Clinical Sites for the IDeA States Pediatric Clinical Trials Network (UG1) | Apply Online

Frequently Asked Questions (FAQs)

What is the purpose of the NIH funding opportunity "Clinical Sites for the IDeA States Pediatric Clinical Trials Network (UG1)" (RFA-OD-16-001)?

The purpose of this opportunity was to strengthen pediatric clinical trials capacity in IDeA-eligible states by directly funding clinical sites. The goal was to help institutions in historically under-resourced regions build the people, processes, and infrastructure needed to run high-quality pediatric clinical trials, and to do so as part of a coordinated national network rather than operating as isolated, standalone sites.

What problem was this program designed to address?

This program was designed to expand where pediatric trials can be conducted, improve access for children and families in IDeA states, and increase the number of investigators and staff trained to take pediatric trials from startup through conduct and closeout. It focused on lifting long-term institutional capacity in regions that have historically had fewer resources for clinical research.

What does it mean that the program focused on "institutional research capacity building"?

Institutional research capacity building means the applicant was expected to propose a structured plan to establish or enhance an on-the-ground pediatric clinical trials team and the repeatable systems needed to support multiple studies over time. The emphasis was not limited to short-term project execution; it centered on creating durable workforce skills and operational infrastructure that can reliably support pediatric trials.

What kinds of capabilities were clinical sites expected to develop or strengthen?

Based on the opportunity description, sites were expected to develop or strengthen capabilities commonly required to run high-quality pediatric trials, including trial operations and management, recruitment and retention of pediatric participants, regulatory and IRB coordination, data collection and quality control, participant safety monitoring, and adherence to Good Clinical Practice (GCP) principles.

Was this funding mainly for equipment and administrative support?

No. While building infrastructure is part of capacity building, a key feature described was supervised professional development in research and clinical trial implementation. The opportunity emphasized building a durable workforce and repeatable systems, not only purchasing equipment or providing basic administrative support.

What is the IDeA States Pediatric Clinical Trials Network?

It was a network intended to support multicenter pediatric studies by integrating funded clinical sites in IDeA-eligible states into a larger, coordinated structure. The network approach was intended to enable consistent trial operations and data standards across multiple participating sites.

How were funded clinical sites expected to work with a Data Coordinating and Operations Center (DCOC)?

Awarded clinical sites were intended to be integrated with a DCOC in a hub-and-spoke style network. The DCOC was envisioned to provide centralized coordination, common standards, and operational support, while the funded sites served as the locations where participants are identified, enrolled, evaluated, and followed.

Why did NIH emphasize a coordinated network instead of independent trial sites?

The network structure was meant to make multicenter pediatric trials more efficient and consistent. By enrolling participants under shared protocols across multiple sites, trials can be completed more efficiently, with broader geographic and demographic representation, and with more consistent operational procedures and data collection.

What scientific areas were within scope for the network?

The network was designed to investigate diseases and conditions relevant to the pediatric population broadly. The announcement also highlighted priority alignment with the Environmental influences on Child Health Outcomes (ECHO) Program.

What specific priority focus areas were highlighted for alignment with the ECHO Program?

The announcement stated that priority would be given to four focus areas: (1) upper and lower airway disease, (2) obesity, (3) pre-, peri-, and postnatal outcomes, and (4) neurodevelopment.

What is the UG1 mechanism, and why does it matter?

The opportunity used a UG1 cooperative agreement mechanism. This matters because it signals substantial NIH involvement compared with a standard grant. Under a cooperative agreement, funded sites generally work closely with NIH program staff and network leadership on planning, prioritization, and implementation.

What did being funded under a cooperative agreement imply for awardees?

Applicants were expected to be prepared not only to run trials, but also to function as part of a coordinated consortium. That includes participating in network governance, working with NIH and network leadership, and following common operating procedures and shared performance expectations.

Who was eligible to apply for this opportunity?

Eligibility was described as broad across organization types, including various government entities, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, tribal governments and tribal organizations, and other organizations as specified in the full announcement.

What was the defining eligibility requirement emphasized in the description?

Even with broad organizational eligibility, the defining requirement emphasized was being located in, or otherwise qualifying under, IDeA-eligible states, because the program was explicitly intended to strengthen clinical research capacity in those jurisdictions.

Which federal agency sponsored this funding opportunity?

The opportunity fell under HHS/NIH.

What type of funding instrument was used?

It was categorized as discretionary funding using the cooperative agreement instrument (UG1).

When was the opportunity posted and when were applications due?

The opportunity was posted on December 7, 2015, and the application due date was April 15, 2016.

How many awards did NIH anticipate making?

NIH anticipated making about 15 awards.

What was the award ceiling listed for this opportunity?

The award ceiling was listed at $315,000.

What kinds of activities did NIH expect funded sites to be able to carry out across the trial lifecycle?

The description emphasized training investigators and staff to carry trials from startup through conduct and closeout, implying readiness for end-to-end clinical trial execution within a pediatric setting, consistent with network standards and coordination through the DCOC.

How did this opportunity aim to improve access to pediatric clinical trials?

By expanding and strengthening clinical trial sites in IDeA-eligible states, NIH aimed to increase the geographic reach of pediatric trials so children and families in those states could more readily participate in studies conducted under coordinated network protocols.

What was the long-term intended payoff of building these clinical sites?

The intended long-term payoff was sustainable improvement in regional pediatric research capacity: sites able to reliably execute multicenter pediatric trials within the network and increased competitiveness of local investigators to win additional pediatric clinical research funding in the future.

What does it mean that the program was intended to create "repeatable systems"?

It means the emphasis was on building standard processes and infrastructure that can support multiple pediatric studies over time, rather than one-off procedures created for a single project. This aligns with the network model, common operating procedures, and consistent performance expectations.