Part 1. Overview Information

Key Dates

It is critical that applicants follow the Multi-Project (M) 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 may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

In 2020, the National Human Genome Research Institute engaged the scientific community to identify future research priorities and opportunities in human genomics, resulting in our 2020 Strategic Vision for Improving Health at the Forefront of Genomics (https://www.genome.gov/2020SV) This vision outlined the guiding principles and values for human genomics, including championing a diverse workforce which includes individuals from backgrounds that are not well represented in biomedical research (see NIH Interest in Diversity: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html) , embracing interdisciplinary teams in genomic research, and increasing access to genomic medicine.

Investigators from different backgrounds bring different perspectives, exchange innovative ideas, and increase the objectivity in generating new data and in its interpretation, which leads to knowledge that is more reliable, but the scientific and biomedical workforce in the United States (U.S.) is not as diverse as the U.S. population, and this extends to the genomics research workforce. This lack of diversity negatively impacts the scope, integrity, and applicability of research. Minority Serving Institutions (MSIs) with a mission to serve historically underrepresented populations have played an important role in supporting scientific research, particularly on diseases and conditions that disproportionately impact racial/ethnic minorities and other U.S. populations that experience health disparities, though they often lack sufficient capacity to conduct and sustain cutting-edge health-related research. . Researchers at these institutions are uniquely positioned to bring novel perspectives and broaden the field of genomics, e.g., by engaging racial and ethnic minority populations in research and helping to translate research advances into culturally competent, measurable and sustained improvements in health outcomes for underserved communities.

This initiative will champion a diverse genomics research workforce by supporting cutting-edge genomic research projects, capacity building and training in genomics at MSIs as defined in section III.

Program Description

Overall Plans for the Center: The purpose of this program is to support the development of innovative genomic research projects through infrastructure building and the formation of interdisciplinary research teams at Minority Serving Institutions (MSIs) with a historical mission to serve underrepresented populations (see section III). Through this initiative, genomic research capacity will be increased in MSIs; the diversity of the genomics research workforce will be enhanced; innovation and creativity will be amplified by bringing new researchers and thus novel ideas into the field of genomics; and participation of underrepresented populations and underserved communities that often experience health disparities will be increased in genomics research.

The primary goals of the Diversity Centers for Genome Research are to enhance diversity in genomics research by establishing Centers to carry out innovative, state-of-the-art genomic research studies; foster genomic research career development and enhancement for trainees and investigators at all career levels; enhance the genomic infrastructure, computational, analytical and ELSI research capability within eligible MSIs; establish sustainable partnerships and disseminate resources and findings.

The proposed Center is expected to support an Administrative Core, Genomic Workforce Development Core, Community Engagement Core, and two to three interrelated, innovative genomic research projects that address one or more critical issues in the following: genomic technology and methods development; genome structure; genome function; genomics of disease; use and impact of genomic information in clinical care; ethical, legal, and social implications of genomic research; genomics and health equity; and/or computational genomics.

Program Governance: Awards made under this FOA will be cooperative agreements (seeSection VI.2., Cooperative Agreement Terms and Conditions of Award). A Consortium will be organized with the principal investigators, key personnel of the Centers funded under this FOA and the companion FOA (RFA-HG-22-027), and NIH staff. Full-scale Diversity Centers for Genome Research funded under this FOA will share experiences and disseminate best practices with developing Centers funded under the companion FOA (RFA-HG-22-027) to provide them with lessons learned as they strengthen their research capacity and ability to accomplish the activities that will be necessary to execute their proposed full-scale Diversity Center for Genome Research.

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) from each Center will be responsible for the scientific direction of the Consortium and will meet in person as a Steering Committee (see Section VI.2., Cooperative Agreement Terms and Conditions of Award) two times per year and by conference call on a monthly basis. The Steering Committee will develop best practices and explore opportunities for synergy among Centers. Working Groups may be established to facilitate collaborative work and explore new research collaborations. Center investigators, collaborators, students, and trainees are encouraged to attend Steering Committee meetings. It is expected that resources and data will be shared within the consortium, as needed.

Required Components of the Diversity Center for Genome Research:

The following components are required for each Center:

• Administrative Core
• Genomic Workforce Development Core
• Community Engagement Core
• Research Project(s): two to three projects
• External Advisory Committee
• Evaluation Plan

Descriptions of Required Components

Administrative Core

The Administrative Core should be directed by the PD(s)/PI(s) of the Center. This core will provide overall management in administrative, fiscal, and scientific aspects of the center including career enhancement activities for students, trainees, and faculty, and foster synergy with other ongoing genomic career development activities at the institution, including any funded through other NIH grants. This core will also develop and monitor core and project milestones which including evaluating each proposed activity/core and the impact of the Center in terms of: 1) enhancing the institutional research capacity and environment necessary to facilitate genomic research; 2) increasing productivity of investigators in peer-reviewed publications and 3) increasing the institution's overall success in applying for and obtaining extramural research funding. Successful applicants will be expected to work closely with NIH to develop and implement common metrics of Core and Project progress and share data on programmatic outcomes for each Center component.

The Centers PD(s)/PI(s) are expected to meet as a consortium with other awardees funded under this FOA and the UG3/UH3 FOA (RFA-HG-22-027) twice per year in person to present research progress, discuss challenges, promote collaboration amongst Centers and share best practices for Center operations. Centers PD(s)/PI(s) will also be encouraged to attend other research consortia and network meetings to increase collaborative opportunities.

Genomic Workforce Development Core

The goal of the Genomic Workforce Development Core is to provide genomic research experiences, genomic career development opportunities and genomic education enhancement activities within each research project. NIH is committed to fostering diversity, inclusivity, and accessibility in the genomics research community. Applicants should strive to compose teams richly diverse in perspectives, backgrounds, and academic disciplines, and provide full opportunity and participation to individuals and groups underrepresented in genomics. This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see Section IV below). Applicants should take advantage of unique aspects of the research cores and projects, the investigators' talents, and other institutional resources to offer innovative, substantive educational, career development and research experience opportunities for K-12 students, undergraduate students, masters level students, pre-doctoral students, post-doctoral fellows, and other investigators to develop and/or enhance expertise in genomics. Research enhancement activities include practical research experiences, seminars, courses, workshops, and other career enhancement activities that increase the recruitment, advancement, and retention of investigators from diverse backgrounds, including those from groups underrepresented in genomic research careers. Genomic career development opportunities include coordination with other genomic activities at the institution and in the geographic area, and development of the individual in a way that is tailored toward their career goals and needs. The core will also support collaborations with other researchers at the applicant institution as well as other institutions.

Community Engagement Core

The Community Engagement core should facilitate engagement of the community in the development of materials for genomic education and training, research design, analyses, and outcome assessment. This includes but is not limited to the development of the genomic research questions, identification of exposures of concern to that community, suitable cohorts, and specific needs of subpopulations; the translation and dissemination of study results, and development of methods for evaluating the success of the project. The community includes but is not limited to population groups, stakeholders, interest groups, citizen groups, neighborhoods, advocacy groups, etc. The core should also coordinate dissemination activities with community members, partner organizations, and relevant service organizations or policymakers, as well as the scientific community, including presentation of findings from research projects to community stakeholders. Core activities are expected to be incorporated within the research projects and strengthen community-engaged research approaches.

Research Project(s)

The Diversity Centers for Genome Research should be structured around two to three research projects that address one or more critical issues in the following: genomic technology and methods development; genome structure; genome function; genomics of disease; use and impact of genomic information in clinical care; ethical, legal, and social implications of genomics research; genomics and health equity; data science and/or computational genomics. Projects may include applications to a particular disease area, but Centers should demonstrate that the methods and knowledge generated are broadly generalizable across disease areas. Studies focused on disease etiology or outcomes should examine the role of both genomic and non-genomic contributors to human health and disease. All applications, regardless of focus, should explain how generalizable, broadly useful, and transformative the findings and approaches will be to the field of genomics. If the research project has areas of focus in clinical genomics, it should improve assessment and/or outcomes in all populations including underserved populations and/or include technological or computational methods for the production or analysis of diverse data sets. The Centers should bring together different areas of expertise and different research approaches to provide synergy and allow each project to accomplish more than it would be able to on its own.

The following list provides some examples of different types of topics that could be the focus of a Diversity Center for Genome Research. Applicants should understand, however, that this list is meant only to provide guidance; it is not exhaustive and appropriate topics are not limited to the examples given.

National Human Genome Research Institute (NHGRI)

Genetic/environmental, including social determinants of health, contributors to disease. A Center application may involve collection of new samples and/or the use of existing samples from one or more populations of interest to study the genetic epidemiology of a diseases or disorders that present a significant public health burden. The individuals from whom samples are collected or re-used should be well-phenotyped to ensure that the disease being studied has been properly diagnosed.

Function Genomics. Functional genomics includes an assessment of how the genome functions, how genomic variation affects genome function to influence phenotypes, and how processes in the body are influenced by genomic variation.

An assessment of inherited diseases. An analysis of individuals affected by monogenic diseases or complex genetic disorders to identify causative mutations, modifier genes, and environmental risk factors during early development.

Pharmacogenomics. Pharmacogenomics research seeks to identify genetic factors that are responsible for individual differences in drug efficacy and susceptibility to adverse drug reactions as well as the role these individual differences may play in the development of antimicrobial resistance.

Ethical, Legal, and Social Implications (ELSI). ELSI research seeks to identify, analyze, and address the ELSI of genomic technological and scientific advances for individuals, families, communities, and society.

Genomic Medicine. Genomic medicine is an emerging medical discipline that involves using genomic information about an individual as part of their clinical care (e.g. for diagnostic or therapeutic decision-making) and the health outcomes and policy implications of that clinical use.

Bioinformatics. Advances in tools and techniques for data generation are rapidly increasing the amount of data available to researchers, particularly in genomics requires researchers to rely more heavily on computational and data science tools for the storage, management, analysis, and visualization of data. Projects could include research and development of transformative approaches and tools that maximize the integration of data (e.g., genomics data, environmental measures, phenotypes, and biomarkers) and data science into biomedical research.

Genomic Technology Development. Research in genomic technology development seeks to advance methods, technologies, and instruments needed to generate increasingly complex genomic data, including new and improved methods for sequencing nucleic acids, detecting genomic variation, and mapping epigenomic and epitranscriptomic features.

Genome Structure and Function. Research in genome structure and function utilizes high-throughput genomic methods to understand how the genome is organized, to detect structurally complex genome variation and 3D genome organization, to assess how the genome functions, and to assess how genomic variation affects genome function to influence phenotypes, including those related to human health and disease.

NHGRI is committed to maximizing the utility of genomics for all populations. Racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, sexual and gender minorities (SGM), and other populations who experience poorer medical outcomes have been vastly underrepresented in genomic research to date. The underrepresentation is widely recognized to seriously impair investigators' ability to interpret genomic variants and use them in clinical care across the spectrum of race, ethnicity, socioeconomic status, access to care, and health and morbidity. Understanding and use of the vastness of human genetic variation for clinical diagnosis, prevention, and treatment require studies of genomic variation and its disease consequences across sociodemographic groups. For this reason, projects are strongly encouraged to include minority health and health disparities populations. Where applicable, projects should emphasize the use of samples that are derived from individuals of diverse ancestry, that allow for consideration of sex as a biological variable, and that allow for the consideration of applications to diseases disproportionately affecting minority health and health disparities populations.

Additional information about the research priorities of NHGRI is available at the following link: https://www.genome.gov/research-funding/Funding-Opportunities.

National Institute of Mental Health (NIMH)

NIMH is interested in research programs examining the contribution of genetic and genomic factors to risk and resilience in psychiatric disorders in ancestrally diverse minority health and health disparity populations as described in our strategic objectives:

Specific interests include but not limited to the following:

• Discovery of genetic variants that are associated with serious mental illnesses in ancestrally diverse racial and ethnic minority populations

• Interaction of genetic and familial risk with and environmental (e.g., socio- economic, demographic factors) that may influence development of serious mental illness in these populations, including genetic risk for suicide

• Deep clinical characterization of cohorts from genetically diverse racial and ethnic minority populations for genetic studies. Collection of a minimum set of clinical data and Common Data Elements is expected as per NOT-MH-20-067

• ELSI research to address a range of ethical, legal and social issues for individuals from minority communities in psychiatric genetics research. Examples of ELSI research include: outreach and community engagement in psychiatric genetics research study design and execution, research on how to avoid or mitigate against stigmatization, group harms, and unintended negative social implications/exacerbations of structural inequalities involving cognitive and behavioral traits, ethical and cultural issues surrounding informed consent, data sharing, and privacy for data collected in a heath care setting

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities (i.e., African Americans/Blacks, Hispanic/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians, and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations).

NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework,https://www.nimhd.nih.gov/about/overview/research-framework.html, for more information).

Specific interest include but not limited to the following:

• Identify novel early diagnostic genetic biomarkers with clinical utility to assess risk, development, and progression of various diseases in populations with health disparities
• Examine the interplay of social, cultural, environmental, and biological factors (including genomics) that affect health disparities and health advantages among racial ethnic subpopulations
• Determine how do structural and interpersonal racism impacts genomic/biological pathways and health outcomes across the life course in various populations
• Examine how social contextual factors affect the epigenome and consequently downstream biological processes
• Identify genetic mechanisms of disease or resilience that contribute to differences in disease phenotypes among different populations with health disparities
• Conduct research to address a range of ethical, legal and social issues to avoid or mitigate stigmatization, group harms, and unintended negative consequences

Awardees are expected to comply with the NIH Genomic Data Sharing Policy (https://gds.nih.gov/) as well as the NHGRI Genomic Data Sharing Policy (https://www.genome.gov/about-nhgri/Policies-Guidance/Genomic-Data-Sharing/data-standards#guidingprinciples). Resources such as study protocols, informed consent form templates, aggregate results, and bioinformatic tools are expected to be made available through an open access section of a database such as dbGaP, AnViL, other public web sites, and/or publication in the scientific literature. Centers are encouraged to get feedback from the communities in which the research will be performed regarding plans for sharing individual level data resulting from the research projects with the scientific community for research purposes. Feedback and recommendations for data access, protection of participant and patient privacy and confidentiality, and management of health information should be integrated into the Center’s data sharing plan. Note that any project receiving NIH funding that collects or uses identifiable, sensitive information is automatically deemed issued a Certificate of Confidentiality (CoC).

This FOA will provide up to $500,000 in direct costs for genomic technology and equipment in addition to the overall cost cap, only in year one of the award period, as a one-time cost expenditure for the Center. If such research resources are requested, the technology and/or equipment should be relevant to the scope of the proposed research and the implementation of the genomic research projects.Resources include but are not limited to laboratory equipment, supplies, statistical and bioinformatic software including computational equipment (e.g., workstations, servers) and cloud computing resources.

Collaborations with research-intensive institutions, industry, and other stakeholders needed to obtain the expertise to perform the proposed research and carry out the aims of the cores can be included. These collaborations in combination with the Research Center should provide the complete capacity needed to carry out the genomic research projects and the didactic and practicum experiences. Collaborations between the Diversity Centers for Genome Research funded through this FOA and RFA-22-027 and other NHGRI Consortia will be encouraged after funding.

Plan for Advisory Committees: Each Center must have an External Advisory Committee (EAC).The EAC should consist of at least six members from the target communities and external scientific advisors with expertise directly relevant to the theme of the Center. A representative from NIH will also serve as an ex officio member of the EAC. Responsibilities of the EAC include but are not limited to: evaluating the progress towards the organization, development, implementation and evaluation of the genomic research center; evaluating protocols, procedures and the identification of appropriate equipment; assessing recruitment and retention of relevant faculty and trainees and plans for capacity building; assessing the solutions for logistical problems; and reviewing the outcomes of the tests and implementation of protocols and procedures. The Center may also have an Internal Advisory Committee (IAC) comprising scientists not directly supported by the Diversity Center for Genome Research Award. The IAC is optional and cannot act as a substitute for the EAC. The EAC and IAC, if needed, should meet quarterly in Phase I.

Program Metrics and Evaluation: It is expected that the Diversity Center for Genome Research will keep track of Center success metrics. These metrics should include, but are not limited to:

• Increased collaborative genomics research through implementation of pilot/developmental studies, NIH-funded studies and studies funded by other federal and non-federal agencies
• Development of additional research projects, analyses, and tools
• Increased submission of applications to genomic research funding opportunities and/or investigator-initiated genomic grant applications, and success in obtaining additional research funding
• Dissemination of research and training products, as reflected by publications in high impact journals and presentations at scientific conferences
• Enhancement of institutional capacity for conducting genomics research including but not limited to capacity to support multidisciplinary research studies
• Institutional commitment and collaboration with other NIH funded programs or consortia
• Number of students, early-stage and experienced investigators, and investigators from various disciplines/departments and specialties exposed to genomic research experiences including those from underrepresented groups (e.g., racial, and ethnic minorities, persons with disabilities, or persons from disadvantaged backgrounds).
• Trajectories toward successful genomic research careers of students, trainees and faculty exposed to workforce development activities
• Progress of the research projects
• Success of community engagement processes and outcomes

Site visits

NHGRI Program staff will perform a site visit (in person or virtual), before the initial award, to assess the environment relative to the Diversity Center for Genome Research aims and integration of the cores.

Non-responsive applications

Applications with the following properties will be considered non-responsive, and will not be reviewed:

• Applications that do not have a primary focus on genomics research.
• Applications that do not include a clear scientific justification for the research projects proposed.
• Applications from ineligible organizations (see Section III below).
• Applications that do not include an attachment to the Overall Component (see Section IV below) titled "Institutional Information" that describes the applicant institution's accomplishments in the education of students from backgrounds nationally underrepresented in biomedical research.
• Applications that do not include all required Components.
• Applications that propose only one or more than three Research Projects.
• Applicants that propose research relevant to only one or a small number of diseases; research utilizing a small number of disease models for proof-of-concept studies may be acceptable when the findings or other outcomes are generalizable.
• Applications that do not include a Milestone Plan.

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the FOA scientific/research contact prior to submission to discuss whether their application is responsive.

Technical Assistance Webinar

NHGRI will conduct a Technical Assistance webinar for potential applicants on Tuesday, October 4, 2022 at 2:00 pm. Information about the webinar will be posted at: https://www.genome.gov/event-calendar/diversity-centers-for-genome-research-FOAs-webinar. The webinar connections will open 15 minutes in advance of the start time. During the webinar, program and grants management staff will give an overview of the FOA and application submission process and field questions from potential applicants. Please send questions in advance to Ebony Madden at [email protected].

Frequently Asked Questions

Questions and answers from the webinar and other frequently asked questions can be found here: https://www.genome.gov/event-calendar/diversity-centers-for-genome-research-FOAs-webinar/faq.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Local Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

To be eligible for this FOA, the applicant institution must be a domestic institution located in the United States and its territories which:

• Has received an average of less than $50 million per year in NIH support and less than $25 million per year of R01 total cost of NIH support for the past three fiscal years;
• Awards doctorate degrees in the health professions or the sciences related to health; and
• Has a documented historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, seehttp://www.nsf.gov/statistics/wmpd/) (i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities)orhas a documented record of: (1) recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers and, (2) for institutions that deliver health care services, providing clinical services to medically underserved communities.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

Ebony B. Madden, Ph.D.
Telephone: 301-503-5620
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Genomic Workforce Development Core: required
• Community Engagement Core: required
• Research Projects: required (two minimum; three maximum)

Overall Component

When preparing your application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments:

The application must include a single attachment titled "Institutional Information" that provides a description and evidence of the institution's explicit accomplishments in the education of students from backgrounds nationally underrepresented in biomedical research, or efforts to provide services to underserved communities.

• For institutions whose historical mission explicitly states that it was founded to educate students from nationally underrepresented backgrounds in biomedical research (i.e., underrepresented racial and ethnic groups [African Americans, Hispanic Americans, American Indians or Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and individuals with disabilities] and/or students from disadvantaged backgrounds, as defined in NOT-OD-20-031), provide the institution's original mission statement and any other information that justified the institution's creation and describes its main functions and services provided.
• For institutions whose mission statement does not explicitly state that they were founded to educate any of the underrepresented groups mentioned above but have a demonstrable historical track record of recruiting, retaining, training, and graduating underrepresented students, the institution must provide information and current figures compared to baseline data from ten years ago that show how the institution's historical track record of training and graduating underrepresented students in biomedical and behavioral-related sciences has improved significantly and how much it has contributed to a substantial increase in the national pool of graduates from underrepresented backgrounds who have pursued or are pursuing biomedical research careers.

Applications must also include a Plan for Enhancing Diverse Perspectives (PEDP).

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

Applications must include a PEDP submitted as Other Project Information as an attachment.

These items must be uploaded as separate attachments in pdf format with filenames that correspond to the individual items. Applications lacking these required items will be deemed incomplete and will not be reviewed.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

The PD/PI must serve a minimum level of effort of at least 3.6 person months (PM) unless there are two or more PD/PIs in multiple PD/PI applications. In such a case, the minimum level of effort can be reduced to 2.4 PM for each multiple PD/PI. If a PD/PI serves a role in multiple components, the effort that is served in each component can be combined to meet the requirement.

Collaborations with research-intensive institutions and industry needed to obtain the expertise to perform the proposed research and carry out the aims of the cores can be included but at least 70% of the budget (direct costs) will need to stay at the applicant institution.

In addition to attending meetings to present Center research, PD/PI(s) should budget for Center leadership including PI(s), Core leads, and Research Projects leads to attend a 2-day consortium meeting in Bethesda, MD twice per year to present research progress and discuss challenges.

PEDP implementation costs: Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7:https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims::Applicants should provide a Program Overview describing the research focus area(s) in genomics supported by the Center and the rationale for seeking support for the proposed focus area(s) within the context of the applicant institution's priorities, and long-range goals and vision for genomic research at the institution. Describe and justify how existing and requested resources will be utilized and leveraged to implement the institutional plan to develop, expand, and maintain an environment and framework suitable for achieving the objectives of the Center.

Research Strategy:

Summarize relevant organizational, educational, and scientific strengths and weaknesses at the applicant institution and describe how the proposed activities will enhance diverse perspectives in genomic research. Describe the overall goals for the Center during the proposed project periods, the specific institutional commitments that will be made to help achieve those goals, and the key activities that will be conducted to achieve each of the proposed goals.

The application should describe the specific aims for the Center, describe the synergism between the cores and the research projects, and summarize how the proposed components and activities will increase genomic research capacity at their institution, enhance diverse perspectives, training, and career development within the genomics research workforce; bring novel ideas into the field of genomics; and increase participation of underrepresented populations and underserved communities in genomics research that often experience health disparities. Applicants should describe how input and recommendations from engagement of the community will be incorporated in all components of the Center.

Milestone Plan:

Applications are expected to include a Milestone Plan. The Milestone plan should:

• Provide a detailed timeline for the anticipated attainment of each milestone and the overall goals.
• Identify any impediments that could require an addendum to the research plans, milestones, or timeline with a discussion of alternative approaches.
• A timeline (Gantt chart) including milestones is required for both the UG3 and UH3 phases. Milestones should be provided for all cores and research projects. Yearly quantitative milestones are required to provide clear indicators of a project's continued success.

The filename "Milestone Plan-PI-NAME.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers. Applications that do not include the Milestone Plan will be considered incomplete and will not be reviewed.

Letters of Support:

Applications are expected to include letters from the appropriate high-ranking applicant institutional official(s) that:

• Indicate the commitment of the applicant institution to the center goals and how the center activities will be integral to the broad institutional vision for genomics research.
• Specify any institutional support, for example financial support, dedicated space, salary support for professional or administrative staff, interface with other grants, centers, and initiatives.
• Indicate the commitment of the institution to participate in activities intended to foster and enhance DCGR programmatic coordination, communication, and research collaborations across DCGR sites, as well as participate in other consortia working towards developing, adopting, and implementing best practices in genomics research and training.
• Applications should include letters of support from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent) from all collaborating institutions to substantiate the institutions commitment to the proposed plan. Each institution should also state its commitment to overcoming any administrative obstacles to the implementation of the application. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned Center. Where applicable, the letter should address institutional commitment to any faculty who participate in associated skill-building activities. It should also address commitment to collaborating and sharing data as appropriate. The letter should also briefly discuss the institution's plans for sustaining an active program of genomics research after the Diversity Center for Genome Research funding.
• Describe the coordination between the training and career development activities proposed in this application and existing activities at the institution. Synergy amongst the programs is encouraged; however, expenses should not duplicate existing activities.
• As the programmatic activities of this initiative will support collaborations, letters of support from the related institution/organization for the relevant programmatic component should be provided with the application. The letter should briefly describe the support of the genomic research programs and capacity building and how the institution plans to sustain genomics research after funding for the Diversity Center for Genome Research ends.

All other Letters of Support for all application components should be included within this section in the Overall component. Do not include letters of support in other components.

Applications that propose work with American Indian or Alaska Native populations, tribes or communities should include letters of support from the appropriate tribal officials and/or tribal organizations as applicable.

The Letters of Support attachment should begin with a table of letter authors, their institutions, and the type of each letter (institutional commitment or resources; collaboration or role in the project).

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

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Administrative Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

• Travel Funds: The budget should include funds to support travel for Center and Consortium activities, including but not limited to supporting the participation of PD(s)/PI(s), Core leads, Project leads, and additional staff members, as needed, at the 2-day bi-annual Consortium meetings that will alternate between the Diversity Centers for Genome Research locations.
• Other:Funds should be allocated for expenses related to the formation and travel needs of the Center’s External Advisory Board and Internal Advisory Board, if applicable.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. FOA specific instructions are required for the Specific Aims and the Research Strategy in each component. FOA-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no FOA-specific instructions.

Specific Aims: Describe the specific aims for the Administrative Core.

Research Strategy:

Plans for the Administrative Core should clearly describe how the PD/PI will manage and coordinate the Cores, Projects, Advisory Committees, and Mentors, if applicable, to implement the Center's overall plans and carry out all responsibilities. Describe how the Administrative Core will monitor progress and ensure that component plans are implemented. Explain the roles and responsibilities of core personnel, including scientific leadership, administrative management, and coordination of proposed activities.

Include a management plan describing the Center’s organizational and governance structure and plans to manage and, where necessary, reassign institutional resources among schools and/or departments to achieve Center goals. Detail the roles of each proposed Center component in attaining the goals of the Center and describe how the proposed components will interact with each other and with relevant existing programs and resources in the institution. Describe the composition and roles of the EAC, IAC, if applicable, and any committees proposed to help manage the Center activities. Applications should describe the types of expertise of the members that will be recruited for the EAC and IAC; however, applicants should not list potential EAC or IAC members in the application or contact them prior to peer review.

Include an Evaluation Plan to facilitate ongoing Center performance and project management to ensure successful completion of the stated aims. Describe how the evaluation will be conducted, principal performance measures and metrics to be used to assess achievement of short- and long-term goals of each core and project, and potential sources of data. The productivity of investigators, including those with pilot projects, should include monitoring related publications, grant applications and awards. The plan should address administrative functioning (process) as well as scientific and investigator accomplishments (outcomes). Describe key milestones and expected outcomes for each area, as appropriate.

Applicants should describe how investigators within the Center will work in partnership to carry out research projects and aims of the Center cores. Applicants should describe how the Center will work within the consortia including all awardees funded under this RFA (RFA-HG-22-026) and RFA-22-027 and other NHGRI Consortia to share resources and strategies used to overcome challenges.

Letters of Support: See Overall section.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Coree)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Genomic Workforce Development Core

When preparing your application, use Component Type Genomic Workforce Development Core.

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

SF424 (R&R) Cover (Genomic Workforce Development Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Genomic Workforce Development Core)

Research & Related Other Project Information (Genomic Workforce Development Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) (Genomic Workforce Development Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Genomic Workforce Development Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Genomic Workforce Development Core)

Budget forms appropriate for the specific component will be included in the application package.

PHS 398 Research Plan (Genomic Workforce Development Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for the Genomic Workforce Development Core.

Research Strategy:

A Diversity Center for Genome Research should offer innovative, substantive education and outreach opportunities and research experiences that help to enhance diverse perspectives within genomic research. Genomic workforce development should include students, trainees, and new and established investigators, including those from other disciplines such as engineering or medicine who want to acquire genomics expertise.

The goal of the Genomic Workforce Development Core is to increase genomic research capacity for students, trainees, and institution faculty. Applicants should describe how their research will provide opportunities for students, trainees, and faculty to build their genomic knowledge and skills in genomic research. Applicants should describe how the Genomic Workforce Development Core will manage, coordinate, and supervise the entire range of proposed activities for capacity building including monitor progress; and ensure that component plans are implemented.Explain the roles and responsibilities of core personnel, including scientific leadership, administrative management, and coordination of proposed activities.

Applicants should describe the didactic, practicum and research activities and experiences (e.g., courses, seminars, workshops, attending scientific meetings, giving talks, writing papers, etc.) that will be undertaken to support genomic knowledge, genomic research skills and capacity, and career development for students, trainees, and faculty.Career development opportunities include coordination with other activities at the institution and in the geographic area, and development of the individual in a way that is tailored toward their career goals and needs. Describe the academic qualifications, research experience, and productivity of mentors, including those from other institutions.Provide a description of how the proposed research projects will be leveraged to provide research experiences and how the didactic and practicum experiences are aligned with the proposed research projects.

For education activities and research experiences, applicants are expected to develop creative approaches, complementing the standard training vehicles used by academic institutions (e.g., training grants, fellowships, research education programs, seminar programs, coursework). This activity should take advantage of unique aspects of the Center, the investigators' expertise, and other institutional resources to offer innovative, substantive opportunities for students, trainees, and other investigators to develop expertise in genomics. Educational activities and research experiences should be related to the Aims of the Diversity Center for Genome Research.

Community Engagement Core

When preparing your application, use Component Type Community Engagement Core.

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

SF424 (R&R) Cover (Community Engagement Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) (Community Engagement Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Engagement Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Engagement Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Community Engagement Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for the Community Engagement Core.

Research Strategy:

Describe the leadership of this core, and the principles, policies, and practices that will guide its operation. Applicants should define the communities that they plan to engage and describe strategies for community engagement with clear objectives of what the engagement is expected to achieve. Applications should describe strategies for recruiting and maintaining long-term relationships with communities to enhance genomic knowledge, how the recommendations from the engagement will be incorporated into Center research projects, how the engagement will promote participation in genomics research and recruitment and retention of study participants, and how findings will be disseminated from the research projects. Describe how the Core will facilitate collaboration between community members and investigators on Research projects. Describe plans to evaluate whether the strategies to engage communities are successful and the objectives achieved. Describe the activities that will be conducted to get communities input on data access and sharing policies, data confidentiality and privacy, data management, etc. as relevant to the scientific objectives. Describe the activities that will be conducted for the timely and appropriate dissemination of information and data generated by the Center, its research projects, and other activities for diverse audiences, including lay community audiences. Describe the expected outcomes of the proposed dissemination strategies and activities and how the impact of dissemination efforts will be assessed.

Research Projects

When preparing your application, use Component Type Research Projects.

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

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Projects)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Projects)

This FOA will provide up to $500,000 in direct costs for genomic technology and equipment in addition to the overall cost cap, only in year one of the award period, as a one-time cost expenditure for the Center. The technology and/or equipment should be relevant to the scope of the proposed research.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Projects)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims for each Research Project.

Research Strategy:

The Research Strategy should describe the significance of the proposed projects, how it aligns with the NHGRI Strategic Vision, what critical issues in genomics the projects address, and the specific contribution that each project will make to the overall success of the Diversity Center for Genome Research. The research strategies that will be pursued in the projects should be described including the utility of the proposed technology, research tools, software, scientific approaches, methods of analysis, knowledge, etc., to the larger biomedical research community. Describe the research design and genomic approaches in detail, including methods and technologies that will be used. The population and samples to be analyzed should be identified and the research strategy should include a plan for data and sample acquisition, storage, management, etc. including phenotypic and genomic data. If environmental measures or risk factors are being analyzed to explain etiology along with genetic risk factors, robust validated environmental measures or biomonitoring should be demonstrated as well as an explanation of how any environmental samples might be collected and stored. All applications, regardless of focus, should explain how generalizable, broadly useful, and transformative the findings and approaches will be to the field of genomics.

The bioinformatics and data science needs of the research projects should be clearly described, including issues of data confidentiality and privacy, the analytic capability and computational approaches and tools that will be used and/or developed, and the relevant investigators' bioinformatics and data science experience. Applicants are encouraged to describe their approaches to ensure that the data and analytical resources supported through this FOA will conform to the FAIR principles (Findable, Accessible, Interoperable, and Reusable; seehttps://www.force11.org/group/joint-declaration-data-citation-principles-final).

The applicant should identify potential major challenges or problems that might be encountered in conducting the proposed research and discuss how these would be addressed should they arise.

Sustainability:A primary goal of the Diversity Center for Genome Research program is to increase genomic knowledge, skills, and research experiences at Minority Serving Institutions with a mission to serve historically underrepresented populations in biomedical research, thereby increasing their opportunities for future funding of genomic research through competitive grant processes, as well as through increased investment in genomics research by the applicant institution. Dedicated funds for the Diversity Center for Genome Research will provide 5 years of support. Renewals will be allowed but are not guaranteed. Therefore, applicants need to discuss the issue of future sustainability of their research programs beyond the Diversity Center for Genome Research funding and how the research activities will contribute to success in continuing the research efforts of its participants. This section of the application should /refer to the letters of Institutional commitments (see below) to provide an overview of the long-term prospects for sustained research.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

• • All applications generating data, regardless of the amount of direct costs requested for any one year, should provide a Data Sharing Plan that includes a timeline for data sharing, information on proposed data sharing platform or database, and descriptions of data types, metadata, and phenotypic data. Applicants should refer to this notice describing NHGRI’s Expectation for Sharing Quality Metadata and Phenotypic Data: https://grants.nih.gov/grants/guide/notice-files/NOT-HG-21-022.html.
  • Applications should adhere to the NIH Genomic Data Sharing Policy, including general NHGRI expectations for implementation of this policy (https://www.genome.gov/about-nhgri/Policies-Guidance/Genomic-Data-Sharing). Whenever possible, NHGRI strongly encourages studies involving human data to use data generated from sources that can document explicit consent for future research use and broad data sharing.
  • Resource sharing plans should include plans for deposition of any variant-level data and assertions generated through these projects into theClinVarpublic archive.
  • Applications involving development of methods, software, or other tools for genomic medicine should include detailed plans where applicable with timelines for disseminating them to the scientific community, so they are readily usable.
  • Methods, tools, and software should be well-documented and where applicable made available via public repositories.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Projects)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

Post Submission Materials

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

Section V. Application Review Information

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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, 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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed center rigorous? If the aims of the center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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 center?

Specific to this FOA:

Regarding the proposed leadership for the Center, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed projects and meet milestones and timelines?

Do they have appropriate expertise in study coordination, data management and statistics?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the center do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

How does the Center promote and support innovation that will strengthen and sustain genomics research at the institution?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA:

Are the proposed collaborators likely to work together synergistically?

Do the interdisciplinary collaborations have unique expertise and/or diverse perspectives to address research questions?

Are potential problems, alternative strategies, and benchmarks for success for the cores and research projects presented?

Is an appropriate Management Plan provided describing the Center’s organizational and governance structure, including external and internal, if applicable, advisory committees, and strategies for overseeing, managing, and coordinating the entire range of proposed Center activities?

Are appropriate measures and procedures proposed for monitoring progress and ensuring that component plans are implemented?

Is an evaluation plan provided that incorporates appropriate performance targets, objectives, and outcomes?

How well does the selection and use of the research projects support the overall goals of the proposed center?

To what extent are the proposed activities likely to enhance investigator expertise, the tools for, and conduct of genomics research at the applicant institution?

To what extent are the proposed activities likely to enhance and sustain productive collaborations and partnerships with stakeholders including community members and organizations to promote research efforts and the dissemination of research findings?

How well does the selection and use of the research projects support the overall goals of the proposed center?

Are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals based on sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Are potential ethical issues adequately addressed?

Is the process for obtaining informed consent or assent appropriate?

Is the eligible population available?

Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection?

Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate?

Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) 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), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA:

How likely is the proposed Center to foster and enhance environments conducive to investigator development, particularly for new and early career investigators from diverse backgrounds?

To what extent do the institutional letters of support indicate that the applicant institution is fully committed to achieving the goals and objectives of the proposed Center, and that the Center will be integral to achieving the broad institutional vision for genomics research?

Is it clearly described how the Center will leverage existing NIH- or other federally funded projects and resources to conduct research and disseminate findings?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Center-Specific Review Criteria

• Are the proposed collaborations conducive to achieving the Center's goals?
• Are adequate mechanisms proposed for regular communication and coordination among investigators in the Collaborative Center?
• Are adequate administrative structures in place for the day-to-day management of the center, including arrangements for internal quality control of ongoing research?
• Do the letters of Institutional commitment suggest that the environment is conducive to a sustained research enterprise?
• Does the Center include adequate plans to ensure future sustainability? What additional collaborations will be pursued to further its research program?
• Are the timelines for the cores and projects described in detail and do they consider start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the Center incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Review Criteria - Administrative Core

• Is an appropriate Management Plan provided describing the Center’s organizational and governance structure, including external and internal (if included) advisory committees, and strategies for overseeing, managing, and coordinating the entire range of proposed Center activities?
• Are appropriate measures and procedures proposed for monitoring progress and ensuring that component plans are coordinated and implemented?
• Are the roles and responsibilities of core personnel clearly delineated and appropriate?
• Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety, if needed, in clinical research projects?
• Is an evaluation plan provided that incorporates appropriate performance targets, objectives, and outcomes?

Review Criteria Workforce Development Core

• Are the roles and responsibilities of core personnel clearly delineated and appropriate?
• Are core personnel conducting research that is relevant to NHGRI’s scientific mission?
• Is there appropriate coordination or synergy (without duplication) of workforce development activities with other existing activities at the institution?
• Are the proposed activities likely to influence genomic career choices for students? Are the proposed activities likely to enhance genomic career development and transition to independence for trainees and faculty? Have individual career goals and needs been considered in developing these activities?
• Are appropriate advisory and technical support resources in place to support rigorous research design, appropriate statistical analyses, and compliance with applicable Federal laws, regulations and policies for research involving human subjects and live vertebrate animals?
• To what extent are the proposed activities likely to enhance genomic research skills and opportunities for students, trainees, and faculty? Do the research experiences and mentoring opportunities encourage participation of students, trainees, and faculty from diverse backgrounds?
• To what extent are plans for overseeing and mentoring students, trainees, and faculty, including commitment of the identified mentors, likely to enhance their professional development?
• Are faculty recruitment and retention strategies clearly described and likely to ensure that the Center will meet its goals?

Review Criteria - Community Engagement Core

• Are the roles and responsibilities of core personnel clearly delineated and appropriate?
• To what extent are the proposed activities likely to successfully establish or enhance sustainable partnerships with community-based organizations and community members to address their health-related concerns and promote participation in the Center's research activities?
• Are plans to engage communities well described and consistent with the objectives of the Center?
• Are plans for dissemination of information to diverse stakeholders well described and consistent with the objectives of the Center?
• To what extent are the proposed activities likely to result in strengthened community-engaged research approaches?

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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

Not applicable.

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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 (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 will receive a written critique.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Human Genome 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 and programmatic balance, including a diversity of approaches; adequacy of data sharing, software and analysis sharing and resource sharing plans; expansion of the community of genomics researchers to include new investigators, experienced investigators who are new to this field, and investigators from diverse backgrounds, including those from demographic groups that are generally underrepresented in genomics.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

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

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

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

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

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Determining, designing, and adapting protocols, setting project milestones, implementing core activities, and conducting the research projects.
• Participating in consortium-wide Steering Committee and other group activities, as needed.
• Implementing Steering Committee recommendations for data collection, and standardization if warranted for cross-study analyses.
• If needed, obtaining the necessary consent or re-consent and IRB approval for participation in the research projects.
• Developing and implementing appropriate educational resources for patients, clinicians, and/or community members.
• Cooperating with other recipients in the multi-center publications and release to the scientific community of methods, tools, and results, and other resources.
• Sharing results according to the NIH Genomic Data Sharing Policy, and any other data sharing policy agreed to between the NIH and the applicant.
• Adhering to policies regarding data access, publication, and intellectual property established by NIH and the Steering Committee for this program.
• Not disclosing confidential information obtained from other members of the program.
• Submitting periodic progress reports in a standard format, as agreed upon by the Steering Committee and the Center’s External Advisory Committee.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist(s) are scientists of the NHGRI who will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the program and that NIH staff will be given the opportunity to offer input to this process. The Project Scientist(s) will participate as a member of the Steering Committee and will have one vote. He/she/they and/or other NHGRI scientists may serve on additional committees, when appropriate. The NHGRI Project Scientist (and other NHGRI program staff) may work with recipients on issues coming before the Steering Committee and, as appropriate, other committees. NHGRI Program staff, on behalf of the NHGRI, will have the same access, privileges, and responsibilities regarding the collaborative data as the other members of the Steering Committee.

The Project Scientist(s) will have the following substantial involvement:

• Serving as a liaison, helping to coordinate activities among and for the recipients, and as an information resource for the awardees about genome research activities. The Project Scientist(s) will also coordinate the efforts of the program with other groups conducting similar studies.
• Attending all Steering Committee meetings as a voting member and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with situations that require coordinated action.
• Reporting periodically on the progress of the program to the Director of NHGRI, as appropriate, and to the National Advisory Council for Human Genome Research, as appropriate.
• Retaining the option to recommend the withholding or reduction of support from any project that fails to achieve its goals or comply with the Terms and Conditions of the award.
• Serving on subcommittees of the Steering Committee, as appropriate.
• Assisting recipients in the development, if needed, of policies for dealing with situations that require coordinated action.
• Providing advice on the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed in the course of this program to the scientific community at large.
• Participating in data analyses, interpretations, and, where warranted, co-authorship of the publication of results of studies conducted through the program.
• Other NHGRI staff may assist the recipients, as designated by the Program Official.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

• The Steering Committee will serve as the main scientific body of the program. The Steering Committee will be responsible for coordinating the activities being conducted by the program. The Steering Committee membership will include one NHGRI Project Scientist, one Project Scientist from component NIH Institute/Centers (ICs) funding an award, and the PD/PI from each awarded cooperative agreement from this and accompanying FOAs. The Steering Committee may add additional members, and other government staff may attend the Steering Committee meetings as desired. It is anticipated that additional coordination mechanisms may be set up with other U.S. and international groups that may collaborate with the program.
• Recipients agree to the governance of the projects through a SC. The lead investigator(s) from each Center and an NHGRI representative will comprise the SC. All major consortium decisions will be determined by a majority vote of the SC. Each Center and the NHGRI Program Office will have one vote. Note that each Center will have one vote, even if there are multiple PD(s)/PI(s). If the Center chooses to utilize the multi-PD/PI mechanism, all the PDs/PIs are expected to participate in all SC meetings and teleconferences; however, each Center has one vote. It is anticipated that SC meetings will be held up to once a month by conference call and 2 times a year in person. The first year, during network establishment, may require more frequent contact.
• Members of the SC will be required to accept and implement policies approved by the SC.
• To address particular issues, the Steering Committee may establish Working Groups as needed, which will include representatives from the consortium and the NIH and possibly other experts.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened including a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

Finding Help Online: 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]

Ebony Madden, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-503-5620
Email: [email protected]

Jonathan Pevsner, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-728-5618
Email: [email protected]

Geetha Senthil, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-402-0754
Email: [email protected]

Rina Das, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: [email protected]

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

Anneliese Galczynski
National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4935
Email:[email protected]

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: [email protected]

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.