It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions will not be reviewed

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

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

The over-arching goal of this NHGRI R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral, social, computational and clinical research workforce in genomics. The DAP Program seeks to expose students at the undergraduate, post-baccalaureate and graduate levels who are from diverse backgrounds, including those from underrepresented groups, to the foundational sciences relevant to genomics to enable them to pursue careers that span all areas of interest to NHGRI - genome sciences, genomic medicine and genomics and society.

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

• Research Experiences: (primary focus) based on the foundational sciences relevant to genomics: genomic sciences (e.g. technology development, data science); genomic medicine (e.g. epidemiology, pharmacogenomics, clinical implementation); and genomics and society (e.g. bioethics, social and behavioral sciences, law, the humanities). Experiences can take place during the academic school year or as summer programs.
• Courses for Skills Development: (secondary focus) complementary didactic activities are encouraged, especially those academic courses that have the potential to increase opportunities for success at the next career level. The field of genomics is data driven. Courses that introduce participants to fundamental knowledge in data sciences, such as bioinformatics, machine learning, statistics, etc., are especially encouraged.

Background

The NIH is committed to enhancing the diversity of their workforce. (Valantine and Collins, National Institutes of Health addresses the science of diversity Proc. Natl Acad Sci USA 112, 12240 (2015)). Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

The National Human Genome Research Institute (NHGRI) is committed to enhancing the pool of individuals from diverse backgrounds who have the training to pursue careers in genome sciences, genomic medicine, and genomics and society research. Genome sciences and genomic medicine research offer tremendous opportunities for improving human health, and genomics and society research offers the chance to not only improve human health, but also to explore some of the most profound ethical, legal and social issues of our time. NHGRI wants the best minds to engage in this research. There are extraordinary career opportunities in genome sciences, genomic medicine, and genomics and society research in which all should have an opportunity to participate. The very nature of research demands a diversity of viewpoints and scientific interests. A major emphasis of this research will be the development of: resources and methods and technologies that will accelerate research in understanding the structure of genomes; understanding the biology of genomes; understanding the biology of disease; advancing the science of medicine; and improving the effectiveness of healthcare. The significant societal ramifications of this research will also need to be addressed. It is clearly desirable to have individuals involved who bring diverse perspectives to this research, including an interest in understanding diseases that disproportionately affect some populations. Genome sciences, genomic medicine, and genomics and society research will affect all populations and thus all groups need to participate in setting the research agenda and examining the broader issues raised by it.

Need for the Program

NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. However, despite advancements in scientific research, some populations have not had access to cutting-edge research and training opportunities, and do not participate fully in the biomedical sciences research workforce. These underrepresented groups include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds, as described in NOT-OD-18-210.

The overall objective of the DAP Program is to support a diverse pool of undergraduates, post-baccalaureates and graduate students, including those from underrepresented groups, to help them successfully transition to the next stage of their research career in a genomics-related field. Recent studies have highlighted the importance of including diverse and under-represented individuals in human genomics research and the striking gaps in attaining that inclusion. The National Human Genome Research Institute is committed to establishing foundational approaches to study the role of genomic variation in health and disease that include diverse populations. Supporting efforts to diversify the genomics workforce serves as an effective strategy for increasing diversity in genomic research studies. (Hindorff et al. Prioritizing diversity in human genomics research Nat Rev Genetics 19, 175 (2018)).

Programmatic Approach

As a leading authority in the field of genomics, NHGRI’s mission is to accelerate scientific and medical breakthroughs that improve human health and well-being. We do this by driving cutting-edge research, developing new technologies, and studying the impact of genomics on society. This requires expertise in the foundational sciences relevant to genomics--biomedical, physical, mathematical, and computer and engineering sciences, biostatistics, epidemiology, bioinformatics, bioethics, social and behavioral sciences, law, and the humanities. Thus, research education in these areas will allow those who participate in NHGRI-supported research activities to be well positioned to contribute to biomedical research in the future.

It is assumed that the institutions that apply for this award will:

- have faculty with broad experiences in one or more of the three areas of genomics relevant to NHGRI: genomic sciences, genomic medicine or genomics and society;

- have experienced mentors who have worked with underrepresented individuals in traditional NIH training programs; and

- be able to demonstrate that related research education or training programs at their institution will work collaboratively with the Diversity Action Plan (DAP) program to ensure a smooth transition of DAP participants to the next career phase.

The guiding principles of what can be supported under this funding opportunity announcement are that participants:

- should be exposed to appropriate didactic training in the foundational disciplines of genomics in order to develop critical thinking skills as appropriate for their career level and research focus;

- should receive research experiences that do not focus on any particular disease or groups of diseases but skills and knowledge that are generally applicable to a variety of biomedical research questions;

- must be so prepared that they can use this knowledge and these experiences to move to the next stage of their career; and

- must be in a research environment where they will have an opportunity to select from a variety of genomic research experiences and mentors.

The types of research experiences that can be supported under this award include:

-summer or semester research experiences and courses for skills development for undergraduate students with the objective of pursuing a doctoral degree in one of the foundational sciences relevant to genomics;

- up to two years of part-time support for post baccalaureate research and courses for skills development with the objective of transitioning to graduate school; participants may take academic courses, but may not be enrolled in a formal graduate program; and

- up to two years part-time support for graduate students with the objective of transitioning to an F31 or other source of peer-reviewed support.

The duration of the research experiences, the transition of participants to individual support mechanisms, and their transition to the next career stage are important considerations in DAP programs. PDs/PIs should limit participant selection to eligible individuals who are committed to a research career.

The career outcome goal for individuals supported by DAP programs is to remain in genomics-related research. This will include both research-intensive careers in academia and industry and research-related careers in various sectors, e.g., academic institutions, government agencies, for-profit businesses, and private foundations. DAP programs should make available structured, career development mentoring and learning opportunities (e.g., workshops, discussions, Individual Development Plans) to provide participants knowledge of various potential career directions and the steps needed to transition to the next stage of their chosen career.

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.

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

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)

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 not 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.

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

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

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

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

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

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

The PD/PI must have significant research funding from NIH (e.g. multiple research grants, a large center grant, or cooperative agreement, etc.) in at least one of the areas relevant to NHGRI's research programs - genome sciences, genomic medicine and genomics and society research.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Only one award will be made per institution for activities that focus in one of three areas - genome sciences, genomic medicine and genomics and society. Institutions that already have an award in one of these three areas are not eligible to apply for an award in the same area, but can apply for an award in a different area. Institutions that have more than one NHGRI-supported R25 diversity program and/or T32 program must demonstrate coordination and collaboration such that there is synergy amongst the programs.

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

Because participants are expected to have the opportunity to pursue their research and educational experiences focused on a variety of genomic research topics, it is expected that the program faculty will have significant research programs in one or more of the three research areas relevant to genomics.

NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, as described in the Notice of NIH’s Interest in Diversity, NOT-OD-18-210.

Participants from engineering, mathematics, computer science, physics, chemistry, biology, biostatistics, bioinformatics, bioethics, social and behavioral sciences, law, and the humanities, and other relevant science programs who have an interest in the genomics should be encouraged to participate in the program.

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

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.

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

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:

Lucia A. Hindorff, PhD, MPH
National Human Genome Research Institute, NIH
Telephone: 240-271-1509
Email: [email protected]

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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

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.

Other Attachments.

Advisory Committee (1-page maximum): Provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Advisory Committee members should only be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf

Tables. The DAP is an institutional program and as such applicants must provide details about the institution and its setting using Data Tables 2, 4, 8A, and 8D (http://grants.nih.gov/grants/funding/424/datatables.htm).

The following Tables are required for new applications:
Training Table 2. Participating Faculty Members, Undergraduate and/or Predoctoral Training Table, as applicable (Programs that include post-baccalaureate participants should include information on faculty mentoring of post-baccalaureates on the Undergraduate Training Table.)
Training Table 4. Research Support of Participating Faculty Members

The following Tables are required for renewal applications:
Training Table 2. Participating Faculty Members, Undergraduate and/or Predoctoral Training Table, as applicable (Programs that include post-baccalaureate participants should include information on faculty mentoring of post-baccalaureates on the Undergraduate Training Table.)
Training Table 4. Research Support of Participating Faculty Members

Training Table 8A (Part I only) Program Outcomes: Predoctoral (for graduate students)
Training Table 8D (Part I only). Program Outcomes: Undergraduate (for postbaccalaureate and undergraduate students)

Please name your files "Table 2-Undergraduate.pdf", "Table 2-Predoctoral.pdf", Table 4.pdf", "Table 8A.pdf", or "Table 8D.pdf" as appropriate.

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

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.
• Use Section A and B for Personnel Costs.
• Use Section E for Participant Support Costs to include all allowable categories of funds requested to support participants in the program, including participant travel.
• For Other Program-Related Expenses, use Sections D (PI/staff travel) and F (other costs).
• Program coordinators are allowed as long as their roles in the program implementation are clearly defined and significantly different from the roles of the PDs/PIs. The duties and responsibilities of the program coordinators must be well described in the budget and must include a strong justification. The number of person months must be strongly justified in relation to the number of program participants.
• Costs of consultants for evaluation of the program is allowed; however, if the evaluator is an employee of the applicant institution, the cost must be included in the category of key personnel salary (effort listed in person months). [Employees cannot be consultants unless it is allowed by institutional policy and the person is consulting in a field distinctly separate from their "normal" field of work.]
• The total compensation package for participants should be reasonable for the work performed and consistent with the compensation paid to all participants in similar circumstances, regardless of the source of support for the activity.

The following account summarizes some of the UNALLOWABLE costs under the DAP Program but is not an all-inclusive list. Please see 45 CFR 75, Subpart E "Cost Principles" for a complete list of costs that may be deemed unallowable under this program:

• Undergraduate and graduate student tuition, housing, or food, during the academic year.
• Food and beverage costs (NOTE: Travel per diem costs provided in accordance with an institution's written travel policies to cover incidental meal expenses is permissible).
• Foreign travel.
• Student support in the form of a stipend (note: stipend differs technically from salary/wages which is allowable. See: https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf).
• Costs for textbooks, laptops, incentives, memberships, or subscriptions to internet services or journals.
• Support for faculty research (all faculty mentors are expected to have their own research support).
• Equipment.
• Costs of workshops or courses with a limited focus such as preparation for a specific test, (i.e., GRE and MCAT costs are not allowable).
• Alterations and renovations.
• Consortium/contractual arrangements.

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

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

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

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

Applications must:

Explain the basis and rationale for the program and any educational principles or evidence of past success that it may be based on.

Provide programmatic detail and rationale for the proposed research experiences and courses for skills development and describe how these activities address the needs of the diverse program participants.

Describe how each proposed activity will contribute toward realization of the specific aims.

Describe the milestones and benchmarks (i.e., anticipated intermediate steps toward the objectives).

Discuss any perceived impediments to implementing the proposed activities and alternative strategies to achieve the measurable objectives.

Provide concise information on the selection and retention process for the participants in the DAP program, including the criteria related to the students academic status, participants research education and training progress, and role of the faculty/personnel involved.

Describe how experiences during the summer and/or academic year will contribute toward measurable objectives and student development. Demonstrate that participants will have authentic, meaningful research experiences in the laboratories or research groups of extramurally-funded investigators who are actively engaged in genomics-related research.

Describe how the students will be exposed to research projects that will give them the foundational knowledge and skills that can be applied to a broader range of genomic problems.

Describe how the PD/PI will specifically interact with program faculty with the goal of preparing students to move successfully to the next career level.

Describe how the PD/PI and program program coordinator will specifically interact, and how the program coordinator will be integrated with the program faculty to facilitate the program.

If applicable, describe how the applicant will coordinate and collaborate with other NHGRI-supported R25 diversity and/or T32 programs to provide synergy amongst the programs.

For renewal applications, describe how this plan resulted in getting participants to their next career level. Special attention should be paid to unique aspects of the plan that resulted in successful outcomes.

For renewal applications, provide information on outcomes of past participants in the program, including, but not limited to, counts (numbers and percentages of participants) and summaries of the following:

• Participants who completed the DAP program (alumni);
• Participants who applied for admission to an academic program at their next career level;
• Participants who enrolled in an academic program at their next career level;
• Participants who completed an academic program at their next career level;
• Participants who are employed in a tenure-track faculty position;
• Participants who are employed in research-related positions;
• Participants who are employed in non-research related positions.

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.

The PD/PI assumes responsibility for the overall execution of the DAP Program and is typically responsible for placement of students in research laboratories and coordination and implementation of developmental education and mentoring activities across the different participating institutions. Describe how the PD(s)/PI(s) will work with the program coordinator and program faculty to monitor and evaluate the progress of the individual program elements and the overall functioning of the program.

The PD/DI must have significant expertise in the foundational sciences relevant to NHGRI programs (genome sciences, genomic medicine and/or genomics and society), experience relevant to the proposed diversity program, and a history of mentoring diverse students.

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 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. Institutions are encouraged to consider whether the proposed participants would help achieve the overall goals of this NHGRI Diversity Action Plan R25 Program.

Applications must:

• Include a description (including size) of the potential applicant pool from the participating institutions based on the selection criteria established for the proposed DAP program;
• Describe the process for selection of the program-supported participants (examples of accepted indicators include, but are not limited to, previous academic success, practical research experience, written statements that express interest and commitment and letters of recommendations from faculty, research supervisors and/or other community leaders that speak to the applicant’s merit and interest in genomics research);
• Describe the retention strategies and follow-up activities that would ensure students remain engaged and are receiving high quality mentorship and guidance within the 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.

Provide evidence that for the duration of this grant the institution will have a significant number of peer-reviewed research projects, (e.g. multiple research grants, a large center grant, or cooperative agreement, etc.) in one or more of the following areas: genome sciences, genomic medicine and genomics and society, in order to provide participants with a variety of experiences. Demonstrate that research and educational experiences will focus on the relevance of the foundational genomic disciplines to the research and not focus on particular disease(s) or health conditions.

Recruitment Plan to Enhance Diversity (NOT-OD-18-210): Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints . NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

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

Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering).

The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.

In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. For more information on racial and ethnic categories and definitions, see NOT-OD-15-089.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf

C. Individuals from disadvantaged backgrounds, defined as:

1.Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

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

The disadvantaged background category (C1 and C2) refers to the financial and educational background of individuals, particularly before graduating from high school, while residing in the United States

Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).

New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of prospective trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Information should be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.

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

Applications lacking a diversity recruitment plan will not be reviewed.

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

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan. Applications must include a plan for tracking the program's participants and evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. The plan should address the overall goals and specific measurable objectives that the institution expects to accomplish in preparing students to advance to the next career level in genomics research and in striving to achieve the goals and expectations of the DAP program. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops. Publication of the program's findings and outcomes in peer-reviewed journals is highly encouraged.

Letters of Support

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

Resource Sharing Plans

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

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

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

Appendix

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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.

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

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

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

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

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NHGRI Referral Officer by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name(s), and title of the application.

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.

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

For this particular announcement, note the following: The goal of this R25 program is to provide research experiences and education for students at the undergraduate, post baccalaureate and graduate levels from diverse backgrounds, including those from groups underrepresented in scientific disciplines relevant to genomics: genome sciences (e.g. computational biology, quantitative sciences, bioinformatics); genomic medicine (e.g. biostatistics, epidemiology, bioinformatics), and genomics and society (e.g.bioethics, social and behavioral sciences, law, the humanities) to enable them to pursue careers in genomics that span the three areas of interest to NHGRI. The goal of the research experience and courses for skills development are to ensure that participants successfully advance to the next career level in genomics 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?

Does the DAP application provide a value-added aspect that other student development programs ongoing at the institutions do not provide? Does the research plan show potential to increase the diversity of the biomedical research workforce in the fields of genome sciences, genomic medicine and/or genomics and society?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Will the program faculty collectively provide the expansive type of research and didactic experiences in genomics research so that the experiences received are not focused on any particular disease, diseases or health conditions? Are individuals with the right expertise in the foundational sciences relevant to genome sciences, genomic medicine and/or genomics and society involved in the development and management of the program? Do the PD/PI and key personnel maintain an appropriate level of involvement to ensure the substantial and unique added value critical to research in genome sciences, genomic medicine and/or genomics and society? Does the program coordinator have the expertise to implement activities that are essential for the success of the participants and their anticipated career? Is the program coordinator sufficiently integrated with the PD/PI and with the program faculty participating in the DAP 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?

For renewal applications, were any innovations implemented by the grantee successful?

Approach

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

Are the activities commensurate with the program goals? Will the activities facilitate participants moving successfully to the next phase of their educational or career program? Are the types of research experiences and education clearly articulated for the appropriate career level of the participant? Are genomic science, genomic medicine or genomes and society topics prominently integrated into planned activities? How does the plan take advantage of the research infrastructure of the applicant institution and other similar programs supported by NHGRI and the PD's/PI's institution? What is the value added and does this program differ from ongoing activities?

For renewal applications, how successful was the program in supporting participants to the next phase of their career in genomics research? Do they show evidence of participants applying to and being accepted in the next stage? Do they show evidence of participants having publications/abstracts resulting from their experience in the program?

Environment

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

Collectively, do the research groups provide access to a broad set of research experiences in genome sciences, genomic medicine and/or genomics and society so that the participants can use the skills, knowledge and expertise to function in any research program focused on genomics? Does the institution have sufficient and varied peer-reviewed projects in the areas of interest to sustain an infrastructure consistent with the intent and duration of this program? If applicable, are the plans to coordinate and collaborate with other NHGRI-supported R25 diversity and/or T32 programs adequate such that there will be synergy amongst the programs? Does the institution have the potential to sustain an intense research program in genome sciences, genomic medicine and/or genomics and society for at least ten years?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

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.

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

Recruitment Plan to Enhance Diversity

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

Training in the Responsible Conduct of Research

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

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 NHGRI, 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. 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.

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.

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

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. 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.

Additionally, applicants must submit the NRSA Training Table 8A: Predoctoral Program Outcome (for graduate students) and/or 8D: Undergraduate Program Outcomes (for postbaccalaureate and undergraduate students), as applicable, in Section G1 of the Research Performance Progress Report (RPPR). Sample and table description can be found at https://grants.nih.gov/grants/forms/data-tables.htm.

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 participant appointed full time for eight weeks or more or the equivalent. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.
• If funds are provided for program evaluation, then any written evaluation report must be provided as an attachment to Section G.1 of the RPPR. Please name your file evaluation report" as appropriate

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

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

In evaluating this research education program NHGRI expects to use the following evaluation measures for all career levels (except when noted in parenthesis):

• Aggregate number and demographic characteristics of participants
• Educational level of participants at the start of the program
• Participants feedback on the program
• New knowledge or skills acquired
• Subsequent educational/career progress, including:

o (For undergraduates) successful completion of an undergraduate degree in a field relevant to the NHGRI mission;

o (For undergraduates and postbaccalaureates) enrollment in an advanced degree program in a field relevant to the NHGRI mission;

o (For undergraduates and postbaccalaureates) successful completion of an advanced degree program in a field relevant to the NHGRI mission;

o Subsequent participation in a formal research training or career development program in a field relevant to the NHGRI mission;

o Subsequent employment in a research field relevant to the NHGRI mission;

o Subsequent authorship of scientific publications in a field relevant to the NHGRI mission;

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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Lucia A. Hindorff, PhD, MPH
National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509
Email: [email protected]

Anissa J. Brown, PhD
Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research
Telephone:301-594-4805
Email: [email protected]

Lu Wang, PhD
Translational Genomics Research Branch
National Institute of Dental and Craniofacial Research
Telephone: (301) 594-4846
Email: [email protected]

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: [email protected]

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected]

Devon Bumbray-Quarles
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-7928
Email: [email protected]

Dede Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
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.