Bioengineering Research Partnerships (U01 Clinical Trial Not Allowed) | PAR 19 156

Frequently Asked Questions (FAQs)

What is the Bioengineering Research Partnerships (U01 Clinical Trial Not Allowed) opportunity (PAR-19-156)?

PAR-19-156 is a National Institutes of Health (NIH) cooperative agreement (U01) funding opportunity intended to accelerate the development and real-world adoption of high-impact bioengineering tools and technologies that address important biomedical problems. The focus is on translating promising concepts into robust, well-characterized solutions that fill unmet needs and can be broadly used in biomedical research or medical practice.

What is the core goal of this program?

The central goal is translational bioengineering progress: moving beyond early proof-of-concept to produce technology that others can reliably use, reproduce, and trust. NIH is looking for solutions engineered for practical adoption, including clear specifications, benchmarking, validation, and an implementation path that supports broad use.

What kinds of outcomes does NIH want to see from funded projects?

NIH is seeking technology outcomes that are positioned for broad adoption as standard tools, platforms, or enabling capabilities. Projects should aim to deliver high-impact solutions that deepen understanding of biological processes or improve the practice of medicine, while demonstrating rigorous performance characterization and validation under realistic biological or clinical constraints.

Is this opportunity focused on invention or on development and adoption?

It is not only about novelty or inventing something new. The emphasis is on turning a promising concept into a robust, well-characterized, and widely usable solution that addresses an unmet need and is engineered for reproducibility and trust by the broader community.

What does "Clinical Trial Not Allowed" mean for applicants?

"Clinical Trial Not Allowed" indicates that applicants should not propose conducting a clinical trial within the scope of the funded work. The supported activities are described as preclinical, methodological, technological, or enabling research and development that prepares a technology for eventual use, without running a clinical trial as part of the project.

What type of funding mechanism is used for this opportunity?

This funding opportunity uses a cooperative agreement mechanism (U01). A cooperative agreement typically means NIH program staff will have substantial involvement during the project compared to a standard research grant, including possible active coordination, shared governance expectations, and participation in steering or oversight activities.

How is a U01 cooperative agreement different from a standard research grant?

Based on the listing description, the defining difference is the expectation of substantial NIH program staff involvement during the project, potentially through coordination and oversight structures. This is more engaged than the typical relationship under a standard research grant.

What is the expected project time horizon or development window?

The stated goal is to support projects that can deliver meaningful solutions within roughly 5 to 10 years. This signals a preference for credible development plans with clear milestones, validation pathways, and a realistic strategy to mature the technology into something that can become broadly adopted.

What research approach is emphasized in this FOA?

The FOA emphasizes integrative and quantitative bioengineering approaches. This typically implies a strong grounding in measurement, modeling, performance validation, and iterative optimization under realistic biological or clinical constraints, with the aim of producing practical, well-benchmarked technology.

Are multidisciplinary team-based partnerships required or encouraged?

Team-based, multidisciplinary partnerships are a defining feature of the FOA. Projects are expected to integrate engineers and quantitative scientists with biomedical researchers and/or clinicians in a tightly coordinated way.

How should biomedical researchers or clinicians be involved in the project?

The biomedical or clinical perspective is expected to be involved throughout the full lifecycle of the project, rather than being added late as an end-user viewpoint. The FOA describes an expectation of tight integration across disciplines from start to finish.

What kinds of projects are likely to be a strong fit based on the summary?

Projects are likely to align well if they propose a clear path from a promising bioengineering concept to a robust, validated tool or technology that addresses an unmet biomedical need and is designed for broad adoption, including reproducibility, benchmarking, and real-world constraints.

What types of organizations are eligible to apply?

Eligibility is broad and includes many institution types and sectors, including government entities, academic institutions (public and private), minority-serving and special-designation institutions, tribal entities, nonprofits (with or without 501(c)(3) status outside of higher education), for-profit organizations (other than small businesses), small businesses, eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations).

Are government entities eligible applicants?

Yes. Eligible applicants include state, county, city, township, and special district governments, as well as independent school districts and public housing authorities/Indian housing authorities.

Are minority-serving institutions included in the eligible applicant types?

Yes. The eligible academic categories include multiple minority-serving and special-designation institutions 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 tribal organizations eligible?

Yes. Several tribal categories are explicitly included, such as federally recognized Native American tribal governments, other Native American tribal organizations, and Indian/Native American tribal governments that are not federally recognized.

Are nonprofits eligible, and do they need 501(c)(3) status?

Yes. The listing states that nonprofit organizations both with and without 501(c)(3) status (outside of higher education institutions) are eligible.

Are for-profit organizations eligible?

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

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

Yes. The eligibility list includes non-domestic (non-U.S.) entities (foreign organizations), which supports the possibility of international participation when appropriate.

Who is the sponsoring agency for this funding opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What is the funding activity category associated with this opportunity?

The funding activity category is listed under environment and health.

What are the CFDA (assistance listing) numbers associated with this opportunity?

The associated CFDA (assistance listing) numbers include 93.113, 93.273, 93.286, and 93.866. The listing notes that these reflect that multiple NIH institutes or program areas may participate or align with the scope depending on the specific scientific focus.

Does the public summary provide an award ceiling or number of expected awards?

No. The public summary does not specify an award ceiling or the expected number of awards. The summary suggests applicants would need to consult the full FOA text and related NIH institute guidance for budget expectations, project period limits, and programmatic priorities.

What are the key dates mentioned in the listing?

The listing includes a creation date of January 8, 2019, and an original closing date of January 7, 2022.

What does it mean that this is a discretionary grant?

The listing categorizes the opportunity as a discretionary grant. The summary does not provide additional detail beyond that classification.

What is NIH looking for in terms of validation and reliability?

The FOA emphasizes building technology that others can reliably use, reproduce, and trust. This points to expectations around rigorous characterization, benchmarking, performance validation, and iterative refinement so the resulting tool or technology works under realistic biomedical or clinical constraints and is ready for broad use.

How does this FOA define "translational" in the bioengineering context?

In this summary, translational progress means moving beyond early proof-of-concept and focusing on engineering a technology into a robust, well-specified, and well-characterized solution that fills an unmet need and is positioned for adoption by the broader research or medical community.