Part 1. Overview Information

Key Dates

No late applications will be accepted for this Funding Opportunity Announcement.

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.

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 goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

The National Heart, Lung, and Blood Institute (NHLBI), part of the NIH, provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases, and sleep disorders and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI expects efforts to diversify the workforce to lead to the recruitment of researchers from all groups, improve the quality of the educational and training environment, balance and broaden the perspective in setting research priorities, improve the ability to recruit subjects from diverse backgrounds into clinical research protocols, and improve the Nation's capacity to address and eliminate health disparities.

The overarching goal of this National Heart, Lung, and Blood Institute (NHLBI) R25 program is to support mentoring and research education activities that enhance the diversity of the biomedical, behavioral and clinical research workforce. The major goal of this R25 program is to establish long-term mentoring that will enable junior faculty and transitioning postdoctoral students from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences (see, e.g., NOT-OD-20-031), to develop a research program and work with their home institution to obtain NIH funding. This FOA specifically invites applications that would support senior faculty, established researchers, and experienced mentors to develop and direct the Summer Institutes for Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE) in order to mentor promising eligible junior faculty and transitioning postdoctoral students from diverse backgrounds who have specific scientific interests in heart, lung, blood and sleep (HLBS) disorders research.

To accomplish the stated over-arching goal, this FOA will support educational activities with a primary focus on Research Experiences and Mentoring Activities (described below):

• Research Experiences for participating junior faculty and transitioning postdoctoral students from diverse backgrounds to enhance their research skills, experiences, and knowledge base relative to HLBS scientific areas and cross-cutting methodological approaches. This can include transitioning postdoctoral scientists who have received a formal full-time faculty appointment letter in hand and will have completed their postdoctoral appointment by the time the Summer Institute program to which they are recruited is convened.

• Mentoring Activities by senior faculty, established researchers, and experienced mentors that include dedicated efforts to provide technical expertise, career advice, insight, and professional skills development opportunities to participating junior faculty and transitioning postdoctoral students from diverse backgrounds so that they can work with their institutions to compete for NIH grantss successfully.

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.

Background

Despite tremendous advancements in scientific research, educational and research opportunities are not equally available to all. Individuals from racial and ethnic groups and individuals with disabilities have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see the National Center for Science and Engineering Statistics (NCSES) Women Minorities, Disabilities Executive Summary and the report Women, Minorities, and Persons with Disabilities in Science and Engineering.)

Research mentoring and research education experiences through summer programs have been identified as a valid means for enhancing diversity in the workforce (see Weaving a Richer Tapestry in Biomedical Science and The National Academies Report Expanding Underrepresented Minority Participation).

Purpose and Description of the Program

The primary goal of the Summer Institutes (SIs) of the PRIDE program is to establish long-term mentoring that will enable junior faculty and transitioning postdoctoral students from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences, to develop a research program and work with their home institutions to obtain NIH funding. Through active involvement in research education and mentorship activities, program participants will further develop their skills and gain experience in advanced methods and experimental approaches in the basic and applied sciences relevant to the NHLBI. Ultimately, the enhanced skills gained from participation in the PRIDE program will contribute to mentees' career development as faculty members and scientists. SI programs have demonstrated efficacy for furtherance of participants' research careers.

This FOA specifically invites applications that would support senior faculty, established researchers, and experienced mentors to develop and direct SIs that will provide opportunities for skills development, research experiences, and mentoring to promising junior faculty and transitioning postdoctoral scientists from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences, who have received a formal, full-time, faculty appointment letter in hand by the time the SI program to which they are recruited is convened. In this FOA, 'applicant' refers to the Principal Investigator(s) of the SI program, and 'mentees' refers to the junior faculty/transitioning post-doctoral scientists.

To facilitate coordination of the research education and evaluation activities among and between SI awardees and the NHLBI, this FOA runs in parallel with a separate FOA soliciting applications for a Coordination Center (CC) for the PRIDE program (described in detail in RFA-HL-24-003). SI applicants may apply to the CC FOA (RFA-HL-24-003) and vice versa; however, the PD/PI for the SI application must be different than the PD/PI for the CC application.

Research Education Objectives

This FOA will support the development, organization, and implementation of NHLBI mission-focused SI programs. The SI programs must be open nationwide to individuals from diverse backgrounds, including those from groups that are identified by the National Institutes of Health as nationally underrepresented in the biomedical research workforce. SI applications must describe plans to support enhancement of mentees' skills through focused research education and mentoring activities in NHLBI mission-relevant areas. NHLBI's mission-oriented goals are at the center of the NHLBI Strategic Vision and are discussed on the Strategic Goals and Objectives web page. It is intended that the SIs will be structured to provide research education activities related to research design, methodologies, skills and strategies important to preparing NIH research grants, as well as to provide mentorship on strategies for success and tips for obtaining external research funding related to HLBS disorders.

Applications submitted in response to this FOA must propose to develop an NHLBI mission-focused research education and mentoring SI program during the last quarter of 2023 and early part of 2024, and to implement the proposed SI program during the summers of 2024, 2025, 2026, 2027 and 2028 with appropriate modifications or refinements following each of the prior years. The CC will support the SI program as detailed in RFA-HL-24-003 and will facilitate cross-site collaborative activities.

This FOA therefore intends to support applicants who offer mentoring and research education experiences in one of the NHLBI mission-relevant disease areas (i.e., heart, lung, blood, or sleep conditions), or cross-cutting HLBS areas such as health disparities or implementation science. Applications characterized by innovation, scholarship, and responsiveness to the priorities and/or changing needs of the NHLBI in meeting its objectives as described in its Strategic Vision are of high programmatic interest.

Examples of relevant topic areas and research approaches include but are not limited to:

• Basic and clinical aspects of the mechanisms of and treatment for HLBS conditions
• Research to mitigate health or health care disparities in HLBS conditions in the United States and abroad
• Health services research focused on treatment optimizing the care for HLBS conditions
• Implementation science research to facilitate adoption of proven-effective interventions to treat and prevent HLBS related diseases
• Intervention research methods, such as adaptive and pragmatic trials, to enhance the efficiency and applicability to populations with HLBS conditions
• Behavioral and social science research targeted at the prevention and treatment of HLBS conditions in areas such as health communication, adherence, behavioral economics, and social and structural determinants of health
• Emerging technology and informatics, such as artificial intelligence/machine learning and integration of wearable technology in research and clinical care of HLBS conditions
• Genomics, populomics , and precision health to advance the science of tailored treatment approaches for HLBS conditions

Applications must contain the following to be considered responsive to this FOA. Non-responsive applications will not proceed to review.

• Evidence of a planned program that occurs during the summer for no less than the minimum required time specified (i.e., 10 days) and for two consecutive summers for each cohort
• The number and positions of the intended participants (specifically HLBS-oriented junior faculty or transitioning post-docs, including those from underrepresented groups) with intent to recruit nationally
• A research education program focusing on NHLBI mission-relevant areas
• An evaluation protocol to assess mentees' progress and program goals
• A detailed account of experiences of the previously awarded program (applicable to renewal applications only)
• Evidence of ability to subcontract small research project (SRP) awards to mentees' institutions, including appropriate letter(s) of support demonstrating the ability to subcontract or the intent to develop appropriate subcontracting relationships with institutions of higher education from which mentees may come
• A proposed budget within the limit specified in the FOA

Program Structure

Summer Institutes (SIs)

While the specifics of the SI program will be left to the applicant, this FOA will support a four-component program consisting of two consecutive summers of research enhancement and skills development activities, supplemented by mentoring and relevant research experiences occurring throughout the intervening and follow-up academic year.

First Component: First Summer Institute (SI-1)

The first component must be an initial summer session lasting from 10-28 days, which may be divided into more than one segment with mentees participating in multiple segments. The segments may involve classroom, laboratory, and/or field research activities. Topics for consideration may include instructional segments about the unique challenges related to conducting research and obtaining funding faced by researchers, including those from underrepresented groups, reviewing manuscripts, participating on grant review committees, research project management, and budgeting for research proposals. It is preferred that these are an in-person format, but allow flexibility for hybrid or fully virtual formats as needed.

Second Component: Longitudinal Mentoring and Networking

The second component must consist of mentoring and networking activities that occur throughout the academic year following the first summer session. It is recommended that mentees plan to commit at least 5% effort between the first and second year to mentoring and networking activities and research experiences. It is anticipated that, with the assistance of the CC, a mentorship committee tailored to the research pursuits of mentees will be developed for each individual mentee. The mentorship committee would ideally consist of experienced or senior faculty from the mentee's institution, from the SI, and/or other thought leaders, nationally. Applicants may want to consider how to leverage existing mentoring resources such as the NIH-funded National Research Mentoring Network, professional society supported mentoring and/or career development programs, or other similar resources to enhance the required mentoring committee. Mentoring plans can be designed for virtual, telephone, and/or in-person interactions. Mentoring activities may include assistance with career goal-setting, research design and statistical analysis, external funding, proposal development for submission, and mentored visits to the laboratory or research site of a mentor during the academic year.

It is anticipated that applications will propose at least one in-person mid-year mentoring meeting that can be held either during intervals between semesters, in conjunction with a conference, a three-day weekend during the winter, or at another appropriate time and location. Additional mentoring activities that could occur during the mid-year meeting include identifying appropriate grant mechanisms and funding agencies, review and feedback on draft research concepts or unfunded applications, and progress on funded and ongoing research projects.

Third Component: Second Summer Institute (SI-2)

The third component is a follow-up session that will be held the following summer (Summer Session 2) as a continuation of the first component of the program. It may be of a different duration than the first summer session. This second summer session could be held either at one location for all mentors and mentees, or each mentee could attend a summer session at the laboratory of their mentor(s). Activities could include developing and writing a grant application, holding a mock study section meeting, additional coursework on relevant topic areas, focused mentoring, or research projects progress updates. It is preferred that these are an in-person format, but allow flexibility for hybrid or fully virtual formats as needed.

Fourth Component: Small Research Program (SRP)

A fourth component will be supported through a separate administrative supplement specifically for PRIDE mentees to support mentee-proposed small research projects (SRPs) to facilitate transition to research independence and possibly lead to support from subsequent NIH research grant applications. Briefly, in collaboration with their host PRIDE Summer Institute, mentees in an active cohort will be eligible to apply for an SRP administrative supplement during or following their first summer institute. Oversight of this component would occur throughout the intervening year between Summer 1 and Summer 2, and updates on projects could be provided at the mid-year meetings or at Summer Session 2. Mentees could also present their research progress and findings at the consortium-wide PRIDE Annual Meetings. Details about the eligibility, application, and administration of the SRP are available in NOT-HL-22-039.

NOTE: Pending scheduling, an optional informational webinar session will be held for applicants prior to application submission and a Notice will be published in the NIH Guide to Grants and Contracts.

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

Other Award Budget Information

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

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

• Eligible Agencies of the Federal Government

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• 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.

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 allowed.

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.

• 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.
• 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.
• Unique Entity Identifier (UEI) A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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.

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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

This FOA specifically invites applications from senior faculty, established researchers, and experienced mentors to direct the SIs of the PRIDE program and to provide research education and mentorship experiences for junior faculty and transitioning postdoctoral students from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences (see, e.g., NOT-OD-20-031. The PD(s)/PI(s) should be an established investigator(s) in the HLBS scientific area to which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the PRIDE research education program, or of providing evidence of a team that has these capabilities. The PD(s)/PI(s) team should also have scientific leadership and background in HLBS topic areas, or expertise in specialized research techniques, methodologies or cross-cutting approaches relevant to HLBS scientific areas as evidenced by scientific publications and a record of peer-reviewed scientific support. The PD(s)/PI(s) or the PD(s)/PI(s) team must also have experience and leadership in mentoring and have a strong record of providing research education and mentorship experiences to individuals from diverse backgrounds, including those from groups underrepresented in the biomedical sciences. A PD/PI with strong scientific experience and expertise could partner with a Program Administrator at their institution who has mentorship and leadership experience, or vice versa, to fulfill the requirements for leadership of this program.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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 groups historically underrepresented in biomedical research, 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 NHLBI mission areas and the proposed SI program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this program. SI PD(s)/PI(s) are expected to recruit mentors nationally who are experts in the HLBS program area(s) targeted by their SI programs. Mentors may be from the mentees' institutions, the SI-sponsoring institution, and/or other institutions as necessary to complement the needed expertise for the mentees' career goals. SI faculty are expected to have significant prior mentoring and research educational/training experience.

Mentees

Eligible mentees for the PRIDE program are those who are junior faculty and transitioning postdoctoral students. Institutions are encouraged to diversify the mentee applicant pool by recruiting potential candidates who are from groups underrepresented in the biomedical, clinical, behavioral, and social sciences (see, e.g., NOT-OD-20-031).

In planning their mentee pool, applicants to this FOA should note that potential mentees may not participate in this program if they are currently appointed to certain research education awards, or if they hold an individual fellowship or an NIH independent research award or equivalent. To be considered for matriculation into the PRIDE program, eligible mentees must submit a letter of support from their department chair or dean that includes a commitment to research time for the mentee; at least 5% effort for participation in the longitudinal mentoring and mid-year meeting components during the academic year and at least 5% effort during each summer to attend the SI sessions (see requirements under Letters of Support).

Mentees must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment.

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:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Telephone: 301-435-0270
Email: [email protected]

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.

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

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

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.

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

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.
• The budget and budget narrative should include the direct costs and facility and administrative (F&A) costs for the component being applied for and cannot exceed the funding levels provided in Section II of the FOA.
• Applications should contain five budget periods of 12 months each. Requested expenses must be itemized.
• Limited program-related and clerical salary costs distinctly associated with the program and that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Normally, all personnel costs (including program-related and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 50% of the total direct cost over the five years of the program (not including consultant fees associated with mentors outside of the grantee institution).

PD(s)/PI(s):

• 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 mentees are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with mentees are not allowable costs from grant funds).
• It is expected that the PD(s)/PI(s) will provide a minimum of 1.8 person months during the academic year and 1.5 to 2.25 person months during the summer. It is expected that the Program Administrator will provide a minimum of 1.6 person months during the academic year and 2.25 to 3 person months during the summer.

Mentee Support:

• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support mentees participating in the SI program. Provide detailed justification for each category for which funds are requested. Refer to Section II for clarification on allowable categories of the budget. Applicants should remember to include travel costs for the following:
  • SI programs are extended face-to-face meetings, and as such, applicants should budget for travel, lodging, and meals for all mentees from their home institutions to the site of the SI; for necessities of meeting logistics including meeting space; and should provide travel, lodging, and meals for mentors.
  • SI mentees should also have one mid-year face-to-face meeting with a mentor. If mentees or mentors are anticipated to travel for this meeting, the application should include the cost for travel.

Annual Consortium-wide meeting:

• In addition to the meeting held during the first and second SI sessions, SI Directors, staff, mentees, mentors, the CC Director and staff, and NHLBI program staff will meet annually for 2-3 days in the Washington, D.C. metro area. SI applicants should budget the cost for travel for their staff, mentees, and mentors to this annual meeting.

Future year funding for the SI component is contingent upon overall SI performance, and recruitment and retention. Funds for the SI programs may be reallocated across the awardees at the time of the noncompeting award.

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

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 :

• Proposed Research Education Program
• Program Director(s)/Principal Investigator(s)
• Program Faculty
• Program Mentees
• Institutional Environment and Commitment
• Recruitment Plan to Enhance Diversity
• 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 describing their program plan, applicants should indicate how the implementation of the proposed program will advance the objectives of this FOA and the mission of the NHLBI. Each SI applicant must propose to design, organize, and implement an SI program that targets junior faculty and transitioning postdoctoral scientists from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences (see, e.g., NOT-OD-20-031) and must be opened nationwide. Each awardee must hold two consecutive summer programs for four separate cohorts, as illustrated by the PRIDE timeline below.

SI awardees will begin developing their program during the last quarter of 2023 and subsequently implement it during the summers of 2024, 2025, 2026, 2027, and 2028 with appropriate modifications or refinements following each of the prior years. The SI programs will run from fiscal year 2024 through fiscal year 2028. The SI awardees will collaborate with the CC (described in RFA-HL-24-003) to implement and execute the PRIDE program as a whole.

For applications proposing joint institutional partnerships, applicants should delineate which of the required elements will be provided by each institution.

The specifics of the individual SI program will be left to the applicants, but NHLBI requests a program consisting of four components as described below:

First Component: First Summer Institute (SI-1)

• Initial summer session lasting from 10 to 28 days
• May be divided into more than one segment with mentees participating in multiple segments.
• The segments may involve classroom, laboratory, and/or field research activities.
• Must include instruction on unique challenges faced by mentees, including those from underrepresented groups, in the biomedical sciences related to conducting research and obtaining funding by an instructor who has been successful in a similar environment(s)
• May include other topics such as manuscript review or participating on grant review committees, research project management, and budgeting for research proposals.
• Requires a minimum commitment of at least 5% effort for mentees

Second Component: Longitudinal Mentoring and Networking

• Mentoring and networking activities that occur throughout the academic year following the first summer session
• Requires a minimum commitment of at least 5% effort for mentees
• Includes plans for how a Mentorship Committee will be developed for each SI mentee tailored to the research pursuits of the mentee consisting of experienced or senior faculty from the mentee's institution, from the SI, and/or from other thought leaders nationally with appropriate expertise
• Designed to be virtual, by telephone, and/or in-person
• Includes mentoring focus on areas such as assistance with career goal-setting, research design and statistical analysis, external funding, and proposal development
• Includes details on the mid-year meeting to be held either during intervals between semesters, in conjunction with a scientific conference/meeting, a three-day weekend during the winter, or at another appropriate time and location, and which addresses activities such as identification of appropriate grant mechanism and funding agencies, and/or review and feedback on draft research concepts or applications, or projects in progress
• May also include a visit to the laboratory or research site of a mentor during the academic year

Third Component: Second Summer Institute (SI-2)

• Follow-up session that will be held the following summer (Summer Institute 2) as a continuation of the first component of the program
• May be of a different duration than the first summer session
• May be held either at one location for all mentors and mentees, or each mentee could attend a summer session at the laboratory of their mentor(s)
• Activities could include developing and writing a grant application, holding a mock study section meeting, additional coursework on relevant topic areas, focused mentoring, or research projects progress updates
• SIs must be able to offer research education experiences in one or more of the following NHLBI mission areas: heart, lung, blood, or sleep conditions and/or relevant cross-cutting areas such as health disparities and implementation science research for HLBS conditions
• Requires a minimum commitment of at least 5% effort for mentees

Fourth Component: Small Research Program (SRP)

• Details about the eligibility, application, and administration of the SRP are available in NOT-HL-22-039. Provide a clear description of the process whereby SIs will work collaboratively with NHLBI Program staff and the CC to develop the plan for soliciting mentees' proposals from the SI sites, for reviewing and selecting meritorious projects for submission.
• Provide a clear description of how the SIs will support mentees in the development and submission of suitable proposals for the SRP administrative supplement
• Provide a plan providing scientific oversight for the SRPs in coordination with the CC and NHLBI Program Office throughout the intervening year between Summer 1 and Summer 2; including opportunities to provide project updates during the program (e.g., during mid-year meetings and/or during Consortium-wide annual meeting)

Meetings

SI sessions are ideally extended face-to-face meetings given the value of informal peer interactions for career development. However, there may be specific circumstances were virtual formats may be utlized and strong justification should be provided for using this format. Applicants should provide a detailed plan that includes a description of the structure of planned summer session meetings and the topic areas that will be covered during research education activities. Applicants should provide sample meeting itineraries that may include: anticipated topics of discussion; preliminary schedule and anticipated duration of each session; proposed mechanism(s) to garner attendee feedback on session impact and value; proposed mechanism(s)/metrics to evaluate meeting success. Without repeating information provided under the R&R budget, describe plans regarding expected logistics (i.e., appropriate budget to cover travel, lodging, and meals for all mentees and mentors from their home institutions to the site of the SI) and logistics related to the anticipated budget for mentees' mid-year face-to-face meetings with mentors, including travel expenses, if applicable.

In addition to the meeting during the SI sessions, SI Program Directors and staff, mentees, mentors, the CC Director and staff, and the NHLBI program staff will meet annually in the Washington, D.C. metro area. In all, there will be five (annual) in-person meetings across the five-year funding cycle. The first meeting will be a one-day face to face kick-off meeting involving SIs, CC, and NHLBI program staff. The remaining four meetings will be the 2-3-day program-wide annual meetings involving SIs, CC and NHLBI program staff, mentees and mentors. SI applicants should also plan for an additional one-day virtual meeting with their staff, mentors, the CC and the NHLBI program office staff annually.

At least one in-person mid-year meeting must be held for the mentees and mentors as a Longitudinal Mentoring and Networking component described above. Applicants should provide a written description that includes planned activities that will be the focus of the mid-year meeting. Examples include:

• Additional mentoring activities such as strategies to identify appropriate grant mechanisms and funding agencies
• Review and feedback on draft research concepts or applications
• Review and feedback on SRPs or other works-in-progress
• A visit to the laboratory or research site of a mentor during the academic year (if appropriate)

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.

PD(s)/PI(s) or PD(s)/PI(s) teams should provide evidence of expertise in NHLBI scientific mission areas and evidence of complementary mentoring, teaching and administrative skills that will foster successful implementation of the proposed SI program.

Program Faculty. Any qualified researcher can participate as a mentor; however, 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. Program faculty/mentors should have expertise in areas relevant to NHLBI scientific mission. Mentors must be committed to continue their involvement throughout the total period of the mentees' participation in the program. SI applicants are expected to work with the CC to identify and recruit mentors nationally who are experts in the NHLBI program focus areas described in their application. SI faculty are expected to have significant prior mentoring and educational/training experience as well. A minimum committment of at least 5% effort is expected for faculty mentors.

Program Participants (Mentees).

Applications must describe the intended mentees and/or specific educational background characteristics that are essential for participation in the proposed SI program. The SI programs are designed for junior faculty and transitioning postdoctoral scientists from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences. Postdoctoral mentees must have received a formal, full-time faculty appointment letter in hand and have completed any post-doctoral or other training program appointment (see NOT-OD-11-026) by the time the SI program to which they are recruited is convened. Mentees must also hold clinical or research doctoral degrees such as a PhD, MD, MBBS, DO, Ed.D., or equivalent. All mentees of the PRIDE program must demonstrate primary commitment/interest to HLBS disorders research or relevant cross-cutting areas such as HLBS health disparities research or HLBS-focused implementation science research. Mentees without a definite focus in NHLBI mission areas are not eligible as participants for the NHLBI-funded PRIDE program.

Each year, PRIDE SI awardees are encouraged to enroll a cohort of up to 12 but no less than 6 eligible mentees in their programs. Each awardee will execute an SI program, consisting of the four program components described above, for four separate cohorts, as illustrated by the PRIDE timeline. The CC (described in RFA-HL-24-003) will work with the SI programs to facilitate recruitment and screening of candidates and achievement of recruitment goals. Applicants should describe how they will work with the CC to recruit and select eligible participants who have a demonstrated commitment to HLBS research.

Applicants should also describe plans to secure, as part of matriculation, a Letter of Support from the mentee's division/department chair or dean, in support for protected time to participate in the SI research education and mentoring activities. Expected commitment includes protected time of at least 5% effort for participating in longitudinal mentoring and mid-year meetings during the academic year and at least 5% effort each summer to attend the SI sessions.

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.

Because the major goal of this NHLBI R25 program is to enable junior faculty and transitioning postdoctoral scientists from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences, to enhance research skills, develop a research program, and obtain NIH funding, the application should describe the institutional commitment that will foster the ability of the participant to achieve this goal.

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.

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 nationally 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 and NOT-OD-22-055. 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 the responsible conduct of research will not be reviewed.

Evaluation Plan.

Each SI must propose a robust evaluation protocol and describe plans to independently evaluate the activities proposed for the SI including the mentees and mentors. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of mentees), as well as measures to gauge the short and long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from mentees to help identify weaknesses and to provide suggestions for improvements. The evaluation plan must assess the effectiveness of the program in terms of the mentees' perceptions of the curriculum and conduct of the program, as well as the longer-term impact, as measured by mentees' success in receipt of external funding support from NIH, other government agencies, or private foundations. The primary desired outcome of the PRIDE program is for each mentee to work with their home institution to submit an NIH grant application or equivalent which focuses on a topic within the NHLBI mission within two years of completing the program. To this end, key condition of selection into any of the SI programs is that mentees accepted into the program must demonstrate and evidence commitment to NHLBI scientific areas of interest and must maintain an NHLBI mission-relevant focus of research throughout their participation in the program. Other desired outcomes are that mentees will further the progress of their academic research careers as evidenced by peer-reviewed scientific publications, scientific presentations, research scholarship and service, or receipt of non-NIH grants and promotions. Thus, aside from maintaining focus on an NHLBI mission focused research area, the evaluation metrics for the program include the following: aggregate number and demographic characteristics of participants; career progress of participants, including participation in independent research, employment and promotion in a research or research-related field, authorship of scientific publications in a STEM field, and independent research grant support from NIH or another source subsequent to participation in the PRIDE program.

The evaluation plan should also be ongoing to permit evidence-based modification of specific (e.g., recruitment strategies) or comprehensive program activities. The CC will work collaboratively with the SIs to coordinate common measures for the site-specific evaluation protocols and will facilitate ongoing follow-up and evaluation of the PRIDE program overall. Annual evaluation data must be provided with the non-competing continuation application/Research Performance Progress Report (RPPR). The Interim RPPR (IRPPR) will be used for the submission of a Competing Renewal application (Type 2) (NOT-OD-17-037). A summary of the final evaluation must be provided to the NHLBI as part of the final report.

After this 5-year program cycle, NHLBI will review the overall success of the entire PRIDE program to determine whether to continue funding it as currently configured. This review will be distinct from the individual reviews that take place under the auspices of the annual Progress Report. NHLBI will consider: a) the duration of the program, given programmatic goals and how long it may take for outcomes to manifest; and whether to b) continue the program as currently configured after the sunset period and review; or c) continue the program with modifications after the sunset period and review, or d) discontinue the program after sunset and review period. Discontinuation of the program is a policy option that will be made at the discretion of NHLBI.

If an application is received without an evaluation plan, it will be considered non-responsive and will be returned without review.

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.

If an application is received without an dissemination plan, it will be considered non-responsive and will be returned without review.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment.) The Letter of Support from the applicant institution must demonstrate the intent to host the SI program if awarded. The Letter of Support must include the provision that mentors and mentees will have access to facilities, such as classrooms, research laboratories, computers, dormitories, food service, and some leisure off-time activities as appropriate for the program being proposed. Include a justification for the use of any site(s) other than the applicant institution. Additionally, the letter must commit facilities as appropriate and include institutional acceptance to provide scientific oversight for the small research project component if the R25 applicant is awarded SRP supplement(s) to support SI mentees as described in NOT-HL-22-039. The Letter of Support should also indicate the institution's ability to subcontract, or describe its intent to develop appropriate subcontracting relationships with institutions of higher education from which mentees are recruited. Applicants must also describe how the PRIDE program complements, but does not duplicate, other ongoing training efforts at the institution and should evidence appropriate collaboration among participating programs, departments, and institutions as well as indicate institutional commitment to the proposed SI program. The Letter of Support must also indicate the plan to recruit and select eligible junior faculty and transitioning postdoctoral scientists from diverse backgrounds, including those from groups underrepresented in biomedical research.

If an application is received without the requested Letter(s) of Support, it will be considered non-responsive and will be returned without review.

Resource Sharing Plan

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 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.

NOTE: Clinical Trials are not allowed under this FOA.

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.

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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 the National Heart, Lung, and Blood Institute, 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.

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:

This FOA intends to support applications that propose to design, organize, and implement NHLBI mission-focused SI programs that will be opened nationwide to individuals who are from diverse backgrounds, including those from groups identified by the National Institutes of Health as nationally underrepresented in the biomedical research workforce.

The goal of this R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce. The major goal of this R25 program is to establish long-term mentoring that will enable junior faculty and transitioning postdoctoral scientists from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences (see, e.g., NOT-OD-20-031), to develop a research program and obtain NIH funding. This FOA specifically invites applications from senior faculty, established researchers, and experienced mentors to develop and direct the SIs of the PRIDE program in order to mentor promising eligible junior faculty and transitioning postdoctoral scientists with a formal full-time faculty appointment letter in hand who have specific scientific interests in heart, lung, blood, and sleep (HLBS) disorders research.

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.

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:

How likely is implementation of the proposed program to advance the objectives of this FOA?

Investigator(s)

Is the PD(s)/PI(s) 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:

How well does the PD(s)/PI(s) team evidence complementary skills that will foster successful implementation of the proposed SI program?

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:

If described, what is the added value for the creation of this proposed SI given existing research education, training and/or career development activities currently supported at the applicant's institution?

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 adequate is the plan for and description of each component of the program and each activity within the components? How adequate is the plan for providing mentees with appropriate mentoring experiences? Does the application contain adequate plans for recruiting experienced faculty/mentors with relevant scientific backgrounds? Is there an effective plan for program administration and coordination of faculty/mentors? Does the application contain adequate plans for recruitment, selection, and retention of candidates from diverse backgrounds? Does the application adequately document the host institutions', collaborating partners', and faculty/mentors' willingness to participate in the PRIDE program? Does the application adequately document the host institution's intent and ability to oversee the SRP program as applicable?

How robust is the proposed evaluation plan that will document the achievement of the program's objectives and demonstrate effectiveness and attainment of the program's goals? Are the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? Is the proposed evaluation plan adequate for obtaining feedback from mentees to measure the quality and effectiveness of the research education 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:

Is there evidence of appropriate collaboration among participating programs, departments, and institutions? Is the institutional commitment to the proposed program appropriate? Are the facilities, environment, and resources adequate and appropriate for the proposed research education program?

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

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Renewals

For Renewals, the committee will consider the progress made in the last funding period in achieving the goals of the program.

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 and NOT-OD-22-055. 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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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), 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.

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.

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 National Heart, Lung, and Blood 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.
• NHLBI Programmatic balance
• Geographic representation

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.

By applying to this FOA, applicants indicate acceptance to work with the PRIDE CC (supported under RFA-HL-24-003) and all other PRIDE SI awardees and the NHLBI program officers as part of the PRIDE consortium.

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:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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.
• Mentee eligibility requirements: Mentees must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment

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.

5. 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(s)/PI(s), and from participants themselves. Where necessary, PD(s)/PI(s) 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 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 Research Experience and Mentoring Programs Involving the Following Groups:

Transitioning Postdoctoral Scientists and Early Career (Junior Faculty) Investigators:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:
• Subsequent participation in research
• 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

Section VII. Agency Contacts

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

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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

Nicole Redmond, MD, PhD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0379
Email: [email protected]

Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]

Chantal Falade, MBA
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-5870
Email: [email protected]

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.

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.