Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating Center (U24 Clinical Trial Required) | RFA DK 18 506

Frequently Asked Questions (FAQs)

What is the funding opportunity number and what does it support?

The funding opportunity is RFA-DK-18-506. It supports continued operation of the Data Coordinating Center (DCC) for the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN), including the central infrastructure needed to coordinate the network's work.

Which NIH Institute is sponsoring this opportunity?

This opportunity is sponsored by the National Institutes of Health (NIH), specifically within the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

What type of award mechanism is being used?

The announcement uses a cooperative agreement mechanism: U24.

Is a clinical trial required under this award?

Yes. The opportunity is described as "clinical trial required," meaning the funded DCC is expected to support clinical trial activities as part of the network's portfolio, not only observational or database work.

What does "limited competition" mean for this opportunity?

The opportunity is described as a limited competition, which aligns with the narrow eligibility described in the announcement and indicates that only certain types of institutions can apply.

What is the main purpose of continuing the NASH CRN Data Coordinating Center (DCC)?

The main purpose is to maintain the central coordinating infrastructure that enables the NASH CRN to finish ongoing interventional clinical treatment trials and continue long-term (longitudinal) collection of clinical data and biospecimens in both children and adults affected by nonalcoholic fatty liver disease (NAFLD).

What kinds of research activities does the DCC enable for the network?

Based on the description, the DCC enables multi-site clinical research to function smoothly by supporting trial operations, maintaining databases, ensuring data quality control, coordinating statistical design and analysis, managing protocol compliance and reporting, facilitating communications across clinical sites, and enabling secure handling and tracking of biospecimens and related clinical metadata.

Which conditions are included under NAFLD for this network?

NAFLD is described broadly and includes simple steatosis, steatohepatitis (NASH), and NAFLD-related cirrhosis.

Does the network include both adult and pediatric participants?

Yes. The opportunity specifies continued collection of longitudinal clinical data and biospecimens from both children and adults affected by NAFLD.

What is meant by "longitudinal" data and biospecimen collection in this announcement?

Longitudinal collection refers to ongoing follow-up over time, with continued collection of clinical data and biospecimens to support future analyses of disease course, outcomes, complications, and treatment response.

Where does continued follow-up occur, according to the announcement?

Continued follow-up is described as occurring through the NAFLD database study.

Why is NIH emphasizing continuity for the NASH CRN?

The announcement frames the goal as preserving the ability to manage active trials to completion, sustain standardized data collection across sites, and protect the scientific value of long-term patient follow-up and banked biospecimens.

How long has the NASH CRN been supported by NIDDK?

The network is described as established and long-running, sponsored by NIDDK since 2002, with prior renewals in 2009 and 2014.

What research themes has the NASH CRN focused on historically?

Historically, the network has focused on understanding causes and contributors to NASH, how the disease progresses over time, what complications arise, and how different therapies perform.

What applicant organizations are eligible to apply?

The listed eligible applicant type is public and state-controlled institutions of higher education.

Are foreign (non-U.S.) institutions eligible to apply as the applicant organization?

No. The announcement states that non-U.S. (foreign) institutions are not eligible to apply as the applicant organization.

Can a non-U.S. component of a U.S. organization apply as the applicant?

No. The announcement states that non-U.S. components of U.S. organizations are not eligible to apply.

Are foreign components allowed in any form?

Yes. The announcement states that "foreign components," as defined in the NIH Grants Policy Statement, are allowed, meaning certain elements of the work can involve foreign components if they meet NIH's definition and requirements, even though the prime applicant must be eligible and not a foreign institution.

Where should applicants look for the precise eligibility definitions and requirements?

Applicants are directed to the full funding announcement for the precise eligibility details and definitions, including how NIH defines "foreign components."

What is the original closing date listed for this opportunity?

The original closing date is October 31, 2018.

When was this opportunity created?

The opportunity was created on August 24, 2018.

What is the maximum award amount (ceiling) listed?

The award ceiling is listed as $2,000,000.

What is the CFDA number associated with this funding opportunity?

The CFDA listing provided is 93.847.

What funding activity category is associated with this opportunity?

The funding activity category is described as aligned with food and nutrition and health.

What is the overall intent of the FOA in plain terms?

The FOA is aimed at sustaining the central coordination backbone of an established NIH-sponsored clinical research network so it can complete ongoing trials and preserve the integrity and long-term utility of NAFLD/NASH clinical data and biospecimen resources.