Limited Competition for the Continuation of the Chronic Kidney Disease Biomarkers Consortium (CKD BioCon) Data Coordinating Center (U01 Clinical Trial Not Allowed) | RFA DK 19 501

Frequently Asked Questions (FAQs): RFA-DK-19-501 (CKD BioCon Data Coordinating Center)

1) What is the grant opportunity RFA-DK-19-501?

RFA-DK-19-501 is an NIH funding opportunity to support the continuation of the Data Coordinating Center (DCC) for the Chronic Kidney Disease Biomarkers Consortium (CKD BioCon). The award mechanism is a limited-competition NIH cooperative agreement (U01), and clinical trials are not allowed under this announcement.

2) What is the CKD Biomarkers Consortium (CKD BioCon)?

CKD BioCon is a multi-center research consortium originally launched in 2009 to accelerate the discovery, validation, and eventual qualification of biomarkers for chronic kidney disease. It leverages existing biospecimens from well-characterized CKD patient cohorts that include longitudinal follow-up data. A second phase was funded in 2014, and the network expanded again in 2015 with two additional centers.

3) Why is NIH funding a Data Coordinating Center (DCC) for CKD BioCon?

At the time of this announcement, CKD BioCon includes eight Participating Clinical Centers (PCCs) and multiple active research protocols. NIH is funding a DCC to provide centralized coordination, consistent data practices, shared analytic support, and operational management so the consortium can function as a unified, high-performing research enterprise over the next two years.

4) What is the main purpose of the DCC award?

The core purpose is to keep the consortium operating efficiently and consistently by providing day-to-day logistical and operational coordination across one or more PCCs, along with specialized expertise and statistical support for consortium projects.

5) What kinds of activities is the DCC expected to manage day to day?

Based on the summary provided, the DCC is expected to handle ongoing logistical and operational coordination across consortium sites, provide specialized expertise and statistical support, and ensure that active projects run smoothly with consistent timelines, milestones, and quality expectations across PCCs.

6) What role does the DCC play in consortium governance and project management?

A major part of the DCC role is governance and project management. This includes overseeing how new study ideas are proposed, reviewed, approved, and tracked, and then supporting the conduct of approved studies so they meet expected timelines, milestones, and quality standards across sites.

7) Does this funding opportunity support new clinical trials?

No. This is a U01 cooperative agreement where clinical trials are explicitly not allowed under this announcement. The emphasis is on enabling and coordinating consortium science, analytics, and resource sharing, not starting new clinical trial activity.

8) What is a cooperative agreement (U01), and what does it imply here?

This opportunity uses a cooperative agreement mechanism (U01), which typically involves substantial involvement from NIH program staff in oversight and direction compared to a standard research grant. In this context, it indicates NIH expects to be actively involved in ensuring the DCC supports consortium operations, coordination, and shared analytic/resource functions.

9) What is meant by "limited competition" for this award?

The competition is described as limited, which generally means only certain invited or otherwise qualifying organizations are expected to apply (often organizations connected to the existing consortium or an incumbent). The specific limitations beyond the summary would be described in the full funding announcement, but the provided information indicates the competition is not broadly open to all applicants.

10) Who is eligible to apply?

The eligible applicant type listed is public and state-controlled institutions of higher education. The opportunity also emphasizes restrictions related to non-U.S. applicants (see the foreign eligibility questions below).

11) Are non-U.S. (foreign) institutions eligible to apply?

No. Non-domestic (non-U.S.) entities (foreign institutions) cannot apply under this opportunity.

12) Can a U.S. organization with non-U.S. components apply?

No. Non-domestic components of U.S. organizations are also not eligible to apply, according to the information provided in the opportunity summary.

13) Are foreign components allowed in any way under this opportunity?

Yes, foreign components (as defined in the NIH Grants Policy Statement) are allowed. This means a U.S.-based eligible applicant may include certain foreign collaborations or elements if they meet NIH definitions and requirements, but the applicant organization itself must be eligible and U.S.-based under the stated rules.

14) What kinds of consortium sites does the DCC coordinate with?

The consortium includes Participating Clinical Centers (PCCs). At the time of this announcement, there are eight PCCs. The DCC is expected to coordinate activities across one or more PCCs and support multi-site consistency in operations, data practices, and analytic work.

15) What is the DCC responsible for regarding data and biospecimens?

The DCC is responsible for coordinating the movement and stewardship of consortium data and biospecimens. This includes supervising transfers among consortium members, supporting repository-related activities within the consortium, and supporting activities connected with the NIDDK repository.

16) What does "stewardship" of data and biospecimens mean in this context?

In practice, stewardship includes maintaining orderly, well-documented data flows; ensuring specimens and datasets are handled in ways that preserve integrity and traceability; and helping the consortium meet expectations for standardized curation, access, and long-term usability of shared resources.

17) Does the DCC provide analytic or statistical support?

Yes. The DCC is expected to provide specialized expertise and statistical support for consortium projects as part of strengthening CKD biomarker research.

18) What is the time frame for the work supported by this award?

The summary describes the goal of keeping the consortium functioning as a unified research enterprise over the next two years.

19) What is the award ceiling for this funding opportunity?

The award ceiling listed in the provided information is $500,000.

20) When was the announcement created and when was the application due?

The announcement was published/created on March 8, 2019. The original application closing date was May 15, 2019.

21) Which NIH institute and mission area does this opportunity align with?

The opportunity is aligned with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and focuses on kidney disease biomarker research and related data and biospecimen coordination.

22) What is the activity category and CFDA number associated with this opportunity?

The activity category is listed under health, with CFDA 93.847.

23) Is this award focused on generating new patient samples?

The description emphasizes leveraging existing biospecimens from well-characterized CKD patient cohorts with longitudinal follow-up data. The DCC role described focuses on coordinating and stewarding consortium data and biospecimens, rather than collecting new samples.

24) What is the relationship between the consortium repositories and the NIDDK repository?

The DCC is responsible for supporting repository-related activities both within the consortium and in connection with the NIDDK repository. This indicates the DCC plays a coordinating role to help ensure data and biospecimens are managed and transferred in line with consortium and NIDDK repository expectations.

25) What is the overall goal of this opportunity in plain terms?

The overall goal is to fund a central operational hub (the DCC) that keeps a large, ongoing CKD biomarker consortium coordinated and consistent across sites, provides governance and project management, and supports shared analytics and controlled sharing of data and biospecimens.