NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required) | PAR 21 102

FAQs: NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required) - PAR-21-102

What is this funding opportunity?

This opportunity is the NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required), Funding Opportunity Number PAR-21-102. It is an NIH discretionary grant mechanism intended to support investigator-initiated, hypothesis-driven, multi-center clinical trials that are considered high risk but have strong potential payoff.

What type of project does NIDDK want to fund under this FOA?

NIDDK is looking for rigorous, hypothesis-driven clinical trials conducted across more than one clinical center. The emphasis is on high-risk studies that, if successful, could meaningfully shift clinical practice and/or improve public health outcomes.

Does my application have to include a clinical trial?

Yes. The FOA is designated "Clinical Trial Required," which means the application must propose an actual clinical trial. Applications focused only on observational research, infrastructure development, or pre-trial planning are not considered responsive based on the information provided.

What does "multi-center" mean in this context?

Based on the FOA description, the supported study must involve more than one clinical center. In other words, it cannot be a single-site trial.

What does "high risk, high payoff" mean for this FOA?

This FOA is designed for trials that are considered high risk (for example, more uncertainty or operational/scientific challenges than typical trials) but that have a strong potential payoff. The intended payoff is evidence that could change clinical practice and/or improve public health outcomes if the trial succeeds.

What clinical topics are within scope for NIDDK?

The clinical topic must align with the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The description provided indicates this broadly includes diabetes, endocrinology and metabolic disorders, digestive diseases, nutrition, obesity-related issues, and kidney, urologic, and hematologic diseases, among related areas.

What is a U01 cooperative agreement, and how is it different from a traditional grant?

This FOA uses the U01 cooperative agreement format. Unlike a traditional "hands-off" research project grant, a cooperative agreement involves substantial scientific and/or programmatic involvement by NIH (here, NIDDK) during the conduct of the study. Awardees should expect ongoing coordination with NIDDK staff, adherence to oversight expectations and performance milestones, and collaboration around trial governance, monitoring, and reporting.

What does "substantial involvement" by NIDDK typically imply for awardees?

The provided description indicates that awardees should be prepared for ongoing coordination with NIDDK staff, following NIH and NIDDK expectations for oversight, meeting performance milestones, and participating in collaboration related to trial governance, monitoring, and reporting.

Are planning activities allowed in the U01 application?

No. A major restriction described for this FOA is that planning activities are not allowed as part of the U01 application. Applicants are expected to have key planning work completed before submission.

What kinds of planning work should be completed before submitting a U01 under this FOA?

The FOA summary indicates that essential elements should already be sufficiently mature to move into implementation. Examples mentioned include protocol development, feasibility considerations, site readiness, recruitment strategies, statistical planning, and operational and regulatory pathways.

What if our team is not ready to launch the trial and still needs a planning period?

The FOA points applicants who need a structured planning period toward an implementation planning cooperative agreement (U34, referenced as TEMP9971) as a more appropriate first step.

Is early consultation with NIDDK recommended before applying?

Yes. The FOA strongly encourages early consultation with NIDDK Scientific/Research staff before submitting either a U34 or a U01. The stated goal is to confirm fit, expectations, and whether the project is mature enough for a U01 submission.

Who is eligible to apply?

Eligibility is described as broad. Eligible applicant types include (as listed in the excerpt): state, county, and city governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized tribal governments; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses.

Are specific institution types explicitly called out as eligible?

Yes. The announcement explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American Tribal Governments other than federally recognized entities, and U.S. territories or possessions.

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

No. The excerpt states that non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.

Can a U.S. organization apply if part of the project will occur outside the U.S.?

The excerpt draws a distinction: non-domestic components of U.S. organizations are not eligible to apply, but "foreign components" (as defined in the NIH Grants Policy Statement) are allowed. This means certain well-justified elements of the research may be conducted outside the U.S. under a U.S. applicant institution, subject to NIH policy requirements and approvals.

What is the funding instrument and NIH mechanism for this opportunity?

The funding instrument is a cooperative agreement, using the U01 mechanism.

What is the Funding Opportunity Number (FON) and FOA identifier?

The Funding Opportunity Number is PAR-21-102.

What is the CFDA number and activity area for this opportunity?

The FOA is associated with CFDA number 93.847 and is categorized under the Health and Food and Nutrition funding activity area.

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

The opportunity was created on December 23, 2020, and the original closing date listed in the excerpt is January 7, 2024.

Does the excerpt specify an award ceiling or the expected number of awards?

No. The excerpt does not provide an award ceiling or expected number of awards. It notes that applicants would need to consult the full FOA text and/or discuss budget scope with NIDDK program staff to understand typical budget ranges, project periods, and NIDDK capacity and priorities for new trials.

What stage of readiness is this FOA intended for?

This opportunity is aimed at teams that are ready to run a rigorous, multi-site clinical trial now, not teams that are still working out whether the trial is feasible.

What is the overall goal NIDDK is signaling through this FOA?

The description indicates NIDDK is seeking bold but well-justified studies with clear hypotheses and a realistic path to producing practice-changing evidence, and that it expects applicants to engage early with NIDDK staff to confirm alignment and readiness.