Opportunity Information: Apply for PA 18 418

The NIBIB Research Project Grant (R01 Clinical Trial Required), funding opportunity number PA 18 418, is a National Institutes of Health (NIH) discretionary grant designed to support a clearly defined, investigator-led research project. The R01 mechanism is meant for a discrete and well-scoped plan of work with specific aims, methods, and outcomes that fit the expertise of the research team. What makes this particular announcement distinct is that it requires applicants to propose at least one clinical trial as part of the project. In practical terms, the research cannot be purely preclinical or theoretical; it must include a trial involving human participants that meets NIH definitions for a clinical trial, and it must be directly connected to the scientific goals of the application.

The proposed work must align with the programmatic interests of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). While the listing does not spell out particular scientific topics, NIBIB generally supports research at the intersection of engineering, imaging, and biomedical technology development and evaluation. Applicants should expect that the project will be assessed not only for scientific merit and feasibility, but also for how clearly it advances NIBIB-relevant areas and how appropriately the clinical trial is designed, justified, and integrated into the overall project. Because the announcement explicitly requires a clinical trial, a strong application typically needs a realistic trial plan, appropriate endpoints, sound statistical considerations, and clear protections for human subjects, along with operational details showing the team can actually run the study.

Eligibility is broad and covers many types of organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; and public housing authorities/Indian housing authorities. Academic institutions are eligible, including public and state-controlled institutions of higher education and private institutions of higher education. The opportunity is also open to nonprofit organizations, whether they have 501(c)(3) status or not (as long as they are not institutions of higher education), as well as for-profit organizations (including small businesses and other for-profits). In addition, federally recognized Native American tribal governments and other Native American tribal organizations are eligible, along with a range of other entities listed as specifically eligible under the announcement, such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations.

From an administrative standpoint, the funding instrument type is a grant, and the activity category is health, with CFDA number 93.286. The opportunity was created on November 30, 2017, and the original closing date shown in the source data is January 7, 2021. The data provided does not specify an award ceiling or the expected number of awards, which usually means applicants must rely on the broader NIH/NIBIB guidance for typical R01 budgeting and review the full announcement details and current NIH policy for any applicable limits, budget formats, and submission requirements.

Overall, this funding opportunity supports investigators who want to pursue a focused biomedical imaging or bioengineering-related research project that includes at least one human clinical trial, with wide eligibility across governmental, academic, nonprofit, for-profit, tribal, and certain international organizations, provided the work fits NIBIB priorities and meets NIH standards for clinical trial design and oversight.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIBIB Research Project Grant (R01 Clinical Trial Required)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286.
  • This funding opportunity was created on 2017-11-30.
  • Applicants must submit their applications by 2021-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • 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.
Apply for PA 18 418

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Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is the NIBIB Research Project Grant (R01 Clinical Trial Required) from the National Institutes of Health (NIH). It is a discretionary grant that supports a clearly defined, investigator-led research project using the R01 mechanism.

What is the funding opportunity number?

The funding opportunity number is PA 18 418.

Which NIH institute is associated with this R01?

The opportunity is tied to the National Institute of Biomedical Imaging and Bioengineering (NIBIB).

What does "R01" mean in this context?

R01 refers to a standard NIH research project grant mechanism intended to support a discrete, well-scoped plan of work. Applications are expected to present specific aims, methods, and measurable outcomes that match the expertise of the research team.

Is a clinical trial required under this announcement?

Yes. This specific announcement requires applicants to propose at least one clinical trial as part of the project.

Can the project be purely preclinical or theoretical?

No. The project cannot be purely preclinical or theoretical under this announcement because it must include at least one clinical trial involving human participants that meets NIH definitions for a clinical trial.

What does it mean that the clinical trial must meet NIH definitions?

It means the proposed human study must qualify as a clinical trial according to NIH definitions. The information provided indicates the trial must involve human participants and be directly connected to the scientific goals of the application.

Does the clinical trial need to be connected to the overall research plan?

Yes. The clinical trial must be directly connected to the scientific goals of the application and integrated into the overall project.

What general research areas are relevant to NIBIB for this opportunity?

While specific scientific topics are not listed in the provided information, NIBIB generally supports research at the intersection of engineering, imaging, and biomedical technology development and evaluation. Proposed work is expected to align with NIBIB programmatic interests.

How will applications be assessed?

Applications are expected to be assessed for scientific merit and feasibility, as well as how clearly the project advances NIBIB-relevant areas. Because a clinical trial is required, the clinical trial design, justification, and integration into the project are also central to assessment.

What kinds of clinical trial details are expected in a strong application?

Based on the information provided, a strong application typically includes a realistic trial plan, appropriate endpoints, sound statistical considerations, clear protections for human subjects, and operational details demonstrating the team can run the study.

What is the funding instrument type?

The funding instrument type is a grant.

What is the activity category?

The activity category is health.

What is the CFDA number for this opportunity?

The CFDA number listed is 93.286.

Who is eligible to apply?

Eligibility is broad and includes many organization types, such as governmental entities, academic institutions, nonprofits, for-profits, tribal entities, and additional specifically listed organizations (including certain U.S. territories and foreign organizations).

Are state, county, or local governments eligible?

Yes. Eligible applicants include state, county, and local governments.

Are special district governments eligible?

Yes. Special district governments are listed as eligible.

Are independent school districts eligible?

Yes. Independent school districts are listed as eligible.

Are public housing authorities or Indian housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.

Are public universities and state-controlled institutions eligible?

Yes. Public and state-controlled institutions of higher education are eligible.

Are private universities and colleges eligible?

Yes. Private institutions of higher education are eligible.

Are nonprofit organizations eligible?

Yes. Nonprofit organizations are eligible, including those with 501(c)(3) status and those without 501(c)(3) status, as long as they are not institutions of higher education.

Are for-profit organizations eligible?

Yes. For-profit organizations are eligible, including small businesses and other for-profit entities.

Are federally recognized tribal governments eligible?

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

Are other tribal organizations eligible?

Yes. Other Native American tribal organizations are listed as eligible.

Are minority-serving institutions specifically mentioned as eligible?

Yes. The provided information lists several categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are specifically listed as eligible.

Are federal agencies eligible?

Yes. Eligible federal agencies are listed as eligible applicants.

Are regional organizations eligible?

Yes. Regional organizations are listed as eligible.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed as eligible.

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

Yes. Non-U.S. (foreign) organizations are explicitly included as eligible in the provided information.

When was this opportunity created?

The opportunity was created on November 30, 2017.

What is the closing date shown in the provided information?

The original closing date shown in the source data is January 7, 2021.

Does the provided information include an award ceiling?

No. The data provided does not specify an award ceiling.

Does the provided information say how many awards are expected?

No. The data provided does not specify the expected number of awards.

How should applicants handle budget and submission expectations if ceilings or award counts are not listed?

Based on the information provided, applicants may need to rely on broader NIH/NIBIB guidance for typical R01 budgeting and consult the full announcement details and current NIH policy for applicable limits, budget formats, and submission requirements.

What is the main purpose of this grant opportunity overall?

The opportunity supports investigators pursuing a focused biomedical imaging or bioengineering-related research project that includes at least one human clinical trial, provided the work aligns with NIBIB priorities and meets NIH standards for clinical trial design and oversight.

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