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 on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Environmental Health Sciences (NIEHS)

National Cancer Institute (NCI)

Funding Opportunity Title
Addressing the Etiology of Health Disparities and Health Advantages Among Immigrant Populations (R01 Clinical trial not allowed)
Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PA-17-041 - Addressing the Etiology of Health Disparities and Health Advantages Among Immigrant Populations (R01)

Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-21-080
Companion Funding Opportunity

PAR-21-081 - Addressing Health Disparities among Immigrant Populations through Effective Interventions (R01 Clinical Trial Optional)

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

93.307, 93.866, 93.273, 93.399, 93.113

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support innovative research to understand factors uniquely associated with the immigration experience that contribute to health disparities or health advantages among U.S. immigrant populations.

Key Dates

Posted Date
November 17, 2020
Open Date (Earliest Submission Date)
January 05, 2021
Letter of Intent Due Date(s)

Not applicable

Application Due Date(s)

Standard dates apply.

All applications 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 the listed date(s).

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)

Standard AIDS dates apply.

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date
January 08, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose/ Background:

The purpose of this Funding Opportunity Announcement (FOA) is to support innovative research to understand factors uniquely associated with the immigration experience that contribute to health disparities or health advantages among U.S. immigrant populations. This includes but is not limited to risk/protective factors associated with immigration processes from influences that push migration from the sending country, through the experience of immigration, to the experience of resettlement, short and long term residence in the U.S. and the process of acculturation that affect the health of U.S. immigrant populations (particularly migrant workers, recent and 1st generation immigrants). For the purposes of this funding announcement, the term "1st generation" refers to people who were born in their native country and relocated to the U.S. The term "2nd generation" refers to the U.S. born children of 1st generation immigrants.

In 2017, the immigrant population in the U.S. was 44.4 million accounting for 13.6% of the U.S. population and the immigrant population is expected to increase over the next decade. While point-in-time data show that approximately 30% of immigrant families have incomes below the federal poverty level and 23% of today's new immigrants tend to be less educated, these static data do not reflect the changing situation for most immigrants as they settle into a range of communities, acculturate to different social and cultural values, food choices, employment and educational opportunities, and health challenges.

Factors associated with immigration processes—prior to and while deciding to immigrate, during the migration experience, and throughout the course of becoming accustomed to a new living environment—can translate into higher risk for diseases in the face of multi-level challenges. Immigrants also face multiple ongoing challenges, such as low health literacy, lack of health insurance, limited English proficiency, barriers to effective patient-clinician communication, other limitations in accessing health care as well as maintenance of traditional health practices. Discrimination and prejudice are common and affect daily experiences with individuals and organizations within the host society. Structural factors such as local national laws and policies, the availability of affordable housing, suitable employment, local infrastructure that hinders or facilitates mobility to jobs, schools, medical care, among other things may also impact immigrant health.

Health disparities among some immigrant populations are well documented. However, immigrants may also have better health outcomes than U.S. born populations despite the adversities they encounter. Despite the numerous challenges facing first generation immigrants, research on the mental and physical health of these populations has demonstrated a paradoxical pattern. Recent immigrants have reported better health status than U.S. born populations, a status that is thought to deteriorate with increasing length of U.S. residence and in subsequent generations. More research is needed to understand the drivers of the immigrant paradox, the protective factors and the health advantages and why later generations may not have better health outcomes.

Importantly, risk factors and disease outcomes also vary by sub-populations among immigrants based on the country of origin; however, many studies consider immigrants as a monolithic group according to world region of origin (e.g., Latin America, Asia, Africa). For example, U.S. immigrants from approximately 20 Latin American countries are treated as one Hispanic/Latino group and not separated into nationality sub-populations, Asians (from more than 30 countries) or Africans (from more than 20 countries) are treated as one immigrant group when the health outcomes are often different among different sub-populations. More research is needed to better understand the risk and protective factors unique to each at immigrant sub-population levels.

Most research on immigrant health does not consider the factors and processes that pushed migration of members from groups or subsets of groups from one country to another. Little attention has been given to integration of the pre-existing experiences, (for example, starvation resulting from rapid environmental changes, changing food sources, exposures to toxic chemicals and pesticides), and how the experience of migration itself, or how the process of adjustment and adaptation to a new cultural, social, political and ecological environment may affect health outcomes. It is also important to consider the period(s) in the life course when immigration was experienced and how that experience may affect health outcomes.

Most research on immigrants has focused on health determinants at the individual level but we have limited knowledge of the complexity and interactive nature at interpersonal, community or society level factors. Singularly or interactively, these multiple factors at various levels may contribute to health disparities observed in immigrant populations.

The lived immigration experience comprises multiple levels of influences on health behaviors and health outcomes. Therefore, to improve health outcomes and reduce observed disparities within these populations, more research to understand the risk and protective factors operating at multiple levels for U.S. immigrant sub-population is necessary.

Research Objectives

Given the scientific literature documenting health inequities among immigrant populations, this announcement calls for multidisciplinary research to address the specific underlying causes and mechanisms of health disparities and health advantages among immigrant populations, particularly among migrant workers, recent and 1st generation immigrants.

Many potential individual, contextual and structural factors influence the health of immigrants; therefore, this FOA invites applications that include multidisciplinary research to understand the interplay of multiple factors that cause health disparities among underserved immigrant populations and the mechanisms through which they operate. A framework to demonstrate the multidomain, multilevel factors that may influence health disparities are available at the following URL:

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

Since cumulative processes over the life course at the individual, family, community and society levels are critical for understanding health disparities among immigrants, applicants are encouraged to focus on these critical time periods and interaction with phases of the immigration process across the lifespan. Attention to pre-existing immigration experiences, cultural values and related health practices, the experience of migration itself, or how the process of adjustment, adaptation and assimilation/ long term residence to a new cultural, social, political and ecological environment may affect health outcomes, is encouraged. It is important to consider processes that support resilience and well-being in the lives of immigrants throughout the immigration experience that may buffer the effects of adversity. The role that ethnic enclaves, social networks, resilience, and frequent contact and visits to native country play in explaining some health advantages needs to be considered.

Research applications are encouraged to integrate multiple disciplines such as biological assessments with consideration of sociocultural or behavioral variables and processes for better understanding of complex interactions for excess risk or resilience to health outcomes. Comparison of immigrant health factors between the U.S. and country of origin is encouraged, as is use of existing data from the native country, when possible for comparisons. Applicants are encouraged to consider the multilevel and multi-domain influences on health outcomes of immigrants, put into motion by the immigration process throughout the life course.

Projects should involve collaborations among relevant stakeholders in U.S. immigrant population groups, such as researchers, community leaders and organizations, public health organizations, consumer advocacy groups, faith-based organizations, and healthcare providers. As appropriate for the research questions posed, inclusion of key immigrant community members in the conceptualization, planning and implementation of the research is encouraged (but not required) to generate better-informed hypotheses, development of measurement tools that reflect the lived experience of community members, address issues of significance to the community, and enhance the translation of the research results into relevant and sustainable practice.

Projects must focus on immigrants from one or more NIH-designated populations that experience health disparities in the United States, which include racial and ethnic minorities (Blacks or African Americans, Hispanics/Latinos, Asian Americans, and Pacific Islanders). For this FOA, residents of U.S. territories (Guam, Puerto Rico, American Samoa, Commonwealth of the Northern Mariana Islands, and U.S. Virgin Islands) who migrate to the U.S. mainland are also considered to be immigrants. Research on refugees is not supported under this FOA.

Please note that exclusion of non-English speaking immigrant participants without compelling scientific justification (e.g., studies focused on second-generation immigrant youth) is discouraged and that appropriate translation services should be provided for in the research plan and the budget.

Research is encouraged among distinct immigrant sub-populations based on the country of origin, rather than larger racial/minority populations when feasible (e.g., Koreans, Vietnamese, Cambodian, etc., rather than Asian Americans). For projects involving comparisons across populations, these comparisons should illuminate immigrant-specific phenomena rather than representing more global comparisons between immigrants with non-Hispanic whites or the U.S. general population. Examples of appropriate comparisons include but are not limited to:

  • immigrant subpopulations within the same racial/ethnic minority group (e.g., Nicaraguan immigrants vs. Mexican immigrants vs. Puerto Rican immigrants;
  • immigrants across racial/ethnic minority populations that share similar experiences in the U.S. (e.g., Asian immigrant garment workers vs. Latino immigrant garment workers) or from the same racial/ethnic minority group that work in different labor markets (e.g., Mexican agricultural workers vs. Mexican construction workers);
  • immigrants with their US-born counterparts (Chinese immigrants vs. U.S.-born Chinese Americans).

Specific Areas of research Interest

Research topics of specific interest associated with the immigration processes include but are not limited to

  • Immigration process experiences, especially how the process of adjustment and adaptation to a new cultural, social, political and ecological environment may influence future health advantages or health disparities;
  • Multi-level, multi-domain influences on living conditions and health in the sending country that may push immigration and result in health advantages or health disparities in the U.S;
  • Interaction of social, cultural, environmental (including the familial, neighborhood, the built and natural environments and rapid environmental change), and biological factors that affect health disparities throughout the immigration process;
  • How factors during the immigration process influence disparities in sleep and sleep related health outcomes and health advantages in the host country among recent immigrant populations;
  • Influence of migrating as an individual or lone family into an unknown community as compared with arriving to live within an established community of people from the same country of origin on health advantages and health disparities;
  • Influence of frequent contact with and return to native country as a potential factor contributing to resiliency and how that impacts health outcomes among immigrants.
  • How exposure to stressful social environments throughout the life course, during transition time periods (prior to, during, and throughout the migration experience to the host environment), increases risk for or provides protection from diseases later in life among different U.S. immigrant sub-populations
  • How toxic exposure to chemicals, occupational, residential and other environmental stressors throughout the immigration process increases risk of co-morbid diseases later in life among different U.S. immigrant sub-populations;
  • Social and cultural factors at individual, family and/or community levels that may support resilience through the immigration experience among immigrant sub-populations that result in health advantages;
  • How local and national policies interact with social and health programming use and its effect on health outcomes among immigrant populations;
  • Structural factors and institutional discrimination/racism that affect the health of immigrant populations that experience health disparities living in different regions of the country;
  • Acculturation stress in conjunction with other stressors, such as poverty, racism and discrimination that affect health outcomes among various immigrant sub-populations and migrant workers;
  • Stress associated with the intersection of race/ethnicity, sexual/gender identification, national origin, and other domains of identification among immigrant populations that experience health disparities;
  • Biomarkers (e.g., allostatic load, telomere length) of cumulative immigration-specific stress that may relate to health disparities among immigrants;
  • Integration of sociocultural factors with biological factors, specifically in the genome, epigenome, metabolome or microbiome, through the immigration and acculturation process due to changes in diet and lifestyle choices in the native country and the U.S. related to health outcomes in immigrant populations experiencing health disparities;
  • Studies that document the mechanisms by which risk and protective factors affect changes in co-morbid conditions, including substance use and other common co-occurring mental health disorders (e.g., depression, PTSD, other anxiety disorders, suicide, etc.) among U.S. immigrant populations;
  • Health care seeking behavior/communications with providers and how factors at individual, family and/or system levels, influence immigrant health;
  • Structural risk factors such as state or local policy increasing vulnerability that may impact health behaviors and health care practices with the changing health care resources in the U.S.;
  • Influence of inter-generational family and household composition on where family members chose to seek health care and how adherence to treatment affect various health outcomes in immigrants;
  • Patterns and quality of health care for immigrants who travel back and forth from the U.S. to the native country and receive care in both countries;
  • Health care practices and behaviors with the changing health care resources in the U.S., specifically as they interact with maintenance of traditional health care practices and the impact on health and health disparities;

The National Institute on Aging (NIA) promotes genetic, biological, clinical, behavioral, social, and economic research related to aging and life course health, including research on Alzheimer’s disease and Alzheimer’s disease-related dementias. A strategic priority of NIA is the understanding of health differences and development of strategies to improve the health status and well-being of older adults in diverse populations, such as immigrant groups. NIA encourages comparisons between immigrant groups, including foreign born versus US born, as well as research on factors affecting health and longevity, such as cultural affiliation, socioeconomic and geographic inequality, gender differences, discrimination, resilience, and stress, among immigrant groups.  NIA interests in this area include, but are not limited to, the following:

  • Research on social, cultural and behavioral factors over the life course, such as early life adversity, education, employment, and health behaviors, using longitudinal models to explain how these factors influence cognitive aging and dementia, the aging process, and morbidity and mortality.
  • Research to elucidate the mechanisms that produce disparate life expectancy, cognitive decline and dementia, morbidity or disability in immigrant populations, including stigma, bias, discrimination, racism, and inequity.
  • Research on resilience and protective factors among immigrant populations that produce increased life expectancy, successful cognitive aging, and lower morbidity or disability in immigrant populations, such as cultural affiliation and social support.
  • Differences in heritable transmission of (grand)parental health trajectories and life spans, comparing recently arrived immigrant populations and first generation descendants to second and later descendants of prior immigrations (e.g., epigenetic marks, telomere length and other biomarkers of the rate of aging).
  • In addition to considering other theories, models and/or frameworks , research is encouraged to consider NIA’s Health Disparities Framework (https://www.nia.nih.gov/research/osp/framework).

The National Cancer Institute (NCI) coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. NCI’s interest in this FOA centers on research directed toward understanding the relationships between environmental or occupational exposures and cancer etiology, cancer survival, and cancer control. Exposures that occur in the home country prior to immigration to the United States as well as exposures that are the result of the unique lived experiences of immigrant populations are of specific interest. Examples of environmental and occupational exposures relevant to the mission of NCI include, but are not limited to: (i) lifestyle factors; (ii) infectious agent; (iii) physical and chemical agents, and (iv) the social and built environment. Research may include investigating the interplay between these factors exposed throughout the life span as related to cancer risk and outcomes. The NCI also is interested in research that leads to the development of prevention and intervention strategies to reduce environmentally induced cancer risk.

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
Resubmission
Revision

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?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 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)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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 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.
  • 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

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

Not Applicable

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Describe how the project will contribute to the understanding of causal pathways that explain immigrant experiences and processes that contribute to minority health and health disparities in U.S. immigrant populations.

Describe how the project uses a multidisciplinary approach, as indicated by consideration of multi-domain and or multilevel influences on health disparity causal pathways with immigration processes to understand the complex factors that contribute to health advantages and heath disparities among immigrants.

Describe how the project engages the immigrant community/ies- and uses community-based approaches to understand the underlying mechanisms of health disparities in the immigrant populations.

Describe specific rationale and how the project focuses on immigrants from one or more NIH-designated populations that experience health disparities in the United States.

If there are foreign component(s), describe how the proposed activities at foreign sites will contribute to the knowledge that will improve minority health and/or help to reduce or eliminate health disparities in the United States.

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

The following modifications also apply:

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. NIMHD will not consider applications at or above $500,000 direct costs annually.

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

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

Scored Review Criteria

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?

In addition, specific to this FOA,

To what extent can the project contribute to the understanding of the etiology and/or mechanisms that influences immigrant health associated with immigration processes in U.S. populations that experience health disparities? To what extent does the project contribute to the understanding of the interaction of multiple factors that influence health outcomes of immigrants in U.S. populations that experience 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?

In addition, specific to this FOA,

Does the composition of the research team have appropriate breadth and inclusiveness of expertise and disciplines (such as for social science, or public health or health disparities expertise)?

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 the 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?

In addition, specific to this FOA,

To what extent does the project propose approaches to integrate health disparity and/or health advantage? To what extent does the project propose multidisciplinary approaches, and considers multi-domain and or multilevel influences due to immigration experiences to understand how they contribute to health advantages and or heath disparities among immigrants? To what extent does the project propose approaches that engage the target immigrant community/ies? To what extent does the project focus on immigrants from one or more NIH-designated populations that experience health disparities in the United States? If there are foreign component(s), has the applicant stated how the proposed activities at foreign sites will contribute to knowledge that will improve minority health and/or help to reduce or eliminate health disparities in the United States?

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?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

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

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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.
  • Representation of immigrant populations and health conditions.

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.

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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

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

Deborah Linares, Ph.D.

National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-2516
Email: deborah.linares@nih.gov

Rina Das, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3996
Email: dasr2@mail.nih.gov

Dorothy Castille, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9411
Email: Dorothy.Castille@nih.gov

Rada Dagher, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
Email: rada.dagher@nih.gov

Frank Bandiera, Ph.D. 
National Institute on Aging (NIA)
Telephone: 301-402-7629
Email: frank.bandiera@nih.gov

Judith A Arroyo, Ph.D.
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Telephone: 301-402-0717
E-mail: jarroyo@mail.nih.gov

Curt Tavis Dellavalle, Ph.D.
National Cancer Institute (NCI)
Telephone:240-276-7225
Email: curt.dellavalle@mail.nih.gov

Liam O'Fallon
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3298
E-mail: ofallon@niehs.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Replace this text with Staff Contact Name

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

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
Email: blakeneyr@mail.nih.gov

Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Phone: (240) 276-6277
E-mail: wolfreyc@gab.nci.nih.gov

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: jenny.greer@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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