NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) | PA 20 185

FAQs: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) - PA-20-185

What is this funding opportunity?

This is the NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) funding opportunity, Funding Opportunity Number PA-20-185. It supports a single, clearly defined research project led by one or more investigators.

What is the purpose of an NIH R01 under this parent announcement?

The purpose is to fund a discrete, specified, and circumscribed body of work. Applications are expected to present a focused set of aims that can realistically be completed within the proposed project period and budget.

What types of research are a good fit for this announcement?

Research that does not involve a clinical trial framework is a fit, including basic, mechanistic, observational, methodological, preclinical, or other biomedical and behavioral research that aligns with an NIH Institute or Center (IC) mission area.

Are clinical trials allowed under PA-20-185?

No. This parent R01 announcement does not accept applications that propose clinical trials.

If my project uses human data or human samples, is it automatically considered a clinical trial?

No. The opportunity can still be relevant if the research is not a clinical trial, even when it involves human data or human samples. Applicants need to ensure the study design does not meet NIH's definition of a clinical trial.

What does NIH mean by a clinical trial in this context?

The summary highlights an example of what to avoid: prospectively assigning human participants to an intervention to evaluate effects on health-related outcomes. Designs like that would meet NIH's clinical trial definition and would not be allowed under this opportunity.

Do projects need to align with a specific NIH Institute or Center (IC)?

Yes. Projects are expected to align with the scientific missions and programmatic interests of at least one participating NIH Institute or Center. Applicants generally need to ensure their topic fits an NIH IC portfolio area and includes a clear rationale for why the selected IC(s) is the appropriate home for the work.

Is this an investigator-initiated opportunity?

Yes. It is described as NIH's general-purpose R01 route for investigator-initiated research that fits an NIH Institute or Center mission area, with the specific restriction that clinical trials are excluded.

Who can apply (in general)?

Eligibility is broad and includes many types of U.S. domestic organizations such as state, county, and local 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; and other Native American tribal organizations.

Are nonprofits eligible to apply?

Yes. Nonprofit organizations both with and without 501(c)(3) status are included as eligible applicants.

Are for-profit organizations eligible to apply?

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

Can small businesses apply?

Yes. Small businesses are explicitly included among eligible applicants.

Are higher education institutions eligible?

Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are included.

Are tribal entities eligible?

Yes. Eligibility includes federally recognized Native American tribal governments and other Native American tribal organizations. The announcement also notes tribal governments that are not federally recognized as additional eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed among additional eligible applicants.

Are non-U.S. (foreign) organizations eligible?

Yes. Non-U.S. entities (foreign organizations) are listed among the additional eligible applicants.

Are specific institution types like HBCUs or Hispanic-serving institutions eligible?

Yes. NIH explicitly notes additional eligible applicants including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), and other designated institution types such as 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 listed among additional eligible applicants.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are listed among additional eligible applicants.

What type of grant program is this?

This opportunity is categorized as a discretionary grant program.

Is this opportunity tied to a single Assistance Listing (CFDA) number?

No. It is associated with a broad range of CFDA (Assistance Listing) numbers, reflecting participation across many NIH components and scientific areas.

What public benefit areas does this opportunity relate to?

The activity category spans multiple public benefit areas including health, education, environment, food and nutrition, and social services, with the dominant focus on biomedical and health-related research consistent with NIH's mission.

When was this funding opportunity created?

The announcement was created on May 5, 2020.

What is the closing date listed in the summary?

The summary lists an original closing date of January 7, 2025.

Is there a stated maximum award amount (award ceiling)?

The posted summary does not specify an award ceiling.

Does the summary specify the expected number of awards?

No. The posted summary does not specify an expected number of awards.

Are there budgetary limits described in the summary?

The summary does not list specific budgetary limits. It notes that this is common in parent NIH announcements because award sizes and counts can vary widely by institute, scientific area, and annual appropriations.

How should applicants think about budgeting for an R01 under this opportunity?

Budgets are typically justified based on the needs of the project. Applicants are expected to request a realistic level of support that matches the scope of the proposed aims, staffing, supplies, and other direct costs, while adhering to NIH policies and any institute-specific guidance.

What core qualities does NIH expect from projects submitted to this opportunity?

The opportunity is aimed at supporting strong, hypothesis-driven or discovery-oriented projects with clear significance, innovation, and a well-developed approach.

What is expected from the applicant organization and project team?

Investigators and organizations should be able to demonstrate the expertise, facilities, and management capability to complete the proposed work.

Can multiple investigators lead an R01 project under this opportunity?

Yes. The R01 is described as being led by one or more investigators.

How focused should the project aims be?

The application should present a focused set of aims that can realistically be completed within the proposed project period and budget, consistent with the R01 concept of a discrete and circumscribed body of work.