SI awardees will begin developing their program during the last quarter of 2018 and subsequently implement it during the summers of 2019, 2020, 2021, 2022, and 2023 with appropriate modifications or refinements following each of the prior years. The SI programs will run from fiscal year 2019 through fiscal year 2023. The SI awardees will collaborate with the CC (described in RFA-HL-19-001) to implement and execute the PRIDE program as a whole.

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

Component One: An initial summer session lasting from 10-28 days, and

• May be divided into more than one segment with mentees participating in multiple segments
• May involve classroom, laboratory and/or field research activities
• Must include instruction on unique challenges faced by mentees from underrepresented backgrounds in the biomedical sciences related to conducting research and obtaining funding from 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.
• Component Two: Mentoring and networking activities that occur throughout the academic year following the initial summer session, and
• Requires a minimum commitment of 0.6 person months for both mentees and mentors
• Includes plans for how a Mentorship Committee will be developed for each SI mentee tailored to the research pursuits of the mentee
• Consists 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 online, 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 conference, or 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

Component Three: A follow-up session (Summer Session 2) to be held the following summer as a continuation of the first component of the program (Summer Session I).

• May be of a different duration than the first summer session program
• 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)
• Could include activities such as developing and writing a grant application, holding a mock study section meeting, progress updates on small research projects (see below), additional coursework on relevant topic areas, and/or focused mentoring, or research project updates
• SIs must be able to offer research education experiences in one of the following NHLBI mission areas (heart, lung, blood, or sleep disorders or relevant cross-cutting areas such as health disparities and implementation science research)

Component Four: A SI site-specific small research project (SRP) component plan that includes

• Intent to provide scientific oversight for SRPs, with a clear description of the process whereby SRPs will be identified for consideration by the SI and how they will be monitored to ensure effective use of SRP funds
• Intent to work with the CC and the consortium as a whole to facilitate the seamless execution of this component. Details of the CC's activities can be found in RFA-HL-19-001.
• A brief summary clearly delineating institutional support for the SRP component, resources available to support this component, including the ability to subcontract to institutions of higher education or intent to create an appropriate subcontractual relationship, and intent to provide scientific oversight. The summary should clearly indicate that SRP funds will not be used for mentors' support, other educational activities, or other operational costs at the mentee's institution, the CC or SI, and that the funds will be used only for new mentees of the PRIDE program. Additional details are provided in Section II. Other Program-Related Expenses.

For the SRP component, types of mentee research studies that can be supported by the SRP funds are limited to, a) ancillary studies to an NIH-funded and registered clinical trial (no independent, NIH-defined clinical trial can be supported), and b) independent, non-clinical trial research studies. These non-clinical trial resesarch studies do not have to be attached to an NIH-funded study and can be qualitative/formative studies such as focus groups, interviews, surveys etc., or basic science studies not involving humans. All studies must focus on an NHLBI mission interest area or cross-cutting methodological area in an NHLBI area of scientific focus. See Does your human subjects research study meet the NIH Definition of a clinical trial? and NOT-OD-15-015 for the NIH definition of clinical trials and clinical research studies.

Details of the SRP fund administration and how meritorious SRPs will be selected will be decided once the consortium of SIs and CC is convened. Briefly, the consortium of SIs will work collaboratively with NHLBI Program staff and the CC to develop the plan for soliciting mentees' proposals from the SI sites, and for reviewing and selecting meritorious projects. The SIs will then work with their mentees to submit competitive projects for consideration to the consortium (inclusive of SI, CC and NHLBI Program Office). Once meritorious projects are selected, the SIs will manage the distribution of the funds to their mentees' SRPs from their budgets. SIs must be able to subcontract to other institutions of higher education or must demonstrate intent to create appropriate subcontractual agreements as needed to support the mentee SRP awards from their institution. The CC and NHLBI Program Office will work collaboratively for the administrative management of this component.

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.

Mentees

The SI programs are designed for junior faculty and transitioning postdoctoral scientists who are underrepresented in the biomedical sciences. Postdoctoral mentees must have received a formal, full-time faculty appointment letter in hand by the time the SI program to which they are recruited is convened.

Applications must describe the intended mentees, and/or specific educational background characteristics that are essential for participation in the proposed SI program. The applications must identify the career levels essential for participation in the planned program. All mentees in the PRIDE program are expected to be junior faculty or postdoctoral scientists transitioning to an academic research career with documented letters of appointment, and demonstrated commitment to heart, lung, blood or sleep disorders research. Mentees must also hold research doctoral degrees such as a PhD, MD, MBBS, DO, Ed.D., or equivalent.

Each year, PRIDE SI awardees are encouraged to enroll a cohort of up to 14 but no less than 8 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-19-001) will work with the SI programs to facilitate recruitment and screening of candidates and achievement of recruitment goals.

SI awardees will begin developing their program during the last quarter of 2018 and will conclude it in the summer of 2023. The SI programs will run from fiscal year 2019 through fiscal year 2023. The SI awardees will collaborate with the CC to implement and administer the PRIDE program.

Program Support

Applicants should describe how they will work with the CC to recruit and select eligible participants who have a demonstrated commitment to HLBS disorders research. Applicants should also describe plans to secure, as part of matriculation, a Letter of Support from the mentee's department chair or dean, in support for protected time to participate in the SI research education and mentoring activities. Expected commitment includes research time of at least 0.45 (for 9-month appointment) to 0.6 (for 12-month appointment) person months for mentorship activities during the academic year and at least 2.97 (for 9-month appointment) to 3.96 (for 12-month appointment) person months for SRP participants and to attend the SI sessions and mid-year meetings. If awarded an SRP grant, mentees' institutions must also include plans to secure a Letter of Support for protected research time for the conduct of the SRP. Applicants' institutions must also describe their commitment to provide oversight for the SRP component. For applications proposing joint institutional partnerships, applicants should delineate which of the required elements will be provided by each institution.

Evaluation

Each SI must propose a robust evaluation protocol and describe plans to independently evaluate their own SI programs. The proposed evaluation protocol should include a timeline and specific and detailed plans for evaluation of both the program mentees and mentors. 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 from NIH, other government agencies, or private foundations. The desired outcome of the PRIDE program is for each mentee to submit an NIH grant application within two years of completing the program. The evaluation plan should also include an assessment of the overall performance of the SRP component and must 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 and 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 results or meeting 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.

Meetings

SI sessions are extended face-to-face meetings. 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 either during intervals between semesters, in conjunction with a conference, or a three-day weekend during the winter, or at another appropriate time and location. 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, and/or review
• Review and feedback on SRPs 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 PD/PI 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. PDs/PIs or PD/PI 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

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. Any qualified researcher can participate as a mentor. However, researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are particularly encouraged to participate as mentors. 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.

Program Participants

Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned. All mentees of the PRIDE program must meet the diversity eligibility requirements; be junior faculty or transitioning postdoctoral scientists who have received formal, full-time faculty appointment letter in hand by the time the SI program to which they are recruited is convened; and 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 definite HLBS scientific focus are not eligible as participants for the NHLBI-funded PRIDE program.

Institutional Environment and Commitment

Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under "Facilities & Other Resources"), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. Because the major goal of this NHLBI R25 program is to enable junior faculty and transitioning postdoctoral scientists who 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: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-18-122).

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 nationally from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Information should be included on how the proposed plan reflects the program's past experiences in recruiting individuals from underrepresented groups.

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

Applications lacking a diversity recruitment plan will not be reviewed.

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

If an application is received without the plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR), it will be considered non-responsive and will returned without review.

Evaluation Plan. Each application must include a plan for evaluating 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.

Other specific details to be addressed in the evaluation plan include: mentees' perceptions of the curriculum, conduct of the program, and longer-term impact as measured by mentees' success in receipt of external funding from government agencies or private foundations.

The primary desired outcome of the PRIDE program is for each mentee to submit an NIH grant application or equivalent which focuses on an HLBS disorder within two years of completing the program. To this end, mentees accepted into the program must demonstrate and evidence commitment to NHLBI scientific areas of interest and must maintain an NHLBI mission focus of research interest throughout their participation in the program as a key condition of selection into any of the SI programs. 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.

Evaluation must be ongoing to permit evidence-based modification of the program or specific activities of the program (e.g., changing recruitment strategies). Annual evaluation data must be provided with the non-competing continuation application and a summary of the final evaluations must be provided to the NHLBI as part of the final report. The CC will facilitate ongoing follow-up and evaluation of the overall program.

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

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 SI mentees are awarded funds. 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 junior faculty and transitioning postdoctoral scientists (with a formal, full-time faculty appointment letter in hand by the time the SI program is convened) from underrepresented backgrounds. If an application is received without the requested Letter(s) of Support, it will be considered non-responsive and will returned without review.

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plan as provided in the SF424 (R&R) Application Guide, with the following Guide 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 if the original investigators are unwilling or unable to do so.

Appendix

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

When involving NIH-defined human subjects research, clinical research, and/or 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 with the following additional instructions:

Delayed Onset Study

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

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

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

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.

This initiative is not subject to intergovernmental review.

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.

SRP designated funds can only be used for mentees' research projects and not for any other program-related cost.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy. Please see NOT-OD-17-066.

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

For this announcement, note the following:

The goal of this Research Education Program (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 who are underrepresented in the biomedical sciences (as defined by NOT-OD-18-122) 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:

This FOA intends to support applications that propose to design, organize, and implement NHLBI-mission-focused SI programs that will be opened to individuals nationwide, who are from backgrounds identified by the National Institutes of Health as nationally underrepresented in the biomedical research workforce. How likely is implementation of the proposed program to advance the objectives of this FOA?

Investigator(s)

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

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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting and retaining individuals from diverse populations underrepresented in biomedical, behavioral and clinical research on a national basis.

Revisions

Not Applicable

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

Recruitment Plan to Enhance Diversity

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

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program, the level of mentee experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel's evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned 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

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.

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

By applying to this FOA, applicants indicate acceptance to work with the PRIDE CC (supported under RFA-HL-19-001) and all other PRIDE SIs awardees and the NHLBI program officers as part of the PRIDE consortium.

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the RPPR Instruction Guide.

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

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

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

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each mentee appointed full time for eight weeks or more or the equivalent. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• Mentee Termination Notice: Within 30 days of the end of the total support period for each mentee, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each mentee appointed full time for eight weeks or more, or the equivalent.

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

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers (ICs) will periodically evaluate their R25 research education programs, employing the measures identified below and may request information essential to an assessment of the effectiveness of this program from databases and/or from program mentees directly. Program mentees may be contacted directly after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Where necessary, PDs/PIs may be contacted after the completion of a research education experience for periodic updates on mentees' 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.

NHLBI plans to review the overall success of the entire PRIDE program after 5 years 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 results or meeting 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.

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 Junior Faculty (Early Career) Investigators:

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

o Subsequent participation in research

o Subsequent employment in a research or research-related field

o Subsequent authorship of scientific publications in a STEM field

o Subsequent independent research grant support from NIH or another source

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Josephine Boyington, Ph.D., M.P.H., CNS
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0446
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]

Kimberly Stanton
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8054
Email: [email protected]

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.