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

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute of Environmental Health Sciences (NIEHS)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Limited Competition: Specialized Centers of Excellence on Environmental Health Disparities Research [P50 Clinical Trial Optional]

Activity Code

P50 Specialized Center

Announcement Type

New

Related Notices
  • September 26, 2019 - Notice of Technical Assistance Webinar for RFA-MD-20-001. See Notice NOT-MD-20-006.
  • NOT-MD-19-024
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128
Funding Opportunity Announcement (FOA) Number

RFA-MD-20-001

Companion Funding Opportunity

None

Number of Applications

Only one application per institution, as defined in Section III. 3. Additional Information on Eligibility.

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

 93.307, 93.113 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications from eligible institutions of higher education for specialized center grants to support multidisciplinary research, research capacity building, and community-engaged research activities focused on understanding and reducing or eliminating environmental health disparities, defined as inequities in population health mediated by disproportionate adverse exposures associated with the physical, chemical, social and built environments.

Key Dates
Posted Date

September 20, 2019

Open Date (Earliest Submission Date)

October 22, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 22, 2019  

All applicants are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

March 2020

Advisory Council Review

May 2020

Earliest Start Date

July 1, 2020

Expiration Date

November 23, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Background

    Social determinants of health--the conditions in which people are born, grow, live, work and age--shape individual and population health and wellbeing across the life course, and include a broad range of factors such as access to safe housing, affordable healthy food, potable water, green space, clean air, and supportive social networks. These health determinants are in turn shaped by wider forces including economics, social policies, politics and personal and community beliefs and value systems. Unequal distribution of health-promoting social determinants across various populations is increasingly understood as a significant contributor to persistent and pervasive health disparities. A focus on health equity calls for addressing determinants of health that put health disparity populations and vulnerable communities at a disadvantage for achieving positive health outcomes.

    Within the context of social determinants of health, “environmental determinants” stand out as critical for improving minority health and reducing or preventing health disparities because they are amenable to intervention and prevention strategies. The term ‘‘environmental determinants’’ encompasses the social environment, built environment, and physical environment, often referred to collectively as the "exposome." Environmental influences are not limited to natural amenities and exposures to physical, chemical, or biological agents; equally important are the interactions between those factors and social and economic stressors, institutional processes and health-promoting factors.

    Evidence suggests that health disparity populations generally experience higher levels of cumulative exposure to adverse social factors such as poverty, lower-quality education, less access to healthy food, chronic and acute psychosocial stress and lifelong patterns of discrimination, in addition to physical, biological and chemical environmental hazards. Conversely, access to the positive effects of the natural environment (e.g., green space), such as opportunities for health-enhancing physical activity and buffering against hazardous exposures, is often disproportionately lower in these populations. Public and environmental health interventions, urban planning and public education programs are recognized approaches that can be used to achieve health and environmental equity and potentially create healthier and safer environments for everyone.

    Existing programs established independently and jointly by the NIMHD and the NIEHS have fostered collaboration across disciplines and enabled multidisciplinary teams of community and academic experts from diverse backgrounds to conduct research and training on environmental health disparities. Building on those efforts, NIMHD and NIEHS are issuing this joint research program to stimulate research on environmental health disparities.

    For the purpose of this FOA, ‘‘environmental health disparities’’ are defined as inequities in health and illnesses mediated by disproportionate exposures associated with the physical, chemical, biological, social, and built environments. NIH-designated U.S. health disparity populations are Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.

    Research Objectives and Expected Outputs and Outcomes

    This initiative will support multidisciplinary research to generate innovative approaches to mitigate environmental health disparities and improve access to healthy and sustainable environments for health disparity populations and vulnerable communities. Each center is expected to foster interdisciplinary collaboration, synergistic research projects (see descriptions of required components below for examples of synergy), and core support that enhances the ability to achieve goals and objectives in the following broad areas:

    Research

    • Stimulate research that takes an integrated and systems approach to assessing and potentially mitigating environmental health disparities.
    • Establish and support multidisciplinary research in behavioral, clinical, population, and environmental health sciences and social sciences, including disciplines such as anthropology, communications, demography, economics, engineering, ethics, occupational health and other relevant disciplines.
    • Develop tools and methodologies for data capture, measurement, analysis, and risk assessment that foster integration of the multiple factors that contribute to environmental health disparities.

    Research Capacity and Training

    • Recruit and train members of health disparity populations as investigators to conduct environmental health disparities research.
    • Develop infrastructure and build capacity to establish or expand consortium partnerships with other biomedical and behavioral institutions (designated or otherwise; see Section III.1, Eligible Applicants, below), including tribal health programs, conducting environmental health disparities research.
    • Build capacity of affected community partners and include them as active members of research teams, to assist with the development of research questions and the translation of scientific findings into locally appropriate language(s) and effective delivery formats.

    Communication and Translation

    • Disseminate scientific knowledge that is culturally appropriate and targeted to specific health disparity communities, developed through research collaborations with researchers and members of affected communities or that is relevant to improve environmental health literacy among health care professionals and policy makers.
    • Generate new knowledge that directly benefits impacted communities and population groups, leading to improved diagnosis, health care, intervention, and prevention strategies.

    Outputs (results) expected from the research funded under this FOA may include:

    • Multi-factorial, multi-dimensional measurements and analytic approaches; databases; models; identification of exposure factors and biomarkers of exposure, susceptibility, and/or effects for use in risk analyses and development of prevention strategies.
    • Tools and methods to assess exposure, cumulative health effects, and disproportionate health risks and impacts.
    • Increased number of early-stage investigators from health disparity populations who are trained in cross-disciplinary fields relevant to environmental health disparities.
    • Peer-reviewed research articles.
    • Research project grants obtained by investigators affiliated with the center to advance the science of environmental health disparities.
    • Greater number of affected community members and other stakeholders actively engaged in the research process.

    Outcomes and potential benefits of the proposed research could include:

    • Increased understanding of the complex interactions of biological, environmental, and social domains over time and their influence on environmental health disparities.
    • Translation of basic science and/or population-based research findings into public health initiatives to reduce or eliminate disproportionate exposures, health impacts and environmental health disparities.
    • Translation and sharing of research findings with relevant stakeholders, such as health professionals, state and local health departments and local planning departments, to improve community health and promote health equity.
    • Broader dissemination and wider use of validated tools and methods for more rigorous analyses of the role of environmental determinants in health disparities.
    • Behavioral and systemic changes that reduce or mitigate disproportionate exposures at both the individual and community levels.
    • Enhanced health promoting factors.
    • Greater number of investigators from health disparity populations conducting research on environmental health disparities.
    • Increased scientific and environmental health literacy of research partners, community members and other stakeholders.

    Specific Areas of Research Interest

    Applicants should propose to conduct original, innovative, multi- and trans-disciplinary research to advance understanding, mitigation and prevention of environmental health disparities. Projects are expected to address intersecting domains of influence (biological, behavioral, physical and sociocultural environment) and levels of influence (individual, interpersonal, community, societal) using a multi-domain, multi-level perspective (see the NIMHD Research Framework, available at https://www.nimhd.nih.gov/about/overview/research-framework.html).

    Projects must include a focus on one or more NIH-designated U.S. health disparity populations (see above). Comparison groups may be included as appropriate for the research questions posed. Projects may address a range of diseases and conditions associated with significant morbidity and mortality in health disparity populations, including but not limited to obesity, diabetes, cardiovascular disease, asthma, COPD and other respiratory conditions, cancer, HIV/AIDS and other infectious diseases, infant mortality, maternal morbidity and mortality, chronic stress, depression, and others with a known environmental component.

    This initiative encourages (1) research on cumulative environmental exposures and specific windows of susceptibility (life stages associated with enhanced sensitivity) that may put individuals at greater risk for adverse health outcomes; (2) studies that integrate etiology, genetics, diagnosis, and intervention to address environmental health disparities; (3) multi-level analyses and interventions examining multiple factors that cut across multiple diseases or conditions; (4) research on the suite of environmental factors that contribute to health disparities in understudied geographic areas; e.g., in rural and remote communities, tribal communities (on and off reservations), migrant and/or immigrant communities; (5) longitudinal or retrospective studies to answer questions not amenable to cross-sectional studies; and (6) community-engaged translational research projects.

    Priorities and Approaches

    Priorities and approaches are categorized below into five broad topic areas. These are provided as examples and are not meant to be comprehensive or restrictive. Applications addressing two or more topic areas should have a unifying scientific theme to promote synergy between the cores and research projects.

    Cumulative Health Effects of Multiple Environmental, Physical, and Social Stressors

    • Characterization of the cumulative effects of exposures to multiple environmental chemical contaminants in combination with the effects of social stressors like poverty, psychosocial stress, and discrimination on health conditions
    • Application of an eco-sociological approach, modeling, or multi-omics analyses to investigate these complex interactions
    • Cumulative health risk assessments related to indoor, outdoor and seasonal exposures in urban, suburban, or rural settings, including effects of occupational exposures 

    Sustainable Approaches to Reduce Disproportionate Health Burdens and Build Community Resilience

    • Qualitative and quantitative effects of “food injustice,” such as lack of access to wholesome food or exposure to chemical or biological food contaminants, on environmental health disparities
    • Ecosystem management methods and approaches for improving environmental conditions and eliminating environmental health disparities
    • The role of natural amenities and services ("ecosystem services," "green infrastructure") in reducing exposures to environmental pollution, protecting and promoting public health and well-being
    • Environmental health literacy (i.e., improved capacity in scientific literacy and numeracy related to environmental risks) among affected communities to enable sustainable lifestyle and community-level changes to improve health
    • Novel methods for economic benefits analysis to measure improved sustainability associated with mitigating health disparities

    Harmful and Healthful Aspects of the Built Environment, Housing and Transportation

    • Linkages between availability and access to neighborhood resources like outdoor green spaces, fresh wholesome food, public transportation, complete and walkable streets, designated bike trails, safe schools and neighborhoods, and healthy housing, or pollution exposures and improved health
    • Relationships between built environment characteristics, pollution prevention and the mental health of residents
    • Impacts of proximity to public transportation infrastructure (e.g. rail lines, airports, large roadways) on social stress, physical activity and pollution exposures and/or the role of city planning organizations in prioritizing transportation infrastructure projects and their placement within low-income communities and approaches for mitigation of impacts
    • Neighborhood physical quality/maintenance as a mediator between lead-contaminated soil or water, airborne lead dust and elevated blood lead in children.
    • Impacts of temporary housing that may include obesogenic environments, lack of physical activity, indoor and outdoor air pollution and psychosocial stress.
    • Contributions of outdoor (from stationary and mobile sources) and indoor sources of air pollution (building materials, home furnishings), and housing conditions (crowding, ventilation) in low-income housing on indoor air quality, moisture problems and mold, and injuries as compared to middle and/or upper income housing

    Contribution of Land Uses and Related Policy-making Processes to Environmental Health Disparities

    • Role of planning, zoning, and development including urban redevelopment and re-purposing of land, or the redevelopment of Superfund sites, formerly used defense sites or brownfields, or siting of waste sites in mitigating or exacerbating environmental health disparities
    • Impacts of resource extraction (e.g. unconventional oil and gas development, hydraulic fracking, logging, mining) on water quality, air quality and public health/health disparities in rural and tribal communities
    • Exposures from abandoned mine land and waste sites on tribal and rural lands that contribute to health disparities
    • Relationships and interactions between socioeconomic factors and environmental exposures associated with land use, and the development of translational approaches to help communities and other decision makers reduce or prevent impacts that produce health disparities

    Differential Exposures of Health Disparity Populations to Environmental Hazards

    • Drivers for differential exposures to better understand environmental contributions to disproportionate impacts on health
    • Disproportionate vulnerability to and impact of extreme weather and disaster events in health disparity populations
    • Exposure to chemical contaminants across the life course or across multiple generations, focusing on critical windows of susceptibility and the differential exposures experienced by low-income and health disparity populations
    • Exposures to consumer chemicals in the home (or workplace) including cleaning and personal care products and chemicals in fabrics (e.g., flame retardants) and facilitation of effective translation of research results to reduce these exposures
    • Approaches for data capture to track exposures to emerging contaminants, tools to process and analyze large volumes of data, or for linking electronic-health records (EHRs) or Healthcare Effectiveness Data and Information Set (HEDIS data sets) from health plans to environmental data  
    • Effectiveness of assessing and reducing exposures to pesticide drifts in communities adjacent to active agricultural fields
    • Interventions to address legacy and more recent contributors to water pollution in urban waterways, vulnerable coastal areas, and regions surrounding shale gas removal (fracking) sites
    • Application of innovative technologies and methods to characterize potentially unique pathways that contribute to disproportionate exposures, e.g., unintended consumer product uses, differential consumer product marketing, and cultural activities that may heighten exposures to chemicals in consumer products
    • New tools to assess internal biomarkers of exposure; characterize prior and concurrent exposures; improve methodologies to understand dose-effect relationships or to expand biomonitoring

    Successful applicants will be expected to work closely with community partners to facilitate development of targeted interventions that can be implemented in real-world settings to mitigate or prevent environmental health disparities and to improve access to healthy and sustainable environments.

    More information about the research priorities of NIMHD and NIEHS is available at the following links:

    NIMHD Research Framework

    https://nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html

    NIEHS

    http://www.niehs.nih.gov/about/strategicplan/index.cfm

    NICHD has specific interests in research on maternal morbidity and mortality.

    Required Components:

    Each center must include the following components:

    • Administrative Core
    • Investigator Development Core
    • Community Engagement and Dissemination Core
    • Research Project(s)

    Descriptions of Required Components

    The Administrative Core will provide overall project oversight and evaluation, ensuring that component plans are implemented per proposed timelines, submitting annual progress reports to NIH, monitoring progress on research projects and pilot projects, and ensuring that research activities comply with applicable federal regulations and policies. The core must be directed by the overall center's PD(s)/PI(s). The core director is expected to interact with the institution's administrative leadership to enhance the success of the center and its partners. The core will oversee establishment and maintenance of a publicly accessible website providing summaries of research projects and progress updated at least annually to include products such as publications and reader-friendly summaries of results and their impact on communities or groups under study. Resources may be requested to support seminars, workshops, and other activities focused on environmental health disparities to stimulate interest in the field and promote the professional development of researchers affiliated with the center. The core is expected to foster synergy between the other cores and the research projects and pilot project program, e.g., through the development of shared resources, tools, common data elements or analytic strategies. Through the efforts of this core, the Center is expected to become a valued, trusted, institution-wide resource for expanding institutional capacity and competence to conduct environmental health disparities research.

    The Investigator Development Core will develop and manage a pilot project program focused on environmental health disparities that provides research training and professional development opportunities to generate preliminary data for subsequent submission of grant applications. Core personnel will develop a program to solicit and select pilot projects, provide necessary mentoring and guidance for the development of pilot projects, and support awardees to ensure successful completion of projects to publication of results and submission of subsequent grant applications. Pilot projects, whether observational or interventional, are expected to use a multi-level, multi-domain approach. Eligibility to receive a pilot project award is limited to the recipient institution's post-doctoral fellows, junior faculty and other early stage investigators as defined by NIH (see https://grants.nih.gov/policy/new_investigators/index.htm#definition). The pilot project program is expected to support the training and professional development of researchers who are members of health disparity populations. Recruitment of early career investigators from groups underrepresented in science http://www.nsf.gov/statistics/wmpd/) is strongly encouraged.

    The Community Engagement and Dissemination Core will facilitate equitable and sustainable collaborative relationships with community and other stakeholders to develop, implement, and advance: 1) strategies to strengthen environmental health literacy of the public, policymakers, and clinical professionals; 2) approaches to foster and sustain bi-directional dialogue with identified stakeholders for appropriate translation and application of scientific findings; 3) research training for community residents to enable their participation in the full research spectrum from study design to conduct to communication of community-engaged health disparity interventions; and 4) strategies to assess the effectiveness of core activities and their contributions to the overall mission of the Center. The core will 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 and pilot projects and strategic planning to translate findings into sustainable community and system-level changes at the local level and beyond. Core activities are expected to contribute to scientific advancements such as improved interventions based on local knowledge, improved cultural competency of investigators, and strengthened community-engaged research approaches, and to improvements within the community (broadly defined) such as increased environmental health literacy, greater knowledge of environmental contributions to health disparities and ways to recognize, prevent, reduce or eliminate them.

    Research Project(s) must address research questions relevant to environmental health disparities. One to three research projects may be proposed that vary in scale and scope, with the caveat that all research projects together should total no more than $500,000 in annual direct costs. Research projects may be observational or interventional (i.e., clinical trials) and are expected to use a transdisciplinary, multi-level, multi-domain perspective. For interventional studies, expected improvements in health or a reduction in an environmental health disparity relative to an existing baseline measure for the population(s) under study should be provided when possible. Projects are expected to support training and professional development of researchers who are members of health disparity populations, and to engage collaborators from relevant organizations and stakeholders as appropriate, which may include but are not limited to academic institutions, clinicians, health systems, state and local public health agencies, school systems, community-based organizations, and faith-based organizations. The research team can include senior and junior faculty, pre- and post-doctoral and other trainees, and community members, all with appropriate justification. Projects may be full-scale projects or more exploratory/developmental projects. All projects must have fully developed and specified research plans at the time of application. Planning-phase studies in which the topic or study design is determined after award as a result of community and stakeholder input will not be supported. There should be synergy between the research projects such that there is added value to conducting them as interrelated rather than independent projects. Examples of synergy include but are not limited to pooling data across studies; sharing resources, tools, or common data elements or analytic strategies; or testing different components of the same conceptual or theoretical models.

    Technical Assistance Webinar

    NIMHD will conduct a Technical Assistance webinar for prospective applicants. Information on the date and time of the webinar will be posted on the NIMHD website at www.nimhd.nih.gov.

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

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New
    Renewal applications may only be submitted by awards funded by RFA-MD-11-002, RFA-MD-11-003, or RFA-ES-14-010 that are currently active.

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIMHD and NIEHS each intend to commit $2 million in FY 2020 for a total of $4 million to fund up to 3 awards and NICHD intends to commit $300,000 in FY2020 for a total of $4.3 million to fund up to 3 awards.

    Award Budget

    Award budgets are limited to $950,000 in direct costs annually, excluding consortium indirect costs.  

    Award Project Period

    The maximum project period is five years. 

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    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

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

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

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

    To be eligible for this FOA, institutions of higher education must meet the following criteria:

    • Have a significant number of members of health disparity populations enrolled as students in the institution, including individuals accepted for enrollment in the institution. NIH-designated health disparity populations are Blacks or African Americans, American Indians or Alaska Natives, Asian Americans, Hispanics or Latinos, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.
    • Have been effective in assisting such students of the institution to complete the program of education or training and receive the degree involved.
    • Have made significant efforts to recruit minority students to enroll in and graduate from the institution, which may include providing means-tested scholarships and other financial assistance as appropriate.
    • Have made significant recruitment efforts to increase the number of minority or other members of health disparity populations serving in full-time faculty or administrative positions at the institutions.
    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:

    Thomas Vollberg, PhD
    Telephone: 301-594-8770
    Fax: 301-451-4484
    Email: vollbert@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    6 pages

    Admin Core

    12 pages

    Core (use for the Investigator Development Core and the Community Engagement and Dissemination Core

    6 pages per core

    Project (Research Projects)

    12 pages per project

    Additional page limits 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.

    The application should consist of the following components:

    • Overall (required)
    • Administrative Core (required)     
    • Community Engagement and Dissemination Core (required)
    • Investigator Development Core (required)
    • Research Projects (required, maximum of three)
    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 two separate attachments that provide: 1) a description and evidence of the institution's explicit accomplishments in meeting the special eligibility criteria regarding health disparity populations and 2) the institutional Maintenance of Effort attestations as described below.

    Special Maintenance of Effort Attestation:

    • ·    With respect to authorized activities, the institution, or institutions in the consortium,
    • as the case may be, must agree to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the level of such expenditures maintained by the institutions involved for the fiscal year preceding the fiscal year for which such institutions receive such an award.
    • ·    With respect to any Federal amounts received by the Center or consortium and available for carrying out authorized activities, the institutions involved agree that the institutions will, before expending the award, expend the Federal amounts obtained from sources other than the award.
    Project/Performance Site Location(s) (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 & 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.  

    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)

    Specific Aims:  Describe the specific aims for the project as a whole and how the proposed activities will have a measurable impact on understanding and reducing one or more environmental health disparities.  

    Research Strategy:  Provide an overview of the proposed center with scientific focus on environmental health disparities, including major goals and objectives, the type of research to be conducted, disciplines involved, and disease/conditions, risk factors or determinants under study.

    Summarize the design, structure, and governance of the center, the features and functions of the proposed cores and how they interact and synergize with each other and with the proposed research projects, and plans and procedures to monitor and assess progress of the center.

    Describe how the center will 1) advance the knowledge and science of environmental health disparities, 2) contribute to expanding the development of a diverse workforce for conducting research in the field of environmental health disparities, and 3) facilitate equitable community stakeholder collaborations. To the extent possible, discuss expected improvement, such as a reduction in an environmental health disparity, that could result from the proposed work, over any relevant baseline for the proposed disease, condition, or significant activity.

    Summarize the proposed research projects and explain how they are synergistic with one another and with the cores and pilot project program. Describe plans and procedures to monitor and assess their progress.

    Summarize existing linkages with community stakeholders and the principles, policies, and practices that will guide when and how the center will engage with communities and for what purposes. 

    Letters of Support: Applicants must provide a letter from the president, chancellor, dean, or provost to:

    • Indicate the commitment of the institution to the COE's specific aims and how the COE's activities will be integral to the broad institutional vision for minority health and health disparities research.
    • Specify any institutional support, at the departmental and higher administrative levels, for example, financial support, support for developing early stage investigators to conduct COE research (e.g., access to core facilities, research design and data analysis consultation, etc.), dedicated space, salary support for professional or administrative staff, and interfaces with other grant funded programs, centers, and initiatives.

    All other letters of support, including those for cores and research projects, should be placed together in this section, accompanied by a coversheet that lists each letter, author(s) and their organizational affiliation, and their role on the project. Include letters of support for any collaborative/cooperative arrangements, subcontracts, consultants, community partnerships, etc.

    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.

    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 ‘Admin 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 ‘Core 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.
    • ·    The Administrative Core must be directed by the PD(s)/PI(s) of the Center. Applications that do not comply with this requirement will be deemed non-compliant to the FOA. 
    Budget (Administrative Core)

    Budget forms appropriate for the specific component will be included in the application package. The PD/PI is expected to attend an annual NIMHD COE grantees meeting, held at or near NIH, Bethesda, MD. Funded junior investigators, collaborators or other members of the project team may also attend as warranted. Funds for travel to this meeting should be included in the budget request.

    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)

    Specific Aims: Describe the specific aims for this core and summarize how its activities will support achievement of the proposed center objectives.      

    Research Strategy:  Describe the COE's administrative structure and the roles and responsibilities of Administrative Core personnel including scientific leadership. Include a Management Plan describing the governance structure and operations, and the composition and role(s) of any internal or external committees or advisory boards proposed to help manage the proposed activities. Do not name potential members of external advisory committees or boards in the application. Instead, membership should be described in terms of the qualities, characteristics and expertise that will be assembled to form an advisory committee or board.

    Describe strategies for overseeing, managing and coordinating the entire range of proposed activities, establishing the appropriate measures for monitoring and accessing progress, and for ensuring that component plans are implemented. Describe plans to promote synergy between the cores, research projects, and pilot project program. Describe any activities intended to stimulate interest in the field of environmental health disparities research and promote the professional development of researchers affiliated with the center.

    Include an Evaluation Plan to facilitate ongoing overall project performance and management to ensure successful completion of the stated aims and achievement of desired results and programmatic objectives. 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 developing investigator accomplishments (outcomes). Describe key milestones and expected outcomes for each area, as appropriate.  

    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.

    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 Core)

    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

    Investigator Development Core

    When preparing your application in ASSIST, use Component Type ‘CORE.’

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

    SF424 (R&R) Cover (Investigator 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 (Investigator Development Core)

    Enter Human Embryonic Stem Cells in each relevant component.

     

    Research & Related Other Project Information (Investigator 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 Narrative: Do not complete.

    Project/Performance Site Location(s) (Investigator 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 (Investigator Development Core)

    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core 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 (Investigator Development 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.

    The Investigator Development Core must support 3-5 pilot projects annually (typically beginning in year 2) with a maximum $50,000 limit for an individual pilot project, corresponding to a minimum of $150,000 per year in direct costs, exclusive of consortium indirect costs.

    PHS 398 Research Plan (Investigator Development Core)

    Specific Aims: Describe the specific aims of this core and summarize how it will contribute to expanding and diversifying the scientific workforce for conducting minority health and health disparities research focused on environmental health disparities.

    Research Strategy: Describe how the proposed pilot project program will support research training and professional development of researchers who are members of health disparity populations. Describe plans to solicit and review applications, prioritize pilot projects for funding, review their methodology and research performance, and provide support to recipients throughout the pilot project to publication of results and preparation of subsequent grant applications. Describe advisory and technical support resources in place to support rigorous research designs, appropriate statistical analysis, and manuscript preparation.

    Describe the scope, eligibility requirements, the limit on dollars available and number of years of support per pilot project, oversight and evaluation procedures, and plans to assure that all pilot projects will comply fully with applicable Federal policies, rules and guidelines for research involving human subjects and live vertebrate animals. Do not include detailed proposals or descriptions of specific pilot projects, as pilot projects should not be selected until after the center grant is awarded.

    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.

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

    PHS Human Subjects and Clinical Trials Information (Investigator Development Core)

    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.

    Community Engagement and Dissemination Core

    When preparing your application in ASSIST, use Component Type ‘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 and Dissemination 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 and Dissemination Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Community Engagement and Dissemination 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.

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

    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core 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 and Dissemination 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 and Dissemination Core)

    Specific Aims: Describe the specific aims for this core and the scientific questions to be addressed with community partners in the field of environmental health disparities.

    Research Strategy: Describe how this core will serve as a critical bridge to communities and other relevant stakeholders that may wish to engage in research and dissemination activities to address local or regional environmental health disparities of concern. Identify existing and potential future partners. Describe the core leadership and the principles, policies, and practices that will guide its operation. Describe the types of activities to be conducted for timely and appropriate dissemination of information generated by research projects, pilot projects, and other activities for diverse audiences, including lay community audiences.

    Describe expected outcomes of proposed dissemination strategies and activities and how the impact of dissemination efforts will be assessed. Describe how the core will coordinate dissemination activities with community members, partner organizations, and relevant service organizations or policymakers. Describe how stakeholders will share in the decision making on what, when, how, and to whom findings from research and pilot projects will be presented. Describe strategic planning processes to translate findings into sustainable community and system-level changes at the local level and beyond.

    Describe how the core will oversee engagement of affected community groups and members, provide culturally sensitive translation of research findings to appropriate stakeholders, promote dialogue between Center members and identified stakeholders, and to build capacity in environmental health literacy and risk prevention.

    Prioritize short-, mid- and long-term community engagement dissemination activities and explain how they align with the Center’s mission and overall objectives. Describe clear and measurable objectives, expected products, anticipated impact and significance for environmental public health. Include an evaluation plan and define evaluation tools to measure the impact of core activities (e.g., see Partnerships for Environmental Public Health Evaluation Metrics Manual published by the NIEHS at http://www.niehs.nih.gov/pephmetrics).

    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.

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

    PHS Human Subjects and Clinical Trials Information (Community Engagement and Dissemination Core)

    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.

    Research Project

    When preparing your application in ASSIST, use Component Type ‘Project.’

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

    SF424 (R&R) Cover (Research Project)

    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 Project)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Project)

    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.

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

    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 Project)

    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 Project)

    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.

    If two or three Research Projects are proposed, the combined annual direct costs for all Research Projects should not exceed $500,000.

    PHS 398 Research Plan (Research Project)

    Specific Aims: Describe the specific aims of the research project, emphasizing its relevance to environmental health disparities.

    Research Strategy: Describe the roles and responsibilities of all members of the research team. For multiple PD/PI projects, include a multiple PD/PI Leadership Plan. Explain how the proposed project will contribute to advancing the science of environmental health disparities. Provide a conceptual model that specifies the determinants and mechanisms of health outcomes to be examined and guides the study design, selection of measures, and data analytic strategy. Describe how the project maps onto the NIMHD Minority Health and Health Disparities Research Framework, http://www.nimhd.nih.gov/. Describe the transdisciplinary aspects of the project and describe how relevant stakeholders will be engaged. Describe how the project receives and provides synergy with other COE components. Describe how study findings can contribute to understanding or addressing environmental health disparities on a broad scale, not just at the specific study sites or for local populations.

    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.

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

    PHS Human Subjects and Clinical Trials Information (Research Project)

    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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and for responsiveness by program staff from NIMHD and NIEHS. 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
    1. Criteria

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

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center as a whole 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).

    Scored Review Criteria - Overall

    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 project 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 project rigorous?  If the aims of the project 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?

    Does the center propose a cohesive and multidisciplinary focus on environmental health disparities? Is there evidence of synergy (degree of interaction, collaborative research opportunities) that will be stimulated to accelerate progress in the field of environmental health disparities?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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 project?

    Have the investigators adequately conceptualized the center’s expected results and potential benefits to the broader public?  

    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?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 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 project 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?

    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?

    Does a coordinated interrelationship exist between research projects and cores, and do these components align with the center's overarching theme? To what extent will the scientific objectives of each research project benefit significantly from interactions with other research projects and cores? 

    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?

    To what extent are the institutional commitment and available resources described in the application likely to contribute to the center's success and foster interactions with other scientists across the institution to promote environmental health disparities research? 

    Additional Review Criteria - Overall

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

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not applicable

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not applicable

    Additional Review Considerations - Overall

    As applicable for the center 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 .

    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.

    Overall Impact - Administrative Core

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core 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).

    Review Criteria - Administrative Core

    Reviewers will consider this core for its strengths and weaknesses relative to the points below in the determination of scientific merit.

    Are strategies and approaches to ensure effective overall management and support for the entire range of proposed activities well described, including coordination among cores and research projects, and do they adequately support the likelihood that each component's aims will be achieved within the project period?

    Are the proposed programmatic activities appropriate for enhancing institutional capacity to conduct research on environmental health disparities and to support the professional development of early career investigators in the various disciplines involved?

    Is the organizational and governance structure adequately described and appropriate for supporting the stated aims? Does the management plan adequately describe the composition and roles of any proposed committees or advisory boards to assist in managing proposed activities in terms of the qualities, characteristics and expertise that will be assembled? Are the Core Lead, collaborators, and other key personnel well suited to their proposed roles?

    Does the application include an evaluation plan that incorporates plans for monitoring progress, including appropriate performance targets, objectives, outputs and outcomes? Is the proposed evaluation plan well-conceived and described in sufficient detail to judge its utility for ongoing project management?

    Overall Impact - Investigator Development Core

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core to exert a sustained, powerful influence on the research field(s) involved and support research training and professional development of post-doctoral fellows, junior faculty and other early stage investigators as defined by NIH at the applicant institution, including those who are members of health disparity populations, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Review Criteria - Investigator Development Core

    Reviewers will consider this core for its strengths and weaknesses relative to the points below in the determination of scientific merit.

    Do the pilot project program and other activities described in this core clearly focus on environmental health disparities, and are they likely to expand opportunities for post-doctoral fellows, junior faculty and early stage investigators from health disparity populations to engage in multi-disciplinary and multi-level research in this field? To what extent is the pilot project program likely to encourage early career investigators to propose innovative ideas of importance to environmental health disparities, e.g., in high risk and/or emerging areas?

    Are criteria and procedures for soliciting, submitting, reviewing and selecting pilot projects for funding clearly described and adequately justified in the overall context of the center’s proposed theme, goals and objectives? Are appropriate advisory and technical support resources in place to support rigorous research design and appropriate statistical analyses? Are plans for ensuring compliance with applicable Federal laws, regulations and policies for research involving human subjects adequately described?

    Is information about the expected number, distribution, direct costs and duration of pilot projects sufficient to support the potential for success, as well as program scope and impact? Is sufficient time built into pilot projects for evaluating progress? To what extent are plans for overseeing and mentoring pilot award recipients, including commitment of the identified trainers and mentors, likely to enhance their professional development?

    Overall Impact - Community Engagement and Dissemination Core

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core to exert a sustained, powerful influence on the research field(s) involved and support the research education and training of community members from health disparity populations, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Review Criteria - Community Engagement and Dissemination Core

    Reviewers will consider this core for its strengths and weaknesses relative to the points below in the determination of scientific merit.

    Is the plan for the core's establishment aligned to the center’s mission, appropriate to the proposed community setting, and adequate for success? Are proposed activities responsive to the needs of the community(ies) involved, and are they based on or do they reference relevant cultural aspects of the community?

    Does core leadership demonstrate expertise in community engagement, health communication, or other relevant disciplines and have a track record of success with community-engaged research partnerships? Are community and other stakeholder organizations/members clearly defined and appropriate for the proposed activities, and is documentation of their commitment to the project provided? If a Community Advisory Board is proposed, does it have appropriate and broadly representative membership to be successful?

    Are strategies identified to facilitate and strengthen bi-directional dialogue and keep community members and other stakeholders informed about Center activities and research findings? Do plans and approaches for dissemination incorporate locally appropriate language(s) and preferred methods of delivery, and use terminology appropriate for the general public?

    Are there adequate plans to assess the effectiveness of community- and stakeholder-level engagement and dissemination efforts, and to measure the impact of core activities on the community(ies) involved, such as enhancing environmental health literacy and numeracy or enhancing community capacity to engage in scientific research?

    Overall Impact - Research Project

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the research project to exert a sustained, powerful influence on the research field(s) involved and support research training and professional development of investigators who are members of health disparity populations, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    In addition, for applications involving clinical trials:

    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.

    Scored Review Criteria – Research Project

    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 project 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 project rigorous? If the aims of the project 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?

    Will the project advance the knowledge and science of environmental health disparities? To what extent is the project likely to contribute to better understanding or addressing the role of environmental determinants in minority health and health disparities on a broad scale? Is there evidence of synergy for this project from interaction with other components of the center?

    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 Project Lead(s), collaborators, and other researchers well suited to the project? 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 project?

    Does the study team include researchers who are members of health disparity populations?

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, 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? To what extent does the research project support the thematic focus?

    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 project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 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 project 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?

    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? 

    Is a clear and appropriate conceptual model provided that guides the study design, selection of measures, and data analytic strategy? If the project involves a multidisciplinary study, is there an investigator record for transdisciplinary research and does the project involve appropriate collaborators? To what extent does this project indicate contributions to and benefits to be received through interaction with other projects and cores?

    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? 

    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?  

    Additional Review Criteria – Research Project

    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.

    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.

    Additional Review Considerations – Research Project

    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.

    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.


    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 NIMHD in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

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

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

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Minority Health and Health Disparities and the National Advisory Environmental Health Sciences 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.
    • Geographic distribution of award recipients.
    3. Anticipated Announcement and Award Dates

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

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

    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 awardee 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).

    Prior Approval of Pilot Projects

    Awardee-selected projects that involve human subjects or live vertebrate animals require prior approval by NIH prior to initiation. 

    2. Administrative and National Policy Requirements

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

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

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees 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.

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, 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: GrantsInfo@nih.gov (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: support@grants.gov

    Scientific/Research Contact(s)

    Nishadi Rajapakse, PhD, MHS
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-496-4338
    Email: chandima.rajapakse@nih.gov

    Symma Finn, PhD
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone:984-287-3259
    Email: Symma.Finn@nih.gov

    Juanita Chinn, PhD
    National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-827-4901
    Email: juanita.chinn@nih.gov

    Peer Review Contact(s)

    Thomas Vollberg, Sr. PhD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-8770
    Email:vollbert@mail.nih.gov

    Financial/Grants Management Contact(s)


    Priscilla Grant, JD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-8412
    Email: pg38h@nih.gov

    Jenny Greer
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3332
    Email: jenny.greer@nih.gov

    Bryan Clark, MBA
    National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-435-6975
    Email: clarkb1@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

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