Opportunity Information: Apply for RFA NS 16 014

  • 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) - Clinical Coordinating Center (CCC) (U24)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350, 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 1 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).
Apply for RFA NS 16 014

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Opportunity Summary:

The Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Clinical Coordinating Center (CCC) (U24) funding opportunity (RFA NS 16 014) is a federal cooperative agreement designed to stand up and run the clinical operations backbone for a national emergency care trials network. The overall aim of SIREN is to make it easier and faster to carry out high-quality, multi-site clinical trials in time-critical emergency settings, with a focus on improving outcomes for patients experiencing neurologic, cardiac, respiratory, hematologic, and trauma-related emergency events. Rather than funding a single trial, this award supports the infrastructure and coordinating functions needed to repeatedly execute multiple major studies across many sites.

SIREN is structured as a coordinated system with three main parts: one Clinical Coordinating Center (the CCC, which is the subject of this announcement), one Data Coordinating Center (DCC), and up to 10 clinical centers referred to as "Hubs." In practice, the CCC functions as the operational command center that helps the network run clinical trials consistently across sites, while the DCC manages data systems and statistical coordination, and the Hubs enroll patients and implement study procedures in emergency departments and pre-hospital environments. The intent is to create a standing, reusable platform where study start-up and execution can be streamlined rather than rebuilt from scratch for every new trial.

A central expectation of SIREN is that it will carry out at least four large, simple, pragmatic clinical trials, each enrolling around 1,000 patients, conducted in emergency department and pre-hospital settings. These are meant to be practical, real-world studies that can be integrated into routine emergency care workflows and still produce rigorous evidence. Importantly, the individual clinical trials themselves are not funded under this coordinating center award; they are expected to be scientifically meritorious, peer-reviewed projects supported through separate funding announcements. The CCC award is therefore about readiness and execution capacity: ensuring that when a trial is funded, the network can launch it efficiently and run it to high standards.

The CCC's role is explicitly focused on facilitating implementation of clinical trials and improving both quality and speed of trial execution. The announcement highlights specific tools and approaches the CCC is expected to use, such as master trial agreements (to reduce contracting delays across institutions) and the use of a central Institutional Review Board (IRB) model (to streamline and standardize human subjects review across multiple sites). These features are especially important for emergency research, where delays in approvals and contracting can make trials infeasible or cause them to miss critical enrollment windows.

Administratively, this opportunity is offered by HHS/NIH (listed as HHS-NIH11) and uses a cooperative agreement mechanism, meaning NIH is expected to have substantial involvement in the program's direction and oversight compared with a standard research grant. The activity area is Health, and the relevant CFDA numbers include 93.350, 93.837, 93.838, 93.839, and 93.853. The opportunity is categorized as discretionary funding and anticipated making one award (ExpectedAwards: 1), reflecting that a single organization would be selected to serve as the network's Clinical Coordinating Center.

Eligibility is broad and includes many types of organizations that could credibly manage national clinical trial coordination. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations both with and without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations (with distinctions between federally recognized governments and other tribal organizations). This wide eligibility reflects that the primary requirement is the capacity to coordinate complex, multi-site emergency clinical trials rather than a narrow institutional type.

Key dates in the source information indicate the FOA was created and posted on March 9, 2016, with an original and current closing date of June 1, 2016. The award ceiling is not specified in the provided fields. Overall, the funding opportunity is best understood as an infrastructure and operations award intended to build a durable, efficient national platform for pragmatic emergency care trials, with the CCC responsible for smoothing the real-world barriers that often slow emergency research, such as contracting, IRB review, and coordinated multi-site implementation.

Frequently Asked Questions (FAQs)

1) What is this funding opportunity?

This opportunity is The Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Clinical Coordinating Center (CCC) (U24), RFA NS 16 014. It is a federal cooperative agreement intended to establish and operate the clinical operations "backbone" for a national emergency care clinical trials network.

2) What is the purpose of the SIREN network overall?

SIREN is intended to make it easier and faster to conduct high-quality, multi-site clinical trials in time-critical emergency settings. The network focuses on improving outcomes for patients experiencing neurologic, cardiac, respiratory, hematologic, and trauma-related emergency events.

3) What does the Clinical Coordinating Center (CCC) do?

The CCC serves as the operational command center for the network. Its role is to facilitate implementation of clinical trials across multiple sites and improve both the quality and speed of trial execution, so studies can be launched and run consistently across the network.

4) How is SIREN structured?

SIREN is described as a coordinated system with three main components: (1) one Clinical Coordinating Center (CCC), (2) one Data Coordinating Center (DCC), and (3) up to 10 clinical centers referred to as "Hubs."

5) What is the difference between the CCC, the DCC, and the Hubs?

Based on the description provided: the CCC runs the clinical operations and implementation coordination across sites; the DCC manages data systems and statistical coordination; and the Hubs enroll patients and carry out study procedures in emergency departments and pre-hospital environments.

6) Is this award meant to fund a single clinical trial?

No. This award supports the infrastructure and coordinating functions needed to repeatedly execute multiple major studies across many sites, rather than supporting one specific trial.

7) Are the individual clinical trials funded under the CCC award?

No. The individual clinical trials are not funded under this coordinating center award. Trials are expected to be supported through separate funding announcements as scientifically meritorious, peer-reviewed projects. The CCC award supports readiness and execution capacity.

8) How many trials is SIREN expected to carry out, and what size are they?

A central expectation is that SIREN will carry out at least four large, simple, pragmatic clinical trials, each enrolling around 1,000 patients. These studies are intended to be conducted in emergency department and pre-hospital settings.

9) What does "large, simple, pragmatic" mean in this context?

In the provided description, these trials are framed as practical, real-world studies that can be integrated into routine emergency care workflows while still producing rigorous evidence.

10) Why is a standing network infrastructure emphasized?

The intent is to create a reusable platform so that study start-up and execution can be streamlined rather than rebuilt from scratch for every new trial. This is especially relevant for time-critical emergency research where delays can make studies difficult to execute.

11) What specific tools or approaches is the CCC expected to use?

The announcement highlights approaches such as master trial agreements to reduce contracting delays across institutions and the use of a central Institutional Review Board (IRB) model to streamline and standardize human subjects review across multiple sites.

12) Why are master trial agreements important for this network?

Master trial agreements are specifically mentioned as a way to reduce contracting delays across institutions, supporting faster trial start-up in emergency research settings.

13) Why is a central IRB model important for SIREN?

A central IRB model is highlighted as a way to streamline and standardize human subjects review across many sites, which can be critical in emergency research where lengthy review timelines can slow or prevent timely enrollment.

14) What federal agency is offering this opportunity?

The opportunity is offered by HHS/NIH (listed as HHS-NIH11).

15) What type of award mechanism is used?

This is a cooperative agreement (U24). The description notes that NIH is expected to have substantial involvement in the program's direction and oversight compared with a standard research grant.

16) What is the funding category and activity area?

The opportunity is categorized as discretionary funding, and the activity area is Health.

17) What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.350, 93.837, 93.838, 93.839, and 93.853.

18) How many awards are expected to be made?

The source information anticipates one award (ExpectedAwards: 1), meaning a single organization would be selected to serve as the network's Clinical Coordinating Center.

19) Who is eligible to apply?

Eligibility is broad and includes: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with and without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations (including distinctions between federally recognized governments and other tribal organizations).

20) Why is eligibility so broad?

The description indicates the main need is the capacity to coordinate complex, multi-site emergency clinical trials nationally, rather than fitting a narrow institutional category.

21) What are the key dates for this funding opportunity?

The FOA was created and posted on March 9, 2016. The original closing date and the current closing date are both listed as June 1, 2016.

22) Is the award ceiling listed?

No. The award ceiling is not specified in the provided fields.

23) What settings are the supported trials expected to take place in?

The trials are expected to be conducted in emergency department and pre-hospital settings, reflecting the network's focus on time-critical emergency care.

24) What kinds of emergency conditions are in scope for SIREN?

The network focuses on emergency events that are neurologic, cardiac, respiratory, hematologic, and trauma-related.

25) In plain terms, what is this CCC award really paying for?

It is paying for infrastructure and operations: the coordination capability and processes that allow multiple major emergency care trials to start quickly and run consistently across many sites, including reducing common barriers like contracting delays and multi-site IRB review timelines.

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