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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from 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 grant applications for a Coordination Center to support four research centers that address the impact of social determinants of health (SDOH) on adverse cancer control outcomes. The Coordination Center will 1) facilitate communication across ACCERT Centers and provide meeting support; 2) lead efforts to manage and share consortium-wide data; 3) connect research Centers with capacity building and training opportunities and disseminate synthesized research products, findings, and tools; 4) stimulate and coordinate consortium collaborative activities; and 5) evaluate the impact of the consortium.

One Coordination Center will be funded as part of the Advancing Cancer Control Equity Research through Transformative Solutions (ACCERT) Consortium, to support up to four ACCERT Centers (RFA-CA-23-026).

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. The 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 adverse conditions that result in poor health, known as social risks.

Multilevel Intervention: Intervention(s) occurring at more than one level of individuals, healthcare systems, community organizations across multiple sectors, payers, or policy settings, 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 the well-being of those people; Community engagement can also be seen as a continuum of community involvement. For the purposes of this RFA, multilevel interventions should be collaboratively developed, delivered, and disseminated 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) Coordination Center.

ACCERT Center(s): The research center(s) funded through the companion RFA-CA-23-026 to conduct community-engaged, multilevel research interventions that address the impact of SDOH on adverse cancer control outcomes.

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 these diverse 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 historically marginalized and underserved populations in the U.S.

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 with 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 cancer control equity 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.

Objectives and Scope

The Coordination Center will be expected to handle the operational logistics, contribute scientific inputs as a participating member of the ACCERT Consortium, and provide administrative and scientific support for ACCERT Centers. The Coordination Center will work with the funded ACCERT Centers and NCI Program Staff to bring together expertise and data relevant to the funded research. The Coordination Center should be able to connect available resources, foster collaborative efforts, build partnerships, and disseminate research products and programs of the ACCERT Consortium.

Applicants responding to this Coordination Center NOFO are expected to familiarize themselves with the companion NOFO (RFA-CA-23-026; U19) and all the detailed requirements for U19 ACCERT Centers as well as the related activities and individual and shared responsibilities required for the ACCERT consortium. The Coordination Center will be expected to identify and facilitate integration of the awarded ACCERT Centers to minimize resources/effort duplication and employ existing resources available. The Coordination Center will have substantial responsibility for the ongoing evaluation of each ACCERT Center as well as the entire ACCERT Consortium.

The same institution may submit applications to this U24 RFA and its companion (RFA-CA-23-026; U19), as long as there is no overlap regarding investigators and direct cost funding.

All applicants must include the following main components:

1. Administrative Component. The Coordination Center must be able to provide close coordination of transdisciplinary research efforts of the ACCERT Consortium. This role will require strong leadership and administrative support, scientific insight, and capacity to bring diverse teams together. The Administrative Component of the Coordination Center will be responsible for the following activities:

• Within the first 30 days of the release of the Notice of Grant Award, convene a kick-off meeting between all funded ACCERT Center investigators.
• Provide scientific leadership and serve as a scientific resource for members of the ACCERT Consortium.
• Facilitate synergy and collaborations across the ACCERT Consortium.
• Provide logistic and administrative support for all the activities of the Steering Committee and its subcommittees, including the External Advisory Board (if established)
• Communicate and coordinate all ACCERT Consortium-wide activities, including evaluation, consortium collaborations, integration and dissemination. As recommended by the Steering Committee, coordinate the establishment of topical Work Groups as relevant to the funded ACCERT Center theme(s) and scientific needs across the ACCERT Consortium.
• Provide logistical infrastructure serving the funded ACCERT Centers and facilitating ACCERT Consortium-related functions and activities including within consortium and external to consortium communications.
• Develop a public website for communication and sharing of activities, events, and resources of the ACCERT Consortium, as appropriate.
• Provide organizational and logistical support for facilitating regular conference calls and activities of the Steering Committee, Work Groups, ACCERT Centers, and the public (if applicable).
• Organize and support the logistics of semi-annual or annual investigators and community partner meetings (with cooperation and approval from NCI designated program staff) and meetings of topical Work Groups (either virtually or in-person at a designated geographic location).

2. Data Coordination Component. The Coordination Center will be responsible for Consortium-wide data coordination and data sharing in collaboration with funded ACCERT Centers. The main goal of this component is to facilitate data sharing across the ACCERT Consortium. Activities of this component will include:

• Develop, modify, and/or support standards and mechanisms for publicly sharing data, resources, and codes developed and utilized in the Consortium, including by the Coordination Center.
• Collaborate with ACCERT Center personnel and community partners to establish data management and sharing policies that align with the NIH Data Management and Sharing Policy and to identify appropriate data repositories. This may involve, if appropriate, a distributed model, e.g., without having to centralize all data to one repository site.

3. Integration and Dissemination Component. The Coordination Center must be able to integrate and disseminate innovations in community engagement, research methods, capacity building, and training modules within the ACCERT Consortium, as appropriate, and facilitate efforts to disseminate findings. Plans for this component must include the following elements:

• Facilitate integration by identifying common data elements and measures, activities, and tools that could be incorporated across multiple ACCERT Centers to minimize resources/effort duplication and utilize existing resources available.
• Provide organizational support with an emphasis on efficient communication and coordination of efforts to facilitate transdisciplinary research across multiple research institutions.
• Working with ACCERT Center investigators, community partners, and NCI Program Staff, bring together expertise and resources relevant to address ACCERT Center themes and to convene Work Groups, as recommended by the Steering Committee.
• Organize sessions and create opportunities to present and disseminate the research findings/outcomes across multiple venues, including at relevant national meetings and community events.
• Disseminate capacity-building and training opportunities for early-stage scientists and community partners within the ACCERT Consortium. As needed, disseminate these resources in culturally and linguistically accessible formats for the public.
• Develop resources that include methodological innovations in multilevel measures of SDOH, health equity, cancer control, community engagement, and other relevant research resources and capacity building tools generated across the consortium.

4. Collaboration Component. The ACCERT Consortium is required to participate in Consortium-wide Collaborative Activities (see Section VI.2, Cooperative Agreement Terms, and Conditions of Award for further details). The Collaboration Component will be responsible for coordinating across each ACCERT Center in their Consortium-wide Collaborative Activities (i.e. collaborative research to be developed and conducted by funded ACCERT Centers post-award). Funding for the Consortium-wide Collaborative Activities will be supported in part by restricted Collaborative Funds (See below and Section II. R&R and Modular Budget for further details). Specifically, plans for this Collaboration Component include the following, but are not limited to:

• Identify commonalities in research directions and specific questions being explored across the Consortium to promote collaborative efforts.
• Coordinate announcement of funding opportunities for consortium-wide collaborative research, review of applications, and funding of successful applications.
• Identify a scientific problem (i.e. consortium-wide pilot project) that could be jointly explored across Research Center grants during the lifespan of the ACCERT Consortium.
• Facilitate collaboration among the ACCERT Centers to develop capacity building and training resources, curricula, and partnerships across the ACCERT Consortium.

Collaborative Funds for Developmental/Pilot Projects

Collaborative Funds (see Section IV.2. R&R and Budget for further details) can be used to support the expansion or inclusion of an exploratory aim, to incorporate identified common measures or targets, develop new methodologies that can be validated via multiple grants, or facilitating diverse study population. This restricted fund may be combined with other Collaborative Funds from awarded ACCERT Centers. Collaborative Funds may also be used to fund Consortium-wide pilot projects or developmental ideas with one or more ACCERT Centers within the Consortium and may involve outside investigator(s) (not funded within the Consortium). The outside investigator(s) must bring a desirable expertise that is not already part of the Consortium and must meet the purpose of the ACCERT Program. The inclusion of outside investigators will require appropriate justification and approval from the Steering Committee. Proposed pilot projects without the inclusion of other awarded ACCERT Centers are considered ineligible for the use of Collaborative Funds. Collaborative Funds should not be used for activities that have been supported under the ACCERT Center awards and outside the scope of the outlined goals of the initiative. Usage of Collaborative Funds to enable conduct of multi-year consortium-wide pilot project or activities are allowable. The Coordination Center may choose to use its Collaborative Fund to provide educational opportunities (e.g., travel awards) for early-stage investigators or students to the Consortium's meetings.

5. Evaluation Component. The Coordination Center must have the capacity to enable evaluation mechanisms promoting timely, corrective actions. The Evaluation Component will closely collaborate with the Steering Committee (see below), members of the ACCERT Centers, and NCI program staff, as appropriate. An evaluation system is expected to be integrated into the design and operations of the Coordination Center.

This evaluation system should track the relevant performance benchmarks of the ACCERT Consortium, taking into consideration the individual accomplishment of each research project grant and any collaborative endeavors. The outcomes will help Steering Committee and funded ACCERT Centers to take corrective steps and optimize their performance. Aspects of evaluation should take an engaged approach with Steering Committee and NCI program staff, with consideration for community partners in assessing impact.

The evaluation of the Awardee (and the activities of this component) will be essential to facilitate and enhance the overall evaluation of the Consortium, to be determined by NCI. The Coordination Center (and specifically this Evaluation Component) will be expected to cooperate with NCI in the evaluation process. For example, this component includes evaluating the quality and innovation of the science conducted by the ACCERT Centers as well as assessing critical intermediate indicators of success such as infrastructure development and capacity building, cross-fertilization, linkages and resource sharing arrangements within and outside the consortium, and the interdisciplinary and multilevel nature of the research. Evaluation variables may include items such as peer-reviewed publications, developed websites, disseminated tools and resources, joint collaborative grants submitted for funding outside the Consortium, or other new collaborations and partnerships. The Coordination Center will have substantial responsibility for the evaluation of each ACCERT Center and the evaluation of the entire ACCERT Consortium.

Areas for evaluation and desirable outcomes will include such aspects as:

• The overall capacity to study the underlying mechanisms between SDOH and cancer prevention and control, focusing on multilevel relationships;
• The capacity of the ACCERT consortium to develop, test and deliver cancer prevention and control interventions using health equity approaches such as community engagement and capacity building;
• The capacity to contribute to resource sharing and collaboration within and among awarded ACCERT Centers;
• The effectiveness of collaborative relationships within and among awarded ACCERT Centers;
• A transdisciplinary research culture which incorporates the perspectives of multiple disciplines, community partners, and multiple levels of analysis; and
• The diversity in scientific, capacity building, and training resources that are offered, delivered, and their impact on new and junior investigators career and scientific growth.

Overall Structure of the ACCERT Consortium

The ACCERT Consortium will include awarded Coordination Center as well as the awarded ACCERT Centers (RFA-CA-23-026; U19) with scientific expertise that cuts across community engagement, social determinants of health, epidemiology, intervention/prevention research, and cancer control. Members of the ACCERT Consortium should identify shared resources that can support needs across the Consortium and optimize synergy and facilitate the collaborative nature and impact.

Upon successful funding, members of the Consortium will be required to participate in a virtual kick-off meeting which will take place within 30 days of the release of the Notice of Award (NOA). Members of the ACCERT Consortium will be required to attend a yearly face-to-face annual meeting and other topic-specific smaller meetings (as appropriate) for the exchange of scientific information across the Consortium. The Coordination Center, in conjunction with NCI staff and the Administrative Core of each ACCERT Center, will facilitate consortium collaborative activities among the ACCERT Centers and identified partners. The ACCERT Consortium will be governed by a Steering Committee comprised of representatives from the funded ACCERT Centers, the Coordination Center, and NCI Program Staff.

Governance

The Steering Committee will be comprised of the PI of each ACCERT Center, the PI of the Coordination Center, and NCI Program Staff. Though the Steering Committee will make recommendations, NCI Program Staff will have final authority to approve or reject any proposed recommendations. All consortium-related activities must comply with NIH, DHHS, and Federal Guidelines.

Additional details on the composition and functions of Steering Committee are provided in Section VI.2, Cooperative Agreement Terms, and Conditions of Award.

Non-Responsive Applications

The following types of activities remain outside the scope of this NOFO, and applications proposing them are non-responsive to this NOFO and will not be reviewed

• Applicants that do not include a comprehensive Resource Sharing Plan for disseminating consortium resources, products, and opportunities with the field at large.
• Applications that do not adhere to FAIR principles and the NIH Data Management and Sharing Policy.

NOTE: Applicants to this NOFO or the companion RFA-CA-23-026 are strongly encouraged to attend at least one of two planned pre-application webinars sponsored by the NCI and contact the designated NCI Program staff as soon as possible in the development of the application (preferably no later than 12 weeks prior to the application due date) to discuss the details of their proposed study so that NCI staff can help the applicant understand whether the study is within the goals and mission of the Institute and is appropriate for this NOFO.

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 Government

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

Other

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

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

This 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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:

Amanda M. Acevedo, PhD

National Cancer Institute (NCI)
Telephone: 240-276-5896
Email: [email protected]

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

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.

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

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

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

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

R&R Budget

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

Restricted Collaborative Fund for Consortium-wide activities: To facilitate synergy within the Consortium and to achieve unmet scientific priorities, awardees of the ACCERT Consortium must budget appropriate funds designated as "Collaborative Fund to facilitate Consortium-wide activities (see Section I. Collaboration Core and Section VI.2, Cooperative Agreement Terms and Conditions of Award). Specifically for the Coordination Center, $50,000 or 10% (whichever is greater) in direct costs per year must be allocated as Collaborative Fund (and should be presented in the Other Expenses category under the heading "Collaborative Fund"), between years 2-5. Collaborative Fund cannot be re-budgeted and unobligated funds, in any year, may be offset as per the recommendation from NCI Program Staff.

Travel Funds: The budget should include funds to support travel for Consortium-related activities, including but not limited to supporting the participation of PD(s)/PI(s) and other team members in annual meetings and/or ad hoc meetings related to the Consortium. Specifically, applicants will be required to budget for a key personnel and team members/ collaborators (in aggregate, up to three members, which may include one trainee and one community partner) to attend one annual face-to-face investigator meeting.

R&R Subaward Budget

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

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

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

Specific Aims. Present the overall vision of the Coordination Center to meet the needs of each ACCERT Center and to advance the goals and objectives of the ACCERT Consortium. Specific aims should address the required structure and main components as described in Section I.2.

Research Strategy: Applicants must organize the Research Strategy to include the following subsection elements. Applicants may include other sub-sections as needed but must include the information requested below.

Sub-section A: Background and Significance

The applicant should describe:

• Overview of how the proposed research coordination approach will advance the goals of the ACCERT Consortium;
• Without duplicating information in the biosketches:
  • Overview of leadership, cross-disciplinary team, and organizational structure to advance the goals of the ACCERT Consortium;
  • Prior experience in bringing together a diverse group of scientists and community partners;
  • Leadership in identifying synergy and collaborative opportunities within a Consortium or Research Network;
  • Experience working with community partners and underserved communities; and
  • Expertise in SDOH and prior work in cancer prevention and control.

Sub-section B: Innovation: Critical to the success of the ACCERT Consortium is optimizing synergy across members and to identify as well as evaluate consortium collaborative activities, including pilot/developmental project(s) and/or integration of common measures/targets, which could not be pursued by individual ACCERT Centers. Describe how the proposed application works to facilitate and optimize this opportunity.

Sub-section C: Approach: Provide a detailed overview for each component of the proposed Coordination Center. In this sub-section, inclusion of the applicant’s approach and capabilities for providing support to and coordinating the efforts of the ACCERT Consortium through each of the following components is recommended.

Administration: The applicant should describe, though not be limited to:

• Provide scientific and logistical support for all the activities of the Steering Committee and its subcommittees;
• Enable state-of-the-art cross-site communication and coordination of transdisciplinary research efforts for awarded ACCERT Centers;
• Capabilities to support the establishment and maintenance of an external Consortium website;
• Capability to promote, synergize and facilitate collaboration across multi-site studies within the Consortium and among investigators; and
• Organize annual/scientific meetings and regular conference calls for the Steering Committee and its subcommittees, Consortium-supported investigators and community partners, and the public/scientific community.

  Data Coordination : Importantly, the plan for coordinating data created by the ACCERT Centers (RFA-CA-23-026; U19) should be discussed in this section. Any data created by the Coordination Center should be described in the Data Management and Sharing Plan. In this subsection the applicant should describe, though not be limited to:

  • Capabilities to support proposed Consortium-wide projects and data sharing among the Consortium members, for example, through the establishment and maintenance of a secure internal Consortium web portal, access to existing data storage and management infrastructure, etc.;
  • Access to specialized expertise in biostatistics, bioinformatics and/or software development, as needed; and
  • Capabilities to facilitate the development of publication, biospecimen (as needed), and data use policies. Note that the data management functions of the Coordination Center may involve, if appropriate, a distributed model, e.g., without having to centralize all data to one repository site. However, the Coordination Center may also serve as a repository for data storage and management to the extent that common data elements will be collected across multiple research projects, and it is determined that centralization of such data would be beneficial to the Consortium by the Steering Committee.

  Integration and Dissemination: The applicant should describe, though not be limited to:

  • Capabilities to compile and disseminate training modules, capacity building tools and developed resources for investigators, community partners, and students to advance SDOH and community engaged research;
  • Capability to bring together expertise from across the Consortium to synergize scientific engagement and establish topical Work Groups (e.g., capacity building and training, social determinants of health measurement, engagement with community partners and others) relevant to the funded research and scientific needs across the initiative;
  • Proposed methods to facilitate communication between the Coordination Center and investigators/community partners in the overall Program as well as investigators involved in complementary research outside the Program;
  • Capability to identify, collect, facilitate assessment and measurement, share, and/or harmonize common measures/targets for usage by members of the Consortium;
  • Methods to facilitate, document, and promote standardization of research approaches and sharing of resources across the Consortium working on common issues;
  • Compile state-of-the-art methods for data collection, novel measures and methods, laboratory procedures and models in use across the Consortium, and leverage their use; and
  • Proposed activities and relevant methods to disseminate information about the ACCERT Consortium and its results to research partners and advocacy communities, including workshops, external seminar series, sessions at scientific meetings, etc.

  Collaboration: The applicant should describe, though not limited to:

  • Plans for coordinating and facilitating management of the Collaborative Funds , including soliciting common measures/targets or pilot project proposals and how potential Consortium-wide projects will be identified, selected, and managed;
  • Innovative value and potential of the proposed Coordination Center functioning for facilitating transdisciplinary research across social determinants of health, cancer prevention and control, intervention research, multi-sector research, engagement science;
  • Capability to promote, synergize and facilitate collaboration across multi-site studies within the Consortium and among investigators to identify common measures or constructs and standardize procedures for data collection and analysis;
  • Plans for coordination and collaboration on Consortium-wide capacity building activities, tools, and resources; and
  • Proposed approach to identify commonalities in research directions and specific questions being explored across ACCERT Centers.

  Evaluation: Data created by the Coordination Center to evaluate activities in the ACCERT Consortium should be discussed in the Data Management and Sharing Plan, as outlined by the NIH Data Management and Sharing Policy. For this sub-section, the applicant should describe:

  • Capability to design an internal evaluation framework for the Consortium, track relevant metrics, offer evaluation results on a yearly basis to the Consortium and Centers, and disseminate results;
  • Describe how yearly evaluation data will inform suggestions for improvement, in collaboration with Steering Committee, NCI Program staff, and community partners;
  • Methods for evaluating the overall performance and implementing corrective actions if required; and
  • Capability to assess the effectiveness of resource sharing, collaboration, as well as capacity building and training activities.

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.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing (DMS) Plan.
• The recipients will be expected to deposit data and data analyses into a publicly accessible repository, with community consent, and/or other public data portals as designated by NCI and as required by the NIH DMS Policy.
• Applicants must propose a DMS plan that addresses rapid data sharing with members and/or collaborators in the Consortium as well as the public and describes plans to adhere to the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable).
• The DMS Plan must be consistent with accomplishing the goal and objective of the initiative and optimizing access to data, resources, and products generated from Consortium-related activities.
• NCI Program Staff may negotiate modifications to the DMS plans prior to funding or post-award.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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.

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Center address the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

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?

Specific to this NOFO: How well do the proposed aims advance the operations of the Consortium to meet the goals and objectives of the Advancing Cancer Control Equity Research through Transformative Solutions program?

Investigator(s)

"Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing social determinant of health and health equity research? Do the investigators demonstrate significant experience with coordinating collaborative cancer prevention and control research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

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?

Specific to this NOFO: How qualified are the Coordination Center investigators and key personnel for participating and managing multi-site collaborations and facilitating interactions and communication among investigators and staff from multiple institutions to optimize synergy?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

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?

Specific to this NOFO: How innovative are the proposed approaches and scope of activities to optimize communication and synergy within the Consortium? What are the innovative aspects of the proposed approaches to facilitate Consortium-wide activities, including identifying common measures and resources between the diverse research projects or pilot projects, and advance the goals and objectives of the initiative?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

In addition, 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?

Specific to this NOFO:

• How well does the application describe the approaches and infrastructure that would streamline research processes, improve communication, encourage collaboration, and increase creativity and performance to meet the objectives of the ACCERT Consortium?
• How well does the proposed approach address critical challenges and proposed strategies to optimize synergy between a diverse group of researchers and community partners?
• How well described is the plan for the identification, collection, standardization, and harmonization of measures and/or endpoints?
• How well does the plan for resource sharing describe a Coordination Center that will efficiently support the sharing of information and resources across the Consortium?
• How appropriate are the proposed outreach and education activities (if applicable) to support the goals of the Consortium?
• How well does the proposed plan to synthesize and disseminate research results provide meaningful information to both researchers and community stakeholders?
• How well does the evaluation plan demonstrate a capacity for the Coordination Center to collaborate with and foster collaborations within the Consortium and NCI program staff on critical evaluation of the transdisciplinary nature of the program and dissemination of research findings?

Environment

Will the institutional environment in which the [Center] will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Authentication of Key Biological and/or Chemical Resources:

For [programs/projects/networks/consortia/resources] 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.

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 FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in 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.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this 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: Recipient 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).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, 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.html and https://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 200 and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the 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 Program (Coordination Center and individual research projects) will have primary responsibility for:

• Overseeing the budget and activities of the award, as detailed above;
• 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;
• Providing goals and estimated costs for procedures and protocols;
• Sharing data, 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 sub-committees as appropriate;
• Participating in the required 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 and materials to the NCI Program Staff, as requested, to facilitate the evaluation of progress and performance, including 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 PD/PI responsible for the Coordination Center will have the following additional responsibilities:

• Organizing the development of Steering Committee and other sub-committees as appropriate
• Organizing and providing logistical support for Steering Committee, Work Groups and other sub-committees.
• Budgeting for, organizing, and providing logistical support for the annual Scientific Meeting.
• Identifying, collecting and managing relevant protocols, data and other resources used by the Consortium members.
• Coordinating and managing an Collaborative Funds for Consortium-wide activities or pilot project program, with significant input from NCI Program Staff and the Steering Committee, to support new transdisciplinary research endeavors questions that emerge from the Consortium.
• Serving as the executive secretary for the Steering Committee, which at a minimum includes compiling monthly minutes and quarterly summaries of consortium-wide activities.
• Coordinating Consortium-wide training for ACCERT Center personnel as needed for standardization of collaborative protocols across sites, etc.
• Expanding and promoting the Consortium by actively synthesizing and disseminating relevant results.

The Consortium will be subject to periodic internal evaluation (coordinated by the Coordination Center and NCI Program staff). Recipients will be expected to participate in such evaluations.All Consortium recipient institutions/organizations will be expected to share with other recipients knowledge, data, research materials, and any other resources necessary and relevant to the Consortium. Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff 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. NIH 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, though not limited to, responsibilities to all Consortium 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 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 ACCERT Centers, 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 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 efforts 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 recipients as well as investigators from other NCI-related initiatives;
• Evaluate the adherence of recipients to any approved data management and sharing plans 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 NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to those recipients' 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 NIH 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 (e.g., community advisory committee), as necessary, to serve the Steering Committee and the 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 sub-committees, 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 funded Coordination Center, who will have one vote.
• A research investigator of each individual research projects (RFA-CA-23-026), who will have one vote. 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 lifecycle of the Award.
• Designated NCI Project scientist/collaborator(s) representing the NCI management group, who will have one collective vote..
• Other NCI Program Staff members as part of the NCI management group may participate in Steering Committee meetings as non-voting members.
• Approved 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 be 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. 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 Advisory Board, comprised of scientific experts from outside the ACCERT Program, to advise the Consortium.
• 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 Program, recipients are required to participate in Consortium-wide collaborative activities and identified pilot projects as recommended by the Steering Committee. Funding for the Consortium-wide collaborative activities will be supported in part by set-aside Collaborative Funds.

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 appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.Not Applicable

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.

4. Reporting

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

• 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

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]

Amanda M. Acevedo, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5896
Email: [email protected]

April Oh, PhD
National Cancer Institute (NCI)
Telephone: 240-753-3154
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.