREN Hub?
Applications are invited from both new institutions and institutions currently participating in SIREN to serve as SIREN Clinical Centers, also referred to as "Hubs."
What kinds of clinical trials does SIREN run?
SIREN is designed to run multi-center, Phase III clinical trials focused on urgent, high-impact conditions encountered in emergency care.
What clinical areas or emergency conditions are emphasized?
The network targets emergency conditions including neurologic, cardiac, respiratory, hematologic, and traumatic emergencies.
What is meant by "practical" or "pragmatic" trials in this context?
The network emphasizes streamlined, pragmatic clinical trials that can be implemented in real-world environments such as emergency departments and pre-hospital settings (for example, EMS), where time pressures and workflow constraints are significant.
Why is a network model important for emergency care research?
Emergency care research often faces barriers such as rapid identification of eligible patients, consistent enrollment workflows, standardized data capture across sites, and coordination across many hospitals and EMS systems. SIREN is structured to help address these challenges through coordinated infrastructure and operations.
What are the main components of the SIREN network?
SIREN consists of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and 11 clinical centers (Hubs).
What is a SIREN "Hub"?
A Hub is a SIREN Clinical Center, typically an academic medical center or tertiary referral center, expected to actively enroll patients into all SIREN trials and provide local scientific leadership and operational capability.
What are "Spokes" in the Hub-and-Spoke model?
Spokes are affiliated satellite enrollment sites overseen by a Hub. The Hub leads and provides administrative oversight for its Spokes to expand geographic reach and support enrollment across a broader set of sites.
Why does SIREN use a Hub-and-Spoke structure?
The Hub-and-Spoke structure expands geographic reach and patient diversity, helps recruit large and varied patient populations, and improves the generalizability of trial results by enabling enrollment across multiple hospitals and EMS systems linked to each Hub.
What are the expected responsibilities of a Hub under this award?
Based on the description, a Hub is expected to (1) actively enroll patients into SIREN trials, (2) provide scientific leadership at the local level, and (3) oversee and support affiliated Spokes, including administrative oversight to help keep the local network trial-ready and compliant with study requirements.
Does this award fund the development of a new trial proposed by the applicant?
No. The award supports participation in the network and implementation of trials that are selected and funded separately, rather than funding an applicant-initiated clinical trial proposed within the application.
How involved is NIH in a U24 cooperative agreement like this?
Awardees should expect substantial NIH involvement in governance and network operations compared with a standard research grant, consistent with the cooperative agreement structure described for this opportunity.
What types of organizations are eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and governments, including state, county, and city governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities.
Are minority-serving institutions and community-based organizations eligible?
Yes. The announcement explicitly highlights eligibility for organizations such as Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and faith-based or community-based organizations (among others noted).
Can U.S. territories or possessions apply?
Yes. The eligibility description explicitly includes U.S. territories or possessions.
Are foreign institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible.
Are foreign components allowed at all?
The description notes that foreign components are allowed as defined by the NIH Grants Policy Statement. This suggests certain forms of international collaboration may be permissible under NIH rules even though the applicant organization must be U.S.-based.
What is the listed award ceiling?
The listed award ceiling is $250,000.
What was the original closing date for the opportunity?
The original closing date was January 18, 2022.
How is this opportunity categorized?
It is categorized as discretionary funding and a health-related activity.
Which CFDA numbers are associated with this announcement?
The announcement lists multiple CFDA numbers: 93.233, 93.837, 93.838, 93.839, 93.840, and 93.853.
What do the multiple CFDA numbers indicate?
They reflect NIH program and institute linkages relevant to the emergency care and neurologic/related research areas that SIREN trials may span, based on the description provided.
In what settings are SIREN trials intended to be implemented?
SIREN trials are intended to be implemented in real-world emergency care environments, including emergency departments and pre-hospital settings such as EMS.
What problem is SIREN trying to solve for emergency research?
SIREN is intended to address common barriers in time-sensitive emergency research, including rapid identification of eligible patients, consistent enrollment workflows, standardized data capture across sites, and coordination across many hospitals and EMS systems.
How many Hubs are part of SIREN according to the description?
The description states there are 11 clinical centers (Hubs) in the network structure.
If this award does not fund a new trial, what does it fund?
It funds the infrastructure and operational capacity needed for a clinical center (Hub) to participate in SIREN, enroll patients, coordinate with Spokes, and execute multiple separately funded and selected network trials.
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