Research Project Grant (Parent R01 Clinical Trial Not Allowed) | PA 19 056

Frequently Asked Questions (FAQs) - NIH Research Project Grant (Parent R01, Clinical Trial Not Allowed) (PA 19 056)

What is the NIH Research Project Grant (Parent R01) under PA 19 056?

PA 19 056 is an NIH discretionary grant opportunity that supports a clearly defined, focused research project proposed by an investigator or a team. It uses the R01 mechanism, which is NIH's primary funding vehicle for investigator-initiated research. Projects are expected to be discrete and well-bounded, with specific aims, a planned approach, and a rationale that aligns with the scientific priorities of one or more participating NIH Institutes and Centers (ICs).

What does "Parent R01" mean in this opportunity?

This is a parent announcement, meaning it is intended to provide a broad, general pathway for investigator-initiated research across many NIH topic areas and participating Institutes and Centers. Applicants are still expected to align their project with the mission and priorities of an NIH institute and ensure the application is reviewable through the standard NIH peer review criteria.

Are clinical trials allowed under this funding opportunity?

No. A key restriction of PA 19 056 is that it does not accept applications that propose clinical trials. Applicants must ensure their proposed work does not meet NIH's definition of a clinical trial.

How does NIH generally define a clinical trial for purposes of this FOA?

NIH generally defines a clinical trial as research that involves prospective assignment of human participants to an intervention with the goal of evaluating effects on health-related biomedical or behavioral outcomes. If a proposed project includes that type of design, it would not be allowed under this announcement.

Can my project involve human participants if clinical trials are not allowed?

Potentially, yes. The information provided indicates that studies involving humans may still be possible depending on the design (for example, certain observational or basic mechanistic studies). However, the application cannot include a clinical trial component under this FOA.

What should I do if my project includes a clinical trial?

If your project includes a clinical trial, NIH typically directs applicants to use a different funding opportunity announcement (FOA) that specifically allows or requires clinical trial applications. This particular announcement is limited to applications that do not propose clinical trials.

What kinds of projects are a good fit for an R01 under this announcement?

The opportunity is intended for projects that are discrete and well-bounded in scope, with specific aims, a planned approach, and a clear rationale. In practice, applicants are expected to frame the work around a research question that fits within an NIH institute's mission area and can be evaluated through standard NIH peer review.

How will applications be evaluated?

Applications are expected to be evaluated through the standard NIH peer review process, including the typical review considerations of significance, innovation, approach, investigators, and research environment.

Who can apply (in general) for PA 19 056?

Eligibility is broad and includes many organization types that conduct or support research. The FOA includes domestic governmental entities, educational institutions, tribal entities, nonprofits, for-profit organizations, and small businesses, among other eligible applicants described in the listing.

Which U.S. government entities are eligible to apply?

Domestic eligible applicants listed include state governments; county governments; city or township governments; and special district governments. The announcement also includes eligible federal agencies and regional organizations as highlighted eligible applicant types.

Are public or independent school districts eligible applicants?

Yes. Independent school districts are explicitly listed among domestic eligible applicants.

Are colleges and universities eligible?

Yes. The eligible applicant types include public and state-controlled institutions of higher education and private institutions of higher education.

Are nonprofits eligible to apply?

Yes. The eligible applicant types include nonprofit organizations with and without 501(c)(3) status (as long as they are not institutions of higher education, since those are listed separately).

Are for-profit organizations eligible?

Yes. The FOA allows for-profit organizations (other than small businesses) and small businesses.

Are small businesses eligible?

Yes. Small businesses are included as eligible applicants.

Are tribal governments and tribal organizations eligible?

Yes. Eligible applicants include federally recognized Native American tribal governments as well as tribal organizations other than federally recognized tribal governments.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included among the domestic eligible applicants.

Does the announcement specifically include certain institution types such as HBCUs and HSIs?

Yes. The announcement explicitly highlights and includes institution types 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).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly highlighted among eligible applicant types.

Are U.S. territories or possessions eligible to apply?

Yes. The announcement includes U.S. territories or possessions among the highlighted eligible applicant types.

Can foreign (non-U.S.) organizations apply?

Yes. The listing indicates that non-domestic (non-U.S.) entities, such as foreign organizations, can apply when permitted by NIH policies and when the project offers unique scientific opportunities or resources that justify foreign participation.

How broad is the scientific scope of this parent R01 announcement?

The scope is intentionally broad and spans a wide range of NIH-related topic areas. The listing notes alignment with multiple CFDA listings (including numerous 93.xxx programs), which signals participation by many NIH Institutes and Centers.

Do I need to choose an NIH Institute or Center (IC) to align with?

Yes. Applicants are expected to select an NIH institute alignment and craft a proposal that speaks directly to that institute's interests, including public health relevance and how the research will advance knowledge in the targeted field.

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

No. The source information does not specify an award ceiling or the number of expected awards. It notes that R01 budgets and project periods are typically driven by scientific need and NIH policy, with final decisions based on peer review outcomes, program priorities, and available appropriations.

What factors influence whether an application is funded?

Based on the information provided, funding decisions depend on peer review outcomes and then on program priorities and available appropriations at NIH.

Who administers this opportunity?

This opportunity is administered by the National Institutes of Health (NIH).

What is the funding opportunity number?

The funding opportunity number is PA 19 056.

What dates are shown in the source listing?

The source listing shows a creation date of 2018-11-05 and an original closing date of 2020-05-24.

Should applicants rely on the closing date shown in the source listing?

Not without checking the active NIH posting. The information notes that NIH parent announcements are periodically reissued and updated. Applicants should confirm current submission dates, participating institutes, and any updated policy requirements in the active NIH posting for PA 19 056 (or its successor).

Why is it important to verify the current NIH posting for PA 19 056 (or its successor)?

Because parent announcements are periodically updated, applicants should confirm the most current submission dates, participating Institutes and Centers, and any updated policy requirements before planning or submitting an application.