Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Eye Institute (NEI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Aging ( NIA )

National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title
BRAIN Initiative-Related Research Education: Short Courses (R25 Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type
New
Related Notices

January 11, 2022 - Notice of Participation of the National Institute on Aging (NIA) in RFA-EY-21-003. See Notice NOT-AG-22-008.

NOT-OD-19-109 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020

NOT-MH-19-010 - Notice of Data Sharing Policy for the BRAIN Initiative

NOT-OD-22-018 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available

NOT-OD-21-181 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients

NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022

NOT-OD-21-170 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

Funding Opportunity Announcement (FOA) Number
RFA-EY-21-003
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.867, 93.173, 93.213, 93.853, 93.273, 93.279, 93.242, 93.865, 93.286, 93.866
Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.  The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

  • Courses for Skills Development

The purpose of this FOA is to encourage applications for the continuation of ongoing and creation of new courses for skills development that will significantly advance the educational goals of the BRAIN Initiative as described in The BRAIN Initiative®2.0: From Cells to Circuits, Toward Cures including neuroethics and opportunities to increase the workforce diversity in BRAIN Initiative research areas. Proposed programs are expected to offer hands-on research experiences, an in-depth conceptual understanding of the techniques and tools employed, and the knowledge to apply appropriate analytic approaches to the resulting data. Participants are limited to graduate/medical students, medical residents, postdoctoral scholars, and/or early-career faculty with an emphasis on diversity as defined by NIH (NOT-OD-20-031). Proposed programs will facilitate the development of a sophisticated cadre of future investigators with the knowledge and skills to apply BRAIN Initiative techniques and approaches and data resources to research questions about brain function and behavior. Programs appropriate for this FOA must include participants from a regionally/nationally recruited cohort.

Key Dates

Posted Date
December 13, 2021
Open Date (Earliest Submission Date)
December 15, 2021
Letter of Intent Due Date(s)

January 15, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
February 15, 2022 February 15, 2022 Not Applicable July 2022 October 2022 December 2022
February 15, 2023 February 15, 2023 Not Applicable July 2023 October 2023 December 2023
February 15, 2024 February 15, 2024 Not Applicable July 2024 October 2024 December 2024

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
February 16, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

Courses for Skills Development: Applications will propose to develop, implement, and evaluate creative and innovative short courses that will provide education in state-of-the-art research skills (e.g., tools, techniques, approaches, data analysis and integration) that are foundational to the objectives of the BRAIN Initiative, as described in The BRAIN Initiative®2.0: From Cells to Circuits, Toward Cures , including neuroethics. Courses should enable the acquisition of specific research skills and knowledge by individuals in the formative stages of their research careers, to ensure that the next generation of research scientists has the appropriate expertise to advance the BRAIN Initiative. The program approaches and activities should be implemented and evaluated with the goal of disseminating the outcomes for the benefit of the larger BRAIN Initiative community.

Each proposed program is expected to have a conceptual and/or technical focus, but all programs will share some common features with the goal of facilitating the development of a sophisticated cadre of future investigators with knowledge of, and the skills to apply, BRAIN Initiative techniques and approaches to research questions about brain function and behavior.

Course duration, the frequency it is offered, and the proposed approach will be guided by the need for the course and the course objectives. Program leaders and faculty should be nationally regarded as leaders in the topic to which they are contributing and should have a strong reputation as educators in their field. Proposed research education programs are expected to be designed for, and available to, a regional and/or national audience.

  • This FOA is not intended to support informational courses that lack concrete, practical experience related to the conduct of research, including continuing medical education courses for physicians or other health professionals, nor is it intended to support the programs with mentoring as the predominant goal. Research education programs submitted to this FOA must also be distinct from educational opportunities that typically occur in conjunction with research conferences.
  • This FOA is a research education funding opportunity from the BRAIN Initiative that shares the goal of augmenting the education and training of the scientific workforce to meet the nation's workforce needs in BRAIN Initiative priority areas. This funding opportunity offers support for 1) ongoing short courses for skills development (this FOA); and 2) design and implementation of new short courses for skills development and research experiences. Applicants are strongly encouraged to discuss potential programs with BRAIN Initiative Program staff (see Section VII for Contacts).

Background - The BRAIN Initiative®

The BRAIN Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat and prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, The BRAIN Initiative®2.0: From Cells to Circuits, Toward Cures which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This FOA and other recently issued FOAs are based on careful consideration by the NIH of the recommendations of the "The BRAIN Initiative®2.0: From Cells to Circuits, Toward Cures report, and input from the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-council Working Group are available at http://www.braininitiative.nih.gov/about/mcwg.htm.

In addition to the National BRAIN Initiative, the NIH continues to have a substantial annual investment in neuroscience research and research training/education. The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov/) support those research and research training/education efforts through investigator-initiated applications as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact Scientific/Program staff if they have any questions about the best FOA for their research education program.

To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from statistics, physics, mathematics, engineering, and computer and information sciences; and NIH welcomes applications from investigators in these disciplines.

NIH encourages BRAIN Initiative applications from investigators who are underrepresented in the biomedical, behavioral, or clinical research workforce (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). Such individuals include those from underrepresented racial and ethnic groups and those with disabilities.

NIH encourages BRAIN Initiative applications from investigators who are underrepresented in the biomedical, behavioral, or clinical research workforce (see NSF data) and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering. Such individuals include those from underrepresented racial and ethnic groups, individuals with disabilities, and those from disadvantaged backgrounds (NOT-OD-20-031).

Education to Advance the BRAIN Initiative

  • According to the long-term scientific plan of the BRAIN Initiative, "training mechanisms will be required to successfully deploy the tools, technologies, and methods developed under the BRAIN Initiative to the neuroscience community…" and "[m]ini-courses in new technologies represent a way to bring an entire community of users up to a high level of understanding—and productivity—in a short period of time” (BRAIN 2025, p. 48). Thus, targeted research education programs can be invaluable to assuring wide dissemination of the skills and knowledge associated with developing and using tools and methods relevant to the research goals of the BRAIN Initiative.
  • A major goal of the BRAIN Initiative is to attract new investigators to neuroscience from quantitative disciplines such as computer science, mathematics, physics, statistics, materials science, and engineering. Not only do educational short courses provide an effective approach to bring the scientific community up to a high level of understanding and productivity in a short period of time, but they also provide an excellent opportunity for cross-training of participants and facilitating potential collaborations among individuals from diverse scientific backgrounds. As such, plans to recruit participants with these diverse scientific backgrounds to the proposed short courses are strongly encouraged.
  • The BRAIN Initiative seeks to promote diversity in all supported programs and to enhance the participation of individuals from underrepresented groups in BRAIN Initiative-funded awards. BRAIN Initiative research training and educational programs are expected to increase the scientific and technical expertise of individuals who are nationally underrepresented in the priority areas of the BRAIN Initiative.

Objectives

This FOA will support short courses, from an introductory to an advanced level for regionally/nationally recruited participants. These short courses must address one or more of the specific goals of the BRAIN Initiative, as described in the planning document The BRAIN Initiative®2.0: From Cells to Circuits, Toward Cures.

Content areas of interest include but are not limited to:

  • Methods, analytical approaches and tools for multi-modal data analysis, integration, and visualization (e.g., -omics, functional and anatomical imaging, electrophysiology, chronic recordings, optogenetics)
  • Methods and tools for data science (e.g. data harmonization, data or metadata standards, data ingest and data archiving)
  • Methods, tools, and approaches in quantitative computational neuroscience
  • Neuroethical considerations related to the development and/or application of neuroprosthetic technologies
  • Neuroethical considerations related to the development and/or application of opto- and chemo-genetic-based approaches to modulate brain circuit function
  • Translation of new technologies into medical devices for therapeutic and diagnostic applications
  • Methods for data access, query, download and analysis using BRAIN Initiative data archives
  • An introduction to neural modeling programs (e.g., NEURON, mCELL, GENESIS) or computer programming languages used to model brain signals
  • Methods to apply cell- and circuit-specific tools to monitor and manipulate brain activity (e.g., transynaptic tracing, non-invasive gene delivery, cell-specific pharmacology, single-cell analysis techniques, correlating activity with gene expression)
  • Use of next-generation recording, stimulating and imaging tools

This FOA is intended for participants who are graduate students, medical students, postdoctoral scholars, medical residents, and/or early-career faculty.

It is expected that all programs will foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, women, and individuals from disadvantaged backgrounds.

 

Short course duration and frequency will be guided by the need for, and the stated goals of, the proposed short course.

Research Experiences Requirements: Programs are expected to provide research educational experiences that enable mastery of advanced research skills and expert knowledge, supported by nationally and internationally recognized faculty. Generally, programs should be focused on intensive hands-on research activities, with in-depth and practical experience of techniques and analytic approaches. Immersive coursework and extensive discussion may also be critical programmatic components.

While the proposed research education program may complement ongoing research training and education occurring at the applicant institution (or elsewhere nationally or internationally), 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/institution, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. In some cases a new research education program may be proposed in the context of an existing course or activity to enhance its relevance to the BRAIN Initiative, for example to incorporate new technologies, approaches or expertise, or to broaden the trainee base. Such cases are welcome but funding should be timed to coincide with existing support.

Educational programs in all areas identified as priorities in The BRAIN Initiative®2.0: From Cells to Circuits, Toward Cures will be considered. Programs must provide a critical educational experience not already available to sufficient numbers of participants. Programs are expected to bring together national and international leaders in a field, or multiple fields, to provide intellectual, technical, theoretical and practical knowledge to trainees, to promote the conduct of cutting-edge scientific inquiry.

In general, programs submitted to this FOA are expected to focus on practical, hands-on activities, integrated with activities to provide an understanding of theoretical aspects of the subject. In all cases, programs should instill in the participants a keen understanding of the principles of rigorous study design and transparent reporting.

All participants should be thoroughly educated in fundamental concepts of experimental design and analysis, and scientific rigor (for details, see NOT-OD-15-103 and the guidance and resources in the NIH Rigor and Reproducibility statement).

Proposed programs should have clear practical content, with an expectation that participants will leave the program with a strong, working knowledge of the subject matter. Thus, faculty should have strong technical expertise, and be practitioners of cutting-edge research related to the programmatic subject.

The principles underlying rigorous and reproducible research and practical consideration of these issues are expected to be incorporated into a proposed short course. Participants should obtain a strong understanding of the requirements of experimental rigor and how to build such processes into their research projects. Courses should incorporate education study design, statistics and analytic techniques appropriate to the content and duration of the proposed course.

Research education programs are intended to be novel and innovative, and be designed to accomplish a specific goal. Consequently, they require a well-conceived evaluation plan in order to determine their effectiveness. Each application must include a detailed plan to evaluate the effectiveness of the activities proposed (see Section IV, Evaluation Plan). For many programs, a plan for disseminating materials and results of the program may be appropriate (see Section IV, Dissemination Plan).

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

See Section VIII. Other Information for award authorities and regulations.

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
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit an estimated $1.5 million to fund 5-8 awards.

Award Budget

Application budgets are limited to a maximum of $250,000 direct cost per year and are expected to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years

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 participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).

Personnel costs may not exceed 25% of the total direct costs in any year. Costs to support the Course Director(s) are considered Personnel costs.

Participant Costs

Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.

Expenses for foreign travel must be exceptionally well justified.

Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

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.

Consultant costs may not be used to substitute for Personnel costs.

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, expenditures for equipment and consortium costs in excess of $25,000), 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 from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession


Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

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 federal 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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review.

Program Faculty

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

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents.

Participants are limited to undergraduate/graduate/medical students, medical residents, postdoctoral scholars, and/or early career faculty.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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 will not be reviewed.

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:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Neeraj Agarwal, PhD

Telephone: 301-435-8155
Email: agarwalnee@nei.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional 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.

Other Attachments.

An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted.

A description of the relationship of the proposed Research Education Program to the BRAIN Initiative is a required component. Attach a one-page description of the relationship of the proposed Research Training Plan to one or more of the specific goals stated in the The BRAIN Initiative®2.0: From Cells to Circuits, Toward Cures Report including neuroethics. The first sentence of this description should state which of the seven, high-priority goals enumerated in this Report is addressed by your Research Education Program. Name this file: BRAIN_Relationship.pdf".

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

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

Follow all instructions provided in the SF424 (R&R) Application Guide.

Biographical Sketches for the PD/PI and Faculty should include, as part of the Personal Statement, a description of technical expertise relevant to the proposed course content and of prior exerience as an educator.

R&R Budget

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

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Personnel costs may not exceed 25% of the total direct costs in any year. Consultant costs may not be used to substitute for Personnel costs. Costs to support the Course Director(s) are considered Personnel costs.
  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application Guide.

PHS 398 Research Plan

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

Research Strategy

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
  • Program Director/Principal Investigator
  • Program Faculty
  • Program Participants
  • Institutional Environment and Commitment
  • Diversity Recruitment Plan
  • Plan for Instruction in the Responsible Conduct of Research
  • Evaluation Plan
  • Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. 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 distinguish between the activities in the proposed research education program and the research training supported by the training program.

In some cases a new research education program may be proposed in the context of an existing course or activity to enhance its relevance to the BRAIN Initiative, for example to incorporate new technologies, approaches or expertise, or to broaden the trainee base. Such cases are welcome but funding should be timed to coincide with existing support.

The research education program should be described in detail. The proposed plan should include a clearly stated goal of the program, a detailed course syllabus, and describe how completion of the agenda will achieve the goal(s) of the program. The application should justify the frequency of program offering and size of participant pool that would be expected to benefit from the program.

The application should describe in detail the educational activities that form the fundamental basis by which the program will provide research experience, in depth and practical understanding of techniques and analytic approaches, and expertise that is only possible with a nationally organized program overseen by a nationally and internationally recognized faculty. The application should describe immersive coursework and any other activities that will be integrated into the research education program in order to provide deep and broad expertise in the subject material. This description should include timelines and durations of activities.

The application should describe why a program, as proposed, is needed. The application should explain why the described program is critical to the goals of the BRAIN Initiative, what are the advantages of creating a national program to achieve the program's goals, and what the program will help achieve that would be less likely to be achieved without the proposed program.

The program should adequately address issues of transparency and rigor, as described in the NIH guidance on rigor and reproducibility in grant applications: https://grants.nih.gov/reproducibility/index.htm and in related materials: https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/RigorAndReproducibility).

The application should describe how it will instill in participants an understanding of the relevant principles of rigorous study design.

Program Director/Principal Investigator. Describe arrangements for administration of the program.  Provide evidence that the Program Director/Principal Investigator 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. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Provide evidence that the short course PD/PI has experience as a mentor and educator, and is actively engaged in research or other scholarly activity relevant to the goals of the proposed short course. If the PD/PI is not actively engaged in research and/or teaching, describe the qualifications of the PD/PI that make him/her an appropriate individual to lead this program. In addition, if the PD/PI is not an active researcher in the scientific area of the program, describe who will provide scientific leadership and how the scientific and administrative leaders will collaborate to create a successful program.

Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. Describe the research expertise, teaching credentials and experience in the practical content of the research education program of the faculty. If different faculty have different roles in the program, this should be described in detail, as should the rationale for selection of each faculty member and the cohort of faculty members as a whole. The application should describe explicitly who will be responsible for development of educational activities, including hands-on research experiences and coursework.

If the faculty is to be recruited from a national and/or international cohort of experts, the application should describe what expertise is needed for the program and why convening these experts is the best approach for implementation of an outstanding program. Alternatively, if the program will rely upon only local faculty, the application should make clear how this local faculty pool has both the breadth and depth of cutting-edge knowledge appropriate for the proposed program.

Program Participants. Applications must identify the career levels for which the proposed program is planned. If participants will include scientists at different career levels, the expected distribution should be described. Describe the number of anticipated participants in each offering of the course. Provide details about the pool of expected participants including their qualifications, and the sources of this pool from a regionally/nationally recruited cohort. Describe plans for announcing the short course, and strategies for recruiting participants and for recruitment of a sufficient applicant pool that is largely U.S. citizens and permanent residents. Describe application procedures, and criteria for selection of participants including information about plans to recruit and select participants whose research interests relate to one or more goals of the BRAIN Initiative.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under “Facilities & Other Resources” or the required “Institutional Commitment Letter of Support,” described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

If multiple institutions are participating in a single application, they should all be clearly involved in the planning, implementation, and assessment of the program, and should all provide appropriate documentation of institutional commitment.

Recruitment Plan to Enhance Diversity  (NOT-OD-20-031):

The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g. those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

Applications lacking a diversity recruitment plan will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. See also  NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to 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.

Evaluation 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 and to provide suggestions for improvements.

Dissemination 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., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: ”Institutional Environment and Commitment."

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

  • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. The BRAIN Initiative has published a guide notice in reference to data sharing (NOT-MH-19-010). Data sharing plans must reflect the guidance in this notice. The Resource Sharing Plan should outline how all the data and tool deliverables from this FOA (e.g. algorithms, theories, models, methods, software, technology, constructs, transgenic lines, etc.) will be shared and disseminated. Project-specific details will be established at the time of award. Budgets should include sufficient resources to prepare and disseminate data.

When relevant, 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:

  • Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date 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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The goal of this R25 program is to support educational activities that provide education in state-of-the-art research skills related to one or more of the goals of the BRAIN Initiative predominantly for U.S. citizens/permanent residents. Applications should be characterized by innovation, scholarship, and documentation of a strong need in the research community for the proposed short course.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, 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 program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? 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?

If the PD/PI is not an established investigator in the scientific area proposed, is there an appropriate plan for a qualified individual to provide outstanding scientific leadership, and a plan for how the scientific and administrative leaders will collaborate for a successful program? Is there appropriate representation of women and individuals from diverse groups among program leadership and faculty? Is the caliber of the faculty, in terms of their research interests, expertise, and teaching experience in the area of the proposed course, appropriate for their roles on the project?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

Does the proposed program duplicate, or overlap with, existing research education activities currently supported at the applicant institution or available elsewhere? Does the organization of the program, taking into account the agenda, skills and knowledge provided, and proposed faculty, provide an innovative approach and/or unique opportunity for participants to master a research area or a set of skills?

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome?  Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program?  If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Are the course content and syllabus appropriate for the course objectives? Is there an appropriate balance between didactic and hands-on education? Are data rigor and quantitative reasoning appropriately integrated into the proposed program? Is the course duration sufficient to accomplish the course objectives? Is sufficient interaction planned between faculty and participants? Is the level of individual attention appropriate to accomplish the course objectives? Are potential problems, alternative strategies, and benchmarks for success presented? Is there adequate description of the sources of the pool of expected participants and their qualifications? Are the stated plans for announcing and advertising the course, recruiting participants, application procedures, and criteria for evaluation and selection of participants appropriate? Is there a well-defined plan to disseminate user-friendly course materials to the broader scientific community? Is the approach to participant selection likely to produce a cohort that is appropriately prepared for the program, fairly selected and appropriately diverse with respect to gender, individuals from underrepresented groups, geography and home institutions? Is the primary focus of the proposed program on intensive activities that will provide research experience, an in depth and practical understanding of techniques, analytic approaches, and expertise that is only possible with a program overseen by a nationally recognized faculty? Will the program instill attention to principles of rigorous study design and transparent reporting? Will the hands-on and/or didactic and discussion-based activities, provide participants with a mastery of the targeted research area, subject matter and relevant experimental design? Are the timeline and duration of the proposed program adequate and appropriate to accomplish the goals of the program? Is the proposed plan for evaluation likely to provide valuable information for evolution and improvement of the program? Does the program appropriately address scientific rigor and transparency? Does the applicant provide an appropriate plan for sharing data?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants?  Where appropriate, is there evidence of collaboration and buy-in 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)?

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

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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.

Revisions

Not Applicable.

Renewals

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 Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans 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 proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years.  See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans 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

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

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) Sharing Model Organisms; and 2) Genomic Data Sharing Plan.

If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

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 NEI, 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 will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 submitted in response to this FOA. 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:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to: 

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) 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 Trainee Diversity Report, in accordance with the RPPR Instruction Guide.

NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

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 recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Failure by the recipient 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.

In accordance with the regulatory requirements 45 CFR Part 75 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75.113 and 2 CFR Part 200.113, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

 

Other Reporting Requirements

  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  • Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

A final RPPR 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 or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below.  In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves.  Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program, the following evaluation measures are expected to be utilized:

For Courses for Skills Development:

  • Aggregate number and demographic characteristics of participants
  • Educational level of participants
  • Content
  • Participants’ feedback on the program
  • New knowledge or skills acquired

For Programs Focusing on Curriculum or Methods Development:

  • Aggregate number and demographic characteristics of participants exposed to the new curricula or methods
  • General educational level of participants
  • Effectiveness of the new curricula or methods assessed by skills/competencies gained compared to existing curricula or methods
  • Dissemination and/or adoption of the new curricula or methods

For Program Focusing on Research Experiences

  • Aggregate number and demographic characteristics of participants exposed to the new research area
  • General educational level of participants
  • Participants’ feedback on the program
  • New research knowledge acquired

 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Scientific/Research Contact(s)

Erin Burke Quinlan, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: (301) 451-0636
Email: erin.quinlan@nih.gov

Neeraj Agarwal, PhD
National Eye Institute
Telephone: 301-435-8155
Email: agarwalnee@nei.nih.gov

Lisa Opanashuk, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-5422
Email: lisa.opanashuk@nih.gov

Peer Review Contact(s)

Brian Hoshaw, PhD
National Eye Institute
Telephone: 301-451-2020
Email: hoshawb@mail.nih.gov

Financial/Grants Management Contact(s)

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Karen Robinson-Smith
National Eye Institute
Telephone: 301-435-8178
Email: kyr@nei.nih.gov

Jeni Smits
National Institute on Aging (NIA)
Phone: 301-827-4020
Email: jeni.smits@nih.gov

Jeni Smits
National Institute on Aging (NIA)
Phone: 301-827-4020
Email: jeni.smits@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 Part 75 and 2 CFR Part 200.

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