Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

Short-Term Research Education Program to Increase Diversity in Health-Related Research (R25 Clinical Trial Not Allowed)

Activity Code

R25 Education Projects

Announcement Type

Reissue of RFA-HL-16-008

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-19-024

Companion Funding Opportunity

None

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

93.233, 93.837, 93.838, 93.839, 93.840

Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.  The over-arching goal of this NHLBI R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce by providing research experiences and related opportunities that enrich the pool of individuals from nationally underrepresented groups who will be available to compete for research opportunities in the mission areas of importance to NHLBI.

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

Key Dates

 

Posted Date

May 1, 2018

Open Date (Earliest Submission Date)

August 10, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

September 10, 2018, February 26, 2019, September 10, 2019, February 26, 2020, September 10, 2020, February 26, 2021), by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)

September 10, 2018, May 8, 2019, September 10, 2019, May 8, 2020, September 10, 2020, May 6, 2021, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review

November 2018, August 2019, November 2019, August 2020, November 2020, August 2021

Advisory Council Review

January 2019, October 2019, January 2020, October 2020, January 2021, October 2021

Earliest Start Date

July 2019; December 2019; July 2020; December 2020; July 2021; December 2021  

Expiration Date

May 7, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 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 will not be reviewed


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 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 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 over-arching 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) enhance the diversity of the biomedical, behavioral and clinical research workforce; (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 over-arching goal of this  NHLBI   R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce by providing research experiences and related opportunities to undergraduate and health professional students from nationally underrepresented backgrounds as defined in Notice of NIH's Interest in Diversity, NOT-OD-18-129.        To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:   

    Research Experiences:

    • The objective of the NHLBI R25 program is to expose undergraduate and health professional students from underrepresented backgrounds in the biomedical and behavioral sciences to research  experiences and related opportunities in mission areas of the NHLBI.
    • For example, for undergraduate students: to provide hands-on exposure to research, to reinforce their intent to graduate with a science degree, and/or to prepare them for graduate school admissions and/or careers in research

    For graduate and medical, dental, nursing and other health professional students: to provide research experiences  and related educational opportunities; to become acquainted with the important role of health professionals in the biomedical research enterprise, and to enhance knowledge, interest, and entrance into basic biomedical, translational, or applied clinical research as a career   

    Overview and Long-term Program Goals

    NIH and NHLBI Interest in Diversity

    Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital. Enhancing diversity in the extramural scientific workforce is critical to the success of the NIH mission and is consistent with the mandates of the 21st Century Cures Act.

    Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds, particularly those from underrepresented groups, who will help to further NIH's mission.

    Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

    In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their postdoctorate and faculty populations to enhance the participation of NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as nationally underrepresented in the biomedical, clinical, behavioral and social sciences.  For more information, see NOT-OD-18-129.

           NHLBI and Health Disparities

    The NHLBI provides global leadership for research, training, and education programs to promote the prevention and treatment of cardiovascular, pulmonary, or hematologic diseases and sleep disorders and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI recognizes a critical need to address national and global health disparities that disproportionately burden racial and ethnic minorities, individuals with disabilities, and disadvantaged populations. The Institute also has a long history of supporting biomedical, behavioral, and clinical and social sciences research and training to address cardiovascular, lung, and blood diseases and sleep disorders in these communities. Significant progress has been made in health outcomes. Recent years have also brought improvements in health disparities, although racial and ethnic minorities still lag in many areas including overall life expectancy. The health disparity populations are more likely to suffer from a host of illnesses such as diabetes, heart disease, stroke, asthma, and kidney disease. Thus, the NHLBI remains committed to addressing health disparity gaps in areas critical to the NHLBI scientific mission.

    Cardiovascular disease and type 2 diabetes ranked first and sixth, respectively, among the leading causes of death and disability in the United States. Research indicates that African Americans and Latino/Hispanic-Americans have a higher risk of death and disability from heart disease and stroke than any other population group in the United States. African American men were 30 percent more likely to die from heart disease than non-Hispanic white males and compared with Whites, Mexican Americans experience higher rates of overweight and obesity, two of the leading risk factors for heart disease. African Americans, Hispanic/Latino Americans, American Indians, Alaska Natives, some Asian-Americans, Native Hawaiians and other Pacific Islanders are at particularly high risk for the development of type 2 diabetes. Diabetes (a risk factor for cardiovascular disease) prevalence rates among American Indians are two to five times those of Whites. On average, African American adults are 1.7 times as likely and Mexican-Americans and Puerto Ricans are twice as likely to have diabetes as non-Hispanic Whites of similar age. Overall, underserved communities are disproportionately affected by these chronic conditions and efforts are needed across the research spectrum to address these and other conditions. The NHLBI is committed to improving health for all through research, training, and education efforts that improve the Nation's capacity to address and eliminate health disparities relevant to cardiovascular, pulmonary, or hematologic diseases and sleep disorders.

    If the US population continues to grow at its current pace, nearly 50% of the 2050 US population will be from medically underserved, vulnerable populations. Given the substantial need for physicians, physician scientists and others to care for vulnerable populations, and to study diseases and conditions that disproportionately affect these groups, more efforts are needed to enhance the pipeline by exposing participants from traditionally underrepresented backgrounds to biomedical research and encourage them to consider careers in research and related fields. See, The Next Generation of Biomedical and Behavioral Sciences Researchers: Breaking Through (2018); Developing a National STEM Workforce Strategy (2016) and In the Nation's Compelling Interest: Ensuring Diversity in the Health-Care Workforce (2004).  An analysis of the NHLBI training programs (independent of diversity targeted programs) indicated that fewer than one-fifth of the NHLBI supported trainees came from any of these groups. Therefore, this R25 Program will provide short-term research opportunities that will promote diversity in the undergraduate and health professional participant populations. These research experiences will contribute to the pool of a future diverse research workforce to address cardiovascular, pulmonary, hematologic, and sleep disorders and conditions of interest to NHLBI. To help meet the goals of the program, the research opportunities should be of sufficient depth to enable the participants, upon completion of the program, to have a thorough exposure to the principles underlying the conduct of research, and help prepare participants interested in research to pursue competitive fellowships, or other research training or career development awards.

    See Section VI. Award Administration Information, 4. Evaluation for a list of the key metrics to be used to determine whether the program goals or outcomes have been met in a future evaluation.

    Areas of Research Education Supported

    The NHLBI is committed to providing research, education and training opportunities leading to research careers in areas relevant to cardiovascular, pulmonary, and hematologic diseases and sleep disorders for undergraduate and health professional participants from underrepresented backgrounds. The NHLBI also encourages training and research that crosses disciplinary boundaries (e.g., biophysics, biostatistics, bioinformatics, bioengineering, systems science, and big data science) to develop a new interdisciplinary workforce. Also of interest to NHLBI are research education efforts that focus on dissemination and implementation research, which recognize the numerous knowledge and practice gaps that impede uptake and spread of evidence-based interventions. Novel strategies are needed to disseminate and implement "real world" interventions that produce optimal health outcomes, particularly in underserved populations.

    The research education program proposed must be directly related to the mission of the NHLBI. The NHLBI supports basic, clinical, and translational research in cardiovascular, pulmonary, and hematologic diseases and sleep disorders. The NHLBI does not support projects primarily focused on malignancy-related research. Studies that address a mechanistic correlation between cancer (i.e., lung cancer) and primary pulmonary diseases may be considered within the mission of the NHLBI. Applications on vaccine development will be considered outside NHLBI's focused intent for this FOA. Applications on respiratory pathogens will be considered within NHLBI's intent for this FOA if studies focus on the host immune response. Other potential overlapping areas of interest shared by the NHLBI and other Institutes/Centers of the NIH include myeloproliferative and myelodysplastic disorders, hematological malignancies resulting from disruptions in hematopoiesis, and the use of hematopoietic stem cell transplantation and other cellular therapies. Applicants are strongly encouraged to contact the NHLBI program Scientific/Research staff before submitting an application to determine the NHLBI programmatic appropriateness for this FOA and the mission of the NHLBI.

    Applications that do not meet these requirements will be considered non-responsive.

    Research education program grant applications submitted in response to this FOA should be characterized by innovation, scholarship, and both individual and group-focused research experiences in relation to the mission of the NHLBI.

    Institutions choosing to submit applications for the September receipt dates are advised that the program should ideally be prepared to start in June for the following year.

    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
    Renewal
    Resubmission

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

    Clinical Trial?

    Not Allowed: Accepting applications that do not propose clinical trial(s)

    Note: Appointed Participants are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

    Need help determining whether you are doing a clinical trial?

    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.

    NHLBI intends to commit $13,495,000 in FY2019 through FY2025 to fund up to 7 new awards in each of the following FYs: FY2019, FY2020, and FY2021.

    Award Budget

    Application budgets should not exceed $119,000 per year in direct costs. However, applications should reflect the actual needs of the proposed project.

    Award Project Period

    Applications may request a maximum project period of five 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).

    Support may be requested up to $2,000 per month total to administer the participants' two to three months research program experience. The maximum allowable expense of $6,000 cannot be exceeded for a 3-month training program per year. The amount requested may be divided among the PD(s)/PI(s), or multiple PD(s)/PI(s), if applicable, and other personnel (clerical, administrative staff). Funds may not be requested for the mentors.

    Participant Costs

    Participants may be paid if specifically required for the proposed research education program and 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.

    Undergraduate Students: The salary and fringe benefits for an undergraduate participant should be consistent with the institutional salary policies for employees in similar positions. Institutional rates for undergraduate salaries should be no more than $12 per hour plus Fringe Benefits, only when such benefits are provided to other employees in similar positions. An additional amount of $2,400 per participant for supplies, per diem (including housing) and travel (scientific meeting and/or to and from grantee institution) may also be requested. Funds may not be used to purchase any equipment, except to accommodate individuals with disabilities, as described below.

    Health Professional Student Participants: The NIH will provide compensation that: (1) conforms to the established, consistently applied salary and wage policies of the institution; and (2) reflects the percentage of time devoted to the PHS-funded project.

    For health professional student participants this compensation may include salary, fringe benefits, and tuition (if applicable) not to exceed current stipend level 0 at time of submission (see: NOT-OD-17-003). Additional funds up to $4,000 per participant for supplies, per diem (including housing) and travel (scientific meetings and/or to and from grantee institution) may also be requested. Funds may not be used to purchase any equipment.

    Reasonable Accommodations for Individuals with Disabilities:

    As part of this award, funds may be requested to make changes or adjustments in the research setting that will make it possible for an otherwise qualified participant with a disability to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided include specialized equipment, assistive devices and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations must be reasonable and documentation of the disability should be included when a request for additional funds is made post-award. These additional funds are in excess of the expenses allowed under "Participation Costs" above.

    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.  

    Awardee Meeting. Upon initiation of the program, the NHLBI will hold one 2-day meeting during the project period to encourage the exchange of information among the PD(s)/PI(s) that lead diversity- focused research education, training, and career development programs. Therefore, in the preparation of the budget for the grant application, the PD(s)/PI(s) should allocate staff travel for no more than two staff to attend one 2-day meeting during the third project year only to be held in or near Bethesda, MD. At these meetings, PD(s)/PI(s) will present their research program, share progress, and discuss next career steps for participants. The meeting may also include other Training Directors who are preparing participants for independent research careers.

    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 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)
    • Eligible Agencies of the Federal Government
    • 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) (formerly CCR) – 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.  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 (see NOT-OD-11-101).
    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 must have successfully completed at least one undergraduate year at an accredited school or university (including baccalaureate schools of nursing) or have successfully completed at least one quarter or semester at an accredited school of medicine, optometry, osteopathy, dentistry, veterinary medicine, pharmacy, allied health professions, public health, or other accredited health professional schools. Each undergraduate or health professional student must be actively enrolled in an accredited school or university to be eligible for participation.

    Eligible participants in this program must meet diversity eligibility requirements.

    Enhancing Diversity

    The overarching goal of this R25 program is to enhance the diversity of the biomedical, behavioral and clinical research workforce by providing research experiences and related opportunities to undergraduate and health professional students from nationally underrepresented backgrounds as defined in Notice of NIH's Interest in Diversity, NOT-OD-18-129.  Eligible participants include:

    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 report 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: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.  In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program.  For more information on racial and ethnic categories and definitions, see NOT-OD-15-089.

    B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended.  See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

    C. Individuals from disadvantaged backgrounds, 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 and are published by the U.S. Bureau of         the Census; are 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 http://aspe.hhs.gov/poverty/index.shtml.

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

    The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

    Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields (see Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics).

    A participant may be appointed for a minimum of two months and a maximum of six months during a budget period; however, the standard appointment length is three months. Where appropriate, institutions are encouraged to appoint a participant for more than one budget period, i.e., two or more successive summer research experiences. A participant may be appointed, in special circumstances, to more than one three-month period during a budget period, provided prior approval is obtained from the staff of the NHLBI. All research education must be full-time during the specific appointment. It is expected that most programs will be designed to provide a summer research experience, but other innovative program designs and time schedules will be considered.

    Participants appointed to the program do not have to be from the applicant institution.

    The only requirement for participant selection is that they fulfill the referenced eligibility requirements.

    The grantee institution will be responsible for the selection and appointment of participants.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms 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 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.

    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:

    • 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:

    Director, Office of Scientific Review
    Division of Extramural Research Activities
    National Heart, Lung, and Blood Institute
    Telephone: 301- 435-0270
    Email: nhlbichiefreviewbranch@nhlbi.nih.gov

    Page Limitations

    All page limitations described in the SF424 (R&R) 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.

    Advisory Committee: Although an Advisory Committee is not a required component of a Research Education program, it may be helpful in structuring and/or evaluating the program. 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 only if they have already been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Name the PDF formatted file "Advisory_Committee.pdf".

    Data Tables: Tables should be included to show: (a) participating faculty members (including their sources of support and records in research training and research education), (b) research support of participating faculty members , and for applicants with a previous history of funding for research education in diverse populations, (c) information about past participants and their subsequent activities. For this purpose, the following Data Tables should be used: Data Tables 2 and 4.  Renewal applications should also include the Trainee Diversity Report along with tables 5A and 8A (health professional participant programs) and/or 5C and 8D (undergraduate participant programs) to reflect past participant outcomes. These tables are not subject to a page limit. They should be compiled as a single pdf file and saved as "Data_Tables.pdf". Data tables are available here:  https://grants.nih.gov/grants/forms/data-tables.htm.

    Additional tables beyond those recommended may be included in the Research Education Program Plan PHS 398 Research Plan; however, these tables will count as part of the page limit for the attachment.

    Participating Faculty Biosketches: Combine all participating faculty biosketches into a single PDF and attach this information here. Faculty biosketches for participating faculty must follow the instructions for a biographical sketch (refer to Biosketch Format Pages, Instructions and Samples) with the following exception: a personal statement, while encouraged, is not required. Please note that the biosketches of the PD/PI and any other senior/key personnel (e.g., co-directors, if applicable, and program staff) should not be included here but they should instead be included in the R&R Senior/Key Person Profile (Expanded) Form.

    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. Indicate the effort commitment of the PD(s)/PI(s). Provide evidence that the PD(s)/PI(s) are appropriately trained and well-suited to the proposed research education program and have the appropriate experience to lead the program. Provide evidence that the qualifications, dedication, and previous participant training record of the PD(s)/PI(s) and all participating faculty, particularly with regard to prior experience with similar programs, is appropriate for the participants' needs.

    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.
    • 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 Component

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

    Research Strategy

    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
    • 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. The description should include the educational and/or career level(s) of the planned participants. The overall strategy, methodology, and analyses should be well-reasoned and appropriate to accomplish the specific aims of the proposed research education program. The proposed program must provide experiences in state-of-the-art approaches to address cardiovascular, pulmonary, or hematologic diseases or sleep disorders. The application should provide a summary of the research program including its objectives, the types of research activities available, and a mentoring plan. Also provide plans for assigning participants to research activities, duration of research training and months in which training will occur, and a description of a typical program including percent time to be spent in various activities. Describe how the proposed program will ensure that participants will be prepared for successful and productive scientific careers. Include benchmarks for success and alternative strategies for potential problems that could affect success of the proposed research program. Describe how implementation of the proposed program will advance the objectives of the proposed program. If the program is innovative or in the early stages of development, describe how effectiveness will be monitored and managed and how the overall goals and objectives of the proposed program will be met. 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. Describe how the proposed research education program is characterized by innovation and scholarship.          

    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.           

    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.  The applicant institution must have the requisite staff to carry out the proposed program. 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. Provide evidence that the collaborators and other researchers are appropriately trained and well-suited to the proposed research education program.      

    Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.  Provide details about the pool of expected participants, their qualifications, recruitment strategies, and sources of applicant pool. The requested number of short-term participants must be justified in the application.     

    Institutional Environment and Commitment. 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 (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.  The applicant institution must have a strong research program in the areas of cardiovascular, pulmonary, or hematologic diseases or sleep disorders, and must have the available research facilities, personnel, and support for the research area(s) proposed. If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified in terms of the research education experiences that will be provided, and adequate plans must be provided for coordination and communication between the multiple sites.    

    Recruitment Plan to Enhance Diversity:

    The overarching goal of this R25 program is to enhance the diversity of the biomedical, behavioral and clinical research workforce by providing research experiences and related opportunities to undergraduate and health professional students from nationally underrepresented backgrounds as defined in Notice of NIH's Interest in Diversity, NOT-OD-18-129.  New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds 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, including successful and unsuccessful recruitment strategies.  Information should be included on how the proposed plan reflects the program's past experiences in recruiting individuals from underrepresented groups.

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

    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, with the following modification:

    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 all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

    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. The one-page limit for post submission materials (beyond citations, budgets, and biographical sketches) will be the same as that which is allowed for Institutional Training and Training-related grant applications (T32, T34, etc.)

    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, behavioral, and clinical research 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 enhance the diversity of the biomedical, behavioral and clinical research workforce by providing research experiences and related opportunities to undergraduate and health professional students.

    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?

    Specific to this FOA

    What important problem or critical question in research education does the proposed research education program address? How will implementation of the proposed program advance the proposed objectives? How likely is the proposed program to ensure that participants will be prepared for successful and productive scientific careers and therefore contribute to a diverse research workforce?  What types of research experiences are provided in inter- or multi-disciplinary research and/or opportunities in state-of-the-art or novel methodologies and techniques to address cardiovascular, pulmonary, or hematologic diseases or sleep disorders?

    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?

    Specific to this FOA

    What evidence shows that the PD(s)/PI(s) have appropriate experience to lead the program? Are the qualifications, dedication, and previous participant training record of the PD(s)/PI(s) and all participating faculty, particularly with regard to prior experience with similar programs, appropriate for the participants' needs?

    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?

    Specific to this FOA

    How innovative is the proposed research education program, and what is the evidence for scholarship?  How 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? What evidence is there of novelty in the proposed concepts, approaches, methodologies, tools, or technologies for this area? How has the application distinguished the activities in the proposed research education program from other ongoing programs in the same department?

    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?

    Specific to this FOA

    How appropriate and well-reasoned are the overall strategy, methodology, and analyses to accomplish the specific aims of the proposed research education program? How well are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the overall goals and objectives of the proposed program be met? What evidence is provided to show that the program is based on sound research concepts and educational principles? How feasible and appropriate is the approach to achieve the stated research education goals? If an Advisory Committee is planned, are its composition and role appropriate to the program?

    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?

    Specific to this FOA

    To what extent are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed? How will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? If multiple sites are participating, how adequate is the justification of additional sites in terms of the research education experiences provided? How adequate are plans 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 six 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 six 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 Children 

    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 children 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.

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis. Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program's evaluation? Has the research education program successfully achieved its stated objectives during the prior project period? Has the research education program successfully recruited a diverse pool of participants (if applicable)? Has the PD/PI effectively shaped the recruitment plan in response to recruitment outcomes? Has the program been innovative in the past and does it continue to demonstrate innovation? Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program's evaluation?  

    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 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 individuals 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. If this is a renewal, is there a report describing past instruction in the five components described above? 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 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) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing 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 NHLBI, 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:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • 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 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 NHLBI National Advisory Council. 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 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 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.

    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.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 "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, awardees 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 Training Diversity Report, in accordance with the RPPR Instruction Guide.  

    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.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions 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. Grantees 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.
    • The Progress Report should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, updates on the evaluation of the research education program and the evaluation metrics described in Section VI.4., and a list of any publications and/or other materials arising from the research education program. Include a paragraph or table that describes the research project of each trainee and his/her mentor's name.

    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 NHLBI expects to use the following evaluation measures:

    For Research Experience and Mentoring Programs Involving the Following Groups:

    Undergraduate Students:

    • Participation in oral or poster presentations during their research experience
    • Aggregate number and demographic characteristics of participants
    • Subsequent educational/career progress, including:

    o  Returning to the program for more than one summer experience

    o  Successful completion of an undergraduate degree in a STEM field

    o  Applying for competitive fellowships for graduate school or other advanced degrees

    o  Enrollment in an advanced degree program in a STEM field

    • Subsequent participation in research or employment in a STEM field

    Health Professional Students:

    • Participation in oral or poster presentations during their research experience
    • Aggregate number and demographic characteristics of participants
    • Subsequent educational/career progress of participants, including:

    o  Returning to the program for more than one summer experience

    o  Successful completion of a STEM graduate program

    o  Subsequent participation in a formal research training or career development program in a STEM field

    • Subsequent participation in research
    • Applying for competitive fellowships for graduate school or other advanced training
    • Subsequent employment in a research or research-related field
    • Subsequent authorship of scientific publications in a STEM field
    • Subsequent independent research grant support from NIH or another source
    • Subsequent participation in research or employment in a STEM field
    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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

    Scientific/Research Contact(s)

    Xenia Tigno, Ph.D.
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0202
    Email: xenia.tigno@nih.gov

    Helen Hunter Cox, M.H.S.
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-827-8163
    Email: helen.cox@nih.gov

    Peer Review Contact(s)

    Director, Office of Scientific Review
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0270
    Email: nhlbichiefreviewbranch@nhlbi.nih.gov

    Financial/Grants Management Contact(s)

    Mykle Lyons
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-827-8043
    Email: mykle.lyons@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.

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