The objective of these funding announcements is to encourage basic, applied, and translational bioengineering research that could make a significant contribution to improving human health. Bioengineering integrates physical, engineering, and computational science principles for the study of biology, medicine, behavior, or health. It advances fundamental concepts, creates knowledge from the molecular to the organ systems level, and develops innovative biologicals, materials, processes, implants, devices, and informatics approaches for the prevention, diagnosis, and treatment of disease, for patient rehabilitation, and for improving health. Some applications are likely to focus on technology development rather than on proving or disproving scientific hypotheses. Bioengineering projects may propose design-directed, developmental, discovery-driven, or hypothesis-driven research. In the case of the Bioengineering Research Grant (BRG) FOAs (PAR-19-158, PAR-19-159) and Bioengineering Research Partnership (BRP) FOAs (PAR-19-156, PAR-19-157), applications will be evaluated against expanded review criteria.

High-risk and early stage development projects are appropriate for all three funding opportunity announcements, especially the Exploratory/Developmental Bioengineering Research Grants (EBRG) PAR-19-149, PAR-19-150. Details of specific interests of individual NIH Institutes and Centers are listed in each of the announcements.

The Exploratory/Developmental Bioengineering Research Grants (EBRG) (Clinical Trial Not Allowed: PAR-19-149, Clinical Trial Optional: PAR-19-150) funding opportunities use the R21 mechanism and encourage applications which establish the feasibility of technologies, techniques or methods that: 1) explore a unique multidisciplinary bioengineering approach to a biomedical challenge; 2) are high-risk but have a considerable pay-off; and 3) develop data which can lead to significant future research. In keeping with the intent of the R21 mechanism, the grant application may or may not include preliminary data.

The Bioengineering Research Grants (BRG) funding opportunities (Clinical Trial Not Allowed: PAR-19-158, Clinical Trial Required: PAR-19-159) use the R01 mechanism and encourage applications that: 1) apply a multidisciplinary bioengineering approach to the solution of a biomedical, biological or behavioral problem; and 2) develop, integrate, optimize, validate or otherwise accelerate the adoption of promising tools, methods and techniques for a specific research or clinical problem in basic, translational, or clinical science and practice. A BRG application is appropriate for single investigators or small teams applying an integrative approach to an open-ended research question. In keeping with the intent of the R01 mechanism there should be sufficient preliminary data to justify the specific aims of the project.

The Bioengineering Research Partnership (BRP) funding opportunities (Clinical Trial Not Allowed: PAR-19-156, Clinical Trial Required: PAR-19-157) use the U01 mechanism and encourage applications that: 1) will establish a robust bioengineering solution to a problem in biomedical research or the practice of medicine; 2) will develop a strategic alliance of multidisciplinary partners based on a well-defined leadership plan; and 3) can achieve a specific end-point within 5-10 years based on a detailed plan of quantitative milestones. A BRP application is appropriate for larger teams tackling biomedical problems where an appropriate solution is developed using intermediate milestones and will result in a specific end-goal within 5-10 years. In keeping with the intent of the U01 mechanism there should be sufficient preliminary data to justify the specific aims of the project.

Applications and awards are administered by the individual Institutes and Centers (ICs) participating in the FOA. Each FOA has a different list of participating ICs (under Part 1. Overview Information) and some of the ICs have additional guidance to applicants within the FOAs (under Part 2. Full Text of the Announcement). Projects must clearly serve the mission of one or more of the NIH Institutes or Centers (ICs) participating in the relevant FOA. Investigators are strongly encouraged to contact NIH program staff for individual IC policies and for feedback on the scope and relevance of the proposed project.

No. However, for BRG and BRP applications requesting $500,000 or more in direct costs in any year must contact NIH program staff at least 6 weeks in advance of submission for approval. Further details are included in BRG and BRP specific questions below. Investigators are also encouraged to include cover letters with all applications, identifying appropriate Institutes or Centers participating in the funding opportunity being targeted, and appropriate study sections.

We strongly recommend that you contact one of the participating ICs to inquire about the fit of your research to their mission, vision, and programs.

No.

The EBRG (PAR-19-149, PAR-19-150) follows the standard R21 mechanism budget and project period: direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed in any single year.

An EBRG grant can be resubmitted. For resubmissions, a review committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Under the current submission policy, it can also be submitted as a new application without reference to the prior submission or review.

The EBRG FOA uses standard dates.

Yes, this FOA is eligible. Please refer to the current guidance on continuous submission.

EBRG applications are primarily reviewed in chartered study sections. Investigators are encouraged to identify study sections with appropriate expertise in their application’s cover letter.

Details of current EBRG awards can be found in the publicly accessible NIH RePORTER database.

Even though not required, it is always prudent to contact one or more participating NIH ICs to ensure that there is a programmatic fit between the BRG application (PAR-19-158, PAR-19-159) and the target program / IC.

No.

The maximum project period for a BRG application is five years (four years at NIBIB) and the budget is not limited but needs to reflect the needs of the project. A funded BRG grant can continue beyond this period with a successful competing renewal application. However, individual Institutes and Centers have their own funding policies for R01 awards and may modify both the duration and budget administratively. For this reason, potential BRG applicants are strongly encouraged to contact NIH program staff to discuss budget and duration.

Furthermore, for applications requesting $500,000 or more in direct costs in any year (excluding consortium F&A) applicants must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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Yes. There is no administrative limit on the competing renewal / revision of BRG grants. For revisions, a review committee will consider the appropriateness of the proposed expansion of the scope of the project. For resubmissions, a review committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Under the current submission policy, it can also be submitted as a new application without reference to the prior submission or review.

The BRG FOAs use standard dates.

No, the BRP FOAs are not eligible for continuous submission.

BRG applications are primarily reviewed in chartered study sections. Investigators are encouraged to identify study sections with appropriate expertise in their application’s cover letter.

Details of current EBRG awards can be found in the publicly accessible NIH RePORTER database.

We strongly recommend that you contact one of the participating ICs to inquire about the fit of your research to their mission, vision, and programs.

If the proposed project has a well-defined end-goal that can be achieved within 5-10 years using a multidisciplinary team and non-hypothesis driven approach, then it is potentially suitable for the BRP FOAs (PAR-19-156, PAR-19-157). If the proposed project is likely to be addressed by researchers from a single discipline, propose an open-ended research strategy, or have an uncertain timeline to achieving a specific goal, then the parent R01 (Clinical Trial Not Allowed), parent R01 (Clinical Trial Required) or BRG announcements (PAR-19-158, PAR-19-159) may be more appropriate.

The value of strategic partnerships is well supported by the literature of both economics and science and technology policy, which documents greater success at research and development by groups that work in strategic alliances, often involving multiple institutions, compared to those working separately. In addition to the benefits to be derived from the research, partnerships help to prepare a new generation of scientists capable of interacting across traditional technical boundaries.

A BRP typically includes three-to-six partners from multiple institutions or multiple departments from the same institution, with each partner bringing critical strengths to the project. Additionally, from the beginning of the project, the partnership should engage the end-users who would benefit from the end-goal of the project to provide assurance that technology is developed to meet desired capabilities. These partners may bring diverse strengths in technology development, appropriate model systems for validation, human factors research, regulatory approval, project management, or commercialization to realize the end-goal of the project. Partnerships led by or involving companies or non-profit organizations are encouraged where appropriate, though not required. Reviewers are alerted that partnerships may be created specifically for the project and may not have a history of working together as a complete partnership.

The goal for a BRP grant at the end of 5-10 years may include but not be limited to: robustly establishing proof of concept, demonstrating the biological effectiveness of engineered constructs, first-in-human testing, construction of a pre-commercial prototype, release of software designs or models, or starting the investigational device exemption or investigational new drug process. To deliver this goal within the time frame of the award, intermediate, quantitative milestones that describe criteria for successful accomplishment of these milestones should be included.

For these FOAs, “end-users” is the broad description given to the community that will benefit if the end-goal is achieved. These communities may include but not be limited to basic translational, clinical, public health and behavioral researchers; clinicians and other healthcare professionals; drug developers; patients, care providers and family members, as well as members of the public.

The expectation for preliminary results for a BRP is the same as the parent R01 funding opportunity announcement.

The maximum project period for a BRG application is five years (four years at NIBIB) and the budget is not limited but needs to reflect the needs of the project. A funded BRG grant can continue beyond this period with a successful competing renewal application. However, individual Institutes and Centers have their own funding policies for R01 awards and may modify both the duration and budget administratively. For this reason, potential BRG applicants are strongly encouraged to contact NIH program staff to discuss budget and duration.

Furthermore, for applications requesting $500,000 or more in direct costs in any year (excluding consortium F&A) applicants must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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Yes. There is an administrative limit of one competing renewal for BRP awards, limiting potential funding to a maximum of ten years. For revisions, a review committee will consider the appropriateness of the proposed expansion of the scope of the project. For resubmissions, a review committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Under the current submission policy, previously submitted applications may be submitted  as a new application but must make no reference to the prior submission or review.  It is strongly suggested to discuss with your program director the best approach to resubmitting an unfunded application.

The current BRP FOAs use standard receipt dates.

No, the BRP FOAs are not eligible for continuous submission.

The goal is to review BRP applications in study sections that can fully consider the multidisciplinary science, the unique characteristics of this initiative and provide consistent review. Where appropriate, applications may be reviewed either in special emphasis panels or in chartered study sections.

Milestone-driven research helps ensure research focused on a well-defined end-goal achieves that goal with greatest efficiency. Because BRPs can be inherently high-risk, the use of milestones also provides clear indicators of a project's continued success or emergent difficulties. The milestones should describe the interim goals of the work and not just a list of tasks or a statement that the work will be completed. These milestones must include objective and quantitative outcomes by which to justify advancing the project.

The criteria for success and rationale of each milestone should be described using objective, specific, quantifiable measures. These should be measures that would be recognizable as appropriate endpoints by reviewers knowledgeable in the specific scientific area. Applicants are encouraged to provide at least one quantitative milestone in each year of the project, and that the chosen milestones provide logical and feasible intermediate assessments on the path towards the end-goal. Milestones are typically composed of the interim goal, a quantitative measure of success, timeline, and brief rationale.  

For example, a sample BRP milestone would be: Identify at least three imaging agents with the requisite sensitivity and specificity (end of year 1). Requisite sensitivity and specificity is 95% and 90% respectively tested in 3T3 cell culture. 3T3 cell culture has predictive value for labelling fibroblast cells in a mouse model.

Details of current BRP awards can be found in the publicly accessible NIH RePORTER database.