Opportunity Information: Apply for RFA DK 18 017

This grant opportunity, titled "Ancillary Studies to the NIDDK Inflammatory Bowel Disease Genetics Consortium (R01 - Clinical Trial Optional)" (RFA-DK-18-017), is a National Institutes of Health program from the Department of Health and Human Services focused on accelerating progress in inflammatory bowel disease (IBD) genetics and biology. The basic premise is that the NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC), working alongside the International IBD Genetics Consortium, has already done a major amount of discovery work by identifying roughly 200 genetic susceptibility loci associated with IBD. The consortium has renewed funding aimed at moving beyond association signals and into the harder, more mechanistic next steps: pinpointing the causal genes and variants inside those loci and explaining how they drive disease processes in Crohn's disease and ulcerative colitis. Because the consortium cannot realistically functionally characterize every candidate gene and pathway on its own, this FOA is designed to bring in outside investigators whose expertise fills gaps and broadens the scientific reach of the consortium.

The central goal is to support ancillary, collaborative projects that expand both the number of IBD-relevant genes studied and the breadth of phenotypes, mechanisms, and physiological domains examined. In practical terms, applicants are expected to propose studies that connect genetic findings to biological function, such as clarifying which gene(s) at a risk locus are truly responsible for the association and how specific variants alter gene regulation, protein function, immune responses, epithelial barrier integrity, microbial interactions, or other processes relevant to IBD pathophysiology. The emphasis is on complementing what the IBDGC is already doing, not competing with it or repeating it. A key requirement is that proposed work must not duplicate studies that are currently underway or already completed by the IBDGC, which implies that prospective applicants should communicate with or otherwise verify overlap and ensure their aims are distinct and additive.

The announcement is structured as an R01 grant mechanism with clinical trial optional, meaning projects may include certain types of clinical research if appropriate, but clinical trials are not mandatory. At the same time, the FOA explicitly states that multi-site clinical trials are not responsive, so applicants should avoid proposing large, multi-center interventional trial designs under this call. The intent is more aligned with mechanistic, translational, functional genomics, and phenotype-expansion studies that can be tightly integrated with consortium resources and questions, rather than large-scale therapeutic efficacy trials across many sites.

From an administrative and eligibility standpoint, the program is categorized as discretionary grant funding in the health area (CFDA 93.847). Eligibility is broad and includes many types of U.S. organizations: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and additional entities as described in NIH eligibility language. This wide eligibility reflects NIH's interest in tapping specialized expertise wherever it exists, including academic labs, research institutes, and certain industry or nontraditional research settings capable of contributing unique tools, datasets, assays, or disease models.

In terms of scale, the listed award ceiling is $200,000, with an expected three awards, indicating a relatively small set of focused, targeted projects rather than a large portfolio. The program was created on September 12, 2018, with an original closing date of February 21, 2019, which situates it as a time-limited call tied to the consortium's renewed phase and the immediate need to expand functional follow-up capacity around established genetic loci.

Overall, the opportunity is best understood as a mechanism to convert IBD genetic discoveries into biological insight by funding well-scoped ancillary studies that plug into the IBDGC ecosystem. Competitive applications would typically be expected to propose clear, testable hypotheses tied to known IBD susceptibility loci, use rigorous modern approaches for causal inference and functional validation, and deliver interpretable mechanistic outcomes that broaden the consortium's coverage of genes, pathways, and clinically relevant phenotypes, while carefully demonstrating that the work is novel relative to ongoing IBDGC efforts and does not constitute a multi-site clinical trial.

  • The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Ancillary Studies to the NIDDK Inflammatory Bowel Disease Genetics Consortium (R01- Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
  • This funding opportunity was created on Sep 12, 2018.
  • Applicants must submit their applications by Feb 21, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $200,000.00 in funding.
  • The number of recipients for this funding is limited to 3 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 DK 18 017

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Frequently Asked Questions (FAQs)

What is the title and identifier of this grant opportunity?

The opportunity is titled "Ancillary Studies to the NIDDK Inflammatory Bowel Disease Genetics Consortium (R01 - Clinical Trial Optional)" and is identified as RFA-DK-18-017.

Which federal agency is offering this funding opportunity?

This is a National Institutes of Health (NIH) funding opportunity from the U.S. Department of Health and Human Services (HHS), focused within NIDDK priorities.

What is the overall purpose of this FOA?

The purpose is to accelerate progress in inflammatory bowel disease (IBD) genetics and biology by funding ancillary, collaborative studies that help convert existing IBD genetic association discoveries into biological and mechanistic insight.

What consortium is this FOA tied to?

This FOA is tied to the NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC), which works alongside the International IBD Genetics Consortium.

What scientific progress has already been made that this FOA builds on?

The IBD genetics consortia have identified roughly 200 genetic susceptibility loci associated with IBD. This FOA is meant to move beyond those association signals toward identifying causal genes/variants and explaining how they drive disease processes.

What kinds of projects are considered a good fit?

Projects are expected to connect genetic findings to biological function. Examples described in the announcement include work to pinpoint the causal gene(s) and variant(s) within a known IBD risk locus and determine how those variants affect relevant biology (such as gene regulation, protein function, immune responses, epithelial barrier integrity, or microbial interactions) tied to Crohn's disease and/or ulcerative colitis.

What does "ancillary" mean in the context of this FOA?

"Ancillary" refers to studies designed to complement and extend what the IBDGC is already doing, bringing in outside expertise to fill gaps and broaden the consortium's scientific reach. The intent is additive collaboration rather than parallel, competing work.

Is the emphasis more on discovery or on mechanism?

The emphasis is on mechanistic next steps: moving from genetic associations to causal inference and functional/biological interpretation, including mechanisms relevant to Crohn's disease and ulcerative colitis.

What biological areas or mechanisms are explicitly mentioned as relevant?

The FOA explicitly mentions mechanisms such as gene regulation, protein function, immune responses, epithelial barrier integrity, microbial interactions, and other processes relevant to IBD pathophysiology.

Does the FOA require that projects be tied to known IBD susceptibility loci?

Based on the description, proposed studies are expected to be connected to established IBD genetic findings (for example, clarifying which gene(s) at a risk locus are responsible and how variants drive biology), rather than starting from unrelated questions.

What does "R01 - Clinical Trial Optional" mean here?

The funding mechanism is an R01. "Clinical Trial Optional" means a project may include certain types of clinical research if appropriate, but a clinical trial is not required.

Are multi-site clinical trials allowed under this FOA?

No. The FOA explicitly states that multi-site clinical trials are not responsive, so applicants should avoid proposing large, multi-center interventional clinical trial designs under this call.

Does this FOA encourage collaboration with the IBDGC?

Yes. The FOA is designed to bring in outside investigators and support collaborative projects that plug into the IBDGC ecosystem and expand the consortium's coverage of genes, pathways, and phenotypes.

Can an applicant propose work that overlaps with what the IBDGC is already doing?

No. A key requirement is that the proposed work must not duplicate studies that are currently underway or already completed by the IBDGC. Applicants are expected to ensure their aims are distinct and additive.

How should applicants handle the risk of duplication with IBDGC efforts?

The description indicates applicants should communicate with the consortium or otherwise verify potential overlap so they can demonstrate that their proposed aims do not duplicate ongoing or completed IBDGC studies.

What is the intended scientific value of adding outside investigators?

The consortium cannot realistically functionally characterize every candidate gene and pathway across all identified loci by itself. This FOA brings in outside expertise, tools, assays, datasets, and models to broaden what can be functionally followed up.

What kinds of outcomes does the FOA appear to prioritize?

The FOA prioritizes interpretable mechanistic outcomes that help identify causal genes and variants and explain how they influence IBD-relevant biological processes, expanding the number of genes studied and the breadth of phenotypes and physiological domains examined.

What is the CFDA number and general program area?

The program is categorized as discretionary grant funding in the health area under CFDA 93.847.

Who is eligible to apply?

Eligibility is broad and includes many U.S. organization types, including: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses, along with additional entities as described in NIH eligibility language.

Are for-profit organizations eligible?

Yes. The description explicitly includes for-profit organizations (other than small businesses) and separately includes small businesses.

Are nonprofit organizations eligible even if they do not have 501(c)(3) status?

Yes. The eligibility list includes nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education).

Are tribal entities eligible to apply?

Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible.

What is the maximum award amount mentioned?

The listed award ceiling is $200,000.

How many awards are expected?

The announcement indicates an expectation of three awards.

What does the expected number of awards suggest about the program?

With an expected three awards and a defined award ceiling, the FOA appears intended to support a small number of focused, targeted ancillary projects rather than a large portfolio.

When was this FOA created and when did it close?

The program was created on September 12, 2018, and the original closing date was February 21, 2019.

Is this FOA time-limited?

Yes. The provided dates (creation in 2018 and an original closing date in early 2019) indicate it was a time-limited call aligned with the consortium's renewed phase and near-term functional follow-up needs.

What disease areas are within scope?

The FOA focuses on inflammatory bowel disease (IBD), specifically including Crohn's disease and ulcerative colitis.

Is the FOA primarily about therapy testing?

No. The description frames the intent as mechanistic, translational, functional genomics, and phenotype-expansion work integrated with consortium resources and questions, rather than large-scale therapeutic efficacy trials across many sites.

What is meant by "moving beyond association signals"?

It refers to shifting from identifying statistical genetic associations (risk loci) to the next steps of determining which specific genes and variants are causal and explaining the biological mechanisms by which they contribute to disease.

Does the FOA expect applicants to broaden phenotypes studied?

Yes. A central goal is to expand the breadth of phenotypes, mechanisms, and physiological domains examined in relation to IBD genetics.

How does the FOA describe the relationship to existing IBDGC work?

Applicants are expected to complement what the IBDGC is already doing, not compete with it or repeat it, and must avoid duplicating studies already underway or completed by the consortium.

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