Creating Biomedical Technologies to Improve Health

RESEARCH FUNDING

Frequently Asked Questions About EBRG, BRG, BRP

General Questions
 
Exploratory/Developmental Bioengineering Research Grants (EBRG) Questions
 
Bioengineering Research Grants (BRG) Questions
 
Bioengineering Research Partnership (BRP) Questions
 
BRP Other Required Attachment Questions
 

General Questions

What is the objective of the Bioengineering Funding Opportunity Announcements?

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. It is expected that some applications will 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 and in the case of the Bioengineering Research Grant (BRG) and Bioengineering Research Partnership (BRP) FOAs, applications will be evaluated against expanded review criteria.

High-risk and early-stage development projects are appropriate for all three funding opportunity announcements. Details of specific interests of individual NIH Institutes and Centers are listed in each of the announcements.

What is the difference between the EBRG, BRG and BRP funding opportunities?

The Exploratory/Developmental Bioengineering Research Grants (EBRG) funding opportunity uses the R21 mechanism and encourages 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, there may or may not be any preliminary results.

The Bioengineering Research Grants (BRG) funding opportunity uses the R01 mechanism and encourages 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 results to justify the specific aims of the project.

The Bioengineering Research Partnership (BRP) funding opportunity uses the R01 mechanism and encourages 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 realize 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 that can be reached within 5-10 years. In keeping with the intent of the R01 mechanism there should be sufficient preliminary results to justify the specific aims of the project.

How are these funding opportunity announcements administered? Is there someone I can contact to discuss whether my idea is a good fit for these FOAs?

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 expressed 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.

Do I need to submit a letter of intent before submitting an application?

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. 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

 

Exploratory/Developmental Bioengineering Research Grants (EBRG) Questions

Are there any significant changes for applications under the current announcement?

No.

Do I need to contact one of the participating NIH ICs before submitting an EBRG?

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.

What are the project budget/period guidelines? 

The EBRG 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. 

Can an EBRG grant be renewed / revised / resubmitted?

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. 

What are the receipt dates for new EBRG applications?

The EBRG FOA uses standard dates

If I am an eligible investigator, can I submit under the Continuous Submission Policy?

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

How are EBRG applications reviewed?

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.

What projects have been funded previously as EBRGs?

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

 

Bioengineering Research Grants (BRG) Questions

Are there any significant changes for applications under the current announcement?

Yes. Some additional questions were included to the standard criteria to guide reviewers in evaluating the bioengineering.

What are the project budget/period guidelines? What do I need to do if my budget is $500,000 or more in direct costs?

The maximum project period for a BRG application is five years 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.

Can a BRG grant be renewed / revised / resubmitted?

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. 

What are the receipt dates for new BRG applications, competing renewals and resubmissions?

The BRG FOA uses standard dates.

If I am an eligible investigator, can I submit under the Continuous Submission Policy?

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

How are BRG applications reviewed?

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.

What projects have been funded previously as BRGs?

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

Bioengineering Research Partnership (BRP) Questions

Are there any significant changes with the current announcement?

There are a number of significant changes for the current reissue of the BRP FOA:
  • The number of receipt dates has decreased to two non-standard dates per year (May 20, 2014, September 18, 2014, May 20, 2015, September 18, 2015) and the announcement will expire after two years (January 8, 2016).
  • The number of Other Attachments has increased to four: Leadership Plan, Needs Assessment, Quality Management and Sustainability Plan, and Facilities and Other Resources.
  • The effort requirements for multi-PI applications has been clarified: key investigators are expected to commit significant effort to the project; the PD/PI of a single PD/PI application must contribute at least 3 (25%) calendar months of effort and for Multiple PD/PI applications each PD/PI must contribute at least 1.8 (15%) calendar months of effort.
  • The definition of innovation has been clarified: Innovation for this FOA is based on a coherent plan to deliver emerging or new capabilities to end-users, including through combinations of proven approaches and recognizing their resources, workflow, and skills. Developing a technology is expected to require innovation, but novelty in and of itself is not a primary requirement. For the purpose of this FOA it is innovative to deliver a new capability to solve an unmet need.
     

Should I apply for a BRP or an investigator-initiated R01?

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 FOA. 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 or BRG announcements may be more appropriate. 

What are the expectations for a partnership?

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 prepare a new generation of scientists capable of interacting across traditional technical boundaries.

A partnership is typically composed of between three and six partners from multiple institutions or multiple departments from the same institution, with each partner bringing critical strengths to the project. The partnership should also engage the end-users who will benefit from the end-goal of the project from the beginning, 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. Where possible, 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.

What is an appropriate end-goal for a BRP?

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. 

Who are end-users?

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

What kind of preliminary results are required for a BRP?

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

What are the project budget/period guidelines? What do I need to do if my budget is $500,000 or more in direct costs?

The maximum project period for a BRP application is five years and the budget should reflect the needs of the project. However, individual Institutes and Centers have their own funding policies for R01 awards and may cap both the duration and budget administratively.  A funded project can compete for one additional funding project period to give up to another five years of funding, for a total of up to ten years of funding.  Potential BRP applications 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) 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.

Download BRP White Paper Template (MS Word 53.6KB) New 

Download BRP White Paper Budget Table Template (Excel Worksheet 12.7KB) New 

Can a BRP grant be renewed / revised / resubmitted?

Yes. There is an administrative limit of one competing renewal for BRP grants, 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, it can also be submitted as a new application without reference to the prior submission or review. 

Please refer to the Notice of Clarification Regarding Submissions to PAR-16-116 Bioengineering Research Partnerships (U01)(NOT-EB-16-006) for information on the change in grant mechanism for Biongineering Research Partnerships (BRP).

What are the receipt dates for new BRP applications, competing renewals, revisions and resubmissions?

The current BRP FOA uses non-standard receipt dates. For the current announcement the receipt dates are: May 20, 2014, September 18, 2014, May 20, 2015, September 18, 2015. This receipt date is the same for new applications, competing renewals, revisions and resubmissions. 

If I am an eligible investigator, can I submit under the Continuous Submission Policy?

No, the BRP FOA is not eligible for continuous submission.

How are BRP applications reviewed?

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.

What are quantitative milestones?

Milestone-driven research helps ensure research focused on a well-defined end-goal achieves that goal with greatest efficiency.  As 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. 

What projects have been funded as BRPs?

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

 

BRP Other Required Attachment Questions

What are the BRP Other Required Attachments?

Given the complexity of the science and management present in many of these partnerships, information beyond the standard research strategy is very helpful for evaluating applications. Historically, in past BRP announcements a leadership plan was the only required attachment to describe structure, roles and responsibilities as well as budget and communication plans. For the current BRP announcement, the number of required attachments has been expanded to four to give investigators the opportunity to include additional supporting information relevant to their project.  These four sections are designed to support and complement the information in the research strategy. The four attachments must be uploaded as separate attachments in pdf format with filenames that correspond to the individual items (Leadership Plan, Needs Assessment, Quality Management and Sustainability Plan, Facilities and Other Resources). For multi-PI applications, the Leadership Plan should be uploaded using the Multiple PD/PI Leadership Plan on the PHS 398 Research Plan form, whereas the Needs Assessment, Quality Management and Facilities and Other Resources plans should be uploaded as separate attachments).

These four attachments can be up to six pages in length each but should be kept short and focused so as to support but not detract from the research strategy. These attachments must not be used to circumvent page limits. Investigators are strongly encouraged to keep these attachments concise. The Leadership Plan, Needs Assessment, Quality Management and Sustainability Plan attachments are not scored during review, but will be evaluated as part of the additional review criteria and included in the application’s overall impact score.  The Facilities and Other Resources is part of the environment criteria.

What should be included in the Leadership Plan attachment?

The Leadership Plan attachment should describe the organizational structure of the team, roles and responsibilities and management principles. The description of organizational structure and processes should include but not be limited to details on decision-making for budgets and scientific direction, publication policy, assignment of intellectual property, a communications plan, and resolution of disputes. A scientific steering group that meets regularly is a good tool for bringing the key investigators in the partnership together to discuss progress and to engage outside expertise as needed throughout the lifetime of the project.

What should be included in the Needs Assessment attachment?

A needs assessment can be an effective tool in the planning process for any project with an end-goal and a group of potential end-users.  The purpose of including a needs assessment attachment in the BRP FOA is to give investigators the opportunity to describe the process used to analyze the biological, biomedical or behavioral problem being addressed, how the gap between the present state and the desired state (the “needs”) has been identified, and how bioengineering principles and techniques from the life and physical sciences will be applied to realize a meaningful tool, technology, or method.  The extent and structure of the needs assessment will vary significantly according to the nature of the proposed project. It is expected that the needs assessment will continue to evolve and be refined during the lifetime of the award, and consequently it may be substantially shorter and less detailed in a new application than in a competing renewal.

A needs assessment is typically composed of three components: 1) describing the present state, 2) analyzing the needs of the end-users, and 3) identifying possible solutions and setting priorities based on the chosen solution. The first component should describe the problem in detail and the deficiencies of existing solutions. This section may include but is not limited to: details about disparities in care, lack of technologies to assess basic biological processes, the challenge of promoting wellness and independent living, or barriers to increasing throughput, sensitivity and specificity of laboratory and clinical studies. The second component should identify the end-users for the project, the needs of these end-users, and the priority for meeting each of the needs as part of the project. This section may include but is not limited to : analysis of published literature such as survey information or reports from end-user groups, gathering and analyzing feedback from a questionnaire, key informants or a focus group, and may use different analytical frameworks including: front-end analysis, gap analysis, cause analysis, PEST analysis, SWOT analysis, or force-field analysis. The final component should identify research strategies and bioengineering principles considered as possible solutions, describe the decision-making process for selecting the specific aims of the project, and discuss if needs will continue to be assessed during the lifetime of the project. 

Examples of the application of these tools and different forms of needs assessments can be found in the published literature and on the internet. For example, a needs assessment for a point of care diagnostic device for rabies to be used in a low-middle income country would describe current diagnostic strategies and their effectiveness in reducing disease burden in that country, identify the end-users and what information they need in order to be able to deliver more effective care, and map these needs to the priorities of the project and performance of the device. In this case, the end-users may be healthcare workers working for a non-governmental organization which is a partner in the BRP and their needs identified through a previously carried out survey, which may illustrate that size and speed of result readout are more important than higher accuracy or cost, and that the device needs to be capable of resolving rabies against tetanus and Guillain-Barre syndrome but not polio. A renewal application may also include an analysis of the experiences of a focus group of users presented with a prototype device.       

What should be included in the Quality Management and Sustainability Plan attachment?

Rigor, control of bias, and transparency of reporting are important for all research. Attention to principles of good experimental design, minimizing bias and reporting results as well as the interpretation of results are essential to enable the scientific community to assess the quality of scientific findings and for peer reviewers. This attachment should explain the rationale for selected models and endpoints in proposed studies, the adequacy of controls, approaches for minimizing bias, the justification of sample size including power calculations, and the statistical methods used to analyze and interpret results.  Additionally, engineering design principles should be described and plans to develop calibrations or standards, for design controls and the development of good manufacturing practices should also be explained as needed. Plans for increasing transparency of findings through depositing dataset in repositories and preserving samples and collections are also encouraged and can be described in this attachment. 

Because of the limited duration of BRP awards, applicants are also asked to discuss plans for sustaining work beyond the award period in this attachment. Discussion of issues related to sustainability including costs, scale-up, standardization, and interoperability are encouraged as appropriate.

What should be included in the Facilities and Other Resources attachment?

This attachment should describe the unique resources available to each partner and any institutional support for the project. The multidisciplinary nature of these partnerships also provides a unique opportunity and environment for students and postdoctoral fellows.   Investigators are encouraged to describe how resources will be leveraged to support and inspire multidisciplinary researchers, smooth the transfer of knowledge between partners and any resources that will be employed to improve communication within the team.