NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) | PAR 24 094

Frequently Asked Questions (FAQs)

What is PAR-24-094 (NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements, U34 Clinical Trial Optional)?

PAR-24-094 is an NIH funding opportunity from NIDDK that supports a structured planning and start-up period for complex, high-risk, multi-center clinical studies. The mechanism is a U34 cooperative agreement (clinical trial optional) intended to help teams strengthen the scientific and operational foundation of a proposed study before committing major resources to full implementation.

What is the main purpose of this U34 planning award?

The purpose is to get a complex, multi-site clinical study ready to launch by funding and structuring the planning work. The U34 supports early peer review of the study concept and detailed protocol refinement, along with development of key operational documents and study infrastructure so implementation can begin with fewer preventable delays.

What types of projects does this opportunity target?

It targets investigator-initiated, hypothesis-driven clinical studies that are high-risk and involve more than one study site (multi-center). The study topic should align with the NIDDK mission (for example, diabetes, digestive diseases, kidney and urologic diseases, and related program areas).

Is this funding for running the full clinical study?

No. This opportunity supports planning and start-up activities before a later, separate application for full study implementation. The program is described as a two-part pathway: a U34 planning phase followed by a separate application to conduct the full study.

What does "two-part pathway" mean in practice?

It means the U34 funds the work needed to prepare the study for launch (planning, protocol finalization, operational setup). After completing that phase, a separate application is expected for the full implementation stage of the clinical study.

What are the four main goals of the U34 planning phase described in the announcement?

The U34 planning phase is designed to: (1) enable early peer review of the clinical question and overall justification; (2) support detailed assessment and refinement of the study design and protocol for feasibility; (3) fund and structure development of core documents needed to run the study, especially a Manual of Operations; and (4) support development of additional essential elements needed for efficient study conduct.

What kinds of feasibility and design details are expected to be refined during the U34 phase?

The planning period is intended to refine practical, feasibility-driving design choices such as eligibility criteria, recruitment strategies, endpoints, follow-up schedules, and the analytic approach, particularly in the context of running the study across multiple sites.

What is a Manual of Operations, and why is it emphasized?

A Manual of Operations is a core study document that standardizes procedures across sites. It typically covers how recruitment is done, how interventions are delivered, how measurements are collected, how data are handled, and how safety reporting is conducted. The announcement emphasizes it because consistent procedures across sites help prevent operational breakdowns and delays during implementation.

What other key study materials may be developed under this planning award?

Examples listed include finalized case report forms, data and safety monitoring plans, quality assurance procedures, site training plans, governance structures, and other operational materials intended to reduce delays once the study moves into implementation.

Why does the announcement describe these studies as "high-risk"?

Based on the description provided, "high-risk" is tied to the complexity of multi-center clinical studies and the possibility that a study concept or operational plan may be weak or infeasible if not thoroughly vetted and prepared. The U34 structure is meant to reduce the risk of moving forward with an under-justified or impractical study.

What does "clinical trial optional" mean here?

The opportunity title includes "U34 Clinical Trial Optional," which indicates that a clinical trial is not necessarily required for every application under this mechanism. The specific applicability depends on the proposed clinical study and how it is defined under NIH policy.

How is a cooperative agreement (U34) different from a standard NIH research grant?

The announcement notes that cooperative agreement-based funding implies more hands-on partnership than a standard research grant. In practice, awardees should expect meaningful scientific and operational involvement from NIDDK staff during the planning work.

Is it recommended to talk to NIDDK before applying?

Yes. Consultation with NIDDK scientific staff is strongly encouraged prior to submission to confirm fit with institute priorities, understand expectations for milestones and deliverables, and reduce the risk of submitting an application that does not match the program’s purpose.

What research areas are considered a fit with the NIDDK mission for this opportunity?

The opportunity is aimed at studies aligned with NIDDK-relevant diseases and conditions, with examples including diabetes, digestive diseases, kidney and urologic diseases, and related areas tied to NIDDK programs.

Who is eligible to apply (in general terms)?

Eligibility is broad and includes many U.S.-based organizations and governments, including higher education institutions (public and private), nonprofit organizations (with and without 501(c)(3) status, other than higher education institutions), for-profit organizations (other than small businesses) and small businesses, and various government and public entities.

What types of government entities are eligible applicants?

Eligible government applicants include state, county, and local governments, special district governments, independent school districts, and U.S. territories or possessions. Public housing authorities/Indian housing authorities are also listed as eligible.

Are tribal governments and tribal organizations eligible?

Yes. The announcement lists Native American tribal governments (federally recognized) and also includes Indian/Native American tribal governments other than federally recognized, as well as tribal organizations that are not federally recognized.

Are small businesses eligible to apply?

Yes. The eligibility list includes small businesses, as well as for-profit organizations (other than small businesses).

Are faith-based or community-based organizations eligible?

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

Are minority-serving institutions included as eligible applicants?

Yes. The announcement highlights categories such as historically black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions (AANAPISIs).

Can a non-U.S. (foreign) organization apply as the main applicant?

No. Non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations under this opportunity.

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

No. Non-domestic components of U.S. organizations are also not eligible to apply.

Are foreign collaborations allowed at all under this opportunity?

Yes, in a limited way. The announcement states that foreign components (as defined under the NIH Grants Policy Statement) are allowed. This means a U.S. applicant may be able to include certain foreign collaborations as part of the project structure, as long as the applicant organization is domestic and the arrangement complies with NIH policy requirements.

What is the funding instrument used for this opportunity?

It is an NIH discretionary funding opportunity that uses the cooperative agreement funding instrument (U34).

What is the CFDA number and category listed for this opportunity?

The opportunity is categorized under Food and Nutrition and Health and lists CFDA 93.847.

What is the listed award ceiling?

The listed award ceiling for this opportunity is $225,000.

When was this opportunity created, and what is the listed closing date?

The opportunity was created on 2024-01-04. The original closing date listed is 2027-06-10, indicating a multi-year window in which applications may be accepted according to NIH submission cycles and the instructions in the full announcement.

Does the closing date mean I can apply at any time until 2027-06-10?

The information provided indicates a multi-year window and notes that applications may be accepted according to NIH submission cycles and the specific instructions in the full announcement. The exact submission timing depends on those NIH cycles and the announcement instructions.

What problem is this U34 mechanism trying to solve?

It is meant to reduce the chance of launching a weak, poorly justified, or operationally infeasible multi-center clinical study by requiring early peer review and supporting a structured planning period that produces a stronger rationale, a workable protocol, and the core operational materials needed for consistent execution across sites.

What should applicants expect regarding interaction with NIDDK after award?

Because it is a cooperative agreement, applicants should expect meaningful scientific and operational involvement from NIDDK staff during the planning work, consistent with a more hands-on partnership than a standard grant.