Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Team-Based Design in Biomedical Engineering Education (R25)

Activity Code

R25 Education Projects

Announcement Type

Reissue of PAR-10-140

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-13-111

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.286, 93.865

Funding Opportunity Purpose

This FOA, issued by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), encourages applications from institutions that propose to establish new or to enhance existing team-based design courses in undergraduate Biomedical Engineering departments or programs. This FOA targets undergraduate students at the senior level but may also include junior undergraduates and first-year graduate students. Courses that address innovative and/or ground-breaking development, multidisciplinary/interdisciplinary training and clincial immersion are especially encouraged.

 
Key Dates
Posted Date

February 8, 2013

Open Date (Earliest Submission Date)

April 13, 2013

Letter of Intent Due Date(s)

30 days before the applicatin due date

Application Due Date(s)

May 13, 2013; May 13, 2014; May 13, 2015, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2013, October 2014, October 2015

Advisory Council Review

January 2014, January 2015, January 2016

Earliest Start Date

April 2014, April 2015, April 2016

Expiration Date

May 14, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies.  The accomplishment of this mission requires biomedical engineers who have not only the theoretical knowledge to address health problems but also the ability to translate new devices and technologies from the laboratory bench to the bedside.  Training of such a workforce is also relevant to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), specifically in the context of advanced rehabilitation technologies to enhance the well-being of persons with disabilities, and non-invasive sensor technologies and telecommunication devices for the care and monitoring of infants and children. 

The NIBIB and NICHD recognize that Biomedical Engineering (BME) students should experience open-ended challenges to develop their problem-solving skills and participate in team-based projects that prepare them for today’s multidisciplinary work environment. These institutes also recognize that future generations of biomedical engineers need to be able to successfully translate and commercialize their design ideas so that these innovations can reach the intended end-users in the clinic, patient homes and the community at large, and improve public health. While BME faculties are motivated to include students in ongoing grant-supported research projects, there are fewer resources available to support the costs associated with design projects.  Without adequate resources, the complexity of projects undertaken, the sophistication of the design solutions advanced, and in turn, the learning opportunities afforded are necessarily limited. 

In this FOA, the NIBIB and NICHD intend to provide support for new or existing design courses that require students to work in teams on open-ended biomedical design projects. In addition to the engineering aspects of design, the courses should include, where appropriate, discussion of the clinical environment, user needs, design planning with clinical mentors, device specification and development, patent searches, regulatory requirements, business planning and ethical considerations relevant to taking design ideas from the bench to bedside. This can include a clinical immersion period during or outside the academic year to introduce students to the clinical environment and clinical needs (for more details about allowable costs, see "Other Program-Related Expenses").

For the purposes of this program, clinical immersion is defined as a 6- to 10-week program, where students engage full-time in the hospital or other clinical environment becoming familiar with the language, issues, and problems that can benefit from an engineering approach. The clinical immersion period, which is expected to be carried out under the supervision of (a) clinical mentor(s), will typically involve rotations in various departments of the hospital. Although students may be involved in solving some clinical problems during this time, the main purpose of the clinical immersion period is to observe the clinical activities, acquire communication skills necessary to interact with clinicians, and identify unmet needs that can subsequently be addressed in biomedical design projects.

Applications to this FOA may address specific target areas such as neural engineering, tissue engineering, sensors, information technologies, or involve a wider umbrella of projects within BME. This FOA targets undergraduate students at the senior level but may also include junior undergraduates and first-year graduate students. While the design courses supported by this FOA are expected to be offered by biomedical engineering departments or programs, participation of students from other appropriate disciplines is welcome and encouraged.

Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. As such, each application must include a plan to evaluate the activities proposed (see Section IV. Evaluation Plan).  For some types of projects, a plan for disseminating results may also be appropriate and may be required as well (see Section IV. Dissemination Plan).

The proposed research education program may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs of up to $20,000 per year may be requested.  Programs that include a clinical immersion program outside the academic year may request an additional $20,000 to cover participant stipends (see Participant Costs section below), yielding a total of $40,000 in direct costs.

Award Project Period

Project durations of up to five years may be requested. 

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).

 Personnel expenses are allowed for technical staff who directly support students in their design projects, and limited administrative costs specifically for restructuring of an existing course to allow for interdisciplinary participation.  Requested salary costs may not exceed $5,000 annually.

Participant Costs

Participants are those individuals who benefit from the proposed research education program.  Allowable participant costs for this funding opportunity are limited salary provided to students engaging in a full-time, 6 to 10-week clinical immersion period outside of the academic year.  The participant salary requested should not exceed $10 per hour and a total of $4,000 per participant, or $20,000 for the program annually.

Expenses for foreign travel are not allowed.

Participant costs must be itemized in the proposed budget and justified in the budget justification.

Other Program-Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

The budgets for applications to this FOA can include support for, but are not limited to, the following items:

  • Purchase of necessary supplies and parts.
  • Hiring of machine shop/prototyping services.
  • Technical staff to oversee and assist students’ activities.
  • Support for guest lecturers from academia or industry with direct experience in design planning, translation, or commercialization.
  • Support for web-based resources for patent searches, regulatory procedures, and business plans,
  • Support for PD(s)/PI(s) or mentor(s) of the program to attend scientific meetings specifically to present activities and outcomes of the course/program supported by the FOA.  
Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

The sponsoring institution is expected to have an established biomedical engineering  or bioengineering department or program. However, there is no requirement that the proposed team-based design course/program be established prior to application.  The application may be for a new course or program or to enhance an already established design course or program.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.


All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The PD/PI should be an established investigator in biomedical engineering or a related field, and must possess relevant experience required to coordinate, supervise, and direct the proposed design course/program.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

 Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Preceptors/Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

Applications must describe the intended participants and identify the career levels essential for participation in the planned program.  Applicants must describe the selection criteria to be used in identifying individuals to participate in various aspects of the proposed research education program, such as the clinical immersion period.

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Zeynep Erim, Ph.D. 
Division of Interdisciplinary Training 
National Institute of Biomedical Imaging and Bioengineering 
Democracy II, Suite 200
6707 Democracy Boulevard
Bethesda, MD 20892-5477
Telephone: (301) 435-6686 
Email: erimz@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed, with the following modification:

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

Facilities & Other Resources

Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.  

SF424(R&R) Senior/Key Person Profile Expanded Component

Key Personnel must include the PD/PI (or multiple PDs/PIs) as well as any other key persons who are integral to the proposed research education program (such as those involved in developing, implementing, directing, monitoring, evaluating the design courses or program).

R&R Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the additional instructions described below:

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below: Proposed Research Education Program, Institutional Environment and Commitment, Program Director/Principal Investigator, Program Faculty/Staff, Program Participants, Diversity Recruitment and Retention Plan, Plan for Instruction in the Responsible Conduct of Research, Evaluation Plan, Dissemination Plan.

Proposed Research Education Program (Component of Research Education Program Plan)

While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed research education program and the research training supported by the training program. The information should include a description of the education and/or career levels of the planned participants.  Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops). Provide a description of the design course(s), discussing its didactic and experiential components and, if possible, providing a syllabus.  Institutions with existing design courses must describe the new and enhanced aspects of the proposed course(s).  Describe how student teams will be formed, how the teams will identify or be assigned a design project, and how faculty advisors will be assigned to the teams. Provide examples of current design projects and, if applicable, past design projects undertaken by course participants.  Discuss the roles of clinical or industrial co-advisors, if applicable.  Provide specifics of the interaction between students and advisors and course leader(s), and how student and team progress will be evaluated.  If a clinical immersion period is proposed, describe the process for selecting the students for participation in this program.  Provide an overview of the activities and deliverables of the proposed immersion period.  Discuss how this period will inform or be incorporated into the activities undertaken in the design course/program.

Institutional Environment and Commitment (Component of Research Education Program Plan)

Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.  The administration of the applicant institution as well as all participating departments should document institutional support and commitment to the goals of the design course/program. The application should include a description of support (financial and otherwise) to be provided to the proposed course(s). This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and/or participating faculty, support for project related expenses or student salaries for activities outside of the academic year, or any other creative ways to improve the climate for the establishment and growth of the course.  Describe ongoing research and clinical programs at the home, and any collaborating, institution that may provide projects for the course participants to undertake.  

Program Director/Principal Investigator (Component of Research Education Program Plan)

Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.  The PD/PI(s) must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed design course(s).  Describe the PD/PI(s)’s relevant experience in teaching design courses, supervising design teams, and designing biomedical devices or technologies.

Program Faculty/Staff (Component of Research Education Program Plan)

Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of NIH.  Additionally, provide evidence that the participating faculty and preceptors are actively engaged in biomedical engineering. The application must include information about the planned faculty and clinical and/or industrial advisors available to provide design problems as well as guidance and expertise in addressing these problems.  The advisors should have strong records as educators and researchers or a strong background in medical device development.  Discuss relevant experience in biomedical device design and in leading student teams in design projects.  Provide examples of the projects the specific advisors may offer course participants.

Program Participants (Component of Research Education Program Plan)

Where the proposed program involves participants, provide details about the pool of expected participants, their qualifications, recruitment strategies and sources of applicant pool, etc.   If a clinical immersion period is proposed, discuss the process for the recruitment or selection of participants for this portion of the program.  

Diversity Recruitment and Retention Plan (Component of Research Education Program Plan)

The NIH recognizes a unique and compelling need to promote diversity among U.S. citizens and permanent residents in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the U.S. Pacific Islands. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

New applications must include a description of plans to enhance recruitment of a diverse participant pool and may wish to include data in support of past accomplishments.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

For those individuals who were enrolled in the program, the report should include information about the duration of education and whether those individuals finished the program in good standing. Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

Applications lacking a diversity recruitment and retention plan may be delayed or not accepted for review. An award cannot be made if an application lacks this component.

Plan for Instruction in the Responsible Conduct of Research (Component of Research Education Program Plan)

Every participant supported by this Research Education grant must receive instruction in the responsible conduct of research. All applications must include a plan to provide such instruction. The plan must address five components (format; subject matter; faculty participation; duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Evaluation Plan (Component of Research Education Program Plan)

Applications must include a plan for evaluating the activities supported by the award.  The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses, assess the relevance of the skills and experiences offered by the design course(s), and to provide suggestions for improvements.  Evaluation results should include, where possible, information on the subsequent activities and career paths of participants, especially those participating in the clinical immersion program, and be included in future competing continuation (renewal) applications and as part of the Final Progress Report.

Dissemination Plan (Component of Research Education Program Plan)

A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc.

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies(GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.  There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modification: 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: 

The overarching  goal of this FOA is a biomedical engineering workforce able to design and translate  new devices and technologies to improve human health and well-being.  The FOA seeks to fund applications that propose to develop courses or programs that offer undergraduate students the opportunity to acquire valuable experience and skills in identifying and addressing open-ended problems and unmet needs in biomedical engineering and design while working in a team environment.  While new applications will be reviewed to judge their potential contribution to a competent biomedical engineering workforce in terms of the new courses and activities proposed,  existing programs will be judged specifically on the quality of the enhancements to their already existing activities.  

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance

Does the proposed research education program address an important problem or critical question in research education or other critical issues?  How will implementation of the proposed program advance the objectives of the proposed program?     

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program?  If Early Stage Investigator or New Investigator, or in the early stages of an independent career, does the PD/PI have appropriate experience to lead the program?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Do the PD/PI(s) have relevant experience in BME design and the teaching of BME design, especially with a team-based approach?  Are there sufficient numbers of qualified faculty and clinical/industrial advisors to provide design problems to students and guide them in designing and building effective solutions to these problems?  For programs that include a clinical immersion period, are there adequate clinical collaborators to supervise and mentor students?  

Innovation

Is the proposed research education program characterized by innovation and scholarship?  Does the proposed program challenge and seek to shift current research education paradigms or clinical practice, or address an innovative hypothesis or critical barrier to progress in the field?  Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area?  Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere?  Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.     

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  If called for, is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program?  Is there evidence that the program is based on sound research concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? Does the proposed course/program include a strong didactic component addressing design concepts and business, regulation, and ethical aspects relevant to taking a design idea from the bench to bedside?  Are the suggested design projects conducive to providing a rich and state-of-the-art design experience to the participants?  Are the methods for student team formation,  the needs assessment and project development by the teams or the assigning of projects to the teams, and the assigning of faculty advisors to the teams clearly described and reasonable?  For programs proposing a clinical immersion period, are the activities in this period well structured and likely to contribute to program goals?  Are the activities and outcomes of this period well-integrated with the main program? 

If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success?  Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed?  Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is there evidence of appropriate collaboration among participating programs, departments, and institutions?  If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? Are the research, laboratory and manufacturing facilities and environment conducive to providing trainees with appropriate experience to prepare them to develop state-of-the-art solutions to similar projects in their future careers?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Resubmissions

For Resubmissions, the 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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting and retaining individuals from diverse populations, including populations underrepresented in biomedical and behavior.

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the research education program, level of participant experience, and the particular circumstances of the participants, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g., lectures and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Do the plans ensure participants will receive instruction (or in the case of more senior level participants, provide instruction) for an appropriate amount of time given the length of the research education experience?  Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIBIB, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned  on the basis of established PHS referral guidelines  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted.Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Zeynep Erim, Ph.D. 
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: (301) 435-6686
Email: erimz@mail.nih.gov

Ralph Nitkin, Ph.D. 
Eunice K. Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 402-4206 
Email: RN21E@nih.gov

Peer Review Contact(s)

David T. George, Ph.D. 
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: (301) 496-8633
Email: georged@nih.gov .

Financial/Grants Management Contact(s)

Angela M. Eldridge 
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: (301) 451-4793  
Email: aeldridg@mail.nih.gov

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telehone: (301) 435-6975
Email: clarkb@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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