Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title
Cancer Control Research in Persistent Poverty Areas (U54 Clinical Trial Optional)
Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type
New
Related Notices
  • April 28, 2022 - Notice of Change to Award Budget and Funding Opportunity Description in RFA-CA-22-015 "Cancer Control Research in Persistent Poverty Areas (U54 Clinical Trial Optional)". See Notice NOT-CA-22-084
  • March 30, 2022 - Notice of Pre-Application Webinar for RFA-CA-22-015, Cancer Control Research in Persistent Poverty Areas (U54 Clinical Trial Optional). See Notice NOT-CA-22-067
Funding Opportunity Announcement (FOA) Number
RFA-CA-22-015
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.393
Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications for Cancer Control Research in Persistent Poverty Areas (Persistent Poverty Initiative). The goal is to provide resources to support the time and effort of transdisciplinary teams, in collaboration with institutions, clinics, and communities/tribes, to develop a cancer prevention and control research program and provide support to early-career investigators that focuses on and serves populations living in persistent poverty areas. For this purpose, NCI will support several U54 Specialized Centers. The long-term goal of this initiative is to build capacity in persistent poverty areas to foster cancer prevention and control research and promote the implementation of programs and practices in institutions/clinics/communities/tribes to alleviate the effects of persistent poverty.

Key Dates

Posted Date
March 08, 2022
Open Date (Earliest Submission Date)
June 06, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 06, 2022 Not Applicable Not Applicable October 2022 January 2023 April 2023

All applications are due by 5:00 PM local time of applicant organization. 

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.

No late applications will be accepted for this Funding Opportunity Announcement.

Expiration Date
July 07, 2022
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 toall 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this Funding Opportunity Announcement (FOA) on Cancer Control Research in Persistent Poverty Areas (Persistent Poverty Initiative), the National Cancer Institute (NCI) intends to provide resources to support the time and effort of transdisciplinary teams in collaboration with institutions/clinics/communities/tribes to develop a cancer prevention and control research program and provide support to early-career investigators (including pre- and post-doctoral researchers) that focuses on and serves populations living in persistent poverty census tracts. The long-term goal of this initiative is to build capacity in persistent poverty census tracts to foster cancer prevention and control research and promote the implementation of programs and practices in institutions/clinics/communities/tribes to alleviate the effects of persistent poverty. For this FOA, any reference to the community includes tribes and tribal organizations.

Key Terms for this FOA

Persistent Poverty: The U.S. Department of Agriculture (USDA) Economic Research Services (ERS) has defined persistent poverty at the county level. According to ERS, counties are designated as being persistently poor if 20% or more of their populations were living in poverty based on 1980, 1990, and 2000 decennial censuses and 2007-11 American Community Survey 5-year estimates (https://www.ers.usda.gov/topics/rural-economy-population/rural-poverty-well-being/).

Definition of Persistent Poverty Census Tracts: NCI recognizes that there are smaller areas, such as census tracts, that experience persistent poverty. The U.S. Census defines census tracts as small, relatively permanent statistical subdivisions of a county or equivalent entity (https://www.census.gov/programs-surveys/geography/about/glossary.html#par_textimage_13). NCI, in working with ERS of the USDA, is defining persistent poverty at the census tract level for the purposes of this FOA. Persistent poverty is wherein 20% or more of the population in a census tract is below the federal poverty line based on 1990 and 2000 decennial censuses and 2007-11 and 2015-2019 American Community Survey 5-year estimates. A list of the census tracts in persistent poverty is provided on the NCI Geographically Underserved Areas website.

By adopting a definition that includes a much smaller geographical area at the census tract level (compared to county level), there is broader representation across all the states and Puerto Rico to include communities in extreme poverty. Hence, for this funding announcement, persistent poverty is defined at the census tract level. All proposed research studies are required to identify persistent poverty census tracts from the provided list.

Community: Population or persons affected by the health condition, or other key stakeholders in the community's health who can be full participants in each phase of the work (from conception - design - conduct - analysis - interpretation - conclusions - communication of results). For this FOA, any reference to the community includes tribes in persistent poverty census tracts.

Intervention: The focus of the Persistent Poverty Initiative is not only to understand the pathways that result in disparate health outcomes in persistent poverty census tracts, but also to develop comprehensive models of how various social, economic, cultural, environmental, biological, and behavioral factors affect health outcomes and their distribution in populations. Thus, projects within the Center should focus on implementing multilevel interventions (directed at more than two factors, especially at the structural/institutional level) that address the social determinants of health, the context of persistent poverty census tracts, and the corresponding underlying structural factors.

Persistent Poverty Initiative Center: A Center that will be proposed in response to this FOA denotes a multilateral partnership that involves institutions, clinics, communities, and/or tribal organizations. The Center is required to have at least two research projects (one intervention); a career enhancement core; a research and methods core; and a developmental core which will develop two pilot studies at each Center, which will be decided upon after the Centers are funded. The cadre of Persistent Poverty Initiative Centers will form a Network that will be expected to engage with the broader cancer research community.

Persistent Poverty Steering Committee: Upon the inception of the program, due to the complexity and highly specialized nature of research activities, a network of researchers and partners will be governed by the Persistent Poverty Steering Committee (SC). The Persistent Poverty SC will provide oversight of research project progress, pilot projects, and career enhancement endeavors. Details on the composition and responsibilities of the Persistent Poverty Steering Committee are provided in Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.

Background

Persistent poverty areas represent an important subgroup of U.S. counties with a higher disease burden, including cancer, where the health consequences of elevated and continuous levels of poverty over time have not been fully investigated. Persistent poverty areas have greater minority populations, more children under the age of 18, environmental degradation, lack of adequate housing, face structural racism, and greater unemployment compared to areas, not in persistent poverty. Residents living in persistent poverty areas are at an increased risk of cancer due to multiple factors, including, but not limited to, greater environmental toxicity/exposure, food insecurity, treatment-related toxicity, inadequate access to health care, higher smoking rates, and low educational attainment.

While persistent poverty by itself is detrimental to health and cancer outcomes, structural and institutional-level factors (e.g., residential segregation and racism) further interact with poverty, creating differential effects on health outcomes. The intersectionality of all these factors results in increased cancer incidence, delayed cancer diagnosis and treatment, increased morbidity, treatment-related toxicity, and subsequently lower rates of survival. People living in poverty have higher rates of cancers associated with occupational, recreational, and/or lifestyle exposures (e.g., colorectal, laryngeal, liver, and lung) and with infectious agents (e.g., anal, cervical, and oral cancers due to the human papillomavirus). Currently, there is very limited research in persistent poverty areas that provides evidence on ways to reduce the overall morbidity and mortality of cancer. Therefore, it is important to understand the interrelated/synergistic effects of persistent poverty and other social, economic, and health factors, at the structural and institutional levels, to implement interventions.

Specific Objectives, Research Scope, and Requirements for this FOA

This FOA will utilize the U54 Specialized Center - Cooperative Agreements activity code.

Required U54 Components

The proposed U54 Center must include all the required components listed below.

  • Overall (required) Provide background information on areas of persistent poverty census tracts and the low-income population included in the Center’s work for cancer control and prevention; the incorporation of the social needs/social contexts; and the synergy among all the Cores and research projects. Address the process by which the Center will move the scientific agenda forward; the involvement of the community; adoption of innovative methodologies to incorporate small populations (if necessary); and inform institutional challenges to improve cancer care and coordination in persistent poverty census tracts.
  • Administrative Core (required) will be responsible for the overall administration, coordination, and management of the Center. The Administrative Core will also be critical in forming the larger Persistent Poverty Initiative Network across all funded Centers.
  • Research and Methods Core (required) will identify and incorporate into all the research and pilot projects the adoption of consistent design(s), contextual, and outcome measures relevant to the research in persistent poverty census tracts. This Core is also expected to consider the development and evaluation of the intervention at multiple levels, and if relevant, include details on the development and use of emerging and innovative technologies relevant to the research.
  • Career Enhancement Core (required) should focus on activities that will facilitate and enhance the professional development of early-career investigators in the U.S.to build a cadre of scholars who are well versed in conducting cancer control and population research in underserved communities, especially in persistent poverty areas.
  • Developmental Core (required) will help develop at least two pilot projects, with one being an intervention, after the Center has been funded in conjunction with all the Centers and the Persistent Poverty Initiative Steering Committee.
  • Research Projects (required). At least two, but not exceeding three, well-defined research projects are required, with at least one being an intervention project. Each project must address a question that advances scientific knowledge in persistent poverty census tracts. The proposed projects must be well developed, rigorous, and supported by a strong rationale that is based on integrating the available relevant information from various sources. (Supporting original research preliminary data are not required albeit encouraged, if possible).

Specific Objectives: The aims of this FOA are to advance cancer prevention and control strategies in persistent poverty census tracts among low-income populations living below the federal poverty line by (1) developing and/or strengthening existing partnerships with communities and local clinics (such as Health Resources and Services Administration/Indian Health Service clinics, primary care clinics) to conduct cancer prevention and control research studies; (2) developing data integration and sharing processes, leveraging existing data resources, and/or conducting preliminary data collection to enhance understanding of the cancer burden to inform research interventions; (3) creating and implementing cancer prevention and control research and interventions developed with institutions/ clinics/communities located in persistent poverty census tracts; and (4) developing and implementing the career enhancement of transdisciplinary teams of early-career researchers to conduct research in persistent poverty communities for cancer prevention and control.

Research Scope: This FOA calls for applicants to include aims focusing on investigating the effects of poverty and its associated factors at the structural and institutional levels, including, but not limited to the following:

  • Residential segregation;
  • Institutional/systemic racism based on race, ethnicity, and/or gender; and
  • Interrelated factors inherent to the economy such as employment, income, and education inequality.

Research projects should aim to:

  • Build institutional/clinic/community research capacity by identifying priorities and resources;
  • Develop strategic plans collaboratively;
  • Create goal-oriented research projects that include career enhancement and skill development, and expand the leadership base to be more diverse and inclusive;
  • Provide ongoing and sustainable support for institutional/clinic staff (including support for collecting, analyzing, and interpreting data they collect);
  • Build trust with institutions/clinics/communities and networks;
  • Create partnerships with community-affiliated clinics or hospitals; state offices of health; area health education centers; state health associations; primary care networks or associations; departments of health, education, or human services; and other community organizations; and
  • Engage with clinic partners, community advisors, and other relevant stakeholders.

Requirements: To be responsive to this FOA, the Center must propose at least two research projects, with at least one being an intervention project. Post-award, Centers will develop at least two pilots, with one being an intervention within the Developmental Core. All studies are required to address structural or institutional level factors associated with persistent poverty among low-income populations below the federal poverty line. Projects are encouraged to incorporate factors related to poverty and the social needs/contexts of the population. Studies should delineate the effects of persistent poverty to develop interventions in these areas such as, but not limited to, identifying and elucidating pathways by which the built/social environment and geography and/or historical and contemporary injustices affect cancer risk, development, and outcomes.

Interventions: All interventions are required to systematically account for and measure the social needs and/or context of the population, and include interventions aimed at the structural or institutional levels. Thus, community-level interventions that are multifactorial and multilevel interventions are encouraged. All interventions should be developed and implemented synergistically through institutional /clinic/community partnerships using a collaborative process that equitably involves all partners in all intervention processes. Projects may focus on community-level health promotion, cancer screening, cancer care, and/or prevention interventions that will improve cancer outcomes. These efforts should recognize the complexities of the multifactorial origins of health disparities and inequities, and target one or more of the factors that can improve outcomes among underserved populations in persistent poverty census tracts and can be sustained after the completion of the project.

Methodology and measures: Randomized controlled trials are not required. Integration of multiple levels of analysis may warrant the refinement of existing methodological approaches or the development of new methodological approaches in the conduct of the Center’s research projects. Methodological research is supported by this FOA to the extent that it is requisite to the achievement of specific aims outlined in the applications. Incorporation of research designs and analyses of small populations is encouraged.

Proposed research projects could also provide a platform for the development of innovative methodologies, such as the development of design, implementation, and analysis strategies for multilevel, multicomponent interventions to prevent and screen for cancer, improve cancer care for patients, and/or improve cancer outcomes; methods to improve the assessment of physical, social, structural, psychological, behavioral, and cultural environmental exposures; development of contextual measures of socioeconomic status (SES) at the level of neighborhoods or census tracts, elucidation of how these measures relate to individual SES, and identification of how this relationship varies for different disease outcomes; etc.

Required Organization and Key Attributes of the Persistent Poverty Centers: The proposed Centers must include the following required components:

A. Administrative Core (required) is expected to manage and coordinate all Center research and activities, within a cohesive organizing framework, including fiscal management, evaluation, communication, and dissemination. The Administrative Core is charged with developing methods and processes for monitoring scientific, dissemination, and fiscal progress and milestones of all Center activities, including the Research and Methods Core, research studies, Career Enhancement Core and the Developmental Core. The Administrative Core will develop policies and procedures for the leadership, ethical conduct, oversight of the research, and organizational structure of the Center’s activities. The Administrative Core will promote opportunities for graduate students, postdoctoral researchers, and investigators in early stages of their independent careers to participate in the Center’s activities. The Administrative Core will be responsible for establishing a Community Advisory Board (CAB) of key stakeholders who will provide scientific, planning, evaluation, and dissemination expertise to Center leadership. CAB members will assist the Center with developing and refining strategies for optimizing research, provide insights into cancer-focused research topics and outcomes, help maximize the external validity of research findings, and support the dissemination of data, tools, resources, and evidence-based findings from the project. Projects should delineate their partnerships with the community (including, but not limited to, patient navigators, clinicians, local/county/state departments of health) and their specific role in the projects. While it is important to form a CAB, it is not sufficient to merely propose the formation of such a board. Applicants are discouraged from naming the members of the CAB in their application. The composition (i.e., areas of expertise, location, etc.) and role of the CAB in the projects should be delineated in the application.

B. Research and Methods Core(required) will identify and incorporate into the research design process, contextual, and outcome measures relevant to the research in persistent poverty census tracts. The Core is also expected to consider the development and evaluation of the intervention at multiple levels. In addition, the Core will, if needed, use appropriate study designs to assess the effectiveness, acceptability, adaptation, and sustainability of cancer control programs; develop or use novel statistical approaches as appropriate; and promote (if feasible) common data elements across the Center’s projects. This Core will also be responsible for evaluating the Center’s research productivity and impact over the funding period. The Research and Methods Core will contribute to activities aimed at disseminating research findings and evidence-based interventions, and/or implementation strategies to multiple stakeholder groups, and design future projects and grant applications that build from the Center’s research activities.

The Research and Methods Core will oversee the development, implementation, and evaluation of the two pilot studies in the Developmental Core and provide expert study design and research methods support to the design and execution of the studies.

C. Career Enhancement Core (required) is designed to enhance the careers of early-stage investigators to work in and with communities and clinics in persistent poverty areas. This core will build a cadre of investigators who will work on the research projects and pilots related to Centers and across the Persistent Poverty Initiative. Centers are encouraged to build programs that allow for a cross-Center exchange of investigators to allow the cross-pollination of ideas and allow for a diverse career enhancement experience. Centers are encouraged to hire early-career investigators (including pre- and post-docs) that reflect the diversity of the populations they are working with on the research projects and pilots.

D. Developmental Core (required): During the post-award period, each Center is expected to develop at least two additional new Pilot Research Projects. One of the projects must be an intervention. Cross-Center projects are encouraged. The Center PD(s)/PI(s) and other designated project team leadership (including the Persistent Poverty Steering Committee members subsequently described) will establish each project-specific research framework, including research objectives and strategies. The new Pilot Research Projects can be based on newly emerging or updated data reported in the literature, and/or data from the community, and can be proposed on a yearly basis. All post-award proposed Pilot Research Projects will be subjected to approval by NCI in accordance with the Cooperative Agreement Terms and Conditions of Awards (Also see Section IV Application and Submission Information). Applicants are to set aside 15% of the direct costs per year for the entire funding period to fund two pilot projects, which will be proposed and funded in the first year by the funded Centers.

E. Research Projects (required): Potential applicants are required to propose research among low-income populations below the federal poverty line living in the provided list of persistent poverty census tracts. To maximize the potential of team science efforts, each U54 Center may combine/integrate capabilities from multiple institutions (including but not limited to health, education, housing, employment, etc.), clinics, and communities/tribes to undertake transdisciplinary research. The Center will propose at least two projects (not to exceed three), with a minimum of one being an intervention that is aimed at understanding and addressing the institutional/structural challenges for cancer control. Awardees will be expected to identify institutional/clinic and community/tribe priorities; address challenges and opportunities related to working in partnership with institutions, clinics, and communities; and build on existing cancer prevention and control strategies to lessen the burden of cancer in persistent poverty census tracts. It is expected that applicants will propose Centers that seek to understand the interaction among various risk factors at multiple levels associated with poor health outcomes experienced by those living in persistent poverty census tracts, including neighborhood/community, structural, institutional, biological, physical, geographic, historical, social, and environmental factors. Many safety net providers are focused on the delivery of primary care, and, as such, may have limited research infrastructure or previous experience participating in cancer prevention and control research. Cancer Centers are encouraged to work with these clinics to build and implement a cancer prevention (primary and secondary) and control research agenda. These areas may also face the added burden of being designated Health Professional Shortage Areas. It should account for the fact that many clinics are not designed to conduct research and may not have the necessary preexisting infrastructure. It also should account for how their goals are to be incorporated into the Cancer Center’s research agenda. An important aspect of this FOA is to develop sustainable cancer prevention and control strategies in persistent poverty census tracts in partnership with local communities/tribes, institutions, community-based organizations, and primary/local clinics/hospitals.

Examples of Possible Research Directions: Proposed U54 Centers must have necessary scientific expertise, technical capabilities/skills, and infrastructure to carry out the expected scope of activities, including, but not limited to some of the areas of investigation listed below:

  • Identifying pathways by which the effects of place on health can be elucidated, such as the interactions of neighborhoods and people, health care or public health systems, and their social and physical environments, etc.;
  • Identifying and elucidating pathways by which the built/social environment and geography affect cancer risk, development, and outcomes;
  • Elucidating the multilevel pathways by which protective factors and mechanisms at a population level result in positive health outcomes (e.g., ethnic enclaves);
  • Characterizing differentials in income and wealth accumulation for subpopulations (e.g., elderly, racial and ethnic minorities, immigrants), and identifying the sources of these differentials and their impacts on health status;
  • Studies of the effects of historical and contemporary injustices, and/or chronic stress experiences on biological processes (e.g., epigenome, inflammation, or other molecular/cellular processes) that contribute to poorer cancer and overall health outcomes;
  • Community-level intervention studies among populations that combine individual and community approaches to healthy lifestyles by integrating psychosocial interventions with management of disease risk factors;
  • Design and implementation of community-based participatory prevention strategies to promote aggregate-level health by changing social, structural, institutional, and community environments (e.g., institutional policies; tobacco-free policy-including promotion of respectful use of tobacco for American Indian and Alaska Native populations);
  • Intervention research focusing on the prevention of cancer that incorporates risk and resilience factors such as historical trauma, immigration policies, discrimination, structural racism, housing, and criminal justice practices, etc.;
  • Identifying and characterizing the social factors that interact with genetic susceptibility/risk factors for cancer and factors that contribute to variation in the prevalence and incidence of cancer – for example, determining whether social factors are equally involved in differential cancer prevalence and incidence in various subgroups (e.g., race/ethnicity, sexual gender minorities);
  • Identifying and characterizing the environmental toxicity factors that interact with chronic stress and genetic susceptibility/risk factors for cancer and factors that contribute to variation in the prevalence and incidence of cancer;
  • Developing models for survivorship care, including but not limited to, mitigating treatment-related toxicity;
  • Implementation and utilization of telehealth systems and capacity to support and sustain cancer control research interventions (including primary care clinics). Centers are encouraged to adopt innovative technologies, however, programs that purely use these technologies without the on-the-ground partnership and/or structural support and development will not be considered as responsive to this initiative;
  • Developing a systems-based approach, i.e., one that integrates with electronic health care record systems and can be generalizable to additional centers or other parts of their health care system; extend cancer control services to family members of cancer patients and/or other persons within their health care system; and include written commitment to the program from leadership at the cancer center, clinic, and/or hospital and/or health care system(s) level (if relevant); and
  • Research on the development of cancer treatment interventions and service delivery approaches that address historical and contemporary inequities and structural barriers to health services, such as staff training, service delivery settings, novel strategies to match the availability of services to population needs, use of digital platforms, emerging technologies, language and health literacy barriers, costs, financial toxicity, etc.

Application Guidelines

Additional Requirements: Potential applicants are required to propose research from the provided list of persistent poverty census tracts among those that are below the federal poverty line. To ensure that the unique social contexts and the historical and contemporary injustices are accounted for and addressed in the research, this RFA allows only within group comparisons in the primary aims of the study. Interventions should be responsive to the unique social contexts and the historical/contemporary injustices. They are required to develop, modify, and implement interventions at the structural and institutional levels to meet the needs, for example, of a particular racial/ethnic and/or geographical area. For example, applicants can compare one persistent poverty census tract(s) to another within an urban area. Applicants are encouraged to visit the NCI website for more details on methodological approaches for this FOA.

Applicants from NCI-Designated Cancer Centers are encouraged (though not required) to develop alliances with states that do not have a P30 Cancer Center Support Grant and/or communities outside of their catchment area to build partnerships to address issues of persistent poverty. Preference will be given to applications that include rural persistent poverty census tracts within the scope of their research.

RFA Progress Evaluation

An internal committee of program directors within NCI will be formed to direct/inform/manage this research agenda. The Centers’ progress will be evaluated consistently through NCI staff and PI interactions and annual evaluation of funded projects’ progress reports. Each research Center’s progress will be based on reviews of short- and long-term accomplishments that determine whether the major scientific aims are being met among the various project components: Administrative Core, Research and Methods Core, Career Enhancement Core, Developmental Core, and Research Projects. Examples of measurable evaluation criteria for the initiative’s success are listed below:

  • Is there an increase in the number of cancer prevention and control strategies and interventions being developed and tested in persistent poverty areas?
  • Is there evidence of new knowledge and research productivity (e.g., presentations, research publications, evidence-based guidelines) filling research gaps with downstream implications for improving cancer care to those living in persistent poverty areas?
  • Have collaborations and experiences working with local communities and clinics serving those living in persistent poverty areas been established and appropriately utilized for the research projects?
  • Have researchers successfully disseminated research products to practices delivering cancer-related care, relevant professional organizations, patients and patient advocacy organizations, and governmental and non-governmental policymakers?
  • Have collaborations been formed among scientists and community organizers/government agencies from different sites and different disciplines to address issues pertinent to cancer care prevention, delivery, and treatment issues relevant to those living in persistent poverty?
  • Is there evidence of collaboration and synergy between awardees and other NCI-supported programs focusing on health disparities and health equity?
  • Is there an increased number (and success) of subsequent grants submitted to NIH based on findings from the Centers, or other evidence of continued community partnered research or programs?
  • Are early-career investigators leading projects and involved in the design, execution, and writing of manuscripts? Are the early-career investigators being offered opportunities for independent research funding?

Non-Responsive Applications

The following limitations are placed on potential applications and projects. Applications not following these guidelines will be deemed non-responsive and returned without review:

  • Proposed research sites should be in the persistent poverty census tract(s) among low-income populations below the federal poverty line from the list provided. Inclusion of sites from non-persistent poverty areas is not allowed. Thus, comparisons between persistent and non-persistent poverty areas are not allowed.
  • The intervention(s) are to be developed and implemented with and for a particular racial/ethnic group. If more than one racial/ethnic group is targeted, it is expected that interventions will not be identical, but uniquely adapted to each racial/ethnic group. Outcome comparisons across racial/ethnic groups are only allowed if the researchers take this adaptation into account.
  • Similarly, no comparisons are allowed between geographic areas. Applications proposing comparisons (for example, among rural, urban, and suburban areas) are not allowed, because they would differ markedly in social context, structural, and institutional factors. However, all these areas can be included with a Center’s scope of the study.
  • This FOA does not focus on issues related to recruitment and retention of participants to clinical trials or other research studies; therefore, these applications would be considered non-responsive to the goals of this FOA and will not be reviewed.
  • The Center should delineate their partnerships with the community (including, but not limited to, patient navigators, clinicians, local/county/state departments of health) and their specific role in the projects. While it is important to form a community advisory board (CAB), it is not sufficient to merely propose the formation of such a board. Applications that do not provide the composition (i.e., areas of expertise, location, etc.) and role of the CAB in the projects will be considered non-responsive. Applicants are discouraged from naming the members of the CAB in their application.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
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).

Funds Available and Anticipated Number of Awards

NCI intends to fund four to five awards, corresponding to a total of $10M (in total costs) for the fiscal year 2023. It is expected that $10M (total costs) per year will be available in subsequent years, but future year amounts will depend on annual appropriations.

Award Budget

Application budgets must reflect the actual needs of the proposed Center, but must not exceed $1.5M per year in direct costs.

Award Project Period

An applicant may request a project period of up to 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

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

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Shobha Srinivasan, Ph.D.
Telephone: 240-276-6938
National Cancer Institute (NCI)
Email: sriniva2@mail.nih.gov

Page Limitations

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

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 12 Required 1 1
Administrative Core Admin Core 6 Required 1 1
Research and Methods Core Core 6 Required 1 1
Career Enhancement Core Core 6 Required 1 1
Developmental Core Core 6 Required 1 2
Research Project Project 12 Required 2 3

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.

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.

The following additional guidance applies.

Project Summary/Abstract: Provide overall goals/abstract/summary for the entire Center application. Provide background information on areas of persistent poverty census tracts and the low-income population included in the Center’s work for cancer control and prevention; the incorporation of the social needs/social contexts; and the synergy among all the Cores and research projects. Address the process by which the Center will move the scientific agenda forward; the involvement of the community; adoption of innovative methodologies to incorporate small populations (if necessary); and inform institutional challenges to improve cancer care and coordination in persistent poverty census tracts.

Project Narrative: In the "Project Narrative", it is encouraged that the relevance of the Center’s research to public health should be stated in lay language, which has been vetted by cancer research advocate(s) working with the PD/PI team.

Facilities and Other Resources: In addition to standard items, describe existing facilities and/or other resources (such as existing institutional shared resource facilities) available to the proposed Center. As applicable and pertinent to the proposed research, describe partnerships (e.g., with communities, clinics) that will provide relevant capabilities.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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)

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

Specific Aims: Outline the specific aims for the entire Center, addressing approaches to cancer control challenges faced by communities living in and institutions/clinics in persistent poverty census tracts and ways to address these challenges to mediate the effects of persistent poverty. The Specific Aims in this section of the Research Plan should be overarching, high-level, and distinct from the aims of the individual research projects.

Research Strategy: The Research Strategy must consist of the subsections A-D defined below:

  • Subsection A. Center Overview: Present a concise overall vision and plan for the proposed Center. Focus on the plans for the funding period of the Center and briefly highlight how the Center will lay the groundwork for addressing cancer control challenges in persistent poverty census tracts among low-income populations. Without repeating information in individual bio-sketches, describe the applicant’s proposed comprehensive, transdisciplinary approach and explain how the collective expertise and experience of the investigators will support the team science environment needed to complete the proposed multidisciplinary work. Applications should demonstrate that a Center mechanism is essential to accomplishing the proposed studies.
  • Subsection B. Center Organization and Integration: Include a concise description of the structure of the Center including the organizing framework. Explain how the components of the Center, including key personnel, will interact to form a transdisciplinary team, why each component is essential for addressing the organizing framework of the Center, and how the organization of the components into a Center will create an entity that is greater than the sum of its parts in terms of achieving the Program’s research objectives defined in Section I. Describe the transdisciplinary research collaborations within and across Centers to be developed and sustained to foster research and the incorporation of early-stage investigators in research and pilot projects. Applicants should demonstrate that use of the Center mechanism is essential to accomplishing the research that would not occur without the climate, facilities, and research resources that a Center can uniquely provide.
  • Subsection C. Research Projects: Briefly describe each project, including its scientific integration with the proposed organizing framework and a rationale for how each project will help, within the funded period, to generate sufficient results to address the challenges in persistent poverty census tracts and meet the challenges of institutions/clinics and address the social needs/social contexts.
  • Subsection D. Outline preliminary plans for sustainability of the program. The sustainability plan for beyond the funding period must include proposed methods to address barriers to implementation in health clinics and workforce, such as complexity of cancer care, licensing or proprietary tools, patient barriers (e.g., awareness/education, time, transportation, food security, and monetary access barriers), Center staff time, ongoing costs, and insurance challenges.

Letters of Support: Applications must include letter(s) of support from an institutional official endorsing the proposed Center and that describes the available institutional resources that will support the research. Letters from investigators who will serve as consultants or collaborators on the project, but with no measurable efforts, should also be included. Do not include letters from investigators who will have committed efforts in the application. Centers proposing to work with American Indian/Alaska Native tribes/communities/clinics/institutions are required to submit letters of support from the respective tribe/community/clinic/institution and, if funded, obtain tribal resolutions/IRB before beginning data collection.

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. For applicants working with tribes, include letters or agreements that has language on exemption to data sharing, if applicable.
  • The Data Sharing Plan should be provided only in the Overall section and encompasses all the activities of the Center;
  • The Data Sharing Plan should briefly describe the types of data and computational resources that are expected to be generated and shared, consistent with achieving the goals of the Center.

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.

List all performance sites that apply to the Administrative Core component. It is anticipated that a Center will centralize the Administrative Core within the applicant institution.

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 ‘Administrative Core Leader’ 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.
  • An Administrative Core leader may also serve as the contact PD/PI.

 

Budget (Administrative 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.

Travel: Appropriate travel funds must be included in the proposed budget to support travel for at least two PI and/or partners participate in an Annual Investigators’ Meeting and/or a Persistent Poverty Steering Committee Meeting, at the NCI’s facilities in Rockville, MD or one of the funded Centers or in conjunction with relevant meetings/conferences.

PHS 398 Research Plan (Administrative Core)

Specific Aim: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support the transdisciplinary research teams, foster synergy and integration of the Center, and support planning and evaluation activities. The Administrative Core will support and coordinate project administration within the Center and coordinate participation in the Persistent Poverty Steering Committee.

Research Strategy: Describe the administrative structure to support the proposed Center, including, but not limited to, the following:

  • Management and Communication Plan: Describe the plans for management and integration of Center activities and communication and evaluation of progress across the Center. Describe the leadership and communication strategies to manage and track the progress of the multiple projects, pilots, and sites that make up the Center; the transdisciplinary teams; and early-stage investigators. Include a description of the Center leadership structure and concisely describe oversight mechanisms that will be used by the Center PD/PI(s). Describe any provisions for the mentoring and development of new investigators;
  • Annual Meeting and Other Network Activities: Provide a brief description of strategies for connecting and integrating the Center with the larger Persistent Poverty Initiative Network. Funded Centers are expected to participate in Annual Investigators’ meetings to present results and to communicate with other centers’ investigators. The Center PD(s)/PI(s) are expected to attend the Annual Meeting and participating faculty, postdoctoral associates, graduate students, and other Center members are all encouraged to attend. The Center PD/PI (contact PD/PI for applications with multiple PDs/PIs) is expected to participate in SC meetings and any other working groups that may be formed to guide the Centers. The Centers are also encouraged to organize and participate in other program meetings and workshops, organize collaborative activities, promote collaborations, and organize and participate in scientific and programmatic working groups;
  • Outreach Plan: Provide a plan that describes how outreach will be conducted to promote the program's research objectives, engage researchers, institutions, and communities on cancer control in persistent poverty areas, provide research experiences to pre- and post-docs, and early-stage investigators in cancer control research. The proposed activities should relate to and integrate with the organizing framework of the Center. Potential activities include, but are not limited to, conferences, workshops, seminar series, skills development, personnel exchanges, and development of a Center website; partnerships with the community (including, but not limited to, patient navigators, clinicians, local/county/state departments of health) and their specific role in the projects should be delineated. While it is important to form a community advisory board (CAB), it is not sufficient to merely propose the formation of such a board. Applicants are required to provide information on the composition (i.e., areas of expertise, location, etc.) and role of the CAB in the projects.
  • Center and Program Evaluation: Describe how the Administrative Core will coordinate participation in Center program evaluation activities, including progress reports, site visits, and providing additional communication and materials to the NCI as needed. Describe the milestones and/or metrics for determining success during the award period and how unanticipated obstacles to the plan may be overcome.

Letters of Support: Include letters of support 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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Resource Sharing Plans should only be included in the Overall component

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.

 

Research and Methods Core

When preparing your application, use Component Type ‘Research and Methods Core.’

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

SF424 (R&R) Cover (Research and Methods 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 (Research and Methods Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research and Methods 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) (Research and Methods 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 (Research and Methods Core)

In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research and Methods 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 (Research and Methods Core)

Specific Aims: Succinctly describe the strategies and goals for managing the research and data of the Center and connecting the Center to the Persistent Poverty Initiative Network.

Research Strategy: The Research and Methods Core is expected to have appropriate and effective administrative and organizational capabilities to support the transdisciplinary research teams, foster synergy and integration of the research projects and pilot projects, and support planning and evaluation of research activities. The Research and Methods Core will support and coordinate the research enterprise within the Center and coordinate participation in the Persistent Poverty Initiative Steering Committee:

Under Approach, describe the structure to support the proposed Center’s research and data endeavors and coordination, including, but not limited to, the following:

  • Describe the plans for management and integration of methods, measures, data tracking, analysis analyses, interoperability of data, modeling, etc. activities of the Center across projects, pilots and the Persistent Poverty Initiative Network;
  • Describe how the research projects and pilots will account for the social needs/contexts of the populations living in persistent poverty census tracts;
  • Describe plans for on-going engagements with institutions/clinics/communities; provide timeline for engagement;
  • Describe methods by which institutions’/clinics’/communities’ contexts will be incorporated in the methods, measures, merging of data sets, analysis and modeling;
  • If small populations are included how will the data be analyzed; describes innovative methodologies/design to incorporate and analyze this data;
  • Provide a plan that describes how outreach will be conducted to promote the program's research objectives, engage researchers, institutions, and communities on cancer control research in persistent poverty census tracts, provide research experiences to pre- and post-docs and early-stage investigators in cancer control research. The proposed activities should relate to and integrate with the organizing framework of the Center;
  • Center and Program Evaluation: Describe how will the Research and Methods Core coordinate participation in Center program evaluation activities, including for developing common data elements across the Center and the Persistent Poverty Initiative Network. Describe the milestones and/or metrics for determining success during the award period and how unanticipated obstacles to the plan may be overcome.

Letters of Support: Include letters of support 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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Resource Sharing Plans should only be included in the Overall component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Research and Methods 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.

Career Enhancement Core

When preparing your application, use Component Type ‘Career Enhancement Core.’

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

SF424 (R&R) Cover (Career Enhancement 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 (Career Enhancement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Career Enhancement 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) (Career Enhancement 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 (Career Enhancement Core)

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

Budget (Career Enhancement Core)

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

NOTE: The Center should set aside funds to have cross-Center career enhancement for at least two of the early-career investigators (including pre- and post-docs). Additionally, the Center should plan for at least two early-career investigators to attend the Annual Meeting of the Persistent Poverty Initiative Network.

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 (Career Enhancement Core)

Specific Aims: Describe the goals of the Career Enhancement Core.

Research Strategy: Applicants should use the standard structure of the Research Strategy section (i.e., sub-sections Significance, Innovation, and Approach) defined in the SF424 Application Guide with additional guidance as defined below.

Address the following additional aspects:

  • Provide a rationale for how this core fits into the proposed framework of the Center and explain its progression plan(s) through inter-subunit coordination within the Center;
  • Establish a selection criterion for hiring and sustaining the participation of early-career investigators including, but not limited to issues of diversity based on geography, income, race/ethnicity;
  • Provide a plan for continuing education of early-career investigators (including pre- and post-docs); involvement in the overall Center; research and pilot projects; the transdisciplinary research teams; Persistent Poverty Initiative Network, workshops; developing curriculum; publications; meetings, etc.

  • Other opportunities facilitating professional development: Outline plans for a range of other research-related activities and/or available opportunities that may enhance investigators' skills and advance their progression towards becoming independent investigators. Activities/opportunities to consider include (but are not limited to)
    • exposure to various research-associated activities (periodic attendance to relevant scientific conferences and presenting own research results, participation in institutional/departmental workshops, seminars, journal clubs, etc.);
    • facilitated access to skills enhancing courses, workshops (e.g., in scientific writing, grantsmanship, mentoring/leadership); and
    • any applicable approaches for gradually increasing responsibilities of early-career investigators involved (commensurate with the skills and level of a given individual).
  • A timeline including milestones is required. Milestones are intermediate steps towards the completion of concrete goals, which create go/no-go decision points in the project and must include clear and quantitative criteria for success. Yearly quantitative milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. Milestones and the timeline must be provided in a separate heading at the end of the Approach section.

Letters of Support: Include letters of support 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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Resource Sharing Plans should only be included in the Overall component.

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 (Career Enhancement 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

Developmental Core

When preparing your application, use Component Type ‘Developmental Core.’

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

SF424 (R&R) Cover (Developmental 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 (Developmental Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Developmental 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) (Developmental 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 (Developmental Core)

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

Budget (Developmental Core)

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

NOTE: Centers are required to set aside 15% of the total direct cost of the Center to fund at least 2 pilot projects every year over the course of the award of the Centers.

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 (Developmental Core)

Specific Aims: Provide areas that the Center would identify as being critical in addressing issues related to persistent poverty and cancer control.

Research Strategy: Describe the plans for the Developmental Core to facilitate and enhance the research in persistent poverty areas.

Address areas indicated below.

Pilot research projects:

  • The Center is required to have at least two pilots (with one being an intervention) for the entire duration of the funding of the Center;
  • No specific projects are to be included in the application, however, provide general types/attributes of anticipated projects;
  • Anticipated duration of pilot projects (up to 2 years but can be shorter), etc.;
  • Provide a few examples of possible directions for research;
  • Describe how pilot projects will be solicited, reviewed, and prioritized for activation; in these plans, explain:
    • How the Developmental Core will ensure that all pilot projects fall within the overall theme of the Center (i.e., are connected to ongoing research projects);
    • How the Developmental Core will ensure that all pilot projects fall within the overall theme of the Persistent Poverty Initiative Network (i.e., are connected to ongoing research projects);
    • Any special approaches that might be needed to provide optimized opportunities for institutions/clinics/communities;
    • Details on planned proposal solicitation frequency and format, review panel composition, basis for prioritization, etc.;
    • Logistics of the process in the context of multiple institutions.
  • Describe how the Developmental Core will monitor, conduct, and evaluate the pilot projects to ensure compliance with all applicable regulations (e.g., annual IRB approvals, Federal wide Assurance (FWA), human subjects research training, etc.) in domestic institutions.

Letters of Support: Include letters of support 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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Resource Sharing Plans should only be included in the Overall component.

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 (Developmental 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, use Component Type ‘Research 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. 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) (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.
  • An Administrative Core leader may also serve as the contact PD/PI.

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.

PHS 398 Research Plan (Research Project)

 

Specific Aims: Describe the goals of each proposed Research Project and key milestones. The Center is required to have at least two Research Projects with one being an intervention.

Research Strategy: Applicants should use the standard structure of the Research Strategy section (i.e., sub-sections Significance, Innovation, and Approach) defined in the SF424 Application Guide with additional guidance as defined below.

Address the following additional aspects for each individual Research Project:

  • Integration: Provide a rationale for how it fits into the proposed framework of the Center and explain its progression plan(s) through inter-subunit coordination within the Center;
  • Persistent Poverty and Cancer: Provide background information on areas of persistent poverty census tracts and the low-income population, include them in the Center’s work for cancer control and prevention, and how these will be addressed in the research projects;
  • Project Timeline: A timeline including milestones is required. Milestones are intermediate steps towards the completion of concrete goals, which create go/no-go decision points in the project and must include clear and quantitative criteria for success. Yearly milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. Milestones and the timeline must be provided in a separate heading at the end of the Approach section.

Letters of Support: Include letters of support 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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Resource Sharing Plans should only be included in the Overall component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Research 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 fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided 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.

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

Post Submission Materials

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

Section V. Application Review Information

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.

For this FOA, note the following:

The emphasis of this FOA is to provide resources to support the time and effort of transdisciplinary teams, in collaboration with institutions, clinics, and communities/tribes, to develop a cancer prevention and control research program and provide support to early-career investigators (including pre- and post-docs) that focuses on and serves populations living in persistent poverty census tracts. Accordingly, reviewers should evaluate based on the criteria described below.

Scoring: Reviewers will provide an overall Impact Score for the entire Center (Overall) and adjectival ratings for individual components (individual , Administrative Core, Research and Methods Core, Career Enhancement Core, Developmental Core, and Research Projects).

For the evaluation of the entire Center (Overall) application, the Research Projects will be assessed as the scientific basis of the Center, with the other components (Administrative Core, Research and Methods Core, Career Enhancement Core, and Developmental Core) enhancing and integrating the overall research program. The overall Impact Score for the entire Center (Overall) will reflect the synergy and integration provided by the inclusion of the Center’s components.

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.

Overall Impact - Overall

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 - 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?

In addition, for applications involving clinical trials

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

Investigator(s)

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

Specific for this FOA: To what extent does the proposed Center include populations that are in persistent poverty census tracts and low income ? How well do the methods adopted include the concerns of the institution/clinic/community and account for the social contexts to improve the understanding and knowledge of cancer control and prevention? How inclusive are the methods in accounting for the social contexts of the populations and discovering efficacious interventions for the populations?

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 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?

Specific for this FOA: How well does the application justify the structure of the Center to accomplish the proposed goals of the Center? How well does the proposed Center take advantage of transdisciplinary approaches for a comprehensive study of persistent poverty and the challenges for the populations and communities? How well does each Research Project specify target higher-risk or population(s)? How effective are mechanisms in place to foster strong collaborative interactions and promote “cross-fertilization” among investigators and participating institutions, clinics, and communities?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

Specific to this FOA: How will the scientific environment at the participating institutions stimulate transdisciplinary research collaborations? How well do multi-institutional teams take advantage of the distinctive strengths available through multi-institutional collaborations, where appropriate? To what extent do early-career investigators appropriately involved in all the projects?

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 - 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.

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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.

Scored Review Criteria - Cores and Research Project

For each of the Center's components below (i.e., Administrative Core, Research and Methods Core, Career Enhancement Core, Developmental Core, and Research Project), reviewers will provide an overall adjectival rating to reflect their assessment of the likelihood for the component to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria, . Criterion scores will not be provided for the Cores and the Research Project.

Review Criteria - Administrative Core

Reviewers will provide only one overall adjectival rating for the Administrative Core (criterion scoring is not used for this component). Reviewers will consider the following aspects for the Administrative Core while determining the scientific and technical merit of the application:

  • How well does the proposed Administrative Core address the needs of the Center that it will coordinate and serve? Is the scope of activities proposed for the Administrative Core appropriate to meet those needs?
  • How well suited are the PD(s)/PI(s) and other personnel to their roles in the Administrative Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research? Do the investigators demonstrate significant experience with coordinating collaborative research in the relevant field? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills? How appropriate are their leadership approach, governance, plans for conflict resolution, and organizational structure for the Center? Does the applicant have experience overseeing selection and management of sub-awards, if needed?
  • How well does the application propose novel organizational concepts or management strategies in coordinating the research program of the Center? Evaluate refinement, improvement, or new application of organizational concepts or management strategies proposed.
  • How well-reasoned and appropriate are the overall strategy, operational plan, and organizational structure to accomplish the goals of the research program of the Center? To what extent does the proposed approach address the communication and management needs of the Center and provide appropriate plans for participation in the Annual Investigators' meeting and other meetings? How well do the Outreach plans address providing opportunities to early-stage career investigators (including pre- and post-docs)for skills development and research experiences in precision cancer prevention and interception and communication opportunities for the Center? To what extent does the applicant address Center program evaluation activities? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy for the Administrative Core adequately establish feasibility and manage the risks associated with the activities of the Center? Are appropriate plans for workflow and a well-established timeline proposed? How effectively will the Center be able to coordinate the efforts of its participating institutions as well as coordinate its efforts with those of the entire Center?
  • How will the institutional environment in which the Administrative Core will operate contribute to the probability of success in facilitating the research of the Center it serves? How adequate are the institutional support, equipment, and other physical resources available to the investigators adequate for the Administrative Core proposed? How will the Administrative Core benefit from unique features of the institutional environment, infrastructure, and/or personnel? Are resources available within the scientific environment to support electronic information handling?

Review Criteria - Research and Methods Core

How well does the proposed Core meet the overall needs of the Center? To what extent are the services of the Research and Methods Core critical to the goals of the Research Projects, Career Enhancement Core, and the Developmental Core? How adequate and appropriate are the qualifications, experience, and effort commitment of the Research and Methods Core Director(s) and other key personnel for providing the proposed facilities or services? How adequate is the proposed Core's plan for providing cost-effective services to the Center, prevent duplication, and/or increase efficiency?

Review Criteria – Career Enhancement Core

Are early-career investigators (including pre- and post-docs) involved in research and pilot projects, as appropriate? Are career enhancement programs on issues related to persistent poverty and working with underserved communities clearly outlined? Are the goals and outcomes clearly outlined for cross-center career enhancement programs?

Review Criteria - Developmental Core

How responsive are the pilot projects to the social needs and context of persistent poverty census tracts? Are the pilot intervention(s) sufficiently well developed to address barriers related to persistent poverty census tracts? Will this Core help in developing cross-center projects to address issues related with persistent poverty beyond local areas?

Review Criteria - Research Project

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Research Projects, and each project will be given one adjectival rating (criterion scoring is not used for this component). A project does not need to be strong in all categories to have a major scientific impact. For example, a Research Project that by its nature is not innovative may be essential to advance the field.

Significance

  • How well does the proposed research project address an important problem related to persistent poverty and cancer control research and interventions? Do the proposed projects account for and address local challenges and the social context of the institutions/clinics/communities? If the aims and milestones of the project are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods in the field cancer control?

Investigator(s)

  • Are the investigators appropriately trained and well suited to carry out this work? Is the project proposed appropriate to the experience and expertise of the project leader and other researchers and team members?

Innovation

  • How well does the proposed project employ novel concepts, novel multidisciplinary transdisciplinary approaches, and/or novel methods to solve the problem stated in the study? Are the aims original and innovative? How does the project challenge existing paradigms or develop new methodologies, and/or theories?

Approach

  • Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate for the aims of the project? Does the proposed project specify target higher-risk population(s)? How adequate are the strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? As appropriate, how well are the potential problems and alternative approaches considered? To what extent are the project timeline and milestones appropriate and realistic for the proposed research objectives?

Environment

  • How well does the scientific environment in which the work will be done contribute to the probability of success? How well do the proposed experiments benefit from unique features of the scientific environment or employ useful collaborative arrangements?

Additional Review Criteria - Cores and Research Project

As applicable for the Cores and Projects proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall adjectival rating, 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

Not applicable

Revisions

Not applicable

Additional Review Considerations - Cores and Research Project

As applicable for the for the Cores and Projects 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 adjectival rating.

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.

2. Review and Selection Process

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

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

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} 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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

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

The PD(s)/PI(s) will have the following primary responsibilities:

  • Planning and conducting the operations defined by the terms and conditions of the cooperative agreement award. This includes determining research approaches, designing protocols, setting project milestones in consultation with NCI staff, and ensuring scientific rigor.
  • Conducting the scientific research in the project, reporting progress on milestones or objectives to NCI staff, and reporting results to the scientific community.
  • Participating in a cooperative, interactive, and collaborative manner with NCI staff, other network investigators, and one another to maximize the impact of the network and meet program goals and objectives.
  • Serving as voting members of the Persistent Poverty Initiative Steering Committee (SC) that is responsible for the governance of activities (as described below).
  • Accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Persistent Poverty Initiative SC.
  • Maintaining the confidentiality of the information developed or handled by the Center, including, without limitation, unpublished data, protocols, data analysis, confidential exchanges between members, as well as any confidential information received by third-party collaborators.
  • Facilitating the public release and dissemination of results, data, reagents, models, technologies, and other products generated through this award in a timely manner. The PD/PI is expected to share data and resources generated through this award in accordance with the approved plan for making quality-assured data and materials available to the scientific community and the NIH as written in the final version of the grant application, and consistent with sharing policies and recommendations developed and approved by the Persistent Poverty Initiative SC, NIH sharing policies, and the goals of the FOA.
  • Ensuring that any industry collaborations should be governed by a research collaboration agreement with terms that ensure the collaboration is conducted in accordance with the applicable NIH policies and procedures and any guidelines/recommendations developed by the Persistent Poverty Initiative SC.
  • Operating in accordance with processes and goals as delineated in the FOA, and in accordance with processes, goals, and procedures established by the Persistent Poverty Initiative SC to the extent of applicable grant regulations.
  • Awardees will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and network policies agreed upon by the Persistent Poverty Initiative SC, to the extent consistent with grants regulations. This includes compliance with program policies and procedures including, as applicable, the use of common protocols, publication of study results, collaborative procedures, confidentiality, and sharing plans to be developed by the Persistent Poverty Initiative SC in collaboration with NCI.
  • Attending an Annual Investigators' Meeting of the PDs/PIs and partners.
  • Adhering to a Network Communication Plan: A consensus Communication Plan will be drafted by the SC during the kickoff meeting of the Centers. This plan will clearly spell out interactive requirements that all investigators are expected to follow within the Center and across Centers, including:
    • Participation in regular conference calls with fellow Center colleagues through contribution to various subcommittees and working groups;
    • Participation in and presentation of findings at the Annual Investigators' Meeting;
    • Coordination of efforts with other members of the Center; and
    • Jointly publishing on collaborations in a timely manner
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

An NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Additionally, an NCI Program staff member(s) will act as a Project Lead Scientist(s) to assist the project team leadership and will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement (as Project Scientists). The specific functions of the NCI staff include, but are not limited to the following activities:

  • Advising the awardees on specific scientific issues as well as programmatic priorities.
  • Serving as NCI lead Project Scientist and a voting member of the Persistent Poverty SC.
  • Co-organizing and participating in Persistent Poverty SC meetings, Annual Investigators' meetings, specialized workshops, seminars, and webinars.
  • Assisting in the management of the Persistent Poverty SC including the development of draft sharing and operating policies that are in accordance with NIH guidelines.
  • Serving as a resource for the Centers and the network in promoting interactions with other ongoing NCI activities that may be relevant to the goals of the Center and facilitating access to databases, technical capabilities, and other resources available through NCI to which the teams may have access.
  • Facilitating collaborative research efforts that involve multiple Centers.
  • Monitoring the performance of the program, making recommendations on overall directions and efficient utilization of resources, and minimizing unwarranted duplication of effort across the program.
  • Reviewing the progress of individual research projects and collaborative activities between the program participants and making recommendations on overall project directions.
  • Reviewing the compliance of awardees with the recommendations developed by the Persistent Poverty Steering Committee and coordinating external evaluation of the Centers
  • Recommending topics and initiatives for the use of supplemental funds that may be available for members to collaborate with researchers external to the Persistent Poverty Initiative.
  • NCI will have pre-publication access to the data generated and will periodically review the data, with the intent of facilitating optimal integration and dissemination of the results. Awardees will engage in data sharing in accordance with the network policies as established by the SC and within NIH guidelines. However, the awardees will retain custody and primary rights to their data developed under these awards. NIH and NCI will encourage timely publication of findings and public access to publications.

Additionally, an NCI Program Director acting as the Program Official and a Science Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include the following:

A Persistent Poverty Initiative Steering Committee will be formed as the main governing body. The Persistent Poverty Initiative SC will consist of the following voting members:

  • The PDs/PI(s) of each awarded Center (or senior investigator as a substitution when applicable) will collectively have one vote; and
  • The NCI Project Scientists collectively have one vote for the NCI.

Additional NIH/NCI program staff and other government staff may participate in Persistent Poverty Steering Committee meetings as non-voting members. The structure is designed to allow awarded investigators and NCI staff to work together to facilitate trans-Center activities based on synergistic expertise and projects.

Additional non-voting members to serve in an advisory capacity may be added to the Persistent Poverty Steering Committee as needed by a decision of the existing voting committee members. Involvement and collaboration with other federal agencies, institutions, and entities as appropriate for research in persistent poverty census tracts may be warranted/deemed appropriate.

The Persistent Poverty Initiative SC may decide to establish subcommittees/working groups for specific purposes. The NCI Project Scientists and Program Officers will serve on such subcommittees, as they deem appropriate.

PD/PI representing one of the Centers will be selected to serve as a chairperson of the SC on a rotating basis following award issuance. All SC decisions and recommendations that require voting will be based on a majority vote.

The Steering Committee will meet virtually monthly (and on an ad hoc basis as needed) and in-person once a year at the Annual Investigators' Meeting. The Persistent Poverty SC responsibilities include:

  • Developing collaborative protocols and network policies, including but not limited to centralized data management and in-network data and resource sharing policies;
  • Identifying scientific and policy issues that need to be, or can benefit by being, addressed at the Network level and developing recommendations to NIH/NCI Program Officials, as appropriate;
  • Reviewing the potential of shared support infrastructure(s) at individual Centers to serve the needs of the entire program;
  • Facilitating communication and fostering collaborations across Centers;
  • Identifying opportunities for sharing techniques, materials, information, and tools developed within the individual Center and member Centers;
  • Evaluating collaborative activities, and providing feedback to the NCI Program Staff;
  • Ensuring that Centers leverage, where feasible, resources and technology from NIH and NCI-sponsored initiatives and tools;
  • Co-leading the planning of major events such as the Annual Investigators’ Meeting
  • Discussing important issues relevant to addressing cancer control research challenges;
  • Reviewing the progress of research towards meeting the overall program goals and determining future directions for the network;
  • Developing publication policies to facilitate collaborations and co-publications by network members;
  • Making recommendations on the possible use of any supplemental funds that may be available for collaborations with members of the scientific community;
  • Discussing the implementation of recommendations or suggestions from NCI and any external consultants and plan a timely implementation strategy;
  • Overseeing, evaluating, and prioritizing the Persistent Poverty Initiative pilot projects; and
  • Coordinating dissemination of the Persistent Poverty Initiative Network output to the broader cancer research community.

Dispute Resolution:

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

3. Reporting

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

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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)

Shobha Srinivasan, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6938
Email: ss688k@nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@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 and 2 CFR Part 200.

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