Part 1. Overview Information

Key Dates

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 Notice of Funding Opportunity (NOFO).

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 NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This notice of funding opportunity (NOFO) invites proposals for research centers to advance cancer control equity by stimulating community-engaged, multilevel research interventions that address the impact of social determinants of health (SDOH) on adverse cancer control outcomes. Each Research Center will: 1) develop interventions that target the multilevel pathways by which SDOH impact adverse cancer outcomes; 2) develop measures, methods, and assess community-level SDOH, community engagement and cancer control equity processes and outcomes; and 3) build capacity and engagement among scholars from diverse backgrounds, including those from underrepresented groups in the biomedical sciences, and community partners to implement interventions that incorporate the lived experiences of those who face cancer inequities.

Background

Numerous factors and determinants intersect to influence health. Addressing the challenges of these intersecting factors requires the engagement of transdisciplinary teams with multisectoral, community, and clinical partners. Incorporating transdisciplinary perspectives will help to effectively address the multilevel and multifactorial causes of disparities, as well as to apply rigorous methods for achieving equitable outcomes. Interventions that address inequities across community, clinic, and individual levels through community-engaged transdisciplinary approaches to research, intervention design, delivery and implementation are needed. Furthermore, advancing SDOH measurement and promoting capacity building could ultimately improve health and quality of life in populations experiencing health disparities and underserved populations in the US.

Recent data indicate that while cancer mortality has declined overall, not all populations have benefited from such progress. Cancer disparities are often the result of historical, social, and structural inequities that have implications across the cancer control continuum. Specifically, SDOH are the unfair and avoidable factors that influence health. This includes the conditions of the environment in which people are born, grow, live, learn, work, play, and age that impact health outcomes, and operate at multiple levels of influence (e.g., individual, family, community, systems, and population levels). Examples of SDOH with the potential to adversely affect cancer prevention and control include housing instability, transportation barriers, structural racism and discrimination, language accessibility, health literacy, food access and insecurity, limited physical activity opportunities, and poor air and water quality. Cancer control equity means that everyone has a fair and just opportunity to prevent and detect cancer, receive quality care, and survive cancer with optimal quality of life.

Achieving health equity in cancer control requires a concurrent emphasis on developing interventions that address the multilevel influences of SDOH on adverse cancer outcomes; collaboration across multiple sectors and partners to leverage community insights and assets; and fostering meaningful community engagement with and building capacity among those disproportionately affected by cancer. In this manner, health equity is not only the goal or outcome, but the approach, process, and methods by which the research is conducted. Community engagement, as an approach to addressing health equity, is well-documented and effective in addressing historical power imbalance, building trust, improving participation in research, as well as enhancing acceptability, feasibility, and uptake of interventions both within and beyond the health care system. This NOFO requires meaningful community engagement in the development and testing of multilevel SDOH interventions.

Key terms for this NOFO:

Health Equity: Achieving health equity requires ongoing societal efforts to address avoidable inequalities, historical and contemporary injustices, the elimination of health and healthcare disparities, and valuing everyone equally. Cancer control equity is defined as everyone having a fair and just opportunity to prevent, detect, receive quality care, and survive cancer with optimal quality of life. Health equity is not only the goal or outcome, but is also the approach, process, and methods by which the research is conducted.

Social Determinants of Health (SDOH): The unfair and avoidable factors in health status that drive health inequities. SDOH are conditions in the environment which people are born, grow, live, learn, work, play, and age that impact health outcomes. These circumstances are shaped by the distribution of money, power, and resources at global, national, and local levels, which are themselves influenced by policy choices. Examples of SDOH with the potential to adversely affect health include housing instability, transportation barriers, structural racism and discrimination, language accessibility and health literacy, food access and insecurity, limited physical activity opportunities, as well as poor air and water quality. SDOH can be positive or negative, but may create the adverse conditions that result in poor health, known as social risks.

Multilevel Intervention: Intervention(s) occurring at individual, healthcare system, community and/or policy levels of influence, and that measures outcomes at two or more of these levels.

Community Engagement: The process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting well-being and health. Community engagement can also be seen as a continuum of community involvement. For the purposes of this NOFO, multilevel interventions should be developed and tested in collaboration with community partner(s).

Advancing Cancer Control Equity Research through Transformative Solutions (ACCERT) Consortium: The ACCERT Consortium consists of the research teams and community partners from up to four (4) U19 ACCERT Centers and one (1) U24 Coordination Center.

ACCERT Center(s): The research center(s) funded to conduct community-engaged, multilevel research interventions that address the impact of SDOH on adverse cancer control outcomes.

Objectives and Scope

This notice of funding opportunity requires each ACCERT Center to conduct at least one signature community-engaged, multilevel SDOH intervention(s) research project and community responsive projects over the course of the grant period. Each ACCERT Center must propose an overarching research theme related to addressing health equity by intervening on multilevel SDOH influences on cancer control outcomes. Themes may focus on addressing inequities related to health promotion, cancer prevention, screening, care delivery, and/or survivorship for individuals, families, neighborhoods, and communities experiencing health disparities and underserved populations. The proposed theme should inform the overall scientific agenda of each ACCERT Center, including study design, methodological approaches, and dissemination activities. The research theme should be identified in collaboration with community partners and transdisciplinary researchers, as well as guide the selection and participation of relevant sectors and stakeholders. Lastly, the research theme should be synergistic, with projects and cores connected by the common theme, and describe anticipated scientific gains beyond those achievable if each project were pursued independently.

Examples of research areas of interest include, but are not limited to:

• Development of multilevel interventions that address pathways by which SDOH impact community and/or individual level cancer risks or outcomes (e.g., cancer-related health behaviors, exposure to carcinogens, psychological distress, financial toxicity, and related cancer decision-making and family cancer caregiving).
• Interventions to modify the effects of historical and contemporary injustices on receipt of cancer prevention, detection, or treatment services (e.g., historical trauma, immigration policies, criminal justice, and others), and/or chronic experiences of structural racism and discrimination, and related individual level experiences with bias and discrimination on cancer control inequities.
• Interventions that combine community and individual approaches to healthy lifestyles by integrating behavioral interventions with interventions that modify related SDOH at community, clinic, and/or policy levels (e.g., combining food environment or built environment with related behavior change interventions).
• Development and testing of SDOH interventions that address historical and contemporary inequities and structural barriers to receipt of cancer-related health services (e.g., staff training, service delivery settings, health care and service utilization, health literacy, cost, and financial toxicity) and individual outcomes to reduce inequalities.
• Interventions to mitigate the effects of community social risks on cancer preventive behaviors, screening, care delivery and follow up for communities experiencing health disparities and underserved populations, including individuals experiencing homelessness, incarcerated or formally incarcerated populations and their families.
• Develop and test strategies that collect and use community level SDOH data (e.g., food access, transportation, housing, interpersonal safety, utilities) to rapidly communicate and inform the delivery of targeted and tailored interventions to reduce disparities in cancer control outcomes.

Key considerations:

• Community partners are a critical part of this funding opportunity and must be integrated in every aspect of the program, including direct involvement in the study planning, conduct, and evaluation.
• Studies must be designed to be relevant to local community needs and context. Consequently, the studies may not be generalizable, thus common data elements will be required to capture the breadth of studies and outcomes.
• The intervention studies included in the research projects must include a cancer-related primary endpoint (e.g., screening, cancer-related preventive behaviors, access to cancer care, adherence to guideline concordant treatment, health-related quality of life, etc.).
• All intervention studies must have component(s) that target and assess mechanisms of intervention effectiveness at multiple levels of influence.

ACCERT Center Components: To support the objectives of the ACCERT Consortium, each ACCERT Center (U19) must apply community-engaged approaches and consider the feasibility, acceptability, and sustainability of the proposed approach in the design of multilevel SDOH interventions. Research teams within each ACCERT Center may be composed of investigators located at one institution, or may be formed through a collaboration of investigators located at different institutions. Community partners within each ACCERT Center should demonstrate collaborative history with the research team(s) as evidenced by community-partnered activities with relevant outcomes (e.g., study design and implementation, communication and dissemination efforts, community education and outreach program development, etc.) Required components of each ACCERT Center are an Administrative Core; two Research Projects; and the Research Methods, Measures, and Data Management (Shared Resources) Core, that serves at least one Research Project. Projects and cores within each team should demonstrate synergy that could not be accomplished without extensive intra-ACCERT Center collaborations among components. Each U19 should propose integrated activities across Cores and projects that address the SDOH and cancer control equity theme and investigation.

Each Center will include the following components:

Administrative Core: The Administrative Core should manage and coordinate all ACCERT Center operational and scientific 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 and evaluating scientific productivity, dissemination, fiscal progress, timeline and milestones of all Research Center activities, including the Cores. The Administrative Core should develop the Center's policies and procedures for overall management, ethical conduct, scientific oversight, organizational/leadership structure, and regulatory compliance. The Administrative Core should also manage and support coordination of efforts for integration, responsiveness, and interaction within the ACCERT Consortium in collaboration with the U24 Coordination Center to promote synergistic research efforts.

The effective management of a Center requires a significant commitment by the Program Director(s)/Principal Investigator(s) (PD/PI). The Administrative Core is responsible for managing, coordinating, and supervising the community engagement activities, including decision-making, IRB, data sharing and norms for collaboration. The Administrative core is also responsible for convening an external and internal advisory board. The Administrative Core lead will work with the Coordination Center to collaborate on consortium-wide activities and is expected to participate in meetings as part of the Consortium's Steering Committee (see Section VI Cooperative Agreement Terms and Conditions for more information). Consistent with the ACCERT Center goals, this core will also facilitate and lead capacity building, engagement, and development activities among scholars from diverse backgrounds, including those from groups underrepresented in the biomedical sciences, and community partners to implement interventions that incorporate the lived experiences of those who face cancer inequities. It will focus on enhancing the ACCERT Center's efforts within the communities served and among its community partners, by building a cadre and network of pre- and post-doctoral scholars who are well versed in conducting community-engaged research focused on cancer control equity. Activities must support capacity building efforts to include community partners as active research team members, to assist with the development of research questions for pilot studies, and the translation of scientific findings into locally appropriate language(s) and effective delivery aligned with the ACCERT Center themes. Capacity building activities may also include training of researchers in community-engaged research methods to advance cancer control equity and address SDOH, cultural tailoring and related adaptations, research methods (e.g., small population research; incorporation of lived experiences of historically disadvantaged communities, and pragmatic research), implementation, dissemination and communication of research findings with and for community partners.

Consortium-wide Collaborative Activities: Each ACCERT Center is required to participate in consortium-wide collaborative activities, including pilot studies that will facilitate synergy, as well as identify, and address unmet scientific priorities across the ACCERT Consortium. ACCERT Centers are required to allocate time and effort for participation in consortium-wide evaluation activities, development of cross-Center tools and resources, dissemination of innovations and research to demonstrate the collective impact of the Consortium’s activities. Restricted set-aside funds will be designated as Collaborative Funds and used to support collaborative activities (see Section IV.2, R&R and Developmental/Pilot Projects for further details). All consortium-wide collaborative activities will be coordinated by the U24 Coordination Center and require approval by the ACCERT Steering Committee.

Research Methods, Measures, and Data Management (RMMDM) Core: The RMMDM Core is a shared resources Core that must work synergistically with the ACCERT Center's research projects on the development, implementation, and evaluation of Center research projects including advancing methods, measures, and assessing SDOH, community engagement and cancer control equity processes and outcomes. The RMMDM Core will be responsible for compiling, identifying, applying or developing measures to assess the impact of the multilevel SDOH intervention(s) on cancer control outcomes from at least two levels of influence (e.g., individual, community) across research projects. Additionally, the RMMDM may involve community partners in the selection, development, and/or adaptation of measures, as well as incorporate key considerations related to data sharing, local community relevance, interpretation of data, dissemination, as well as the potential unintended consequences of data collection and sharing. The Core must track and evaluate community engagement processes, approaches, and outcomes as they relate to the multilevel outcomes and disseminate results that translate Research Project findings into sustainable community- and system-level changes. ACCERT Center metrics may include capturing and assessing equity indicators such as power and control, decision-making influence, responsibility, mutual benefit, resource-sharing, and ownership, as well as contextual factors impacting community engagement (e.g., history, trust, relationship building, respect, and transparency).

The RMMDM core is also responsible for the Center’s compliance with NIH and NCI Data Sharing policies.

Social Determinants of Health (SDOH) Research Project (at least one large multilevel SDOH intervention required): The signature multilevel SDOH intervention(s) must be informed by a conceptual model that guides hypotheses and mechanisms by which the intervention and related components will impact cancer control equity outcomes across multiple levels. To assess the impact of the multilevel intervention, measures of health equity and related cancer control outcomes will be required at two or more levels in the study design, with an assessment and analytical plan that evaluates the cumulative effects as well as individual effects of the SDOH and related interventions at and across each level. The intervention project(s) will be conducted over the duration of the award. Cancer Control Equity outcomes must be specified. The intervention studies must examine NIH-designated United States populations that experience health disparities. NIH defines health disparity populations as racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, and sexual and gender minorities (SGM). See, https://www.nimhd.nih.gov/about/strategic-plan/nih-strategic-plan-definitions-and-parameters.html#:~:text=NIH%20defines%20health%20disparity%20populations,or%20more%20of%20these%20descriptions. ).

Community Responsive Projects: Community responsive projects (at least two) are of shorter duration (~1-3 years) and should allow for iterative, rapid cycle research, and be responsive to community context. Each ACCERT Center will be expected to detail a process by which they will employ community feedback and engagement for rapid and responsive studies on the following topics to advance the signature SDOH intervention: cultural adaptations or other studies that are complimentary to the signature SDOH intervention(s); advancement of multilevel cancer control equity outcome measures; projects that consider evolving community policies, needs, or community multi-sector change impacting equity outcomes and SDOH; or dissemination and communication tools to enhance community engagement, equity, or reach and acceptability of the SDOH intervention. Paired with the signature SDOH project, it is expected that these projects will generate critical time and context-sensitive research related to the Center’s theme. The Community Responsive Projects must examine NIH-designated US populations that experience health disparities, i.e., racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, and sexual and gender minorities (SGM). See, https://www.nimhd.nih.gov/about/strategic-plan/nih-strategic-plan-definitions-and-parameters.html#:~:text=NIH%20defines%20health%20disparity%20populations,or%20more%20of%20these%20descriptions.

Milestones: Each ACCERT Center must propose clear, quantitative milestones that reflect the Center’s ability to produce data and show overall progress towards the achievement of the Center’s goals, as well as milestones related to collaboration across the ACCERT Consortium with the U24 Coordination Center. Prior to funding an application, NIH Program Staff may contact the applicant to discuss the proposed milestones and any changes suggested by the review panel or Program Staff.

Steering Committee: NCI and each U19 will establish a Steering Committee with the PD(s)/PI(s) of each award and the U24 Coordinating Center serving as the governing body for the ACCERT Consortium. This committee will promote scientific collaboration and exchange of scientific findings among the ACCERT Centers.

Non-responsive Applications

Applications meeting the following conditions will be considered non-responsive and will not be reviewed:

• Applications that only propose observational research studies;
• Applications that do not identify and focus on communities experiencing cancer health disparities;
• Applications proposing studies that do not test intervention(s) at more than one level;
• Applications that include clinical trials in which the primary objective is to test the safety or efficacy of an investigational vaccine, adjuvant, or other product;
• Applications that are focused on clinically relevant experimental models (e.g., animal, computational, in vitro) that do not extend or guide mechanistic analysis of SDOH in human samples;
• Applications that do not specify the SDOH to be examined;
• Applications that do not specify a shared theme for investigation or community partner(s) aligned with the specified theme to collaborate on Research Center activities;
• Applications proposing studies that do not include human subjects;
• Applications that do not provide clear milestones.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations

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

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

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

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

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

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

2. Cost Sharing

This NOFO 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 NOFO. See the administrative office for instructions if planning 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 notice of funding opportunity 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:

April Oh, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-753-3154
Email:[email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

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

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

The application should consist of the following components:

• Overall: required
• Admin Core: required, maximum of 1
• Research, Measures, Methods and Data Management Core: required, maximum of 1
• Social Determinants of Health Research Project: Maximum of 2
• Community Responsive Project: Maximum of 4

Overall Component

When preparing the 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.

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.

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 NOFO) 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 minimum total effort for each Overall PD/PI or MPI of the U19 is 2.4 person months (PM) in aggregate for all functions served on the U19; effort cannot be reduced below this level during the entire project period.

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: List the aims of the proposed U19 Research Center. Summarize the expected outcome(s) of the U19 as a whole, including the impact that the results of the proposed project(s) will have on cancer control health equity. Briefly describe how the U19 is structured and how the Research Projects and Shared Resources Core(s) alone and together fit into the overall goals.

Research Strategy: This section should summarize the structure and the overall research strategy for the multilevel social determinant of health intervention design, approach, community engagement structure, capacity building and coordination with the ACCERT Center and Coordination Center. The overall concept of the ACCERT Center should be conveyed by describing how the development and testing of the multilevel intervention will be approached. Summarize supportive data and collaborations with community partners that demonstrate the proposed theme for the Center and related activities are responsive to underserved community needs and interests in cancer prevention and control equity. Identify how community engagement will be included in the Center approach overall. Identify the rationale for specific social determinants of health that will be examined and addressed in the intervention and specify each level of intervention. Specify any innovations, special features in the environment and/or resources that make this U19 strong or unique to the overarching goals of the ACCERT Consortium. The Research Strategy should be organized into sections that address the following: Overall Significance; Overall Innovation; Overall Approach; Overall Investigators and Community Partners; and Overall Environment. Specifics of Research Projects and Cores should be described separately.

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

• Subsection A. Center Overview: Present a concise overall vision and plan for the proposed ACCERT Center. Describe why the proposed U19 is important in the context of the known challenges to development and testing of multilevel SDOH interventions in cancer control. 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 cancer control equity, capacity building, and advancing SDOH research. 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 visual and narrative description of the organizational structure of the Center. 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. Describe how communities and/or community partners are engaged in the research. Describe how the capacity building activities, resources, personnel, will be integrated within the Center organization. State the overall milestones of the U19 that are anticipated in the funding period. Describe how the U19 will collaborate with the U24 Coordinating Center.
• Subsection C. Research Projects: Briefly describe each project, including its scientific integration with the proposed organizing framework, Cores, and a rationale for how each project will help, within the funded period, to generate sufficient results to address the challenges in cancer control equity and development of SDOH interventions. Provide a narrative description of the overall structure that clearly outlines all resources and expertise to develop and test multi-level interventions in SDOH. Provide a rationale for the selection of Research Projects and Shared Resources Core(s). Provide preliminary data that led to proposing the U19 application. Detailed preliminary studies sections should be included in the individual Research Projects and Shared Resources Cores. Cross-reference information when applicable. Explain how the proposed Research Projects and Core(s) will, together, address the overall goals of the U19.
• 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.
• Subsection E. Investigators: Succinctly describe specific expertise of the Overall PDs/PIs and Project Leaders that makes them appropriate for their associated roles on the U19 team, without duplicating information in biosketches. For the Overall PD(s)/PI(s), describe prior experience leading multi-institutional, multidisciplinary research endeavors. Describe how this selected team has collaborated and published together in the past. Include a description of proposed community partnerships including evidence of prior collaborative projects , if applicable. Describe how the scientific, clinical, community, and/or technical expertise of the U19 team is complementary and will strengthen the ACCERT Consortium.
• Subsection F. Environment: Summarize the unique aspects of the participating organizations that are important to the success of the U19.Describe how the scientific, clinical, community and/or technical resources of the U19 team will strengthen the ACCERT Consortium, without duplicating information in the facilities and resources sections. Describe how the SDOH intervention engages with multi-sector partners, if applicable and the environmental capacity for supporting research on the SDOH selected for study.

Letters of Support: Letters of support from partner organizations and entities that specify nature of collaboration and role in the U19. 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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Management and Sharing Plan (DMSP). The data/resource sharing plans must be consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles (see https://www.go-fair.org/fair-principles/). Instructions for the DMSP are provided in the SF424 Application Guide. The plan should include steps for creating standard operating procedures, accessibility requirements, and review process for granting access to the research community, and dissemination of that information.

• DMSP should be consistent with accomplishing the goals of the program, including
  • DMSP should acknowledge that the Coordinating Center will be required to accommodate data, as identified by the Steering Committee as a common data element, to be uploaded from awardees of the individual research project sites and upon request from NCI Program staff.
  • DMSP should acknowledge that the Coordinating Center make available data sets constructed for activities and projects approved by the Steering Committee.
  • DMSP should acknowledge that the Coordinating Center make available all of their data from any Pilot Projects and collaborative activities, as approved by the Steering Committee, to the Awardees of the individual research grant.
  • DMSP should acknowledge that the Coordinating Center will be required to make available algorithms produced for harmonization, standardization, and analysis of common data elements, and any new data deriving from pilot/collaborative projects, will be released and shared.
  • Sharing Additional Resources: Consistent with achieving the goals of this program, all resources generated (e.g., standards and SOPs) by the Awardees of the Consortium will promptly become available through a Coordinating Center resource. It is anticipated that other distribution avenues will be made available by the NCI if determined to be necessary. NCI Program Staff may negotiate modifications to these plans prior to funding or post-award
  • Intellectual Property Policy: Consistent with achieving the goals of this program and maximizing the benefit of all research funded as part of the Consortium for the improvement of public health through discoveries of the scientific community, the Data Sharing and Data Release policies expect a broad freedom-to-operate for all users of data generated by members and/or collaborators of the Consortium (e.g., by rapidly making data and results available in the public domain).

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

SF424 (R&R) Cover (Admin 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 (Admin Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

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

The U19 overall PD/PI(s) is/are expected to serve as Core Lead of the Administrative Core with a minimum effort of 0.6 person months. If multiple PD/PIs serve as co-leads of the Administrative Core, each is expected to devote at least 0.6 person months. The minimum total effort for each PD/PI or MPI of the U19 is 2.4 person months in aggregate for all functions served on the U19.

Core Lead (s) must commit to a minimum of 0.6 person months of effort.

Restricted Funds for Consortium-Wide Collaborative Pilot Projects

• Each ACCERT Center must have a special restricted Pilot Project Fund of $50,000 or 10% (which ever is greater) in direct costs for years 2-5 per year for supporting participation in cross-center pilot projects. These funds must be allocated in the "Other Expenses" category on the Budget form as "Restricted Funds for Collaborative Pilot Projects." Collaborative funds cannot be re-budgeted and unobligated funds, in any year, may be offset as per the recommendation from NCI Program Staff. NCI will retain the final approval for the release of any collaborative funds.
• Approval from the U24 Coordinating Center and NCI staff is required for the release of restricted funds for proposed pilot projects.
• The funds to support approved pilot projects will be allocated to the U19 awardee institution.
• Proposed pilot projects without the inclusion of other award recipients are considered ineligible for the use of Collaborative Funds.
• Collaborative Funds may also be used to support outside investigator(s) (i.e., not recipients within the ACCERT Consortium). The outside investigator(s) must bring a desirable expertise that is not already part of the Consortium and must align with the theme(s) of ACCERT Center. The inclusion of outside investigators will require appropriate justification and approval from the ACCERT Steering Committee.
• Collaborative Funds should not be used for activities that have been supported under the awards for individual research project grants and outside the scope of the outlined goals of the initiative.
• Use of Collaborative Funds to enable conduct of multi-year cross-consortium pilot project or activities are allowable.

Travel: Travel funds must be included in the proposed budget to support travel to Consortium related activities, including but not limited to supporting participation of U19 PD/PI and community partners (in total up to 5 members) to attend and participate in face-to-face annual grantee Meetings during the grant cycle. Each funded research project should plan to host one annual/scientific meeting with appropriate meeting support and assistance from the Coordinating Center during the life cycle of the Consortium. The budget should include funds to support travel for new or junior investigators that are part of capacity building activities that are established as part of the capacity building aims and activities.
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 (Admin Core)

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

Specific Aims: Succinctly describe the specific objectives and goals of the Administrative Core.

Research Strategy: The following aspects should be addressed:

Leadership: For U19 leadership, describe prior experience leading large research endeavors with complex budgets. Describe and/or diagram the chain of responsibility for decision-making and administration. Provide a succession plan which describes the process by which new leadership will be selected if the U19 PD(s)/PI(s) is no longer willing or able to lead the U19 Program.

Administrative management: Describe the plans for the fiscal management, clerical support, manuscript preparation, and compliance to NIH public access policy (PMCID), and meeting organizations. Discuss how quality control in U19 Research Projects, Core(s), and associated institutions will be administered. Indicate the relationship of the Administrative Core to the administrative structure of the applicant institution and partnering institutions.

Planning and evaluation: Describe the function and intended areas of expertise of a required internal advisory board. Describe how progress of the U19 will be internally evaluated during the project period, how milestones will be assessed, and how decisions to initiate changes will be made. Address how the U19 team will handle potential problems and provide alternative strategies in case of milestone delay or failure.

Integration of U19 components: Explain how coordination and communication among the Research Projects, Shared Resources Core(s), and participating institutions will be achieved at the overall program level. Explain how the U19 components contribute to and relate to the overall Center theme.

Interactions with other U19s: Address how decisions on the use of yearly U19 Network of Pilot Project Funds will be made. Explain the process for soliciting, reviewing and selecting pilot collaborative projects. Examples of pilot collaborative projects could include model sharing; high-risk, high-reward projects; cultural tailoring or measurement validation and testing; pre-implementation and dissemination studies.

Communication with U24 Coordination Center: Provide a statement of commitment with specific plans to collaborate with the designated Coordination Center (U24) for (1) sharing of ACCERT Centers research resources, and (2) participation in collaborative pilot studies (3) collaboration on capacity building activities, measures, assessment, and data analysis.

Capacity Building and Growth: Capacity Building is a key aspect of the Core function in building and growing the ACCERT Center research and engagement with community partners and new investigators. Capacity building and growth activities include but are not limited to Clinical, Biospecimen, Biostatistics/Informatics, Population Science, Behavioral Science, Organizational Science, Policy, Community Engagement, Health Equity, Psychology or other Social and Behavioral Science, Medicine and Community Practice expertise and training. Identify curriculum, resources, tools and structure to enhance objectives for capacity building that relate to the overall U19 cancer control health equity research projects. Establish a selection criterion for hiring and sustaining the participation of early-career investigators; Provide a plan for continuing research development and capacity of early-career investigators (including pre- and post-doctoral scholars) and capacity building for community partners; involvement and development opportunities in the overall Center; research projects; the U19 Network, workshops; publications; meetings, etc.

Community Partner Engagement: Describe the approach and process for engagement with identified partners, conflict resolutions, shared resources, and evaluation.

Letters of Support: Provide letters of support from the Institution(s) and partners that are included in the U19 Center.

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

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

PHS Human Subjects and Clinical Trials Information (Admin 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.

PHS Assignment Request Form (Admin Core)

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

Research, Methods, Measures, and Data Management (RMMDM) Core

When preparing your application in ASSIST, use Component Type Core

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

SF424 (R&R) Cover (RMMDM Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (use "Project 1", "Project 2", etc.")
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (RMMDM Core)

Research & Related Other Project Information (RMMDM 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) (RMMDS 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 (RMMDS 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.
• For projects with multiple leads, in the Project Director/Project Investigator section of the form, use Project Role of Other (Specify) and designate the role under 'Other Project Role Category' as Project Co-Lead and provide a valid eRA Commons ID in the Credential.
• In the additional Senior/Key Profiles section, list Senior/Key persons 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 (RMMDM 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 (RMMDM Core)

Specific Aims: Succinctly describe the specific objectives and goals of the RMMDM Core. In addition, list in priority order, the broad activities, and services of the RMMDM Core. In addition, state the Core's relationship to the U19's goals and how the Core relates to one or more of the Research Projects in the application.

Research Strategy: The RMMDM Core has two main functions: first, it may be proposed as distinct components that support non-hypothesis-driven research activities for one or more of the Research Projects of the U19, including data management. These activities may include but are not limited to community engagement, measure development, study or methods adaptation, ethical considerations, and data sharing. Second, the RMMDM Core is also responsible for supporting and administering Community Responsive studies in the ACCERT Center.

Research Methods, Measures, and Data Management:

• Describe the plans for management and integration of data, methods, measures, data tracking, analysis, interoperability of data, modeling, etc. activities of the Center across projects, pilots and the ACCERT Centers.
• Indicate why the RMMDM is an essential part of the U19, and how the proposed services will facilitate accomplishment of the proposed goals and milestones of the U19 and related projects.
• Describe the role(s) of the Core Lead and key participants, including community partners, and do not duplicate information provided in the Biosketches or the Budget Justification.
• Describe role of the core in measurement of impact of the multilevel intervention on cancer control outcomes and SDOH from at least two levels of influence (e.g., individual, community). Describe proposed measures for evaluation of impact on health equity for the Center.
• Core should describe how it will work with community partners in the selection, development, and/or adaptation of measures, as well as incorporate key considerations as they relate to data sharing, local community relevance, meaning of data collected, as well as the potential unintended consequences of data collection.
• Describe process and measures to track community engagement.
• Describe how the Core will manage responsibility and compliance with NIH and NCI Data Sharing policies for the Center.

Letters of Support: Provide letters of support from collaborators detailing nature and extent of participation.

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

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

PHS Human Subjects and Clinical Trials Information (RMMDM Core)

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 (RMMDM Core)

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

SDOH Multilevel Research Project

When preparing your application, use Component Type Project.

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

SF424 (R&R) Cover (SDOH Multilevel 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 (SDOH Multilevel Research Project)

Research & Related Other Project Information (SDOH Multilevel 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 Summary/Abstract: Summarize the objectives of the SDOH Multilevel Research Project. Provide information regarding the proposed SDOH intervention(s), multiple levels of impact assessed, relationship of the project to the proposed Center theme and cancer control equity related outcomes.

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.

Facilities and Other Resources: Describe the institutional environment, including the availability of facilities and educational resources that can contribute to the planned Research Education Program.

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

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

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 (SDOH Multilevel Research Project)

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

Each Research Project must be led by a minimum of two co-leaders: one scientist and one community partner. Each Project Leader should devote at least 1.8 person months effort (15%).

If the Research Project involves a clinical trial, the Applicant is responsible for including the costs of all support for statistical design, data collection, analysis and management, data deposition into NCI or other portals and ClinicalTrials.gov, as well as costs for clinical site monitoring, project management and quality assurance. If clinical trial costs will be covered by sources other than the U19, applicants should indicate the source of funds and provide letters of support. Specific cross-references should be made to clarify how these necessary functions will be supported.

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 (SDOH Multilevel Research Project)

A U19 Research Project may focus on preclinical research and/or clinical trial(s). Projects may include hypothesis-driven, hypothesis-generating and/or milestone-driven Aims.

Specific Aims: List the Aims of the proposed Research Project. Concisely describe the hypothesis or hypotheses to be tested and/or milestones to be achieved and guiding models or theories. A timeline of specific tasks over the project period is encouraged. In addition, state the individual Research Project’s relationship to the U19’s overall goals and milestones and how it relates to other Research Projects or Cores.

Research Strategy:

Significance: Explain the critical SDOH(s) impacting cancer control outcomes that the proposed Research Project addresses, and how cancer control health equity research and public health and/or clinical care and practice will be changed if the proposed aims are achieved. Explain why and how the SDOH(s) are selected for intervention(s) and community relevance. Describe the scientific premise for the proposed Project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of the Project. Discuss how the proposed project relates to addressing cancer control health inequalities. Explain how the proposed Project will improve scientific knowledge, technical capability, and/or clinical care or community services, to advance health equity in cancer control in communities experiencing health disparities and underserved populations.

Innovation: Explain how the Project challenges and seeks to address SDOH(s) using multilevel research paradigms and multicomponent interventions. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s).

Approach: Describe the overall strategy, methodology, and analysis to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted. Emphasize how the experimental design and methods proposed will achieve robust and unbiased results. Discuss potential problems, alternative strategies, benchmarks, and milestones for success anticipated to achieve the specific stated aims and the overall aim of the intervention trial(s) in the 5-year grant period. Discuss plans for collaborations with community partners. Measures and plans to inform future sustainability and dissemination of research results are required. Centers are also required to assess the feasibility and acceptability of the intervention by the communities impacted. Define the multiple levels that will be examined, how SDOH, social risk, social needs are defined at each level, rationale, measures, and related intervention components, and plans for measurement of proximal and distal impacts on cancer control outcomes and equity. Explain and define how the intervention(s) will impact cancer control outcomes, how this will be assessed and identified. Define the social determinant(s) of health that are targeted, the health equity outcome and approach taken to define each level of examination in the intervention(s).

Clinical Trials:

• Provide a clinical study synopsis keeping the relevant review criteria in mind, but do not duplicate information in the required clinical trial documents (e.g., PHS Human Subjects and Clinical Trials Information Form or IRB-approved clinical trial protocol):
• Describe the scientific rationale/premise of the study(ies) that is/are based on previously well-designed preclinical and/or clinical research.
• Describe the planned analysis and statistical approach for the proposed study design.
• Demonstrate that the eligible population of participants are available within the institutions for study.
• Address potential ethical issues.
• Describe how the recruitment timelines are feasible for adequate accrual.
• Address the differences, if applicable, in the intervention effect due to sex/gender and race/ethnicity.
• Describe the plans to standardize, assure quality of, and monitor adherence to, the clinical protocol and data collection or distribution guidelines.
• Describe the plan to obtain required study agent(s), if not within one or more of the applicant institutions.
• Describe how existing available resources, as applicable, will be used.
• Describe the procedures for data management and quality control of data at clinical site(s) or at U19 laboratories, as applicable.
• Describe the methods for standardization of procedures for data management to assess the effect of the intervention and quality control.
• Describe the plan to complete data analysis within the proposed period of the award.
• Include information on preliminary studies, data, and/or experience of the co-leaders of the Project that are pertinent to the Project.

Letters of Support: Provide letters of support from collaborators detailing nature and extent of participation, including letters for functions not supported by the U19 budget.

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

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

Draft or IRB approved protocols can be attached to the appendix

PHS Human Subjects and Clinical Trials Information (SDOH Multilevel 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, 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

Community Responsive Project

When preparing your application, use Component Type NOFO Specific.

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

SF424 (R&R) Cover (Community Responsive 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 (Community Responsive Project)

Research & Related Other Project Information (Community Responsive 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 Summary/Abstract: Summarize the objectives of the Community Responsive Project. Provide information regarding the research areas and processes for identifying and conducting rapid and responsive pilot studies related to the overall Center theme, SDOH, and how the process and project will be responsive to community interests related to cancer prevention and control.

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.
Facilities and Other Resources: Describe the institutional environment, including the availability of facilities and educational resources that can contribute to the planned Research Education Program.

Project /Performance Site Location(s) (Community Responsive 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 (Community Responsive Project)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

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

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Responsive Project)

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

Each Research Project must be led by a minimum of two co-leaders: one scientist and one community partner. Each Project Leader should devote at least 1.8 person months effort (15%). Centers are required to set aside 15% of the total direct cost of the Center to fund at least 2 projects every year over the course of the award of the Centers.

If the Research Project involves a clinical trial, the Applicant is responsible for including the costs of all support for statistical design, data collection, analysis and management, data deposition into NCI or other portals and ClinicalTrials.gov, as well as costs for clinical site monitoring, project management and quality assurance. If clinical trial costs will be covered by sources other than the U19, applicants should indicate the source of funds and provide letters of support. Specific cross-references should be made to clarify how these necessary functions will be supported.

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

PHS 398 Research Plan (Community Responsive Projects)

A U19 Research Project may focus on preclinical research and/or clinical trial(s). Projects may include hypothesis-driven, hypothesis-generating and/or milestone-driven Aims.

Specific Aims: Describe at least one potential Community responsive project. Concisely describe potential hypothesis or hypotheses to be tested and/or milestones to be achieved and guiding models or theories. Describe the scope, scale, and process for identifying Community Responsive Projects.

Research Strategy:

Describe the plans for the Community Responsive project to facilitate and enhance the research related to the Center theme of social determinants and cancer control and the signature SDOH intervention. The research strategy should include two parts:

1) Community Responsive Project: Describe at least 1-2 potential Community Responsive Project that would be conducted in the first year of the Center Projects. The focus of these research studies should be directly linked to the focus of the Center and should have clear theoretical or conceptual bases and plans for integration of measures within the center data ecosystem. Innovative cross-disciplinary linkages and high-risk /high-pay-off studies designed to advance innovative science are particularly encouraged. The project must be conducted in the first two years of the study period.

2) Community Responsive Project Research Process: Describe the process for selection, review, and implementation of future community responsive projects which may begin in year 2. Applications must address areas indicated below:

• Anticipated duration of projects (up to 2 years but can be shorter);
• Provide a few examples of possible directions for research and typical attributes of anticipated projects and research and community scope of projects;
• Describe how projects will be solicited, reviewed, and prioritized for activation; in these plans, explain:
  • How the projects will coordinate with the RMMDM Core and ensure that all pilot projects fall within the overall theme of the Center (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 Projects will work with Center structure and organization to 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, NIH Clinical trials requirements, etc.) in domestic institutions.
  • Describe how the Consortium-wide collaborative Pilots will be coordinated with proposed projects. Specifically, anticipated areas for collaboration, process for collaborative meetings, shared data and human subjects infrastructure.

Letters of Support: Provide letters of support from collaborators detailing nature and extent of participation including letters for functions not supported by the U19 budget.

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

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

Draft or IRB approved protocols can be attached to the appendix

PHS Human Subjects and Clinical Trials Information (Community Responsive Projects)

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, 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

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 applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

Important reminders:

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

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

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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.

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 NOFO, note the following:

A meritorious U19 application is expected to be well-balanced in interdisciplinary science that spans expertise in both SDOH and multilevel intervention implementation.? The overarching goal of the ACCERT Consortium is to advance community-engaged, multilevel research that addresses the impact of social determinants of health on adverse cancer outcomes. Exemplary applications should articulate how the proposed multilevel SDOH intervention will produce new and effective strategies and build sustainable capacity for improving cancer control equity among medically underserved communities. The application should specify how community partners are engaged in the U19 Research Centers.

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.

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

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

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the 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?

Specific to this NOFO: How does the U19 address an important problem or a critical barrier to progress in the field? How rigorous is the prior research that serves as the key support for the proposed project, and how does it support the research agenda proposed? If the aims of the U19 are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How sound are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention justified by preliminary data, clinical and/or preclinical studies, or the literature on knowledge of SDOH? For trials focusing on clinical or public health endpoints, how essential is this trial for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors and services, or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, how will this trial advance scientific understanding? How will it impact cancer control inequalities? How will the U19 address a critical challenge in addressing cancer control inequalities?

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?

Specific to this NOFO: 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? To what extent do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate for the science proposed? Does the application identify a core of potential center investigators and staffing for a coordinating center? To what extent do the overall PD/PI(s) have experience leading multi-institutional, multidisciplinary research program(s), which may predict success of the U19? How well does the application describe a history of collaboration and willingness to participate in team science and share information, and level of engagement in collaborative activities as members of the Consortium? How well does the application describe a history of collaboration with identified community partners?

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 to this NOFO: To what extent 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 on cancer control inequalities? How innovative is the proposed multilevel intervention Research Projects to the communities that the PIs plan to engage with? If similar interventions were previously tested in other communities, to what extent is there a clear rationale for pursuing the Research Project(s) proposed in the U19? How strong is the research plan in describing how it will measure and assess the multilevel intervention on cancer control equity outcomes specified in the application?

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?

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?

Specific to this NOFO: How strong is the likelihood that the U19 will, as an integrated effort, achieve the stated Overall Aims and meet proposed milestones. How significant is the potential impact of the proposed multilevel intervention's inclusion of cancer control outcomes, community engagement, and identified cancer control equity outcome and potential impact on addressing cancer control inequities.

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?

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

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

If multi-sites/centers, how strong is the evidence and adequacy 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?

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.

Scored 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? How appropriate is the scope of activities proposed for the Administrative Core appropriate to meet those needs?
• Leadership: How well suited are the PD(s)/PI(s) and other personnel to their roles in the Administrative Core? How appropriate are the experience and training, and demonstrated experience and an ongoing record of accomplishments of the PDs/PIs in managing research and capacity building activities for researchers and practitioners? If the Center is multi-PD/PI, how complementary and integrated are the investigators' expertise and skills? How appropriate are their leadership approach, governance, plans for conflict resolution, and organizational structure for the Center? How sound is the applicant’s experience overseeing selection and management of sub-awards, if needed?
• Administrative management: How well does the application propose novel organizational concepts or management strategies in coordinating the research program of the Center?. 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?
• Communication and Network coordination: To what extent does the proposed approach address the communication and management needs to coordinate activities and projects in the Center? To what extent does the proposed approach address the communication and management needs to coordinate activities and projects of the Center with the Consortium, including pilot projects? How adequate are plans for participation in the Annual Investigators' meeting and other meetings?
• Planning and evaluation: 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? To what extent does the applicant address Center program evaluation activities? 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 does the approach describe the inclusion of community partners in Center activities?
• Capacity building activities: How clear and innovative are the outlined career enhancement, capacity building, and training programs on issues related to social determinants of health, cancer control, community engagement, intervention design and delivery, and working with underserved communities? How clear are the approaches for recruitment and development of capacity building and career enhancement activities for researchers and practitioners?
• Environment: To what extent will the institutional environment in which the Administrative Core operates contribute to the probability of success in facilitating the research of the Center it serves?

Scored Review Criteria Research, Measures, Methods, and Data Management Core

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

To what extent does the proposed Core meet the overall needs of the Center and research projects? To what extent are the services of the Core critical to the goals of the SDOH Projects and Community Responsive Projects and Admin 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?

Scored Review Criteria Social Determinants of Health 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 cancer control health equity? How well do the proposed project(s) account for and address local challenges and the social and physical context of the institutions/clinics/communities? If the aims and milestones of the project are achieved, assess how significant will scientific knowledge be advanced in cancer control and social determinants of health? Are the levels of analysis, intervention and social determinant of health identified consistent with the overall goal of the Center?

Investigator(s)

• How well are the investigators trained and well suited to carry out this work? To what extent 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, multi-level methods, multi-component intervention, and/or novel methods to solve the problem stated in the study? To what extent are the aims original and innovative? How does the project challenge existing paradigms or develop new methodologies, and/or theories?

Approach

• How significantly are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate for the aims of the project? How adequately does the proposed project specifically target populations experiencing cancer control inequalities? 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? To what extent are proximal and distal outcomes of the intervention identified across each level of intervention specified? Does the application account for any potential overlap or intersection of multiple SDOH influence on intervention outcomes?

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?

Scored Review Criteria Community Responsive Projects

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

• To what extent is the Community Responsive project identification process consistent with the Center theme proposed and criteria for selection and support of pilot studies described? How impactful will the process be in identification and testing of pilot studies within the Center? How adequately will the selection process identify responsive projects to community identified needs and interests related to cancer prevention and control, SDOH, and cancer control equity? How impactful will the Community Responsive Projects be to the overall scope and goals of the SDOH Research project?

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 Animals 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.

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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, NIH 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 NOFO.

Applications will be assigned on the basis of established PHS referral guidelines to NCI. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. 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 the NIH Grants Policy Statement.

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

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and 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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

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

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

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

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

The following special terms of the 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 NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), 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 award recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the award 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have primary responsibility for: The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the proposed research in accordance with terms and conditions of the award.

All PD(s)/PI(s) of the ACCERT Consortium (Coordination Center and individual ACCERT Centers) will have primary responsibility for:

• Overseeing the budget and activities of the award, as detailed.
• Cooperating with other Consortium investigators and partners and NCI Staff, as appropriate, in the design and conduct of protocols, analysis of data, and reporting of results of research undertaken by the Consortium. This includes, but is not limited to: Providing goals and estimated costs for procedures and protocols, protocols and other research resources generated through the award
• Promoting and coordinating Consortium-wide scientific collaboration
• Ensuring training of study site personnel as needed for standardization of collaborative protocols across sites and for accurate and timely data entry
• Facilitating the formation of and participating in appropriate Work Groups to promote the exchange of preliminary findings, experiences, protocols, and ideas across the Consortium
• Interacting and complying with requests for information from the Steering Committee and other subcommittees as appropriate
• Participating in the annual PD/PI scientific/business meetings, and monthly committee calls organized by the Coordination Center, as relevant
• Contributing to the planning and agenda of annual scientific meeting
• Cooperating in the program evaluation activities, as needed
• Accepting and implementing all scientific, practical, and policy decisions approved by the Steering Committee to the extent consistent with applicable grant regulations
• Serving on the Steering Committee (for details, see "Areas of Joint Responsibility" below)
• Providing information to the NCI Program Directors and Project Collaborators concerning progress by submitting annual progress reports in a standard format
• Complying with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events
• The Consortium will be subject to periodic internal evaluation (coordinated by the Coordination Center). All Consortium's award recipients will be expected to participate in such evaluations.
• All Consortium's award recipient institutions/organizations will be expected to share with other award recipients knowledge, data, research materials, and any other resources necessary and relevant to the Consortium consistent with the approved DMSP and other resource sharing plans.
• Award recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

The PD/PI(s) responsible for a research project grant will have the following additional responsibilities:

• Determining and coordinating research approaches and procedures that can be standardized across the Consortium, and overseeing the analysis and interpretation of such research
• Encouraging, participating, and coordinating consortium-wide collaborations to test novel hypotheses in a complementary fashion across multiple research project grants as recommended by the Steering Committee
• Overseeing the timely release of data according to approved plans
• Complying with Coordination Center requests, as directed by NCI Program Staff and the Steering Committee, to facilitate monitoring of progress

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

• One or more NCI Program Directors will be substantially involved in the Consortium as NCI Project Scientists/Collaborators. NCI Project Scientists/Collaborators will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards.
• NCI Project Scientist/Collaborator(s) will have the following responsibilities to all Consortium award recipients:
  • Have substantial involvement to guide, coordinate, and participate in the conduct of the Consortium activities;
  • Attend and participate in all Steering Committee and subcommittee meetings of the Consortium;
  • Coordinate and facilitate the interactions among the award recipients under the cooperative agreements;
  • Serve as a liaison between the Steering Committee, the Consortium, the NIH/NCI and other federal agencies as needed;
  • Monitor the operations of the Coordination Center and individual research projects, review their progress and compliance with the operating policies of the Steering Committee, and make recommendations on overall project directions and allocations of project funds;
  • Facilitate and coordinate the exchange of information and interactions between Consortium award recipients to support collaborative efforts;
  • Participate in organizing and coordinating annual scientific/business investigator meeting and/or other meetings identified at post-award as coordinated by the Coordination Center;
  • Advise on the design of research activities, availability of resources, and/or management and technical performance of projects, as appropriate;
  • Participate as collaborators to the investigators in some shared activities, if appropriate;
  • Assist in avoiding unwarranted duplication of effort across the Consortium;
  • Provide oversight in the evaluation of the Consortium as coordinated by the Coordination Center;
  • Monitor progress of the projects towards meeting milestones and adherence to the strategic goals of the program;
  • Facilitate collaborative research efforts and related activities that can involve award recipient as well as investigators from other NCI-related initiatives;
  • Evaluate the adherence of award recipients to any approved DMSP or intellectual property plans.

Additionally, an agency program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those recipient institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance. The NCI Program Official will be responsible for monitoring the level of performance and making recommendations for any corrective actions.

Areas of Joint Responsibility include:

• A Steering Committee will serve as the governing board for the Consortium. The Steering Committee will have primary responsibility for:
  • Overseeing the overall organization of the Consortium initiative and for reviewing its research goals
  • Monitoring transdisciplinary progress of the Consortium.
  • Establishing advisory committees and subcommittees, as necessary, to serve the Steering Committee and the award recipients.
  • Establishing topical Work Groups for specific purposes, as needed, and developing the appropriate structure to promote the exchange of experiences, protocols, novel research findings, etc. across the Consortium. The NCI Program Staff will serve on such subcommittees, as they deem appropriate and/or designate an NCI representative.
  • Reviewing the potential for sharing resources located at individual research project sites to serve the needs of other projects or the entire initiative.
  • Making recommendations for re-directing the Consortium's focus in order to accommodate new scientific opportunities and directions and maximize the transdisciplinary nature of the Consortium.
  • Sharing and reviewing annual progress among the projects of the Program.

The Steering Committee will be comprised of the following voting and non-voting members:

• The PD(s)/PI(s) of the Coordination Center (RFA-CA-23-027), who will have one vote.
• A research investigator of each individual research projects (RFA-CA-23-026), who will have one vote. Award recipients with MPIs must designate a PI as the representing voting member. The non-voting PI of the MPI award may participate in all Steering Committee meetings. The MPIs may alternate role as voting member of the Steering Committee during the life cycle of the award.
• Designated NCI Project scientist/collaborator(s) representing the NCI management group, who will have one collective vote..
• Other NCI program staff as part of the NCI management group may participate in Steering Committee meetings as non-voting members.
• Ad-hoc members may participate in Steering Committee meetings as non-voting members.
• Each entity must also designate a stand-by should the voting member is absent or unable to serve.
• Other relevant details, including:
  • The PD(s)/PI(s) for each research project grant award and the Coordination Center will agree to serve on the Steering Committee for the full project period.
  • Steering Committee representatives from each project will be elected at the initial kick-off Consortium meeting and should reflect a balance between research investigators and disciplines.
  • The Steering Committee will meet virtually or in person once every year, at a geographical location recommended by the Steering Committee in consultation with the NCI. Award recipients are encouraged to host at least one annual meeting.
  • A Steering Committee Chair will be elected every twelve months from among the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NCI staff cannot serve as Steering Committee Chair.
  • In the event that PD(s)/PI(s) cannot agree on critical aspects of the Consortium, such as common protocols, then the Steering Committee, in consultation with NCI Program Staff, will vote on a recommendation for how to proceed. Recommendations of the Steering Committee must be consistent with NIH, DHHS, and Federal Guidelines.
  • Other guidelines for the Steering Committee, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the Steering Committee will meet at least once per month by teleconference.
  • The Steering Committee may establish an External Community Board, comprised of scientific experts from outside the ACCERT Consortium, consult with the Steering Committee and the recipients.
  • The Steering Committee may establish a Community Advisory Board, comprised of community members and patient advocates with lived experiences relevant to ACCERT Center theme(s), to advise the Consortium.

Consortium-wide Collaborative Activities: To facilitate synergy within the Consortium to achieve unmet scientific priorities of the ACCERT Consortium, award recipients are required to participate in Consortium-wide activities and identified pilot projects as recommended by the Steering Committee. The Consortium-wide collaborative activities will be developed and conducted by recipients at post-award as part of the Collaboration Component coordinated by the Coordination Center. Funding for the Consortium-wide activities will be supported in part by restricted Collaborative Funds (See Section I.1 Consortium-wide Collaborative Activities and Section IV.2 R&R and Budget).

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to Dispute Resolution. The Dispute Resolution Panel will have three members: one NCI designee and two designees with expertise in the relevant area, chosen by the Steering Committee. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appeal-able in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs 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 75.113 and 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 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

April Oh, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-753-3154
Email:[email protected]

Brenda Adjei, M.P.A., Ed.D.
National Cancer Institute (NCI)
Telephone: 240-276-6185
Email:[email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Section VIII. Other Information

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

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