Limited Competition for the Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Clinical Centers (U01) | RFA DK 17 505

Frequently Asked Questions (FAQs)

What is the funding opportunity number for this grant?

The funding opportunity is identified as RFA-DK-17-505.

What type of NIH award is this?

This opportunity uses the cooperative agreement mechanism (U01). A U01 indicates substantial NIH programmatic involvement, with awardees expected to work closely with NIH and the CRIC consortium on study priorities, operations, and common protocols.

What is the focus of this funding opportunity?

The focus is to extend the Chronic Renal Insufficiency Cohort (CRIC) Study, a long-running, multi-center, prospective observational cohort that follows men and women living with chronic kidney disease (CKD).

What is the CRIC Study?

The CRIC Study is a prospective observational cohort that began in 2001 and has enrolled about 5,500 participants. Participants have been followed through annual in-person clinic visits with interim telephone contacts, generating a large dataset and biospecimen resource for understanding CKD and its complications, especially cardiovascular disease (CVD).

Why is this FOA described as a continuity or continuation effort?

The announcement emphasizes continuity because NIH intends to keep supporting the existing CRIC Clinical Centers that originally enrolled and have continued to follow participants, along with the broader CRIC study infrastructure.

Is this a limited competition?

Yes. The FOA is described as a limited competition intended to sustain established clinical sites and their capacity to retain participants, conduct standardized follow-up visits, and collect high-quality clinical measures over time.

How many CRIC sites or components are mentioned?

The infrastructure described includes seven Clinical Centers and a Scientific and Data Coordinating Center (SDCC).

What kinds of follow-up activities are central to CRIC under this continuation?

The CRIC cohort has been tracked through annual in-person clinic visits plus interim telephone contacts. The continuation emphasizes retaining participants and conducting standardized follow-up visits with high-quality clinical measures.

What scientific priorities does the FOA emphasize for the next phase?

The FOA prioritizes moving beyond routine follow-up by emphasizing novel methods for clinical assessment of CKD and CVD risk factors and pairing those approaches with modern analytic strategies.

What are CKD endophenotypes in the context of this FOA?

In this FOA, CKD endophenotypes refer to more refined CKD subtypes defined by measurable traits, with the goal of linking these subtypes to clinically meaningful outcomes.

What outcomes does the FOA highlight as important to connect to endophenotypes?

The FOA specifically mentions clinically meaningful outcomes such as CKD progression and acute kidney injury, as well as mapping cardiovascular sequelae that commonly accompany kidney disease.

How does cardiovascular disease (CVD) relate to the CRIC Study in this opportunity?

CVD is highlighted as a major complication of CKD and a central area of investigation within CRIC. The FOA emphasizes improved assessment of CVD risk factors and better understanding of cardiovascular sequelae in the CKD population.

What is the long-term goal NIH is aiming for with this continuation?

The long-term goal is to develop a clearer picture of the natural history and consequences of CKD and related CVD, supporting better management strategies, stronger evidence to guide future clinical trials, improved risk prediction, earlier identification of high-risk subgroups, and more targeted intervention development.

What role does consistent longitudinal follow-up play in this FOA?

Maintaining consistent longitudinal follow-up in a large cohort is positioned as a key strength of CRIC, enabling insights that are difficult to obtain from shorter studies or from clinical care data alone, especially when combined with new assessment and analytic methods.

Who is eligible to apply (in general terms)?

The announcement lists many domestic applicant types typically eligible for NIH funding, including government entities, higher education institutions, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses.

Which government entities are listed as eligible applicants?

Eligible government applicants include state governments, county governments, local governments, U.S. territories or possessions, and federally recognized tribal governments.

Are tribal organizations and tribal-serving institutions included in the eligible categories?

Yes. The FOA explicitly includes federally recognized tribal governments and other tribal organizations, as well as categories such as Tribally Controlled Colleges and Universities.

Are colleges and universities eligible to apply?

Yes. Public and private institutions of higher education are listed as eligible applicants, and the FOA also highlights several institution types such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly highlighted among the eligible categories.

Are nonprofits eligible, and do they need 501(c)(3) status?

Nonprofits are eligible whether they have 501(c)(3) status or not, according to the categories listed in the announcement.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.

Are foreign organizations or foreign institutions eligible to apply?

No. The FOA explicitly excludes foreign organizations and foreign institutions from eligibility.

Are non-U.S. components of U.S. organizations eligible?

No. The FOA states that non-U.S. components of U.S. organizations are not eligible.

Are foreign components allowed under NIH policy for this opportunity?

No. The FOA states that foreign components (as defined by NIH policy) are not allowed.

What is the original closing date listed for this funding opportunity?

The original closing date is October 26, 2017.

What is the award ceiling mentioned in the opportunity?

The award ceiling is listed at $650,000.

What is the CFDA number associated with this opportunity?

The CFDA number provided is 93.847.

What broad research areas does the opportunity align with?

The activity aligns with health-related research and is categorized in the source data under Food and Nutrition and Health.

Where should applicants look for detailed operational and scientific requirements?

The FOA directs applicants to consult the full funding opportunity announcement for specific expectations, including study governance, performance milestones, data coordination, participant follow-up procedures, and collaboration within the CRIC network.

What does NIH involvement look like under a cooperative agreement for this consortium?

Because it is a cooperative agreement (U01), NIH is expected to have substantial programmatic involvement, and awardees are expected to work closely with NIH and the CRIC consortium on priorities, operations, and common protocols.

What practical impact is NIH seeking from the scientific approach described?

The FOA frames the practical impact as improving understanding of heterogeneity in CKD, why some patients decline faster than others, and how cardiovascular risk evolves in this population, ultimately supporting better risk prediction and more targeted intervention development.